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U-M HRPP Operations Manual References
IRB approval criteria:
Part 3, Section III, C 4
Regulated/not regulated research:
Part 4, Section V
Exempt research policy:
Part 4, Section VI
Using the U-M IRB System
IRB staff and board members have access to the IRB application and posted correspondence via the eResearch Regulatory Management (eRRM) system. The system facilitates the IRB review process by:
- Providing regulatory checklists that guide IRB staff review
- Routing submissions to ancillary committees (e.g., COI-UMOR), as applicable
- Re-routing submissions to a different U-M IRB, if applicable
IRB-HSBS Turnaround Times
"Turnaround" is the estimated time it takes to complete the IRB review and determination process.
Full-board: 4 - 8 weeks
Expedited: 2 - 4 weeks
Exempt: < 1 week
03/23/2020: Due to the temporary restriction on human subjects research through May 1 to facilitate COVID-19 prevention measures, IRB-HSBS guidance is to NOT use the system-generated exempt or not regulated self-determination functions to initiate research projects.
New IRB applications or amendments to existing studies (including exempt and not regulated studies) for research related to COVID-19 must first obtain prioritization approval from the UMOR Research Prioritization Committee by completing the COVID-related Research Prioritization Form prior to IRB review. Upload the committee's approval/authorization in Section 44 of the IRB application or as a posted correspondence.
The U-M Institutional Review Boards (IRBs) fulfill their goals to protect human subjects and support the design and conduct of sound research by reviewing and approving IRB submissions for new applications, amendments, and continuing reviews.
All projects that meet the definition of research with human subjects (45 CFR 46.102)(link is external)) must be reviewed and approved by an IRB, or receive an exempt determination, prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.
Types of IRB Review
The basic types of IRB Review are: Comprehensive, Exempt, and Not Regulated. The type of IRB review and the associated review process (e.g., full board, expedited, limited IRB review, system-generated) are determined by the:
- Level of risk to subjects associated with the project
- Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
- Sensitivity of the research questions or complexity of the research design
- Involvement of vulnerable populations as research subjects
- Use of identifiable information or indentifiable biospecimens
- Applicability of one or more of the criteria for exempt or expedited review
The IRB may conduct either an expedited or full board review for IRB-regulated research proposed in the Interaction/Intervention or Secondary Use application types to ensure:
- Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
- The subject selection is equitable
- Privacy and confidentiality are protected
- Informed consent processes meet federal regulatory and U-M requirements
Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves more than minimal risk to human subjects, does not meet the criteria for one of the categories of expedited review, or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, IRB-HSBS may require full board review when the research involves:
- Vulnerable populations, particularly prisoners
- Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality (CoC) to protect subject data from compelled disclosure
- Research involving genetic/genomic analyses
- A complex research design requiring the expertise of multiple board members to evaluate
The IRB posts submission deadlines for upcoming IRB meeting dates. If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next IRB meeting date (see Related Information to the right for schedule links), except where the agenda is already full or a reviewer with the necessary expertise is not available for that meeting. IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.
IRB Full Board Determinations
Approved with Contingencies: the application is approved, contingent on submission of specified changes to the protocol, informed consent document(s) and/or other supporting materials. Final approval status is granted when the IRB has reviewed and approved all requested changes. The date of the "approved with contingencies" determination is deemed the date of approval.
Action Deferred: the IRB needs additional information from the investigator before the IRB can make all of the determinations found at 45 CFR 46.111 necessary to approve the study. The principal investigator must submit the requested additional information before the IRB will consider the application for further review.
Disapproved: the protocol does not provide adequate protection to human subjects, and it is unlikely that it can be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision, and provides the opportunity for the investigator to respond to the IRB in person or in writing.
Tabled: the IRB full board did not have time to review the application at the convened board meeting. The application is placed on the agenda for the next convened meeting.
Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:
- Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories
- Minor changes to research previously approved by the full board
Applications qualifying for expedited review are assigned to an expediting reviewer, an experienced IRB member appointed to the role by the IRB Chair. The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval. Only the full board has the authority to disapprove a study. Most studies that qualify for the expedited review process do not require annual Continuing Review.
IRB Expedited Review Determinations
In addition to the Approved and Approved with Contingencies determinations (described above) reviewer may issue a Changes Requested determination, when substantial changes to the application and/or materials are required before the expediting reviewer can approve the study.
Per university policy, investigators must submit an IRB application for determination of exemption before research begins. Applications are routed for exempt review through the Interaction/Intervention application or the Secondary Use application types. IRB-HSBS recommends using the Brief Protocol for Exempt Research Projects (download) to provide an overview of you exempt project or as a data entry guide when completing the IRB application.
Projects that meet the criteria for a federal exemption category (45 CFR 46.104) or for a U-M exemption #5 may be granted a determination of exemption by the IRB, or where applicable, through the system-generated review process. The review determination, whether conducted by the IRB or system-generated, is limited in scope to the information necessary to determine if the proposed exemption applies. The IRB does not review informed consent documentation or recruitment materials for proposed exempt studies. Exemptions may be granted by the IRB Chair, expedited reviewers, or (in most cases) qualified IRB staff members.
Projects receiving an exempt determination are not subject to the Continuing Review process. Amendments are required only if the changes to the project would alter the exemption criteria. An exempt determination does not lessen the researcher's ethical obligations to subjects as articulated in the Belmont Report or to the codes of conduct for specific disciplines.
Research involving prisoners or certain types of research with children (e.g. surveys, interviews/observations of public behavior where the investigator interacts with the children) does not qualify for exemption.
The Common Rule provides a Limited IRB Review process, which is a required expedited review of subject privacy and data confidentiality for exempt 2 and 3 projects that collect or use sensitive and identifiable data. An exempt determination is issued once the expediting reviewer confirms that these protections are acceptable.
For some exempt research, the Principal Investigator is permitted to issue a system-generated exemption determination letter, based on repsonses to key questions in the IRB application. The IRB does not review system-generated determinations, however the U-M HRPP may conduct a post-determination validation audit to ensure the exemption criteria are being applied in accordance with regulatory requirements and that the potential risk to human subjects remains minimal. Investigators may choose not to issue the system-generated determination letter but, instead, choose to csubmit a study for an IRB determination of exemption.
Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human subjects research. Hoever, investigators may wish to submit a brief eResearch IRB application for a formal “not regulated” determination for funding or publication purposes; or, the investigator may be able to issue a system-generated determination letter without submission to the IRB.
Submission to the IRB is not required for the following activities:
- Case studies
- Class activities
- Journalism/documentary activities
- Oral history
- Quality assurance and quality improvement activities
- Research on organizations
- Research using deidentified data or biospecimens
- Research using publicly available data sets
Some categories require IRB review for the purpose of assessing compliance with HIPAA or other regulations. These include:
- Research involving existing information or biospecimens that have been coded before the researcher receives them, but identifiers exist
- Research involving deceased individuals only
- Pre-review of clinical data sets preparatory to research
- Standard public health surveillance or prevention activities
For a complete list of not regulated research activities, see the HRPP Operations Manual, Part 4.
If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:
1. Is it research?
Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge ~ Federal definition, 45 CFR 46.102(l)
- Systematic investigation is an activity designed to test a hypothesis and to draw conclusions as described in a formal protocol that sets forth an objective and procedures to reach that objective.
- Activities such as the practice of public health, medicine, counseling, or social work are not research.
- Generalizable knowledge is information expressed in theories, principles, and statements of relationships that can be widely applied (e.g, by publishing findings or presenting findings at a professional meeting).
- Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.
2. Does the research involve human subjects?
Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens. ~ Federal definition 45 CFR 46.102(e)(1)
3. Is the university engaged in the conduct of the research?
The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities. See OHRP's Guidance on Engagement of Institutions for more information and examples.
- Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.
- If you answer "no" to any of these questions, you may have other obligations than IRB review. See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.