Frequently Asked Questions

Table of Contents

Why an IRB? Which IRB?

Study team qualifications

Submitting applications and documents

Common questions about application content

Review and approval process

Ongoing review

Other required reporting to IRBMED

Additional research oversight

Other application types

Repositories 


Why an IRB? Which IRB?


What kind of research and other activities require IRB review?

Please contact the IRB for assistance in determining whether your project requires review. The U-M HRPP Operations Manual Part 4 also provides information.

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."

FDA regulations and policies also make IRBs responsible for oversight of some non-research activities, including Humanitarian Use Devices and Expanded Access (compassionate use).

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:

For more information, see Central IRB Information webpage and contact IRBMEDcentralIRB@umich.edu

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?

Many of the tips below are covered in more detail in other FAQ questions, or in other guidance on the IRBMED website or the HRPP website.

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.

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 and 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 offers educational workshops on eResearch as well as on regulatory topics.

What application type should I select?

Most studies, especially involving interaction/intervention with subjects, require a “Standard, non-exempt research project” application. Studies limited to secondary analysis data and/or specimens may have a range of application types available.

Information in the “help” section of eResearch under Section 01-1 can assist you in selecting the correct application type.

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 at https://research.medicine.umich.edu/office-research/institutional-review-boards-irbmed/informed-consent-templates 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,

  1. Download from Section 10-1 of the eResearch application the most recent IRB-approved clean version of a consent.
  2. Turn on Microsoft Word “Track Changes” functionality
  3. Make all necessary changes
  4. 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

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.

Review and 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?

Generally you should be able to expect a decision within 4-8 weeks for full board review, and 2-4 weeks for expedited review. Please alert the IRB if your application is time-sensitive.

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.

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

Ongoing review

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

You are not required to submit an amendment regarding exempt studies (or “not regulated” projects) 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?

Most IRB approvals are valid for one year from the date of approval; however, exceptions may occur. The current “Expiration Date” is listed on the main page for your approved application. Approval period can only be extended by IRB approval of a “continuing review” application (see “How do I apply for a Scheduled Continuing Review?”).

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.
1. 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.
2. Enrollment of new subjects during a lapse is prohibited
3. 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.

Do I need to tell the IRB when I am finished with my research?

Yes. You should submit a termination report via eResearch (i.e., create a new continuing review report (SCR) and select “Termination Report”). If you wish to engage human subjects in research after a study is terminated, a new eResearch application must be submitted.

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 UMHS 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?

There is a state requirement that many privately administered lotteries/raffles be licensed by the state. Please see our guidance at webpage guidance and short presentation.

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,

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 regarding QI projects is available from UMMS Office of Continuous Professional Development (OCPD) overview 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).

Repositories

For information on IRB oversight of data and/or biospecimen repositories, see website guidance Repository Overview and sub-pages, including FAQ: Repository Application (REP).

 

 

Page created 9/25/2012
Updated 7/20/2017