A collection of short videos and voiceover slide shows that address topics relating both to ethics in human subjects research and to IRB procedures.
The University of Michigan's IRBs are committed to providing educational materials online, as well as in the classroom. Follow the link below to view a listing of all University of Michigan IRB Collaborative (U-MIC) presentations stored in Dropbox. Most topics have the presentation (.pptx or .mp4) and also a script (.pdf or .doc) available.
AAHRPP is an international, independent, nonprofit organization that reviews and accredits human research protection programs (HRPPs). Since 2008, U-M has been AAHRPP-accredited. This presentation summarizes the accreditation process.
This presentation defines anonymous, coded, and de-identified data, clarifying how the three concepts differ.
These presentations summarize federal regulations outline requirements for obtaining the assent of human participants under 18yo, for obtaining parental permission, and for documenting these processes.
Presentation Part 1 - Children
Presentation Part 2 - Parental Permission
Presentation - Assent and parental permission requirements (and consent documentation)
The Belmont Report (1979) is a cornerstone document in ethics for research with human participants. This two-part presentation presents the three basic ethical principles put forward in the report, and examines ways in which researchers should apply them.
Community-based participatory research involves the collaboration of academic researchers and members of the general community. This presentation provides an overview.
Studies may collect sensitive and identifiable information about participants that could put them at risk if their research data were disclosed. NIH issues Certificates of Confidentiality to protect against forced disclosure by researchers for these studies.
Guest presenter Diane Lehman Wilson from the UMMS Office of Regulatory Affairs provides an overview of the ClinicalTrials.gov registry.
Consent capacity is the ability to understand information relevant to an informed, voluntary decision to participate in research. Cognitive or decisional impairment refers to situations in which an adult participant’s ability to provide valid initial and ongoing consent is limited.
Because adequate knowledge about the effectiveness and risks of standards of care is sometimes lacking, studies designed to evaluate two or more standards of care have become common. Such studies are often referred to as comparative effectiveness research.
Occasionally, researchers have financial interests that create the potential for bias. This is referred to as a conflict of interest. These presentations summarize considerations for IRB reviewers when either study team members, or the University, have financial conflicts of interest on a study.
This presentation looks at the ethical use of deception and concealment in research involving human participants.
These two presentations summarize the additional regulations governing research involving any Department of Defense (DoD) component.
When incorporating race and ethnicity factors and data in research, FDA recommends use of the categories standardized in 1997 by the federal government’s Office of Management and Budget. This short presentation outlines these categories and other recommendations for achieving diverse and inclusive research populations and outcomes.
These presentations concern documents uploaded in the eResearch application: IRBMED processes surrounding finalization and version control, and study team resources for version control and version comparison.
Presentation - Finalization at Continuing Review
Presentation - Version Comparison feature
Presentation - Version Control for Informed Consent Documents
These two presentations present a brief overview, and then further detailed recommendations, for securing electronic research data.
Electronic informed consent, or eIC, is the use of electronic processes and systems to convey study information to potential participants or legally authorized representatives to obtain and document their informed consent. SignNow is electronic signature software available for use by U-M personnel and students from all University of Michigan campuses, including Michigan Medicine.
Presentation Part 1 - Overview
Presentation Part 2- Multiple Variable Combinations of Signers
The Food and Drug Administration's regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research participants. IRBs may approve certain emergency research protocols in which participants are unable, due to their medical condition, to provide informed consent at the time of enrollment. This short presentation provides a summary.
IRBs and other research administration units at U-M have a single standard defintion of enrolled. Guest presenter Lark Speeyr summarizes enrollment reporting in eResearch.
eResearch Regulatory Management enables some study team, IRB members and staff, and staff of other committees involved in the review and approval process to communicate within the Regulatory Management system. This functionality is called Posted Correspondence. This short presentation provides an overview.
NOTE: This is partially out-of-date since Revised Common Rule changes to the Exemptions.
This presentation offers a summary of Exemptions 1 (some educational research) and 2 (some survey/interview research). Exemption 2A flexibility initiative is obsolete, but in some ways resembles current Exemption 3. See also U-MIC presentation on Revised Common Rule Exemption changes.
For minimal-risk research that falls under one of nine categories, federal regulations allow review by a single member of the IRB, with no vote by the full committee. This presentation outlines category 5: research involving materials collected for purposes other than that specific study.
The Federal Drug Administration (FDA) imposes additional requirements on IRB review of studies involving experimental drugs, biologics, and/or medical devices. FDA also requires IRB review for some non-research activities with experimental agents. These presentations explain several FDA-regulated scenarios.
Presentation - HUD - Humanitarian Use Device
Presentation - IVDs - in vitro diagnostic products
Presentation - MMAs - Mobile Medical Apps
Presentation - Significant Risk and Nonsignificant Risk Devices
The Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the confidentiality of personally identifiable information contained in a student's educational record. FERPA requirements may apply to research involving information about undergraduate, graduate, and professional students.
GINA is a federal law the prohibits health insurance companies and employers from discriminating based on genetic information. GINA may apply to research that collects or creates genetic information about participants.
HIPAA Privacy Rule protects the confidentiality of information held by healthcare providers and insurers about patients and clients. This is known as Protected Health Information (PHI). These presentations explain what qualifies as PHI, and how researchers can obtain access to PHI for research purposes.
IRBs are components of a comprehensive Human Research Protection Program (HRPP). This presentation summarizes the concept of HRPPs in general and outline's the University of Michigan's HRPP.
Obtaining the consent from a participant is a process that goes far beyond asking for a signature on a document. These many presentations explain facets of the informed consent process, requirements for the informed consent document(s), and situations where assent, parental permission, or an exception to the informed consent requirement may be appropriate.
Presentation - Writing ICDs – Part 1– Fundamentals
Presentation - Writing ICDs – Part 2 – Exhibit
Presentation - Documentation and waiver of documentation
Presentation - Assent and parental permission requirements (and consent documentation)
Presentation - Parental Permission for Research Involving Minors
Presentation - In an Emergency Care Setting
Presentation - EFIC – Exception from Informed Consent – Emergency Research
Presentation Key Information in Revised Common Rule
Presentation - Specialty Templates – one-time sample and eligibility screening
The International Council on Harmonization (ICH) brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan, and the United States. ICH offers many benefits to regulatory authorities and the pharmaceutical industry, and ultimately promotes the protection of public health. This presentation summarizes ICH-GCP requirements for research studies involving human participants.
The investigators in research with human participants take on many responsibilities toward the participants, and also towards their institutions and the regulatory authorities. These presentations provide overviews of some of these sets of responsibilities.
Presentation - Overview - OHRP and U-M
Presentation - Post-approval study monitoring Part 1
These presentations explain some of the requirements for IRB members and review processes.
Presentation - Membership and Quorum
Presentation - Regulatory Determinations
Presentation - Continuing Review Requirements Assessed by IRBs
This presentation explores lotteries as incentives for research participation, including a summary of Michigan's legal requirements.
As part of the U-M Precision Health Initiative, increased integration is becoming possible across several large-scale Michigan Medicine research resources, including the Michigan Genomics Initiative (MGI), the Central Biorepository (CBR), and DataDirect. This presentation provides an overview.
Because prisoners are in a situation severely restricting their autonomy, research involving human participants who are or may become prisoners requires additional protections to ensure they can provide informed consent on an initial and ongoing basis without coercion or undue influence.
Presentation Part 1 – Federal Requirements
This short presentation addresses the rights of participants in research studies to personal privacy, and to confidentiality of the information they provide.
Research repositories aggregate data, with or without biospecimens, for future use by researchers or for purposes not determined at the time of data/biospecimen collection. U-M IRBs oversee research repositories through a separate REP application in eResearch Regulatory Management, often in concert with a HUM.
In 2018 the Office for Human Research Protections (OHRP) issued the first major update since 1991 to the regulations governing IRB review. U-M implementation of the new regulations involved changes to eResearch Regulatory Management applications and informed consent templates, as well as to business processes. These presentations explain several facets of the changes.
Presentation - Continuing Review changes for study teams
Presentation - Continuing Review considerations for IRB reviewers
Presentation - Exemption Changes
Presentation - Key Information in Informed Consent Documents
Study recruitment and screening of participants are related, but distinct, activities. Recruitment involves information and activities designed to provide information to potential participants. Screening involves the collection of information from or about potential participants to determine whether they are eligible to participate in the research. This presentation compares and contrasts the two activities.
Increasingly, studies that take place collaboratively at more than one institution in the United States are expected to assign a single IRB (sIRB, also known as reviewing IRB or IRB-of-Record) to provide oversight for the study, rather than relying on review by local IRBs. These presentations explain several of the many terms and many business processes involved in sIRB research.
Presentation - Collaborator Agreements – IAAs, IIAs, and CIAs
In certain circumstances, the U-M may participate as a study site only if UM-specific protocol modifications are implemented, as required by the IRB. This presentation outlines procedures.
When research participants make reference to individuals who are not involved in the study at hand and with whom researchers have no interaction, we call these individuals third parties. This presentation provides a summary.
Guest presenter Lark Speyer offers an overview of projects lacking immediate plans for involvement of human participants, that nonetheless require an application to the IRB. These are known as umbrella projects.
Federal regulations require that researchers report promptly unanticipated problems involving risk to subjects or others (UPIRSOs or UaPs). This presentation provides an overview.
Federal regulations and institutional policy identify certain categories of research participants (known as vulnerable populations) who are likely to be vulnerable to coercion or undue influence. This presentation summarizes the populations and the special responsibilities associated with research in which they may be enrolled as participants.
2800 Plymouth Road
Ann Arbor, MI 48109-2800
IRBMED has full accreditation by they Association for the Accreditation of Human Research Protection Programs, Inc.
