What is the IRBMED Fee Structure for Industry/Commercial Sponsors?
Beginning April 3, 2017, the IRBMED fee for its review of new studies with industry/commercial sponsors will be raised from $1,800 to $2,500. In circumstances where IRBMED will cede IRB oversight to an external IRB and the study has an industry/commercial sponsor, a new charge of $1,000 will be collected for IRBMED's efforts related to ceding review. These changes are based on a benchmarking effort conducted with other similar IRBs. Implementation will affect contracts finalized after April 3, 2017.
The IRBMED fee is a financial/budgeting transaction. For more information, visit the Grant Services & Analysis page: Budgeting & Costs.
WHY AN IRB? WHICH IRB?
What kind of research and other activities require IRB review?
OHRP regulations and the Common Rule make IRBs responsible for review and approval of "human subjects research." This includes "clinical investigations" also regulated by FDA. Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." A human subject is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
IRBs enforce HIPAA regulations about the use of Private Health Information for research purposes.
Some activities that feature research methodologies are not regulated under OHRP or FDA regulations (e.g. case studies, analyses of publicly available datasets, research on organizations, quality assurance/improvement activities, standard public health surveillance, oral histories, journalism, etc.). Importantly, these projects may still be subject to HIPAA regulations.
Do I need to submit an IRB application?
You are required to submit an IRB application, and wait for IRB review and approval, before doing any “research” that also “involves human subjects.” Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." A human subject is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
Some non-research activities also require IRB oversight; see “What kind of research…?” question above.
Some “human subjects research” is eligible for Exemption, which means IRB must review and confirm Exemption before the research starts, but ongoing IRB oversight is not required.
Do I need IRB review to publish a report?
You are required to submit an IRB application, and wait for IRB review and approval, before doing any “research” that also “involves human subjects.” Journals require documentation of IRB approval for publications about human subjects studies. However, people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Quality improvement projects that were not undertaken for research purposes, as well as case studies, do not require IRB approval, and publishing the results do not require IRB review. See also FAQ on Not Regulated projects.
Should my application be reviewed by IRBMED or IRB-HSBS?
If your primary appointment is with the Health System, Medical School, Dental School, or School of Nursing or your research involves the health system patients or facilities, IRBMED would have jurisdiction over your application. IRB jurisdiction may also depend on the nature of the research and/or the expertise required to conduct a review.
The U-M HRPP Operations Manual Part 5.II also provides information on IRB jurisdiction.
Can I use a Central IRB for a multi-site study?
For multi-site studies, a single “central IRB” may provide IRB oversight trial-wide: the central IRB is “IRB-of-record” for all sites. U-M has procedures for “ceding IRB oversight” from IRBMED to an external IRB in the following circumstances:
- The central IRB is a commercial/independent IRB which has a Master Agreement with U-M to provide oversight for multi-site, industry-sponsored clinical trials
- generally not for Phase I studies
- available with selected commercial IRBs
- The central IRB is based at another institution (generally another academic centers), if ceding is deemed appropriate upon consultation with UMOR and IRBMED (e.g. if required by NIH grant) and the Authorization Agreement Process is used
NOTE THAT “ceding” IRB review does not lessen U-M researchers’ obligations to other research administration units within the U-M HRPP:
- Approval of an eResearch Regulatory Management (eRRM) application before study activity is required, through the streamlined application type “Request Review by non-UM IRB”
- Application must be maintained in an approved state through “continuing review” and other submissions, as appropriate
- Review by non-IRB research review units (e.g. “ancillary committees” such as CRAO, Research Pharmacy (also known as IDS) or Conflict of Interest Review Committee) may be indicated
The U-M HRPP Operations Manual Part 5.III and IV also provides information on IRB review for multi-site studies.
What are some of the basic tips about research oversight at U-M?
- Study Team Members need to have PEERRS training completed prior to approval of an application. You should complete a web-based educational module about doing “human subjects research” through http://my.research.umich.edu/peerrs/
- Applications for IRB review are entered into a web-based “smartform” system, eResearch Regulatory Management (eRRM). IRBMED has a basic overview about using eRRM online. There’s also links to several other specific resources on this page.
The “smartform” interface means that, when you’re filling out an application, your early answers determine what questions you are asked later. The intent is that you are only asked relevant questions. To make this more likely to work well, it’s very important to fill out questions only on system-required pages. There’s some more information about this in the “General workflow” heading at the page linked above.
- It is critical that eResearch applications and all supporting documents are consistent throughout. See the eResearch Cross-reference table. IRB regulatory staff will require clarification for inconsistencies.
- Short educational presentations (.ppt + voiceover) are available on the U-MIC page on regulatory topics, some of which also specifically address eResearch concerns. A few you might find useful:
- eResearch: Before We Get Started
- IRB Board Tip: Protected Health Information (PHI)
- IRB Board Tip: Documentation of Informed Consent
- IRB Board Tip: The HIPAA Privacy Rule: Requirements and Waivers
- Principal Investigator Responsibilities per the HRPP Operations Manual and the Common Rule
- More IRBMED guidance webpages are found here.
- Student researchers: You should have a Faculty Advisor on your application if you will be the listed Principal Investigator (PI), or you could list yourself as a “Co-Investigator” and the faculty advisor as the PI. See http://research-compliance.umich.edu/operations-manual-roles-and-respons... details.
- Children in research: there are specific additional regulations and policies about informed consent and assent for parents and children when children are research subjects. See more information here.
- PHI: For any study that involves accessing (hearing/viewing) PHI, HIPAA regulations about medical data apply – even if the PHI is not recorded. See more information here.
STUDY TEAM QUALIFICATIONS
What is PEERRS and do I have to complete PEERRS training in order to conduct research?
The Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) is a web-based instruction and certification program. Certification is obtained by passing a short quiz that covers required modules.
IRBMED recommends that all study team members complete PEERRS Human Subjects certification, or obtain waivers for equivalent certification, to demonstrate completion of human subjects protection training.
The U-M Office of Research (UMOR) requires PEERRS certification for all PIs, Co-Is, faculty advisors, and study coordinators who conduct research with human subjects.
UMHS Compliance Office requires PEERRS certification for all study team members who access MiChart for research purposes.
Can I use Collaborative Institutional Training Initiative (CITI) or another institution's "Human subjects protection training" instead of completing PEERRS?
You may request a Waiver of PEERRS for equivalent certification.
Can a student, trainee, House Officer or Fellow lead a research project?
Students, trainees, etc. may be listed as Principal Investigator (PI) on an application if they also list an eligible Faculty Advisor, or students may be listed as a “Co-Investigator” and the faculty advisor as the PI. See UM HRPP Operations Manual Part 6.I for details.
See also IRB-HSBS main webpage, “References and Resources” heading:
- Guide for Student Investigators
- Tips for Student Researchers
- Tips for Faculty Advisors
How do I add a non-UM study team member?
Study team members without U-M affiliation (“external collaborators”) can be added to the eResearch application after obtaining a U-M “Friends account.” Like any other study team member, external collaborators are expected to accept their role on the study, fill out questions about outside financial interests, and to obtain PEERRS certification (or waiver) if their study role and/or duties indicate this. (See other FAQs “What is PEERRS…?” and “…conflict of interest disclosure?”
External collaborators who are “engaged in the conduct of human subjects research” in a “regularly regulated” study (approved by expedited or full board process, not exempt or “not regulated”) should either
- Provide documentation of oversight for their activities by a local IRB/ethics board, or
- use the Authorization Agreement process to request IRBMED provide direct oversight for their activities
See also the FAQs at the Authorization Agreement process website.
Sharing study data and/or specimens with external collaborators often also requires Data Use Agreement (also known as Data Sharing Agreement) and/or Materials Transfer Agreement. Please see ORSP Unfunded Agreement webpage for more information. These agreements are processed separately from any IRB application.
SUBMITTING APPLICATIONS & DOCUMENTS
How do I submit an application to the IRB?
Applications are managed through the eResearch Regulatory Management (eRRM) system. For further information, see
- IRBMED resources
- eRRM tips webpage
- ITS eRRM resources
IRBMED offers educational workshops on eResearch as well as on regulatory topics.
What application type should I select?
Human Subjects research involving interaction or intervention … – Most research studies, especially involving any primary collection of data and/or specimens (survey, interview, physical exam, blood draw, biopsy). A few of these are eligible for Exempt determination (See FAQ heading “Other application types”).
Secondary research uses … – Most studies that do not involve any interaction or intervention with subjects, but focus on analyzing data and/or biospecimens (with or without identifiers). These may receive a range of regulatory determinations (See IRBMED guidance webpage “Elements and Uses of a Repository”).
Note: the dedicated Repository (REP) application pathway is not intended for an analysis application (See IRBMED guidance page “FAQ: Repository applications”)
Activities not regulated as human subjects research – choose only if the project does not meet the regulatory definition of "research" and/or does not meet the regulatory definition of "involving human subjects.” (See FAQ headings “Other application types…” and "Why an IRB? Which IRB?")
Note: secondary use analysis is usually better captured under “Secondary research uses …” type, even if the analysis is eligible for “not regulated” determination. (See IRBMED guidance webpage “Elements and Uses of a Repository”)
The other application types are more rare and specialized:
- Projects lacking immediate plans (aka "Umbrella") – most often associated with an NIH "Just-in-Time" request, or sometimes an NIH Genomic Data Sharing "Institutional Certification" request. See also U-MIC "Umbrella Projects."
- Single-patient Expanded Access ... – there are separate "Drug or Biologic" and "Device" versions for this application. See IRBMED guidance page "FDA Expanded Access Program ..." and contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu
- Humanitarian Use Device – See IRBMED guidance webpage "Humanitarian Use Device Requirements ..." and U-MIC "Humanitarian Use Devices (HUDs)."
- Requesting Review by a Non-UM IRB (aka "Ceding") and Multi-site Research where U-M is a Coordinating Center and/or IRB of Record (aka "Single IRB or sIRB") – See IRBMED guidance webpage "Multi-site Research"; U-MIC "Central Institutional Review Boards," "Collaborator Agreements," and "Single Institutional Review Board...," ; and U-M HRPP webpage "NIH Single IRB-of-Record (sIRB)"
Should my simple study be Exempt?
Exemption eligibility depends on the study using only research methodologies specifically designated as “Exemptable” in the OHRP regulations 45CFR46.104 or by U-M HRPP Flexibility Initiative policy. Many simple studies (e.g. one-time blood draws, or survey + medical record review) do not fit into any Exemption category/ies.
Generally, an IRB application for comprehensive review and approval requires more information from the study team than an application for Exemption, and is more likely to require Amendment during the study ‘lifecycle.’ However, some comprehensively reviewed and approved studies are eligible for “no continuing review required.”
Note: “Exempt” does not mean the same thing as “Expedited,” and does not mean the same thing as “not regulated.” See also FAQ headings “Other application types,” "Review & Approval Process," and "Ongoing Review."
Does IRBMED require the use of standardized informed consent templates?
IRBMED strongly encourages the use of IRBMED templates. Sample templates that contain all necessary regulatory information are available online. IRBMED offers a Standard Template that can be used for studies of all risk levels, as well as Specialty Templates for some simple, low-risk studies. Contact your regulatory staff to determine which consent template is most appropriate for your study.
How do I upload a document like a stand-alone protocol, consent document, or recruitment flyer into eResearch?
Please see ITS guidance for uploading documents into eResearch
How do I update a previously uploaded document?
Please refer to the step-by-step guidance on 'stacking' documents. “Upload revision” button in eResearch puts a new document ‘stacked’ on top of previous version(s) while maintaining a full history of all versions uploaded. Documents previously uploaded to eResearch should be retained for historical and regulatory reference purposes, and should not be deleted.
Updating an informed consent document – special additional instructions
For updating informed consent documents:
- Download from Section 10-1 of the eResearch application the most recent IRB-approved clean version of a consent
- Turn on Microsoft Word “Track Changes” functionality
- Make all necessary changes
- Upload the tracked-changes version into Section 10-1, maintaining the IRBMED standard naming conventions
Further instructions on updating informed consent documents are available at:
- Cover page in any IRB-approved clean version of a consent downloaded from Section 10-1 of the eResearch application
- IRBMED Statement of Practice “Version Control of Informed Consent Documents”
- U-MIC presentation on Version Control of Informed Consent Documents
- Instructions for Amendments at Standard Informed Consent Template guidance page
COMMON QUESTIONS ABOUT APPLICATION CONTENT
What does “de-identified” mean? What does “coded” mean?
Study teams should expect IRB staff to ask for confirmation when an eResearch application indicates data is “de-identified.” The term “de-identified” or “anonymized” should be used only to describe data that
- Previously contained identifiers, which have been stripped, and
- No “code” linking the data back to identifiers still exists, such that
- The dataset cannot be “re-identified” by anyone.
Data is not “de-identified,” but “coded” and “indirectly identifiable” if:
- Researchers have “coded” a data and store the code separately from the research dataset, or
- The data provider has the “key” to “coded” data, even if the researchers do not, or
- Anyone can “re-identify” the data by linking the dataset to direct identifiers.
U-M uses “de-identified” in this way to avoid confusion about whether data are “coded” or not, and in accordance with OHRP definitions and guidance. For further clarification, see the U-MIC educational presentation "Anonymous, Coded, and De-identified Data..." or the "Key Definitions" heading at the U-M HRPP Data Security Guidelines webpage.
Caveat: HIPAA Privacy Rule has a different definition of “de-identified,” applicable only to data based on Protected Health Information (usually medical records). Please specify “HIPAA-de-identified” if this definition is intended.
Does my study reimburse subjects, pay them, or give them an incentive?
"Reimbursement" is compensating subjects for specific out-of-pocket expenses, which should be documented by receipts the subjects provide to study team. If a set amount is provided to each subject for a given study visit, this is "payment."
For example, if each subject receives $20 this should not be characterized as “reimbursement for travel," since one subject's travel expenses could be a round-trip AATA bus ride ($3), while another's could be the cost of gas for driving from and to Saginaw plus parking here (closer to $25).
Information about money provided to subjects (when, how, how much) should be clear and consistent in the Informed Consent Document(s) (section 8 if using the IRBMED Standard Template) and in eResearch application section 13, and other sections as applicable. You may find the "eResearch Cross-reference table" available through Statements of Practice webpage of use.
Does my research involve Protected Health Information (PHI)?
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule governs the use and release of a patient's personal health information, also known as Protected Health Information (PHI), by a covered entity. IRBMED studies most commonly involve access to PHI for at least some of the study activities, for instance:
- Medical record review and/or use of clinic schedule records to identify eligible subjects
- Data collection of clinical variables from the medical record (by direct chart review and also by tools such as EMERSE or DataDirect)
- Clinical trials providing study-related treatment at UMHS
- Receiving external PHI as part of multi-site data collection (often with a Data Use Agreement/Data Sharing Agreement)
HIPAA considerations are addressed mostly in eResearch Regulatory Management section 25 and sub-sections.
When is medical or health-related information NOT Protected Health Information (PHI)?
Data directly provided by a subject to a U-M researcher for research-only purposes is not considered Protected Health Information (PHI). This holds true even if the data provided by the subject concerns the health or medical history of the subject or a family member. As such, surveys for research purposes usually do not create PHI. However, any identifiable information that is added to the medical record is governed by HIPAA.
Survey-based studies may access PHI in the course of a study for several reasons, for instance:
- Medical record review to identify eligible subjects for recruitment purposes (usually under a Waiver of HIPAA Authorization)
- Survey responses are correlated with individual Michigan Medicine health data, for instance to explore patient recall of certain care conversations (usually with individual signed HIPAA authorization, often incorporated in the IRBMED Specialty Informed Consent Template for Survey Research)
- “Patient-reported outcome” measures are used as part of a clinical trial and the results are entered into the medical record (usually with individual signed HIPAA authorization incorporated into the IRBMED Standard Informed Consent Template)
IRBMED studies most commonly involve access to PHI for at least some of the study activities.
Can the Patient Portal MyUofMHealth.org be used in a research study?
MyUofMHealth.org is designed for Michigan Medicine patients to access their medical records, and for communication between patients and providers/clinics.
Researchers may NOT use the Patient Portal for research recruitment (contacting potential subjects). Communication through the portal is allowed to subjects who have consented to this communication method as part of a specific study (e.g. sending messages about upcoming research appointments).
REVIEW & APPROVAL PROCESS
Why do some studies require full board review?
According to federal regulations, studies that pose greater than minimal risk to subjects must be reviewed at a Convened Board meeting. Sensitive or complex studies, as well as those involving vulnerable populations, might also require full board review.
When can I expect a decision about my IRB application?
IRBMED staff makes every effort to complete initial processing on an application within 2 weeks of receipt to IRBMED. Total time to approval will vary with an individual application's review needs, including additional reviews, application completeness and clarity at initial submission, and IRB Board reviewer schedules.
PLEASE NOTE: some applications, particularly clinical trials, require eResearch review and approval from non-IRB U-M research units after submission by the study team and before receipt by IRBMED.
Can I get an expedited review because I have a deadline for completing the study/ submitting the abstract/ a student’s summer availability/etc.?
IRBMED processes submissions on a ‘first-in, first-out’ basis. However, if there is a particular time pressure about a submission, please alert your IRB regulatory staff.
Please note that "expedited review" means review by one IRB member on behalf of the Board. Expedited review is available for some human subjects research applications, based on risk level and certain other characteristics. It does NOT necessarily imply faster processing.
How will I be notified when my IRB application is approved?
Determination notices are issued via eResearch. You will receive an email notification with a link to your approved study in eResearch. You also can track a submitted application through its eResearch progress; the step-by-step guide Tracking a Submitted Application shows how.
May I begin my research if the IRB approves it with contingencies?
No. You may begin only after the IRB has determined that all contingencies have been resolved (as evidenced by an “Approval” determination notice). The step-by-step guide Study Approval and Contingencies provides information on making requested changes to an application "approved with contingencies." Your IRB regulatory staff can also help.
Where is my current IRB approval determination?
The current IRB determination letter (“Approved,” “Exempt” or “Not Regulated”) is available under the “Activities and Correspondence” heading of
- the main study space (aka HUM space) before an Amendment or Continuing Review is finalized
- the submission workspace for the most recent completed Amendment (Ame) or Continuing Review (CR)
The HUM workspace shows dates for the Last CR and Last Amendment approval dates. If both are blank, the letter in the main HUM workspace is current. The study in the example below has had a CR but no Amendments (“Last Amendment” is blank).
Go to the deep blue tab near the top of the HUM workspace for "Amendments" or “Continuing Reviews,” whichever is most recent. Click into the individual submission workspace, scroll down to Activities and Correspondence heading, and find the "See Approval Letter" link (or “Exempt” or “Not Regulated”). The letter opens in a new tab, from which you can print or "print-to-.pdf" a copy.
Can a previously issued determination notice be revised?
Contact the IRBMED regulatory staff assigned to your application if something appears to be missing or mistaken on a determination notice you have received.
Sponsors may require specific language in determination notices, such as the version number and date for the Protocol reviewed by the IRB. In these cases, study teams should enter the desired language in eResearch field 44.2 (new Application or Amendment) or 15.1 (AE or ORIO report). This text prints word-for-word on the determination notice as "Supporting Documents." To include specific language in a Continuing Review determination notice, contact the IRBMED regulatory staff assigned to your application.
eResearch determination notices list the ID and may list the expiration date for the U-M FWA. It is not a regulatory deficiency for you to present to a sponsor or journal a notice showing an apparently lapsed FWA, as long as the date shown was current at notice issuance. For the current U-M FWA expiration date, use the OHRP web search: enter FWA Number: 00004969 or Institution/Organization Name: U Michigan
What kinds of changes require an amendment?
Any change to an approved, non-exempt study requires submission of an amendment application via eResearch. Examples of such changes include, but are not limited to:
- alteration of study design, methodology, or recruitment methods
- changes to surveys
- changes to consent documents
- addition/deletion of principal investigators or key personnel
- addition/deletion of research performance sites
- alteration of project title
Some approved, non-exempt studies that do not require continuing review (see also FAQ "How long is my approval valid?"): amendments are still required for these studies.
Exempt studies and “not regulated” projects do not require amendment unless the proposed change exceeds the scope of the determined category/ies, or unless ancillary review is indicated.
See also FAQ “How do I update a previously uploaded document?”
How do I submit an amendment to an approved study?
Go to your approved application within eResearch and click “New Amendment” under “Create New Submission.” An Amendment must include both a "Cover Sheet" and changes to the eResearch application. The step-by-step guide Creating an Amendment provides useful information on the Amendment process.
How long is my approval valid?
If an approved study space shows an Expiration Date, the study requires "continuing review" and re-approval at regular intervals. The approval period is usually one year. Approval can only be extended by IRB approval of a “continuing review” application (see FAQ “How do I apply for a Scheduled Continuing Review?” and "What happens if my approval expires...?").
Some ongoing studies no longer require annual Continuing Review (CR) per 2018 Revised Common Rule (effective January 21, 2019) or per 2018 Flexibility Initiative . The study workspace indicates “No Continuing Review Required for this application” when applicable.
How do I apply for a Scheduled Continuing Review?
eResearch sends notifications prior to expiration of study approval (at 90, 60, and 30 day intervals). To submit a Scheduled Continuing Review (SCR), go to your application within eResearch and click “New Continuing Review” under “Create New Submission.” The step-by-step guide Creating a Continuing Review also provides information on this submission type. The IRB will review your application and notify you of the outcome via eResearch.
Can a Continuing Review and an Amendment be processed at the same time?
Yes; in eResearch these two types of submissions can be processed concurrently. Only one Amendment and only one SCR active at any given time.
What happens if my approval expires before I submit the renewal?
Per U-M policy (OM Part 3.III.C.4.f),
If an investigator fails to provide a continuing review application to the IRB, or the IRB has not reviewed and approved the continuing review application by the expiration date of the current approval (regardless of the reason or circumstances), the study will be considered lapsed.
- The research must stop unless the IRB finds it is in the best interest of individual subjects currently participating in the study to continue the research interventions or interactions.
- Enrollment of new subjects during a lapse is prohibited
- IRB will remind investigators that resources must not be expended for unallowable activities.
Lapses of IRB approval on a single study, or a pattern of lapses across multiple studies raise serious concerns. Non-compliance with federal or institutional requirements to maintain continuous IRB approval for human subjects research may require corrective action including: review by the full IRB, additional education of the PI and study team, study monitoring, suspension of IRB approval status, and/or referral to higher institutional authorities or federal agencies. Suspension or termination of IRB approval is reportable to UMOR (U-M Office of Research) and ORSP (Office of Research & Sponsored Projects) and may be reported to external regulatory agencies under federal regulations.
When and how do I close or Terminate my IRB application?
Submit a termination report via eResearch when
- research activity is limited to analysis of de-identified data (i.e., all identifiers, links, or codes have been destroyed), OR
- the research has ended.
Note that ‘de-identified’ means the dataset cannot be “re-identified” by anyone (See FAQ “What does ‘de-identified’ mean?...”).
Industry-sponsored studies: upload the study closure visit confirmation into the termination report.
What happens to a study when the PI leaves U-M?
Contact UMMS Regulatory Affairs Office UMMS-RegAffairs@med.umich.edu for comprehensive guidance. The “Faculty Exit Checklist” linked from the main Regulatory Affairs webpage is an excellent resource for departing faculty and their support people; in the 11/2014 version, pp11-21 deal with research-related considerations (including but not limited to human subjects research).
Active studies where the departing faculty is on the study team should be amended to change or remove his/her participation. Your IRB regulatory staff can help compile a full list of these studies. See step-by-step eResearch instructions Changing the PI on an application.
When the departing faculty will remain involved with the study (even if only analyzing “coded” or “de-identified” study data), new agreements may be necessary. Units supporting these agreements may include UMHS Compliance Office, ORSP (particularly regarding research equipment or Data Use Agreements), and Office of Technology Transfer (regarding Materials Transfer Agreements).
OTHER REQUIRED REPORTING TO IRBMED
The Standard Timetable for reporting adverse events (AEs) requires us to report some adverse events that are not related to the research we are conducting. Do we still have to follow it?
Yes, follow the Standard Timetable unless
How do I include a study-specific AE reporting plan in an application?
Include a study-specific reporting plan in eResearch section 32-1 as part of a Data Safety and Monitoring Plan (DSMP). Until you receive a 'Notice of Outcome' indicating IRB approval of the study-specific plan, follow the Standard Timetable.
Study-specific AE reporting plans are often appropriate for
What is an ORIO? When should I submit an ORIO report?
An ORIO is a way to tell the IRB about information or occurrences, other than adverse events, related to the conduct of your research. IRBMED requires reporting of some kinds of ORIOs. Study-specific ORIO reporting plans may also be appropriate for some studies, similar to study-specific AE reporting.
ADDITIONAL RESEARCH OVERSIGHT
Does the University of Michigan require a conflict of interest disclosure?
All Michigan Medicine Faculty, House Officers, and Staff must disclose outside interests or activity, including any potential Conflicts of Interest (COIs) and any potential Conflicts of Commitment (COCs) through MInform. A helpful “decision tree” for determining what to disclose is available at: http://research.umich.edu/conflict-of-interest/m-inform-decision-tree/. The COI Committee reviews disclosures and, when necessary, works with the faculty or staff member to eliminate, minimize, or manage the conflict An interface between MInform and eResearch Regulatory Management identifies study team members with possible COI.
How are research incentives/payments processed?
Payment for research is taxable income. University Treasury office tracks payments to subjects and issues IRS 1099 forms if >$600 received by an individual in a calendar year. To comply with this, study teams should have subject payments processed through Human Subjects Incentive Program (HSIP). See http://spg.umich.edu/policy/501.07-1 HSIP should be involved in "regularly regulated," Exempt and Not Regulated studies unless they are using a third-party vendor, or another institution is handling the incentives.
What are the requirements regarding lotteries as incentives for research participation?
How are other agreements related to research processed?
Human subjects research, especially clinical trials, often requires permissions and/or agreements beyond IRB approval. Although some types of additional agreements are referred to in the IRB application, they are not processed by IRB staff, nor finalized through IRB approval.
Faculty, chairs, and departmental administrators do not have authority to sign legal agreements on behalf of the University.
At University of Michigan,
- Unfunded Agreement (UFA) system processes Data Use Agreements (DUA, also known as Data Sharing Agreements or DSA), Business Associate Agreements (BAA), Materials Transfer Agreements (MTA), and some other contracts/agreements not directly related to funding
- Proposal Approval Form (PAF) system processes grants, contracts, and cooperative agreements for funding.
- Certificates of Confidentiality (from NIH or CDC) are processed through UMOR and IRB staff.
- Authorization Agreements for external collaborators in U-M research are processed through UMOR and IRB staff.
OTHER APPLICATION TYPES
What is an exempt study?
Exempt studies are a subset of human subjects research that do not require ongoing IRB oversight. Exempt status does not lessen the ethical obligations of researchers to subjects. For further information, see IRBMED Exempt Human Subjects Research webpage.
What is a “not regulated” project?
To be "not regulated," a project must NOT meet the regulatory definition of "research" at 45 CFR 46.102 (d) (Common Rule), and/or NOT meet the regulatory definition of "involving human subjects" at 45 CFR 46.102(f) (Common Rule) or at 21 CFR 56.102 (e) (FDA). See FAQ "Why an IRB? Which IRB?" heading for more information on these definitions. This means that some research involving medical data or specimens, and some other activities conducted by medical researchers, are "Activities Not Regulated as Human Subjects Research."
There is no OHRP, University of Michigan or IRBMED requirement for researchers to obtain a formal determination of "Not Regulated" (see U-M HRPP Operations Manual Part 4.V.A). However, if your project will be accessing/viewing/obtaining Private Health Information (PHI) for research purposes (analyzing a HIPAA Limited Data set, analyzing PHI from Decedents, or review of PHI preparatory to research), submit a "Not Regulated" application to ensure HIPAA compliance.
There is a shortened eResearch application path for this, beginning on page 01-1 "Application Type." Study teams may seek a "Not Regulated" determination through eResearch at any time; this is most common when you are uncertain whether the proposed activities should be regulated, or your funding requires input from the IRB.
Some “Not Regulated” categories permit a “self-determination” through eResearch, where you enter information into an application in eResearch, but the IRB never receives or reviews the application.
NOTE THAT a “not regulated project” is not the same as an “Exempt study,” although some of the requirements (and lack thereof) are similar.
Do I need IRB approval for a case study? Do I need to obtain consent?
Case study applications are limited to reports about ONE or TWO individuals. Because these cannot be assumed to be generalizable, case study reports are not regulated as "research." See U-M HRPP Operations Manual Part 4(section I on "research" definition, section V on "not regulated" projects). The question of “research consent” as you have probably heard about it before regarding IRB oversight does not apply.
The use of medical charts (including protected health information or PHI) to write up case studies is regulated under the HIPAA Privacy Rule. It is common for journals to require HIPAA authorization (written permission) from patients whose cases are described in submitted articles. However, IRB regulations on Informed Consent (process and documentation) do not apply to case studies.
If it is feasible to obtain written HIPAA authorization from the patient, this is BY FAR PREFERABLE. You can draft an Authorization adapting the "SAMPLE AUTHORIZATION LANGUAGE" available at the NIH webpage on HIPAA Authorizations for research or use the UMHS standard Authorization to release copies of a medical record NOTE THAT a copy of the signed authorization should be sent to the Health Information Management (HIM) Release of Information Unit (2901 Hubbard Rd., Room 2722, Ann Arbor, MI 48109-2435, fax 734-936-8571) for processing and inclusion in the patient's medical record per Michigan Medicine (formerly UMHS) Policy 01-04-310.
HIPAA authorization is not required (though still PREFERABLE) if you will REMOVE all HIPAA identifiers ("de-identify") from the write-up or presentation of the case, AND if you have no reason to believe the case is unique enough to be identifiable by the characteristics described. See “Publishing a case study” heading at HIPAA De-identfied data sets IRBMED guidance page.
Do I need IRB approval for quality improvement/quality assurance activities?
IRB approval is usually not needed to perform quality improvement/quality assurance (QI/QA) activities or to present or publish QI results internally or externally, because QI/QA does not usually meet the regulatory definition of "research" at 45 CFR 46.102 (d) (Common Rule). However, OHRP FAQ on QI define “QI activities” more narrowly than the term QI is sometimes used. You should understand those technical definitions and be sure your project does not include sufficient “research” components that IRB approval is needed before you initiate the project. NOTE WELL that projects undertaken jointly with QA/QI and research intent (“research on QI” or “research with QI”) DO require regulation as research. Examples include the CDC Prevention Epicenters Program and Dr. Peter Pronovost’s Indwelling Catheter QI Procedures.
If you wish to obtain IRB input on whether the regulations apply to your QA/QI project, fill out an abbreviated eResearch application describing the project (“Activities Not Regulated…” application type), and submit it to IRBMED. IRB staff are also available by phone or email for consultation: ask for the Exempt/Not Regulated Coordinator. An informative overview is available from UMMS Maintenance of Certification (MOC) Part IV on presenting and/or publishing QI (Section 6 of that page is about IRB considerations).
IRB strongly recommends you submit an application to confirm “Not Regulated” determination for QA/QI activities if these involve data analysis from multiple sites, or through a registry of clinical data (e.g. a national health registry), or if the QA/QI activities involve multiple methodologies (e.g. data collection from medical charts and educational intervention(s) for providers).
What is a "Self-determined" Exemption or Not Regulated notice?
A "self-determination" option appears at the "Section 45 End of application" screen for some Pre-Submission HUM applications requesting Exemption or Not Regulated determination. The eResearch system offers the "self-determination" option only if the information provided indicates that the eligibility for Exemption (or "not regulated" determination), and the inapplicability of additional regulatory requirements such as HIPAA or FERPA, are so settled that personal review of the application by IRB staff would not substantively add to research participant protection.
The PI has the choice to "Submit to IRB" rather than take advantage of "Generate Self-Determination Letter" if s/he wants formal confirmation that s/he answered the form questions accurately. After an application is Submitted to IRB, the "self-determination" option is no longer available. A PI who wishes formal input from the IRB after a "self-determination" can Create an Amendment and "Submit to IRB."
The "Self-exemption" process is described at
- U-M HRPP webpage Exemption changes (heading "Review Path Definitions")
- IRBMED guidance webpage "Exempt human subjects research" (heading "How are Exempt studies regulated?")
- U-M HRPP Operations Manual Part 4.6.C
- for a Pre-submission HUM application eligible for "Self-determination," at the "Section 45 End of application" screen, and
- for a finalized "Self-determination," at the "View ... Letter" link in the HUM workspace "Activities and Correspondence" heading
How and why do I Terminate an Exempt study or Not Regulated project?
For Exempt studies Termination comprises a simple single pop-up screen, and can be completed by any study team member with edit rights. See ITS step-by-step guide "Creating a Termination - Submit a request for terminating an exempt study." Exempt studies receive an "Annual Touch Point" reminder of the option to Terminate on the anniversary of the Exempt determination.
Not Regulated projects need not and cannot be formally closed in the eResearch system.
Exempt Termination is a new functionality as of eResearch 4.3 update in June 2018. It is not a regulatory requirement, but an opportunity to improve the HRPP's 'picture' of ongoing research.
REVISED COMMON RULE with eRESEARCH 4.3 RELEASE
My study involves federal funding. What do I need to know?
Please ensure your application identifies any current or pending external funding in section 02 (see step-by-step guide “Adding a Sponsor” available through eResearch Training and Reference Materials page, heading “Procedure Documents & Tips”). In most cases the eResearch ‘smartform’ will appropriate route studies regardless of funding. IRB staff will work with the study team to ensure each project receives the correct type of review and outcome determination.
Requirements under the Revised Common Rule ("2018 requirements") apply to studies with direct or prime sponsorship from DHHS (including NIH) and/or other federal agencies applying the Common Rule which are
- newly IRB-approved on or after January 21, 2019, or
- ongoing as of January 21, 2019 if the IRB formally 'transitions' the study from “pre-2018 Requirements.”
IRBMED does not intend to transition most ongoing studies with current or pending federal funding. On a case-by-case basis, studies may be transitioned when this will reduce administrative burden (for instance, ending the requirement for continuing review for studies that have completed subject intervention/interaction and are in final analysis and/or accessing follow-up clinical data).
Please follow eResearch system-generated reminders and communications from the IRB, including determination letters for eResearch submissions.
01-1 - Why is there already a “yes” answer to the new question “Does the research involve any of the following”?
For simplicity of transition, the new ‘screener’ question pre-populates to “yes” for all studies previously approved under “Standard” application type. This means study teams are not required by eResearch to consider whether previously approved studies are newly eligible for Exemption.
Study teams may update the new ‘screener’ question at next convenient Amendment if the pre-populated answer is inaccurate; IRB staff may recommend this if it will simplify or clarify future reviews. A “no” answer to this question activates at least one additional question about possible Exemption eligibility for studies involving interaction/intervention; see Overview of Changes document section II.
Do not open an Amendment solely for the purpose of correcting pre-populated question(s).
01-1 - Why does my ‘prospective secondary use’ study now say it involves interaction or intervention?
Studies previously approved under “Standard” application type transition to the new “interaction/intervention” application type. However, the old “Standard” application type also encompassed some “prospective secondary-use-only” studies, where data/biospecimens were obtained on an ongoing basis.
Study teams may update to the new “Secondary research uses...” application type at next convenient Amendment if it will simplify or clarify future reviews. This will activate a new “Scope of secondary use research” section in the application, and will also eliminate or change some previously system-required sections. This is more likely to be valuable if the study is likely eligible for an expanded Exemption 4 in that data recorded in the research analysis dataset never includes direct or coded identifiers (Exemption 4(ii)), or all data is Protected Health Information "used" ("use" has a HIPAA-specific technical definition) inside the Michigan Medicine Covered Entity (CE).
Do not open an Amendment solely for the purpose of correcting pre-populated question(s).
01-1 - Why can’t I select Exemption category 4?
The new ‘Exemption category’ question in page 01-1 is embedded under the “interaction/intervention” application type, and so only addresses Exemption categories that may involve interaction/intervention. Studies limited to secondary use should select the “secondary research uses...” application type, which allows for an IRB "approval," "exemption 4," or "not regulated" determination, based on the research activities.
02 – Where is my previously entered external funding detail?
As of eResearch 4.3 update in June 2018, indicate external sponsors only by selecting/linking to application(s) from the Proposal Management system (eRPM) (Proposal Approval Form (PAF), Award (AWD) and/or Unfunded Agreement (UFA)). Previously entered PAFs display in the updated view of section 02. Previously entered external sponsor data not linked to a PAF will display only in a linked view (pop-up window) for historical purposes.
10.1 and 10.2 – Informed Consent/Assent: what has changed?
The checkboxes for questions 10.1 “What type of informed consent...?” and 10.2 “What type of informed assent...?” have been re-worded and re-ordered, with the intent to help study teams select the correct option(s). These are text-only changes: the regulatory options for consent and assent mechanisms have not changed.
In most cases, selections prior to June 10, 2018 will display and do not need re-answering.
In some cases, questions 10.1 and/or 10.2 must be fully re-answered at the time of the next Amendment (or before the next “Submit Changes to Core Staff”), as these cases have answers that could not be directly converted. This applies to studies where the previous 10.1 (consent) answers included one or more of
- Request for waiver of documentation of informed consent
- Request for waiver of documentation of assent for cognitively or decisionally impaired adults";
and to studies where the previous 10.2 (assent) answers included one or more of
- Request for waiver of documentation of child's assent
- Request for waiver of documentation of parental informed consent/permission
10-3 – What is the new required box?
A new sub-question appears under question 10-3.2 for studies that request full or partial waiver of informed consent (as well as consent alteration requests). This sub-question requires a checkbox and free-text answer to the prompt “If the research involves identifiable private information or biospecimens, the research could not be practicably carried out without using such information or biospecimens in an identifiable format.”
Most IRBMED studies that fill out the waiver of consent section answer a very similar question regarding waiver of HIPAA authorization at 25-2.6: "Why could this research not practicably be conducted without access to and use of the PHI?" In many cases the 25-2.6 answer can be adapted to the new question at 10-3.2.
During the U-M flexibility initiative pilot prior to January 21, 2019, study teams were encouraged to answer this question simply “n/a – 2018 Common Rule Requirement does not apply.” Studies may be asked to re-answer this question at their first Amendment after January 21, 2019
- the study has current or pending federal funding (see question earlier in this section), and
- the waiver is still applicable to ongoing and future study activity.
COVID-19 Related FAQs (from March 30, 2020 C3RG Presentation)
If an IRB application does not specify electronic and/or telephone recruitment can this be done without submitting an amendment?
An amendment should be submitted if adding electronic or telephone recruitment. An amendment should be submitted if adding any new recruitment methods that were not previously approved.
Some studies are being updated to allow virtual visits (telephone or video) and are updating the consent to describe new formats for study visits. Will the IRB require a full re-consent of subjects that have already been enrolled?
Informed consent documents only need to be updated for enrolled participants if COVID-19 related changes to procedures may impact a participant’s decision to remain in the study. Some procedural changes may not impact a participant’s decision to remain in a study and would therefore not require formal re-consenting. Even if re-consenting is not required, it is recommended that enrolled participants be informed of procedural changes by way of a letter or other document. Study teams should also develop a process for having questions answered.
Depending on the nature of the changes to study procedures (e.g., if the changes could impact a participant’s decision to remain in the study), the IRB may require a full re-consent process.
If the study is sponsored, the sponsor should be consulted to see if they have additional requirements.
Can remote or telephone consent procedures be used for consenting or re-consenting subjects on active studies that have been amended? What are the requirements for implementing remote/telephone consent procedures for studies, including ceded studies?
Refer to IRBMED Guidance on Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents (see the section titled, “General Requirements and Considerations for Remotely Obtaining Informed Consent Using Paper Documents):
An impartial witness may be needed if the study is FDA-regulated and the participant is unable to return an image of the signature electronically (e.g., smartphone picture, scan) or by fax at the time consent is obtained. Please refer to Q10 of the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.
If the study is sponsored, the sponsor should be consulted to see if they have additional requirements.
If IRBMED is not the IRB of Record, please contact the IRB overseeing the research to see if they have additional requirements.
Is electronic informed consent only valid during the COVID-19 pandemic or this will be the case in future as well?
Electronic informed consent, including SignNow, can be used for any studies where electronic consent is appropriate. Electronic informed consent is not limited to studies conducted during the COVID-19 outbreak.
If subjects or legally authorized participants (LAR) return a signed paper consent form by sending a photograph, how should that photograph be stored? Are there any implications of the original paper consent document is not obtained?
Study teams should develop a method to retain the signature with a copy of the informed consent form. For example, printing the image of the signature page and attaching it to a full copy of the consent form that is signed by the study team. The study team should also document that informed consent was obtained remotely. It is not expected that the study team will have a paper copy of the consent form returned to them.
Will initial recruitment contact methods such as using MiChart patient portal messages or emails to replace mailed letters or person-to-person contact be permissible due to the COVID-19 outbreak?
Use of the MiChart portal is not an approved method of recruitment at this time and there is no known timeframe for when it would be considered permissible.
When will it be permissible to conduct human subject studies that require in-person visits at UM?
The decision to allow in-person research visits will be informed by national and state government restrictions as well as University of Michigan research policies. Currently, the U-M research restriction has not been lifted and is being re-evaluated given COVID-19 circumstances.
If an ORIO and an Amendment (AME) are submitted to address a COVID 19 contingency plan for a study (an ORIO for time sensitive changes & an AME for updated Informed Consent Forms & Protocol), should the corresponding submission ID's be cross referenced in
Yes, cross linking the submissions will always be helpful. If an ORIO is submitted to notify the contingency plan and then an Amendment is submitted for protocol changes, ensure that the following is selected in 1.6 of the Amendment cover-sheet: “Response to an adverse event (AE) or other reportable information or occurrence (ORIO)”. This will allow the study teams to link the ORIO submission, in 1.6.1, where the contingency plan was approved.
Should COVID-19 guidance letters from sponsors be submitted to the IRB?
Yes, please submit these letters/documents from sponsors to IRBMED.
Sponsor approval has been received to allow various changes to study procedures (e.g. shipping medication to patients, telemedicine visits, etc.) as a contingency plan to reduce person-to-person contact. However, it is unknown which contingency plan will
Yes, this is fine. The initial ORIO should include the overall contingency plan. Any changes or minor deviations to this plan can be submitted via ORIOs or as an aggregate report within the next SCR submission.