Glossary

OVERVIEW

The following are terms commonly used in research. The terms and definitions are gathered from various resources.

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Numerical
14 Calendar days The IRBMED office should receive reports within 14 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)
21 CFR… Title 21 - Food and Drugs: Title 21 of the Code of Federal Regulations houses all the regulations related to the Food, Drug and Cosmetics Act can be found.  Some of the more popular are:
Part:                                  

 

11: Electronic Records; Electronic Signatures

50: Protection of Human Subjects

54: Financial Disclosure by Clinical Investigators

Part:                                  

 

56: Institutional Review Boards

312: Investigational New Drug Application

812: Investigational Device Exemptions

45 CFR 46 Title 45, Part 46 of the Code of Federal Regulations covers the Protection of Human Subjects. These regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject research today. 45 CFR 46 Subpart A is often called the Common Rule as nearly all divisions, centers or institutes within the DHHS has agreed to follow the regulations in the protection of human subjects.
510(K) Device A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."
7 Calendar days The IRBMED office should receive reports within 7 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)
A
Adverse Drug Reaction (ADR) All harmful and unintended responses to a research use of a medicinal product (drug) related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between the drug and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.
Adverse Event (AE) Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio. The FDA also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g., a bacteria is identified in a culture from the same batch of cells used to produce a vaccine which has been administered, even if no cases of infection have been reported). The event may or may not be caused by an intervention (e.g., headache following spinal tap, death from the underlying disease, car collision). Adverse Events also include psychological, social, emotional, and financial harms. See also Serious Adverse EventAdverse Drug Reaction, and abnormal preclinical finding.
Adverse Reaction An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). Onset may be sudden or develop over time. See Adverse EventSide Effects
Affiliated IRB membership status designating association with the University. A member (or alternate) is considered to be affiliated if he/she or a member of his/her immediate family is a current or past: employee (full or part-time); clinical, adjunct, or visiting faculty member or instructor; healthcare provider holding credentials to practice; volunteer working at the University (unrelated to IRB service); or University consultant or advisor (paid or unpaid). An emeritus faculty or retired staff member is also considered to be affiliated if he/she has been retired or involved in paid or unpaid University activities (including research or service). Current undergraduate, graduate, and postdoctoral students are also considered to be affiliated, as described by UM HRPP policy.
Alternate Member An individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named, who substitutes for the member at convened meetings when the member is not in attendance. IRB members and alternates have equal responsibilities in terms of required education, service, and participation.
Amendment (AME) A change in the terms and conditions of a grant or contract mutually agreed upon by the agency and the recipient organization; may also be referred to as a modification. Amendments are completed in eResearch in order to modify an already approved project. Some examples of changes include updates to the protocol or informed consent, or changes to the study team.
Anonymity Anonymity exists when there are no identifiers on project materials which could link the data with individual subjects. Even the research investigator cannot know the identity of participants.
Anonymous Anonymous means entirely without name or identifier, so the individual cannot be discerned in any way by anyone. No one can link an individual person to the responses of that person, including the investigator. For this reason, face-to-face interviews are never anonymous. If phone numbers are not stored, then telephone interviews could be considered anonymous. Questionnaires that are returned via US Mail are considered anonymous only if no tracking codes are used.
Appeal (Decision) Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, and noncompliance. An appeal is reviewed by the convened IRB responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal. PIs may submit a request for reconsideration if a decision is not positive.
Appointment / Visit Deviation A scheduling deviation is a reportable occurrence if and when a procedure or intervention did not take place in accordance with the time frame established in the protocol for safety and/or scientific purposes of testing and evaluation. Protocol descriptions of treatment(s) to be administered, dosing schedule(s), treatment period(s), and follow-up period(s) should reflect reasonable flexibility in accordance with sound experimental design. Deviations are reported in eResearch as an ORIO.
Approval Date The first date that research could be performed (following notification from the IRB).For research reviewed by the convened IRB, the approval date is the date that the research was approved at a convened meeting, or if modifications were required (to secure approval), the date that modifications were met by the investigator. For research reviewed using expedited procedures, the approval date is the date that the research was approved by expedited review, or if modifications were required, the date that modifications were met by the investigator. See also Approval Period.
Approved (Decision) An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and University policy.
Approved Drugs The FDA must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
Arms Any of the treatment groups in a research project. Many projects have two "arms," but some have three "arms," or even more.
Assent Agreement to participate in proposed research, given by an individual not competent to give legally valid informed consent (e.g., a child or mentally limited person). Mere failure to object may not be construed as assent.                                  

 

  • Assent means a child's affirmative agreement (verbal or written) to participate in a clinical investigation. Children age 10 and up are generally able to provide their assent.
  • Assent is an adult's affirmative agreement (verbal or written) to participate in a clinical investigation. Adults may be assented (instead of consent) if they have a cognitive disability rendering them unable to consent for themselves. Steps should be in place to assure that all participants are given the opportunity to consent or assent.
Association for the Accreditation of Human Research Protection Programs (AAHRPP) The AAHRPP promotes high quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs. An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence, through policies, procedures, and practices, of their commitment to scientifically and ethically sound research and to continuous improvement. 
Assurance A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and use of animals and stipulates the procedures through which compliance will be achieved.
Autonomy Personal capacity to consider alternatives makes choices, and act without undue influence or interference of others.
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B
Bank Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.
Baseline The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.
Behavioral Research The scope and diversity of research areas in the behavioral and social sciences is quite broad. Some research is readily applicable to human affairs; other studies may broaden understanding without any apparent or immediate application. Some research is designed to test hypotheses derived from theory; other research is primarily descriptive. Still other research may be directed at evaluating an intervention or social program. Behavioral research involving human subjects generates data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention.
Belmont Report A document that is part of the Federal Register that sets forth fundamental ethical principles that form the foundation for rules for all government funded research involving human subjects. There are three basic ethical principles that are particularly relevant to the protection of human participants.  They are: Respect for persons, Beneficence, and Distributive Justice. (hyperlink each term)
Beneficence An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (l) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Benefit A valued or desired outcome; an advantage.
Bequests A type of donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available.
Bias When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization. See Blind and Randomization
Biologic(s)
  • A biological product subject to licensure under the Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Examples include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology.
  • Any therapeutic serum, toxin, antitoxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.
Biological
  • Of or related to life or to living organisms
  • A drug derived from a biological source.
Biological product A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.  Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.
Biomedical Research Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Subjects of some biomedical studies engage in ordinary tasks while measurement of physiological and bodily functions are made. Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups.
Blind A randomized study is "Blind" if the participant is not told which arm of the study he is on. A clinical project is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. See Single Blind Study and Double Blind Study
Blinded Study Design A study in which one party, either the investigator or participant, is unaware of what medication or study arm the participant is assigned to (Single-Blind study). A clinical study design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy (Double-Blind study). Double-blind studies are thought to produce more objective results, since the impact of expectations of the doctor and the participant about the experimental drug are minimized. Also referred to as a "masked" study.
C
CareWeb A web-based clinical patient record that provides rapid access to patient data from a wide variety of clinical systems, including lab, radiology, medical records and others.  The CareWeb system was replaced by MiChart.
Case Report Form (CRF) A paper or electronic questionnaire specifically used in clinical trial research. The CRF is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
Case-control Study A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors. See also: Retrospective Studies
Cause An assessment made by the investigator and/or sponsor regarding the proper attribution of an adverse event. Examples: Study intervention (e.g., drug, device, or therapy); Concurrent non-research therapy; Disease progression; Other or unknown source.
Central Institutional Review Board (CIRB) The CIRB is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB's use of the CIRB facilitated review mechanism enables an investigator to enroll patients into studies significantly faster than when employing traditional method of IRB review.
Certificate of Confidentiality (CoC) Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Certificates of Confidentiality protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this.
Certified Translation A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes. Certified translators attest that the target-language text is an accurate and complete translation of the source-language text. Certified translation of consent documents ensures that the tone, meaning and content of the translated documents remain consistent with the IRB-approved English version.
Children Persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. In Michigan, the legal age is 18 years old with some exceptions.
Class I, II, III Devices Classification by the FDA of medical devices according to degree of potential risks or hazards.
Clinical and Translational Science Award (CTSA) Working together as a national consortium, at least 60 CTSA institutions have committed to improve human health by streamlining science, transforming training environments and improving the conduct, quality and dissemination of clinical and translational research. The CTSA program is part of the NIH.
Clinical Investigator A clinical investigator involved in a clinical research project is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The qualifications must be outlined in a current resume and readily available for auditors.
Clinical Research Calendar Review Analysis Office (CRAO) The mission of CRAO is to complete analysis for all human subject research that have billable items and services to assure consistency and to allow for the appropriate adjudication of charges. CRAO supports and collaborates with researchers and study teams to produce a uniform process for the Research Billing Calendar, Budget and Enrollment. CRAO ensures the Clinical Research Billing process is utilized throughout the research continuum and ensuring that UM is compliant.
Clinical Trial
  • A prospective study involving human subjects designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions; these may include drugs, treatments, surgical procedures, devices, behavioral or nutritional strategies. Clinical trials are typically conducted by investigators who have entered into an agreement with a sponsor to conduct the study. For clinical drug and device trials, investigators agree to conditions regarding the conduct of the study outlined by FDA.
  • A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (hyperlink each Phase)

Not all human subject research projects are ‘clinical trials’.

Clinical Trials Office (CTO) The Clinical Trials Office (CTO) serves as the centralized core facility of all clinical research trials conducted by investigators at the UM Comprehensive Cancer Center (UMCCC). This includes investigator-initiated, peer-reviewed clinical trials, NCI-CTEP approved protocols, pilot transitional institutional studies, cooperative group trials and industry sponsored trials. The CTO offers a broad range of expert services to investigators to help them facilitate the conduct of their studies according to federal regulations and GCPs.
Code of Federal Regulations (CFR) The CFR is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal Regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections -- the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations.
Coded Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s), but the original identifiers are retained in such a way that they can still be traced back to the source(s).
Coercion Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.
Cognitively Impaired A person having a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from post-traumatic or degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests. See the UM HRPP Operations Manual, Part 7 for details on UM policies regarding these subjects.
Cohort A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
Cohort Study A form of longitudinal study used in medicine and social science
Co-investigator (Co-I) Any individual member of the clinical trial team designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions. See also InvestigatorSub-Investigator.
Collaborating Entities Entities engaged in human subject research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money, drugs, or identifiable specimens, co-authorship, intellectual property, or credits).
Common Rule The ‘Common Rule’ is the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46 subpart A, and parallel regulations promulgated by agencies such as the FDA.
Common Terminology Criteria for Adverse Events (CTCAE) Is designed as an instrument to be used to document AEs identified through a combination of clinical and laboratory evaluation. CTCAE is NOT a tool to assist with data extraction from source documents without the direct participation and supervision of clinical investigators. AE grading and attribution require documentation by medical personnel who are directly involved in the clinical care of protocol subjects.  Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term.                                  

 

Grade is an essential element of the Guidelines and, in general, relates to severity for the purposes of regulatory reporting to NCI as follows: Grade Description: 0: No AE (or within normal limits). 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. 2: Moderate; minimal, local, or noninvasive intervention (e.g., packing, cautery) indicated; limiting age-appropriate instrumental activities of daily living. 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. 4: Life-threatening consequences; urgent intervention indicated. 5: Death related to AE.

A severe AE, as defined by the above grading scale, is NOT the same as serious AE which is defined in Section 2.1.22 (FDA, 21 CFR 312.32; ICH E2A and ICH E6).

Compassionate Use
  • A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.
  • Use of an investigational drug or biologic or unapproved medical device for a single subject (or small group of subjects) with a serious disease or condition, who does not meet the requirements for inclusion in a clinical investigation, and for whom no standard acceptable treatment is available. Prior FDA and IRB approval are required for compassionate use.

Note: The terms compassionate use and emergency use are not synonymous.

Compensation Payment, merchandise, class credit, or other gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation. Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.
Competence A legal term used to denote capacity to act on one’s own behalf. The ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health and other factors. Therefore, mental status should be reevaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person’s abilities are so diminished that his or her decisions or actions (e.g., writing a will) should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person’s ability to function in other situations.
Competing Proposals Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.
Compliance In relation to research: Adherence to all relevant trial-related requirements, good clinical practice (GCP) requirements, and the applicable institutional, state and federal regulatory requirements.
Concealment Withholding of full information of the study. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. The IRB recognizes that deception or concealment may be necessary for certain types of behavioral research. Because people act differently depending on circumstances, full knowledge by the subject might bias the results in some cases.
Concurrent Standard Therapy Treatment (e.g., surgery, drug) a subject is receiving while participating in a research study that is not the treatment under investigation; treatment the subject would be offered even if not enrolled in the research study. For example, in a comparison study of two anti-nausea drugs in cancer patients, the chemotherapy would be the "concurrent standard therapy" and the anti-nausea drugs would be the "investigational therapy."
Concurrent Reporting Reporting should occur in parallel or no later than 5 calendar days to all oversight bodies or agencies. Exceptions to this rule may be requested by submitting a study-specific reporting plan for IRB approval.
Confidential Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code. Although the identities may be recorded, data can be kept confidential if they are carefully coded, if face sheets and consent documents are separated from survey instruments, if computer sheets and other papers are properly disposed, if access to identifiable data is limited, if research staff are educated about the importance of protecting confidentiality, and if records are stored in secured locations. More elaborate procedures may be appropriate for research involving sensitive data that may involve a greater risk should confidentiality be breached, and investigators may want to seek Certificates of Confidentiality to protect such data from subpoena.                                  

 

Unless federal statutes mandate this confidentiality confidential surveys that are not anonymous are not eligible for exemption using these criteria. Confidential surveys may still be eligible for exemption if any disclosure of the human subjects' responses outside the research could not possibly place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.

Confidentiality
  • Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without written permission in ways that are inconsistent with the understanding of the original disclosure. (OHRP)
  • Right of privacy and of non-release of disclosed personal information. The investigator should protect subjects against invasion of privacy and loss of confidentiality. Lack of secure handling of completed personality tests, questionnaires, interview protocols or data and recorded materials augments risk and must be avoided.
Confidentiality Regarding Trial Participants Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.
Conflict of Interest (COI)
  • A COI occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another. A COI can only exist if a person or testimony is entrusted with some impartiality; a modicum of trust is necessary to create it. The presence of a COI is independent from the execution of impropriety. Therefore, a COI can be discovered and voluntarily defused before any corruption occurs. A conflict could be financial and it includes both actual and perceived conflicts.
  • A conflict of interest is a situation in which an employee has the opportunity to influence a University decision that could lead to financial or other personal advantage, or that involves other conflicting official obligations. A COI can also occur when the conduct of research or other sponsored activities is or has the potential to be influenced by the outside financial interests of an investigator.
  • A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual's professional judgment in exercising any University duty or responsibility, including the review of research.

For IRBMED members, financial and non-financial interests/opportunities are evaluated.

Consent See: Informed Consent.
Consortium Agreement Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.
Consultant Individuals hired to give professional advice or services for a fee as long as they are not an employee of the University. Consultants do not perform a portion of the programmatic work.
Continuation Project (Non-Competing) Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects do not compete with new project proposals and are not subjected to peer-review beyond the initial project approval.
Continuing Non-Compliance Non-compliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing non-compliance may include but are not limited to: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.
Continuing Review (CR) DHHS Regulations, 45 CFR 46, require at Section 46.109(e) that "an IRB shall conduct continuing review …at intervals appropriate to the degree of risk, but not less than once per year…" Continuing review must be substantive and meaningful. Review by the convened IRB, with recorded vote, is required unless the research is otherwise appropriate for expedited review under Section 46.110. Also known as a Scheduled Continuing Review (SCR).
Contraindicated Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).
Contraindication A contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment. Some contraindications are absolute, meaning that there are no reasonable circumstances for undertaking a course of action. For example, children and teenagers with viral infections should not be given aspirin because of the risk of Reye's syndrome; and a person with an anaphylactic food allergy should never eat the food to which they are allergic. Other contraindications are relative, meaning that the patient is at higher risk of complications, but that these risks may be outweighed by other considerations or mitigated by other measures. For example, a pregnant woman should normally avoid getting X-rays, but the risk may be outweighed by the benefit of diagnosing (and then treating) a serious condition such as tuberculosis.
Control In Science: Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, and then allow one group to try the drug. Another example might be testing plant fertilizer by giving it to only half the plants in a garden (the plants that receive no fertilizer are the control group, because they are kept normal).                                  

 

In Research: Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.

Control Group The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. See Placebo and Standard Treatment
Controlled Trials Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.
Convened IRB Review Review of proposed human subject research by an IRB that meets the membership requirements specified in federal regulations regarding the number, qualifications, diversity, and affiliation of its members, at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas.
Cooperative Agreement An award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.
Cooperative Protocol Research Program (CPRP) Programs involving multi-protocol, multi-site research, in which data from standardized protocols are pooled across institutions. These protocols, conducted or sponsored by DHHS, are approved and monitored by DHHS Protocol Review Committees that are recognized by OHRP as satisfactorily addressing the quality of human subject protections.
Cooperative Research Projects Research projects covered by 45 CFR 46 that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with federal policy [45 CFR 46.114].
Cross-Over Design A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
Custom Device A device that necessarily deviates from devices generally available or from an applicable performance standard or pre-market approval requirement to comply with the order of an individual physician or dentist and that is:          

 

  • Not generally available or generally used by other physicians or dentists;
  • Not generally available in finished form for purchase or for dispensing upon prescription;
  • Not offered for commercial distribution through labeling or advertising; and
  • Intended for use by an individual patient named in the order of a physician or dentist and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
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D
Data When data is anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to connect the information to the individual from whom it came. Anonymous data does NOT have direct identifiers like names, addresses, clinic or hospital number, Social Security Number, or insurance agency numbers. Data that is linked to subjects via a CODE are NOT anonymous. When data is confidential, there is a link between data and the individuals who provide it, but the link is obscured by coding or other procedures so that even someone who has access to the raw data cannot identify a subject without also having access to the link between the subject code and the subject's identity.
Data and Safety Monitor An individual assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. The individual should have expertise in the relevant medical, ethical, safety and scientific issues.
Data and Safety Monitoring Board (DSMB) An appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design. Also known as a Data and Safety Monitoring Committee (DSMC).
Data and Safety Monitoring Plan (DSMP) A defined process to protect the safety of human subjects and maintain the scientific integrity of human subject research and the validity of the data. A DSMP may be a stand-alone document or the section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research). It includes procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g., study team, FDA, IRB, or DSMB). It describes the frequency with which each oversight group reviews the collected information. A study does not need to have a DSMB to have a DSMP.  The purpose of a DSMP is to minimize risks for subjects to the extent possible by explicating procedures for monitoring their safety. A DSMP would formalize action items such as:                                 

 

  • methodology for notifying an attending physician of emergent events
  • obtaining psychiatric consults for findings of likely suicide
  • procedures and education for staff regarding protection of private information
  • procedures to follow when subjects experience significant social or emotional upset in response to the research interaction (e.g., a panic attack after an interview and questionnaire)

Note that data collected for safety monitoring (or for research purposes) does not necessarily have to be submitted to IRB as an adverse event report.

Data Points Any text or numbers generated during a study.
Data Use Certification (DUC) A DUC is the application a user submits for consideration for authorized use of controlled dbGaP data. The DUC should include a list of the controlled data set(s) required by the user and a brief description of the proposed research use of the requested data. The user must also offer the following assurances in the DUC that:          

 

  • the data will only be used for approved research;
  • data confidentiality will be protected;
  • all applicable laws, local institutional policies, and terms and procedures specific to the study's data access policy for handling dbGaP data will be followed;
  • no attempts will be made to identify individual study participants from whom data were obtained;
  • controlled-access data from dbGaP will not be sold or shared with third parties;
  • the contributing investigator(s) who conducted the original study and the funding organizations involved in supporting the original study will be acknowledged in publications resulting from the analysis of those data;
  • all NIH supported genotype/phenotype data and conclusions derived directly from them will remain in the public domain, without licensing requirements;
  • an annual research progress report will be submitted.

The completed DUC must be co-signed by a designated official representing the institution for which the applicant works.

Database of Genotypes and Phenotypes (dbGaP) dbGaP was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Such studies include genome-wide association studies, medical sequencing, molecular diagnostic assays, as well as association between genotype and non-clinical traits. The advent of high-throughput, cost-effective methods for genotyping and sequencing has provided powerful tools that allow for the generation of the massive amount of genotypic data required to make these analyses possible.
Dead Fetus An expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Generally, some organs, tissues, and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead.
Death Reports generally refer to the death of a research subject but also death of another (a person not enrolled in the study) that is definitely, probably, or possibly related to the study must be reported (e.g., in a study of anti-psychotic medications, the study drug is found to increase irritability and the research subject commits murder).
Debriefing (in Research) Giving subjects previously undisclosed information about the research project following completion of their participation in research.
Deception The intentional misleading of a subject about the nature of the study. Deception increases ethical concerns and should be used with discretion, because it interferes with the ability of the subject to give informed consent. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. The IRB recognizes that deception or concealment may be necessary for certain types of behavioral research. Because people act differently depending on circumstances, full knowledge by the subject might bias the results in some cases.
Declaration of Helsinki A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries.  The fundamental principle is respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient or volunteer, and while there is always a need for research, the subject's welfare must always take precedence over the interests of science and society, and ethical considerations must always take precedence over laws and regulations. The recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, in which case their assent should still be obtained if at all possible.
Deferred An IRB action that specifies conditions under which research can be reconsidered for approval, pending substantive clarifications or modifications to the protocol and/or informed consent process/document, without which the IRB could not fully evaluate the research under review.
Definitely related adverse event An adverse event that         
  • is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure
  • ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting)
  • includes data that was only collected for the study
  • included disturbing or upsetting questions that the subject was asked for the purpose of the research
De-identified All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). For purposes of the HRPP policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule).
Deviation An incident involving noncompliance with the protocol, but one that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the participant, researcher, or staff.
Diminished Decision-Making Capacity In informed consent: lacking the ability to provide valid informed consent to participate in research, e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia. Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.
Disapproved (Decision) An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document.
Dose Limiting Toxicity (DLT) Size-effects severe enough to prevent giving more of the treatment.
Dose-Ranging Study A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.
Double-Blind Study A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.
Double-Masked Design A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as "double-blind."
Drug-Drug Interaction A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.
E
Effective Dose A measure used to estimate the risk resulting from an exposure of ionizing radiation, calculated as a weighted average of exposure to different body tissues. The effective dose is measured in rems or sieverts.
Efficacy Of a drug or treatment: The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy and Phase III trials confirms it. See Phase II and III Trials                                  

 

In medicine:  Is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.

Eligibility Criteria Summary criteria for participant selection. See Inclusion/Exclusion Criteria
Emergency and/or Urgent Treatment For purposes of Adverse Event reporting: An event that was not life-threatening but still warranted urgent professional treatment for physical or psychological trauma or injury such as treatment in an emergency room, urgent care center, psychiatrist's office, psychologist office, or other facility providing immediate care (e.g., battered women's shelter).
Emergency Use Use of an investigational drug or biologic or unapproved medical device for a human subject in a life-threatening situation for which no standard acceptable treatment is available and when there is not sufficient time to obtain full IRB approval. An urgent page to the IRB Chair on Call can replace the IRB approval prior to use.  Please note: After the Emergency Use is accomplished; an eResearch application still needs to be completed to notify the IRB of the use.
Empirical Denotes information acquired by means of observation or experimentation. Empirical data are data produced by an observation or experiment.  A central concept in modern science and the scientific method is that all evidence must be empirical, or empirically based, that is, dependent on evidence or consequences that are observable by the senses. It is usually differentiated from the philosophic usage of empiricism by the use of the adjective empirical or the adverb empirically. The term refers to the use of working hypotheses that are testable using observation or experiment. In this sense of the word, scientific statements are subject to, and derived from, our experiences or observations.
Encryption The process of encoding a message so that it can be read only by the sender and the intended recipient.
Encryption software Software whose main task is encryption and decryption of data, usually in the form of files on hard drives and removable media, or email messages sent over computer networks or the Internet.
Endpoint In clinical research: Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. In a clinical research project, an endpoint generally refers to occurrence of a disease, symptom, sign or laboratory abnormality that constitutes one of the target outcomes of the trial, but may also refer to any such disease or sign that strongly motivates the withdrawal of that individual or entity from the trial, and then often termed humane (clinical) endpoint.
Engaged Involved in human subject research in such a way (or to the extent) that the ethical and regulatory requirements for human subject protection are applicable. An individual (or organization) becomes engaged in human subject research when for the purposes of non-exempt research the individual (or organization’s employee or agent) obtains any of the following:                                  

 

  • Data about research participants through intervention or interaction
  • Identifiable private information about research participants
  • Informed consent of research participants.

Note: An organization is also engaged in human subject research whenever it receives a direct federal award to support the research.

Enrolling The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.
Entity For conflict of interest matters, this term refers to the company or organization in which an investigator is disclosing their financial interests. An "entity" may be, but is not necessarily, a "sponsor" of a project.
Equitable Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
eResearch Proposal Management (eRPM) eRPM is used to accommodate the electronic routing, approval, and submission of funding proposals to external sponsors, including Grants.gov.
eResearch Regulatory Management (eRRM) eRRM is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
Exception from Informed Consent (EFIC) FDA regulation 21 CFR 50.24 provides a narrow exception to the requirement for informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. The intent of the new regulation is to allow research on life-threatening conditions for which available treatments are unproven or unsatisfactory and where it is not possible to obtain informed consent, while establishing additional protections to provide for safe and ethical studies.
Exempt Review The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. UM is authorized by the federal government to determine whether studies thought by the PI to be exempt from federal regulations -- actually qualify for exemption. Only the IRB has authority to make a determination that a study is exempt from federal regulations and from IRB review and approval. When the IRB notifies a PI that a research project is EXEMPT, it also notifies the PI that the research is approved for initiation or continuation. In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption and it cannot place subjects at greater than minimal risk. If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.                                  

 

What Exemption Means: "Exemption" as used in this document means exemption from the requirements set forth in Regulations for the Protection of Human Subjects (45 CFR 46), such as the requirement for a written informed consent document.

What Exemption Does Not Mean: "Exemption" does not mean that the research activity is exempt from the law, and it does not mean that the research need not conform to the canons of sound research ethics.

For additional information regarding Exempt Review categories, see OHRP Decision Charts #2-7for Exempt Categories.

Existing Available data (or specimens) at the time the research is submitted for a determination of exempt.
Expanded Access Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
Expanded Availability Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.
Expected Event An event that is expected in that it has been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB Reports, published literature, other documentation, or characteristics of the study population. If an 'expected' event is of unexpected duration, magnitude, or frequency then the occurrence(s) should be reported within the timeframe of an unexpected Adverse Event.
Expedited IRB Reviewer The IRB Chair and those experienced IRB members designated by the Chair who may perform some or all types of expedited reviews.
Expedited Review A procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. An IRB may use the expedited review procedure to review either or both of the following:                                  

 

  • Some or all of the research appearing on the list of categories of research and found by the reviewer(s) to involve no more than minimal risk,
  • Minor changes in previously-approved research during the period for which approval is authorized.

The following criteria must be met in order for research to be considered for expedited review:

  • The research activities must present no more than minimal risk to human subjects. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
  • All of the research activities involve only procedures listed in one or more of the research categories established in the Federal Register. The categories in this list apply regardless of the age of subjects, except as noted. Categories one (1) through (7) pertain to both initial and continuing IRB review.

For additional information regarding expedited review categories, see OHRP Guidanceand OHRP Decision Chart #8.

Experienced IRB Member An IRB member determined by the IRB Chair to be qualified to perform reviews using expedited procedures. The following criteria are considered when determining whether an IRB member is experienced: length of IRB service, training regarding expedited review procedures, research experience/expertise, and/or work with the research participants being studied.
Experiment Any use of a drug except for the use of a marketed drug in the course of medical practice or any evaluation of the safety and efficacy of a medical device.
Experimental A term often used to denote a therapy (drug, device or procedure) that is unproven or scientifically un-validated with respect to safety and efficacy. A procedure may be considered “experimental” without necessarily being part of a formal study to evaluate its usefulness. Synonymous with Research.
Experimental Study An experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. See also: Quasi-Experimental Study
Expiration Date The date that the IRB’s approval of research has lapsed and research can no longer be performed; an expiration date may not be longer than one year from the date the approval period begins.
External Adverse Event From the perspective of an Investigator engaged in a multicenter clinical trial, external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial (not under IRBMED authority).
External event An event occurring in research at a site(s) other than UM, over which another IRB has jurisdiction.
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F
FDA Oversight The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices and biologics. Contact the IRBMED Office if there is any question regarding whether FDA oversight of a clinical trial is required.
Federal Demonstration Partnership(FDP) The FDP is a cooperative initiative among federal agencies and institutional recipients of federal funds. It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.
Federal Policy The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Sixteen federal agencies have adopted the Policy known as the "Common Rule."
Federal Wide Assurance The Policy for the Protection of Human Subjects requires that each institution "engaged" in Federally-supported human subject research file in "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. The UM's FWA number is 00004969. The expiration date changes regularly as IRBs update their Rosters.
Fetal Material The placenta, amniotic fluid, fetal membranes, and umbilical cord.
Fetus The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See also: embryo.
Financial Conflict of Interest An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Financial interests include, but are not limited to: salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Financial Disclosure Written declaration of external, financial interests of an individual that are related or potentially related to research or other sponsored activities taking place within the university. Disclosures are required under requirements promulgated by federal and state agencies and the IRB.
Finding of Non-Compliance An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).
Follow up report A supplemental report from a sponsor or investigator providing additional information, clarification, or corrections to a previously reported (to IRBMED) Adverse Event.
Food and Drug Administration (FDA) The FDA oversees safety of foods, drugs, devices, biologics and cosmetics for human use. The FDA also works with the blood banking industry to safeguard the nation's blood supply.
For-Cause Audit/Review An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subject research and/or human subject protection.
Form 483 The FDA-483 is the written notice of objectionable practices or deviations from the regulations that is prepared by the FDA investigator at the end of an inspection. The items listed on the form serve as the basis for the exit discussion with the researcher at which time the PI can either agree or disagree with the items and can offer possible corrective actions to be taken. The PI may also respond to the district office in writing after it has had sufficient time to properly study the FDA-483 (hyperlink). The receipt of and a PI’s response to the Form 483 is submitted to IRB as an ORIO (hyperlink).
Freedom of Information Act (FOIA) The FOIA is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the US government. The Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute.
Full Board / Committee Review Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
Full Review If the study does not meet the criteria for exempt or expedited review, then it must be submitted for full review.
G
Generalizable Knowledge Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.
Genetic Information Nondiscrimination Act (GINA) GINA is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health. The new law prevents discrimination from health insurers and employers.
Genetic Screening Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.
Genome All the genetic material in the chromosomes of a particular organism; its size is generally given as its total number of base pairs.
Genome-Wide Association Studies (GWAS) A GWAS is an approach that involves rapidly scanning markers across the complete sets of DNA, or genomes, of many people to find genetic variations associated with a particular disease. Once new genetic associations are identified, researchers can use the information to develop better strategies to detect, treat and prevent the disease. Such studies are particularly useful in finding genetic variations that contribute to common, complex diseases, such as asthma, cancer, diabetes, heart disease and mental illnesses.
Genotype The genetic constitution of an individual.
Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Good Laboratory Practice (GLP) GLP Standard compliance monitoring program ensures the quality and integrity of test data submitted in support of product registration.
Group C Treatment IND "Group C" Treatment IND was established by agreement between the FDA and the National Cancer Institute (NCI). The Group C program is a means by which oncologists can use investigational drugs for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are generally Phase III study drugs that have shown evidence of relative and reproducible efficacy in a specific tumor type. They can generally be administered by properly trained physicians without the need for specialized supportive care facilities. Group C drugs are distributed only by the NIH under NCI protocols. Although treatment is the primary objective and patients treated under Group C guidelines are not part of a clinical trial, safety and effectiveness data are collected.
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H
Health Information Technology for Economic & Clinical Health (HITECH) The HITECH Act was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. Subtitle D of the HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules.
Health Insurance Portability and Accountability Act of 1996 (HIPAA) The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by "covered entities" (generally, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions). By regulation, the DHHS extended the HIPAA privacy rule to independent contractors of covered entities who fit within the definition of "business associates". PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.
HUM Number The number assigned to project applications through eResearch.  Through the life of a study, each project will only ever have one HUM Number, though for Amendments and AE/ORIO submissions will be given a second identifying number. For example: HUM0001234, ADV0004567.
Human Pluripotent Stem Cell Research Oversight Committee (hPSCRO) The hPSCRO provides local oversight of ethical issues related to derivation and research use of human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. The HPSCRO also provides local oversight of research with human pluripotent stem cells in experiments designed or expected to yield gametes (oocytes or sperm) or with the intent or potential to integrate these cells into the central nervous system of animals.
Human Research Protection Program (HRPP) The HRPP is an integrated institution-wide program coordinated by the Office for the Vice President for Research in concert with the Executive Vice President for Medical Affairs, Chief Financial Officer, Provost, and consultation with the Office of the General Council. Major components of the HRPP include the nine Institutional Review Boards for human subjects research and several additional committees that provide research review, such as the Institutional Biosafety Committee, the Conflict of Interest Review Committees, the Radiation Policy Committee, the Investigational Drug Service, the Comprehensive Cancer Center, the Michigan Clinical Research Unit, the Biomedical Engineering Unit, and the Tissue Procurement Service.
Human Subject OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)                                  

 

FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” 21 CFR 50.3 (g), 21 CFR 56.102 (e)

Humanitarian Device Exemption (HDE) An application that permits the marketing of a humanitarian use device.
Humanitarian Use Device An FDA regulated medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affect fewer than 4000 individuals in the US per year, but not yet approved for unrestricted use. The use of a HUD is subject to IRB oversight. Contact IRMBED Office for guidance.
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I
Inclusion / Exclusion Criteria The medical or other standards determining whether a person may or may not be allowed to enter a research study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
Individual Investigator Agreement (IIA) This agreement is used when a collaborating investigator engages in research with a collaborating investigator who is not affiliated with the covered entity; a collaborating investigator who is affiliated with an institution/hospital/clinic that may not have its own IRB to review the study; a collaborating investigator who is not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the institution.
Individually Identifiable Health Information The term 'individually identifiable health information' means any information, including demographic information collected from an individual, that--                                  

 

  • is created or received by a health care provider, health plan, employer, or health care clearinghouse; and
  • relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and--
    • identifies the individual; or
    • with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.
Informed Consent Informed consent is the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required.                                  

 

  • Use of a written consent form that includes all of the basic elements.
  • The process of learning the key facts about a research study.
  • A process by which a subject voluntarily confirms his or her willingness to participate in a particular research project.
  • Informed consent is documented by means of a written, signed, and dated informed consent form unless such documentation is waived by the IRB. (45 CFR 46.116)
  • In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence (21 CFR 50.20 and 50.25).
  • It is a continuing process throughout the study to provide information for participants.
Informed Consent Document (ICD) or Informed Consent Form (ICF) A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Institutional Conflict of Interest (iCOI) A common understanding is that an institutional conflict of interest (iCOI) occurs when the university, members of senior administration (chairs, deans, vice chancellors, directors), or affiliated organizations have a financial interest in a company that is associated with university research that may financially benefit the institution. Examples include, but are not limited to, grant and contract dollars, license fees and royalty payments, gifts to the institution, investments in start-up companies associated with faculty inventions, research relationships with companies that make significant contributions for facilities or endowed chairs, or stock ownership in companies that conduct research at the university.
Institutional Review Board (IRB)
  • Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520 (g) of the act. (FDA)
  • A specially constituted review body established or designated by an institution to protect the welfare of human subjects recruited to participate in biomedical or behavioral research (OHRP)
Institutional Review Board (IRB) Approval The determination of the IRB that the proposed clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. On IRBMED studies, approval is communicated to the investigator by a document called a "Notice of Outcome" which is faxed to an investigator.
Institutional Review Board of the Medical School (IRBMED) IRBMED has 5 individual review Boards.  They are designated as A1, A2, B1, B2 and C1.  Boards A and B meet on alternate Thursdays and C1 meets on Friday.
Intent to Treat Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized even if they never received the treatment. See Randomization.
Interaction A research related communication or interface between an investigator and a research subject other than those that involve an investigational agent or procedure as it relates to a disease or disorder (an intervention). Interactions may occur in person, by phone, computer, fax, or mail. Examples include surveys, focus groups, fMRI, and tests on healthy normal subjects.
Internal Adverse Event From the perspective of an Investigator engaged in a multi-center clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the Investigator(s) or at their site. In the context of a single-site study, all adverse events would be considered internal adverse events.
Interpreter A qualified interpreter is an individual who is fluent (can speak, read and write) in English and the language of the subject, and (preferably) understands human research informed consent requirements. The interpreter should not be a member of the potential subject's family. Family members may have their own biases regarding research participation.
Intervention Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interventions may occur in person, by phone, computer, fax, or mail. Examples include clinical trials, behavioral or nutritional counseling, and surgeries.
Investigational Clinical investigation means any experiment in which a test article, even an approved drug, is administered or dispensed to, or used involving, one or more human subjects. (FDA) The use of a marketed drug in the course of medical practice that is outside the label indications ("off-label" use or innovative care) does not in and of itself constitute investigational use of a drug, unless that use is part of an experiment or systematic investigation meeting the criteria for human subject research.
Investigational Device A device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Devices are classified as significant and non-significant risk. A significant risk device means an investigational device thatpresents a potential for serious risk to the health, safety, or welfare of a subject. (FDA)
Investigational Device Exemption (IDE) Approval by FDA for investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully across state and international boundaries for the purpose of conducting investigations of that device. (FDA) Most devices under investigation should have an IDE.
Investigational Drug A new drug or biologic (i.e., not approved for marketing by FDA) used in a clinical investigation, including a biological product used in vitro for diagnostic purposes.
Investigational Drug Service (IDS) The IDS at UMHS ensures that investigational drug studies and other drug related research at the Hospitals and Clinics are conducted in a safe and efficient manner. In doing so, the IDS assists investigators in complying with the requirements of the FDA, study sponsors, Michigan State Board of Pharmacy Regulations, JCAHO and hospital and pharmacy policies. The IDS will only handle protocols that have approval of IRBMED.
Investigational New Drug (IND) A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Use of investigational drugs requires application to the FDA and is usually limited to subjects enrolled in clinical studies covered by an Investigational New Drug agreement with the FDA.
Investigational New Drug Application (IND) An application that permits an investigational drug that would otherwise be required to have pre-market approval by FDA to be legally shipped for a clinical investigation.
Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Investigator
  • A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH Guidelines)
  • An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader. (FDA)

See also Co-Investigator and/or Sub-Investigator.

Investigator Response An assessment made by the investigator and/or sponsor regarding whether or not an adverse event, or DSMB or other Report, necessitates a change to the study protocol, informed consent document or process, or investigator's brochure in order to promote subject safety and/or autonomy.
Investigator’s Brochure (IB) The IB is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is critically important throughout the drug development process and is updated with new information as it becomes available.                                  

 

  • The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other trials.
  • An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.
  • An IB may introduce key aspects and safety measures of a protocol, such as:
    • Dose (of the study drug),
    • Frequency of dosing interval,
    • Methods of administration, and
    • Safety monitoring procedures.
  • The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.
Investigator-Initiated Proposal A proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.
Ionizing Radiation Any radiation capable of displacing electrons from atoms or molecules, thereby producing ions. Examples include alpha, beta, gamma, and X-rays. High doses of ionizing radiation may produce severe skin or tissue damage.
IRB (Institutional) Authorization Agreement (IAA) This agreement is used when one institution engages in research with: A performance site with whom institution ‘a’ currently does not have a Cooperative Review Agreement and Only one institution's IRB will review the study to avoid the need for dual review - Either institution ‘a’ or the performance site.
J
Justice An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
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Legally Authorized Representative (LAR)
  1. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (FDA)
  2. A person authorized either by statute or by court appointment to make legal decisions on behalf of another person. In human subject research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Limited Data Set Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual's relatives, employers, or household members. Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR 164. For more information, including the list of identifiers that must be removed from health information in a limited data set, see HIPAA and Human Subjects Research.
Local Event / UM Event An event which occurs in a study under the supervision of the UM IRBMED and whose principal investigator is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UMHHC, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the adverse event. If interventions take place at several different UM locations, please specify at which location the event occurred.
M
Masked The knowledge of intervention assignment. See Blind.
Masked Study Designs Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs. See also: Double-Masked Design and Single-Masked Design
Material Transfer Agreement (MTA) A MTA is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagentscell linesplasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. Each call for different terms and conditions.
Maximally Tolerated Dose The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity.
Medical Device
  • A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (that is, not a drug or biologic). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment. (OHRP)
  • A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals… The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the information sheets entitled "Medical Devices," "FAQ about IRB Review of Medical Devices" and "Significant Risk and Non-significant Risk Medical Device Studies." (FDA)
Michigan Billing Enrollment Calendar Tool (MBECT) A tool to assist researchers with one point of data entry for building a clinical research budget and billing calendar and tracking your subject enrollment.
Michigan Clinical Research Unit (MCRU) MCRU provides the clinical staff, resources, and infrastructure necessary to conduct human clinical research protocols at the UM. MCRU hosts investigators funded by federal, state, and local agencies as well as those funded by the private sector. MCRU also serves as an institutional resource for investigators to perform pilot studies that may result in further agency funding. Investigators whose research protocol is federally, departmentally, or philanthropically funded currently can access resources and services without fee. Industry-sponsored studies are billed differently but all research discounts apply.
Michigan Institute for Clinical and Health Research (MICHR) MICHR’s mission is to enable & enhance clinical & translational research. Their aim is to make UM a world leader in translating scientific discoveries into real health gains. MICHR educates funds, connects, & supports research teams across U-M and the communities we serve. MICHR is proud to be a part of a national consortium of 60 medical research institutions working together with a common vision, funded through Clinical & Translational Science Awards (CTSA).
MICHR IND/IDE Investigator Assistance Program (MIAP) MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA. The MIAP program offers regulatory assistance to Investigators planning to utilize either a drug or biological product classified by the FDA as an IND per 21 CFR 312, or an investigational medical device subject to IDE regulations, per 21 CFR 812.
Mild Adverse Event An event which does not pose any significant or permanent risk of harm to the subject. A mild adverse event is considered Grade Iusing CTC Common Toxicity Criteria. See also Severity.
Minimal Risk Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests. 45 CFR 46.102(i)                                  

 

Prisoners: Research projects with Prisoners automatically incur a higher risk level than those of non-Prisoners.

Minor Changes Changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research. A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.
Moderate Adverse Event An event which causes discomfort and perhaps requires treatment, but does not pose any significant or permanent risk or harm to the subject or require in-patient hospitalization. An event that is Grade II by CTC Common Toxicity Criteria.
Modifications Required An IRB action that specifies conditions under which research can be approved, pending the completion of minor, non-substantive (i.e., not directly relevant to the determinations required for approval by the IRB) clarifications or modifications to the protocol and/or informed consent process/document. Review of the investigator’s response(s) may be performed by expedited review.
Multicenter Research Project A research project conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one set of investigators.
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Neonate A newborn up to four weeks old.
Non-Affiliated Member To be eligible for participation on IRBMED as a community representative/non-affiliated member, neither the member nor any member of his/her immediate family may otherwise have a direct affiliation (i.e., as an employee, contractor, student in a degree program, or active emeritus faculty member) with the University. Immediate family includes spouse, parents, grandparents, children and grandchildren, brothers, sisters, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, sons-in-law, adopted, half, and step members.
Non-Compliance Failure (intentional or unintentional) to comply with applicable federal regulations, state or local law, the requirements or determinations of the IRB, or University policy regarding research involving human subjects. Non-compliance can result from action or omission. Non-compliance may be non-serious (minor) or serious, and may also be continuing.
Non-Financial Conflict of Interest An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultant’s) obligation to protect research participants and potentially compromises the objectivity and credibility of the research review process.
Non-physiological Adverse Event An Adverse Event involving social or psychological trauma, insult or injury rather than physiological or biomedical harm.
Non-Scientist An individual appointed to the IRB who (due to training, background, and/or occupation) is inclined to view research activities from the standpoint of someone outside the scientific or scholarly discipline of the IRB on which he/she serves.
Non-Serious or Minor Non-Compliance Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subject protection program. Examples of minor noncompliance may include, but are not limited to: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.
Non-Significant Risk Device (NSR) An investigational medical device that does not present significant risk. The determination that a device presents a non-significant risk is first made by the sponsor. If the IRB agrees with the sponsor’s finding that a device presents non-significant risk, the device is considered a non-significant risk device.
Non-Therapeutic Research Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
Non-Viable Fetus An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. See also: Viable Infant.
Normal Subject Subjects used in study of normal physiology and behavior, or subjects who do not have the condition under study in a particular protocol used as comparisons with subjects who do have the condition. “Normal” does not necessarily connote normal in all respects. For example, patients with broken legs may serve as normal volunteers in studies of metabolism, cognitive development and the like. Similarly, patients with heart disease but without diabetes may be “normal” in a study of diabetes complicated by heart disease.
Notice of Outcome Written acknowledgement from the IRBMED, faxed to the study coordinator and/or investigator at the fax number provided in the submission application, regarding the outcome of the review of that application. Outcomes may be "approved", "acknowledged", or "disapproved". Adverse Event and ORIO reports are generally acknowledged, but if accompanying changes to the protocol or consent form are requested these require approval in order to take effect.
Null Hypothesis The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.
Nuremberg Code A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
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Office for Civil Rights (OCR) Federal civil rights laws and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, together protect your fundamental rights of nondiscrimination and privacy. Civil Rights help to protect you from unfair treatment or discrimination, because of your race, color, national origin, disability, age, gender, or religion. Federal laws also provide conscience protections for health care providers. The Privacy Rule protects the privacy of your health information; it says who can look at and/or receive your health information, and also gives you specific rights over that information.
Office for Human Research Protection      (OHRP) An office within the DHHS responsible for implementing DHHS regulations (45 CFR 46) governing research involving human subjects. The office within the NIH, an agency of the Public Health Service, DHHS, responsible for implementing DHHS regulations governing research involving human subjects.
Office of Human Research Compliance Review (OHRCR) The mission of the OHRCR at UM is to facilitate safe, ethical, efficient and high quality human subject research. They accomplish this mission through: Compliance Reviews of research studies and components of the UM HRPP; Education of individuals and groups engaged in the research enterprise; Outreach to the University research community and Innovation and Leadership. OHRCR conducts a number of not-for-cause audits each year within the University.  The report received from OHRCR needs to be submitted to the IRBMED via eResearch and the ORIO function.
Office of Research and Sponsored Projects (ORSP) ORSP’s is to assist faculty and staff members in all aspects of externally funded research projects and other scholarly activities throughout the life of the project. ORSP Project Representatives provide liaison with specific groups of sponsors. They keep apprised of agency policies and programs in technical, scientific, and scholarly fields and devote attention to the specific requirements of the sponsoring agencies. ORSP is formally known as the Division of Research Development and Administration (DRDA).
Office of the Vice President for Research (OVPR) OVPR has central responsibility for nurturing excellence in research, scholarship and creative activity across the entire campus. It has primary responsibility for research policy, oversight of responsible conduct of research education and compliance, and oversight of administration and support of research activity by the faculty. OVPR has administrative responsibility for several independent, interdisciplinary research units, as well as units which provide support to the research and technology transfer activities on campus. OVPR works with the deans and department chairs to develop and support interdisciplinary research initiatives and symposia.
Off-Label Use A drug prescribed for conditions other than those approved by the FDA. The off-label use of a marketed drug in the course of medical practice does not in and of itself constitute investigational use of a drug, unless that use is part of an experiment or systematic investigation meeting the criteria for human subject research.
Open Design An experimental design in which both the investigator(s) and the subjects know the treatment group to which subjects are assigned.
Open-Label Trial A clinical trial in which doctors and participants know which drug or vaccine is being administered.
Other Reportable Information or Occurrence (ORIO) Any event not an adverse event, that occurs during a clinical research study.
Orphan Drugs An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a Manufacturer specific financial incentives to develop and provide such medications.
Oversight Body or Agency Reports to or from internal oversight bodies (such as the CC CTO or the OVPR) or outside agencies (such as the FDA, NCI, NIH, or sponsor) should be submitted to the IRBMED for review according to the IRB Timetable for AE or ORIO OR as required in the Study Specific AE Reporting Timetable which may allow for non-concurrent reporting.  The terms Oversight Body or Agency or Entity are interchangeable.
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Parallel Track IND The FDA's Parallel Track policy permits wider access to new drugs for life-threatening diseases under a separate treatment protocol (Parallel Track IND) that "parallels" the controlled Phase II and III clinical trials performed to establish the safety and effectiveness of investigational new drugs. For example, under this prospective mechanism, persons with AIDS and HIV-related diseases who are not able to take standard therapy or for whom standard therapy is no longer effective, and who are not able to participate in ongoing controlled clinical trials, can have access to promising investigational new drugs. Applications to permit expanded availability of an investigational new drug under the Parallel Track mechanism must be submitted (typically by the manufacturer of the drug) to the FDA as an amendment to the existing IND.
Participation When participation is anonymous, it is impossible to know whether or not an individual participated in a study. When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff that has legitimate access to participation records.
Phase 0 Trial Phase 0 is a designation for exploratory, first-in-human trials conducted in accordance with the FDA’s Guidance on Exploratory IND Studies. Phase 0 trials are also known as human micro-dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub-therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.
Phase I Trial Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-100 healthy volunteers will be recruited. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organizations who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer. The tested range of doses will usually be a fraction of the dose that caused harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. Volunteers are paid a fee for their time spent in the volunteer center. Pay depends on length of participation. There are different kinds of Phase I trial: Single Ascending Dose; Multiple Ascending Dose; and Food effect. 
Phase II Trial Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB.                                  
  • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
  • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Phase III Trial Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.                                  

Studies in this phase are by some companies categorized as "Phase IIIB studies." While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA. Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life.

This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities. They will review the submission, and, it is hoped, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.

Phase IV Trial Phase IV trial is also known as Post-marketing surveillance Trial. Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term AE over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).
Phase V Trial Phase V is a growing term used in the literature of translational research to refer to comparative effectiveness research and community-based research; it is used to signify the integration of a new clinical treatment into widespread public health practice.
   
Placebo A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
Placebo-Controlled Study
  • A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
  • A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.
Placebo Effect A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.
Planned Emergency Research Research involving human subjects who are in need of emergency medical intervention (e.g., comparison of methods for providing cardiopulmonary resuscitation), but who cannot give informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative to provide consent.
Possibly related adverse event An adverse event that         
  • is a lesser known or possible effect of the drug, device, or procedure
  • occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure
  • could be explained by the characteristics of the population under study
Pre-Review The process performed by a IRBMED Regulatory Team to determine that a submission for IRB review is complete, including the required materials, and that institutional requirements, such as completion of human subjects protection education and conflict of interest disclosure, have been met.
Previously Unreported Adverse Event A specific adverse event that has not yet been reported to the IRBMED. For example, the hospitalization of a subject due to infection after the second dose of a study medication would be a "previously unreported adverse event" even if there had been an earlier report submitted to IRBMED when that same subject had been previously hospitalized due to similar infection after the first dose. All previously unreported adverse events are reported to IRBMED using the AE submission in eResearch.
Principal Investigator (PI) The scientist or scholar responsible for the conduct of research or other activity, described in a proposal for an award. The PI is responsible for all programmatic and administrative aspects of a project or program. The scientist or scholar with primary responsibility for the scientific, technical and administrative conduct of a funded research project. See also: Investigator and Lead Researcher
Prisoner Federal Regulations define "prisoner" as "any individual involuntarily confined or detained in a penal institution”. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Privacy Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. The state of being free from the observation, intrusion, or attention of others.
Privacy Board Privacy Board is the subsection or subcommittee of the IRBMED charged with handling HIPAA matters referred to the IRBMED and in accordance with the Standard Operating Procedures (SOPs)
Private information Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. See the UMHS HIPAA Web site for further information. (hyperlink)
   
Probably related adverse event An adverse event that         
  • is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure
  • ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure
Proposal An application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.
Prospective Studies Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. These studies need not involve manipulation or intervention, but may be purely observational or involve only the collection of data.
Protected Health Information (PHI) (Including demographic information) about a patient that (i) is created or received by a health care provider or health plan; (ii) relates to the past, present, or future physical or mental health of the patient; and (iii) identifies the patient or with respect to which there is a reasonable basis to believe it could be used to identify the patient
Protocol The formal design or plan of an experiment or research activity; specifically, the plan submitted to a Scientific or Peer Review committee for review and to an agency for research support. The protocol usually also gives the background and rationale for the trial. The protocol includes a description of the research design, methodology to be employed, the eligibility requirements for prospective participants and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a project, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Protocol Amendment A written description of any change(s) to or formal clarification of a protocol. Submit protocol amendments to the IRBMED using the Amendment submission in eResearch. Except to avoid the possibility of immediate harm to subjects, protocols should not be changed without prior IRB authorization. When changes for safety are made, an amendment should be submitted to the IRBMED within 7 days of the action.
Protocol Deviation Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff. Departure from the IRB approved research protocol without prior IRB approval for the variation.
Protocol Exception Term used by FDA and some sponsors to refer to a departure from the protocol that receives approval from the IRB before implementation (a one-time exception as distinguished from an amendment to the protocol). Approval requests for a protocol exception should be submitted using the ORIO submission in eResearch. Investigator should specify the extent of the exception (e.g., one-time only for patient X and note if data will be included in the study analysis).  If the exception is to become a permanent change, an Amendment submission in eResearch needs to be submitted.
Protocol Violation Accidental or unintentional changes to or non-compliance with the IRB approved protocol without prior sponsor and IRB approval. Violations generally increase risk or decrease benefit, affects the subject's rights, safety, or welfare, and/or the integrity of the data.
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Radioactive Drug Any substance defined as a drug the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.
Radioactive Drug Research Committee (RDRC) An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].
Randomized Control (RC) Study A type of scientific experiment - a form of clinical research - most commonly used in testing the safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy or effectiveness of healthcare services (such as medicine or nursing) or health technologies (such as pharmaceuticalsmedical devices or surgery). Study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed up in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls, etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments."
Recruiting The period during which a trial is attempting to identify and enroll participants. Recruitment activities can include advertising and other ways of soliciting interest from possible participants. See recruitment status and enrolling.
Recruiting Methods Materials, compensation, and other practices or procedures used to inform potential participants about research.                                  

 

Methods for recruiting research participants are generally distinguished from those of marketing, advertising, or public relations’ efforts, which have promoting a product, service, or idea as goals.

Recruitment Bonus Payment, merchandise, or other gift or service offered by a sponsor as an incentive or reward to an organization, investigator, or key personnel conducting research designed to accelerate recruitment that is tied to enrollment rate, timing, or numbers.
Recruitment Materials Announcements; advertisements; flyers; posters; scripts for telephone or other oral communication; letters or email messages; bulletin board tear-offs; Internet postings; newspaper, radio, television, or video broadcasts, or other media used to attract potential participants for research.
Recruitment Status Indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:                                  

 

  • Not yet recruiting: participants are not yet being recruited or enrolled
  • Recruiting: participants are currently being recruited and enrolled
  • Enrolling by invitation: participants are being (or will be) selected from a predetermined population
  • Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
  • Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
  • Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
  • Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
  • Withdrawn: study halted prematurely, prior to enrollment of first participant
Regulatory Compliance Following the rules set by a governing body.  There is a category called ‘continuing non-compliance’ where an investigator or study team repeatedly fails to follow the regulations.  For example, year after year they are late in submitting their scheduled continuing reviews, therefore their study lapses each year.
Regulatory Concern As it relates to the need to report to the IRB, this would be an issue or incident of non-compliance with laws and regulation or to an incident or information that regulations require an IRB consider. In the ORIO guidance the term is used as a criterion for determining what kinds of submission should be sent to the IRB within 7 days. Examples include but are not limited to:                                  

 

  • Unanticipated problems.
  • Deviations from the research in order to eliminate hazards to subjects or others.
  • New information about safety concerns.
  • Failure to obtain consent.
  • Documenting informed consent of a non-English speaking/reading subject or the legally authorized representative of the subject on an English-only informed consent document.
  • Improper training of study team (e.g., the PI did not require new staff, fellows, or students to complete the appropriate PEERRS human subject modules).
Regulatory Non-Compliance Failure to adhere to regulations, policies, procedures or special conditions related to the conduct of research. Examples of such noncompliance include, but are not limited to, failure to obtain/maintain approval for research; coercion of human subjects; performing unapproved procedures; and conducting research at unapproved sites.
Relatedness (adverse events) An assessment regarding the causal relationship between a drug or intervention and an adverse event.     

 

EVENTS RELATED

Definitely Related  

  • The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • The event follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure.
  • The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).
  • The event includes data that was only collected for the study.
  • The event included disturbing or upsetting questions that the subject was asked for the purpose of the research.

Probably Related

  • The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • The event follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure.

Possibly Related

  • The event is a lesser known or possible effect of the drug, device, or procedure.
  • The event occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
  • The event could be explained by the characteristics of the population under study.

 

EVENTS NOT RELATED 

Unlikely Related

  • The event is NOT a previously known or suspected effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily explained by the characteristics of the population under study.

 Unrelated

  • The event is NOT known to be an effect of the test drug, device, or procedure.
  • The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
  • The event can be readily and easily explained by the characteristics of the population under study.
  • Subject never received study drug, study device, or underwent research study procedure.
Remuneration Payment for participation in research. It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries. Also known as Compensation.
Renewal Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.
Repository Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.
Research Under HHS Regulations (46.102)research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. For example, some “demonstration” and “service” programs may include research activities.                                  

 

Under FDA Regulations (21 CFR 56.102) the term “clinical investigation” is synonymous with “research” and is defined as “any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Food, Drug and Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Clinical investigations regulated by the FDA under Sections 505(i) and 520(g) of the Act, include investigations of food, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. The term “clinical investigation” does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part. Research is subject to 21 CFR 50 and 56 when it involves the use of any drug other than the use of an approved drug in the course of medical practice. Research is subject to 21 CFR 50 and 56 when it involves the use of any medical device other than the use of an approved medical device in the course of medical practice.  

Research Performance Site Location/site at which human subjects research may be performed because of an understanding of the local research context and appropriate oversight mechanisms that ensure protection of research participants.
Respect for Persons An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy are protected.
Retrospective Studies Research conducted by reviewing records (i.e., birth and death certificates, medical records, school or employment records) or information about past events elicited through interviews with persons who have, and controls who do not have, a disease under investigation.
Review (of research) The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
Revision A modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.
Risk The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.” See also “Minimal Risk.”
Risk Benefit Ratio The risk to individual participants versus the potential benefits to the individual and/or society. The risk/benefit ratio may differ depending on the condition being treated.  The IRB must determine that the risk benefit ratio of a research project is sufficiently favorable in order to approve the research, and reexamines that determination in light of adverse event, other reportable incidents, and unanticipated problems.
Routine (Not-for-Cause) Review An assessment or examination of something (e.g., a practice or procedure) with the possibility or intention of instituting change if necessary.
Routine Research Educational and Regulatory Review (RRERR) Routine Research Educational and Regulatory Review (RRERR) conducted by the Office of Human Research Compliance Review (OHRCR)
S
Scheduled Continuing Review (SCR) SCRs are completed through eResearch and are required to be submitted and approved prior to expiration. See also Continuing Review.
Serious
  • Refers to the outcome of an adverse event.
  • An event is "serious" if it adversely alters the risk-benefit relationship of the research.
Serious Adverse Event Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes: death, a life-threatening experience, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or capacity, or a congenital anomaly or birth defect.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
  • Any untoward occurrence that:
  • Results in death,
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization,
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly/birth defect.
  • An unexpected result of therapy or other intervention that is severe, life threatening, or fatal, corresponding to grades III, IV, or V using NCI/CTC Common Toxicity Criteria.
Serious Non-Compliance Non-compliance that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects protection program. Examples of serious noncompliance may include, but are not limited to: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to insure the safety of human subjects and the integrity of the research/data.
Severe Social or Psychological Trauma Loss of job, insurance, benefits; criminal prosecution, stigmatization of community/group, destruction of familial/social relations.
Severely Debilitating Refers to diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of limb, loss of hearing, paralysis, or stroke).
Severe-Serious Distinction Serious adverse events result in death, disability, hospitalization (or prolongation of a hospital stay), or birth defects. Therefore, an adverse event that in and of itself would be graded as mild or moderately-severe becomes a serious adverse event if it leads to one of those outcomes. For example, a case of myelosuppression could require prolongation of an existing hospitalization, making it a "serious AE" for reporting purposes even if the myelosuppression was itself only moderately severe (Grade II). Compare to a subject experiencing a migraine after a hormone injection-the patient might consider the migraine to be severe, but if it did not result in hospitalization or other serious problems, it is not reported as a serious adverse event. See Serious Adverse Event Severe, and Severity.
Severity An assessment regarding the intensity of an Adverse Event (rating the event mild, moderately severe, severe, life threatening or fatal; or Grade I, II, III, IV or V).
Short Form A written document stating that the elements of informed consent required by regulation have been presented orally to the participant or the participant's legally authorized representative. The short form consent document must be written in a language understandable to the participant or the participant's legally authorized representative.
Side Effects Any undesired actions or effects of a drug or treatment. Negative or AE may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. See also Adverse Event.
Significant Risk (SR) Device An investigational device that is:                                  

 

  • Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
  • For use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
  • For a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
  • Otherwise presents a potential for serious risk to a subject.
Single-Blind Study A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. See Blind and Double-Blind Study.
Single-Masked Design Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."
Site This term refers to the location of the responsible oversight investigator and IRB. If the event occurred on a study directed/supervised by UM faculty or staff, it is local.
Social or Psychological Trauma Harm, insult, or injury affecting social status or standing, or relationships, or psychological health/well-being. Such harms include but are not limited to: invasion of privacy; breach of confidentiality; significant embarrassment; stigmatization; anxiety; fear; effects of stereotyping; loss of insurance or other benefits; criminal prosecution; effects on employment including job loss or demotion; interruption, disruption, or destruction of familial/social relations.
Sponsor
  • The company/person who initiates the study. The sponsor is typically the manufacturer or research institute that developed the drug or device. In this case, the sponsor does not actually conduct the clinical trial but rather distributes the investigational drug or device to clinical investigators who direct local conduct of the trial. A clinical investigator may, however, serve as both the sponsor and investigator (investigator-sponsor) of a clinical trial. The sponsor assumes general responsibility for the studies involving the investigational drug or device, including responsibility for compliance with applicable laws and regulations. The sponsor is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.
  • A person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than that individual (e.g., a corporation or an agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (FDA)
Sponsor-Investigator An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., it does not include a corporation or agency. The obligations of a sponsor-investigator under this part include both those of a sponsor and those of an investigator. (FDA)
Standard of Care Is a medical or psychological treatment guideline, and can be general or specific. It specifies appropriate treatment based on scientific evidence and collaboration between medical and/or psychological professionals involved in the treatment of a given condition. Some common examples include: treatment standards applied within public hospitals to ensure that all patients receive appropriate care regardless of financial means; or treatment standards for gender identity disorders
Stipulation(s) Express IRB provisions that must be satisfactorily addressed before a human subject research project can be approved and any involvement of human subjects in the research may begin. Under no circumstances do stipulations constitute contingent approval of the research project—approval is neither given nor implied until the PI has received written notice of IRB approval.
Study Drug The drug under investigation in a research study (includes approved and unapproved drugs).
Study Endpoint A primary or secondary outcome used to judge the effectiveness of a treatment.
Subject An individual who participates in research, either as a recipient of the investigational product (s) or as a control. Individuals can be the subject of research without being aware of their participation when informed consent is waived.
Subject Confidentiality Right and understanding of a subject that private data or protected health information will be divulged only as noted in the informed consent document, and/or as necessary for subject's health and safety, and/or as necessary by law. Investigators should take steps to protect subjects' confidentiality including where appropriate removal of patient specific identifiers (patient name, registration number, social security number, etc.) in reports to the IRBMED. Subject initials, unique coding specific to a study, and/or age are acceptable alternatives to names and registration numbers in IRBMED reports, and useful in correlating subject/patient specific information.
Survey Studies Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Suspended A study may be suspended for many reasons. Different parts of the study can be suspended, i.e., recruitment or all study activities.  The suspension can be required by the Sponsor or the IRB, or the PI can voluntarily suspend the study.
Suspension An action taken by the IRB Chairs, Vice Chairs, or convened IRBs to withdraw approval for some research activities, temporarily or permanently, or all research activities temporarily, short of permanently withdrawing approval for all research activities. The Institutional Official may also suspend research on an urgent basis.
T
Tabled An IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of convened IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.
Technology Transfer (Tech Transfer) Tech Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on technology.
Terminated A study may be Terminated for many reasons. Different parts of the study can be terminated, i.e., recruitment or all study activities.  The termination can be required by the Sponsor or the IRB, or the PI can voluntarily suspend the study.
Termination An action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). This may occur on a particular study or on all studies where an investigator is named PI.
   
Test Article Any drug, biological product, medical device, human food additive, color additive, electronic product, or any other article under investigation in a research study (included approved and unapproved drugs, biologics and devices).
Test Procedure Any investigational method (other than test articles) being developed, tested and evaluated, designed to develop or contribute to generalizable knowledge. Examples include surgical techniques and psychological therapy.
Therapeutic Intent The research physician’s intent to provide some benefit to improving a subject’s condition (e.g., prolongation of life, shrinking of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient’s condition, as well as assessing the safety and pharmacology of a drug.
Therapeutic Misconception Research participant's belief that enrolling in a research study will provide therapeutic benefit. Participants confuse the goal of clinical therapy which is to provide benefit to the individual patient and where any new knowledge gained is incidental and the goal of research which is to gain knowledge to help future patients (generalizable) and where therapeutic benefit to individual maybe secondary.
Therapeutic Research Research involving an intervention that has the likelihood of providing a therapeutic, diagnostic or preventive benefit to the subjects.
   
Toxicity An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.
Treatment and Parallel Track INDs Investigational new drugs may be made available outside of a clinical trial, through a treatment protocol, to multiple patients with life-threatening or other serious diseases for which no satisfactory alternative drug or other therapy exists.
Treatment IND IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the US. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial.
Trial design Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.
U
UM Event An event which occurs in a study under the supervision of the UM IRBMED and whose PI is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UM hospital, health center, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the Adverse Event. If interventions take place at different UM locations (e.g., the Michigan Clinical Research Unit {MCRU}), please specify at which location the event occurred.
Unanticipated An event is when "unanticipated" when it was unforeseeable at the time of its occurrence. Unanticipated and Unexpected are not synonymous. A research protocol can monitor for an unexpected event, but cannot monitor for an unforeseen event. All unanticipated events are unexpected but not vice versa.
Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO / UaP) Often referred as an Unanticipated Problem. An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future. Assessment Criteria:                                  
  1. Unanticipated Severity:  The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
  2. Related:  There is a reasonable possibility that the procedures involved in the research caused the problem.
  3. Increased Risk:  The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).
Unapproved Medical Device A device used for a purpose or condition for which the device would require but does not have pre-market approval or an approved investigational device exemption (IDE) from FDA.
Underlying condition A disease or other circumstance affecting the research subject that is not a result of the intervention or experimental design of a research study.
Undue Influence Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by their own free will or without adequate consideration of the consequences.
Unexpected Not identified by nature, severity or frequency in the current University IRB-approved research protocol or informed consent document
Unexpected Adverse Drug Reaction A term used by some sponsors to refer to an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochures for an unapproved investigational product or package insert/summary of product characteristics for an approved product).
Unexpected Adverse Event Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is notconsistent with either:                                  
  1. the known or foreseeable risk of AEs associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or
  2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the AE and the subject’s predisposing risk factor profile for the AE.
Unexpected Magnitude, Duration or Frequency An event or occurrence(s) should be reported to the IRBMED according to the Timeline for unexpected events when the intensity (severity), how long the event takes or persists, or the rate of occurrence is different than described in the informed consent document (ICD), even if the event is otherwise described in the ICD. For example, the ICD notes that some subjects experience mild, brief ringing in the ears following an fMRI. If a subject experiences ringing of significant intensity (such that she cannot work or attend classes) or the ringing persists for several weeks, the event would be reportable as an unexpected event. Likewise, if elevated liver enzymes were described in the ICD as expected at statistical rate of 2% but monitoring revealed 10% of subjects experienced such elevations, this should be reported as an unexpected adverse event.
Unlikely related adverse event An adverse event that         
  • is NOT a previously known or suspected effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily explained by the characteristics of the population under study
Unrelated Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.
Unrelated adverse event An adverse event that         
  • is NOT known to be an effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily and easily explained by the characteristics of the population under study
  • involves a subject who never received study drug, study device, or underwent research study procedure

 See also CauseRelatedness.

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V
Viable As it pertains to a neonate, able to survive after delivery to the point of independently maintaining heartbeat and respiration. The Secretary may, from time to time, take in account medical advances and publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of 45 CFR 46.
Violation Accidental or unintentional changes to or noncompliance with the IRB approved protocol that affects the subject's rights, safety, welfare, and/or the integrity of the data.
Voluntary Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.
Vulnerable Subjects Vulnerable populations can be defined as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons. If vulnerable individuals are involved in clinical trials, IRBs must ensure that additional safeguards have been included to protect the vulnerable group. Safeguards may include the presence of interpreters or social workers to explain the research and ensure informed consent. IRBs have a specific obligation to protect those individuals who are particularly susceptible to coercion or undue influence (21 CFR 56.11). Studies involving vulnerable groups often pose difficult ethical questions. For example, vulnerable subjects may not be allowed to participate in research that involves more than minimal risk but conveys no benefits directly to the subjects. (21 CFR 56.11 and 45 CFR 46 Subparts B, C, D).
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Washout Period Period of time without active treatment, usually scheduled before the beginning of the placebo and active treatment arms. This can refer to a required period of withdrawal from treatment before active treatment starts.
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Page Created on 4/5/12
Revised 3/20/2015