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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
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 for approval IRB submissions: new applications, amendments to approved studies, and continuing reviews.
All projects that meet the federal definition of research with human subjects (45 CFR 46.102 f) must be reviewed and approved, or receive an exempt determination, by an IRB 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
- Level of risk to subjects associated with the project
- The type of research being conducted (e.g., an educational intervention, a survey, an ethnograhpich observation, etc.)
- The sensitivity of the research questions or complexity of the research design
- The involvement of vulnerable populations as research subjects
IRB-Regulated Research Review
The IRB may conduct either an expedited or full board review for IRB-regulated research proposed in the Standard 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 an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects 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 testing
- A complex research design requiring the expertise of multiple board members to evaluate
Applications requiring full board review are accepted by the submission deadlines and reviewed by the full board on the IRB meeting date (see Related Information to the right for schedule links). 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.
IRB Full Board Determinations
Approved with Contingencies: the application has been 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 an accurate assessment of the application can be made. 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 may 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 providing 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 accepted and reviewed on a continuing basis. Expediting reviewers are experienced IRB members 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.
IRB Expedited Review Determinations
In addition to the Approved and Approved with Contingencies determinations (described above) a Changes Requested status may occur, where 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 exempt application for review and final determination by the IRB. Projects that meet the criteria for a federal exempt category (45 CFR 46.101 b) or for a U-M exemption (Exempt 2a or Exempt 7) may be granted a determination of exemption by the IRB. Most research receiving an exempt determination poses no more than minimal risk to the subjects.
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.
IRB Exempt Review Process
The IRB review of an exempt application is limited in scope to the information necessary to determine if the proposed exemption applies. It does not review informed consent documentation or recruitment materials for proposed exempt studies. A suggested template for a brief protocol for use in exempt applications can be found here. 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.
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, d
- 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 obtains data through interaction/intervention with the individual, or obtains identifiable private information? ~ Federal definition 45 CFR 46.102, f
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.