Ohio State University - May 14, 2025
By reviewing studies and participating in Board discussions, you will become knowledgeable about the wide spectrum of Ohio State research, and you will gain information about the latest research methods. Since science and technology are rapidly advancing, you will be taking part in lively discussions about evolving research ethics.
This guide is provided as your reference to the Ohio State IRB procedures. New members are required to observe an IRB meeting before beginning to review studies. In addition, all members have access to the Institutional Review Board Member Handbook through University Libraries.
Required Training: New IRB members must complete a web-based Collaborative Institutional Training Initiative (CITI) human subjects protection training course before serving as reviewers. Details on the required training are found here.
The Office of Responsible Research Practices (ORRP) provides support to the university review committees. The ORRP staff members are pleased to assist you in your role as an IRB member. Your primary contact will be with the IRB analysts.
ORRP staff responsibilities include:
Visit the human subjects page for policies, guidance, and IRB member rosters.
The university has three internal IRBs:
(Research that does not involve biomedical procedures)
Note: Research (clinical trials) that is industry sponsored and not designed by Ohio State researchers is reviewed by an independent IRB unless ORRP staff determine that the research should be reviewed by one of the local Boards.
For some types of research, other institutional committee approvals are also required:
Ohio State has documented its intent to ensure that human subjects research is done properly through the university's Federalwide Assurance (FWA) #00006378. By signing this document, the institutional official has documented the university's commitment that:
An Ohio State IRB may only approve human subjects research activities at locations for which the Board has an understanding of the local research context, and the university has oversight and control mechanisms in place.
Persons are considered to be "engaged" in human subjects research when they:
A quorum of the full IRB membership must be present to hold a convened meeting. Most IRB members have another member with whom they alternate their meeting attendance. While it is recognized that both members might occasionally be unavailable for a meeting, this should be rare.
Important: If a member is unable to attend a scheduled meeting, they should first contact their alternate to determine if they can attend an additional meeting or trade scheduled meeting dates.
Please refer to your Board's specific schedule for meeting dates. Meetings are held every two weeks or monthly and usually last from two to three hours.
Approximately seven (7) days prior to each convened meeting, the analyst will notify you via email that the meeting agenda is finalized, and your assignments are available in the Huron IRB system.
All IRB members review:
Primary or secondary reviewers also review:
Plan on spending several hours reading materials and preparing your reviews.
Helpful preparation hints:
All guests will complete a confidentiality agreement. When a principal investigator (PI) is present during the convened IRB meeting, the IRB will review the application and begin discussion, engaging the PI as appropriate. After the PI is excused, the IRB will complete discussion until resolution prior to voting.
As an IRB member, you are required to disclose all potential and actual conflicts of interest before a study is reviewed. IRB members with conflicts are excused from the meeting but may be asked to answer questions. The member must leave prior to final discussion and voting.
The following procedures will be used for each submission reviewed:
In their motion, the primary reviewer should propose:
Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during routine physical and psychological examinations or tests.
Greater than Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are more than those encountered in daily life. This requires ongoing monitoring and may also require monitoring by an independent safety monitor.
| IRB Action | Requirements | Outcomes |
|---|---|---|
| APPROVAL | All criteria for approval have been met, including:
|
Investigator receives an IRB approval letter. Research may be subject to further review by the Senior Associate Vice President for Research Operations. |
| MODIFICATIONS REQUIRED | Minor clarifications or explicit revisions that require simple concurrence by the investigator. | Chair designates an IRB member to review investigator responses under expedited procedures. Research may not begin until required modifications are made. |
| DEFERRAL | Criteria for approval have not been met. Additional information including substantive changes is required. | Investigators are notified of deficiencies. Application is scheduled for re-review at a convened meeting after revisions are submitted. |
| DISAPPROVAL | Risks outweigh potential benefits and/or the proposed research is inconsistent with HRPP SOPs. | ORRP notifies the principal investigator of reasons for disapproval. No research may be initiated without approval. The Board's vote is final. |
In-person meetings use show of hand votes. Electronic meetings use polls to vote. Members with disclosed conflicts may not vote and do not count towards the meeting quorum.
A motion passes when no more than one IRB member of the duly convened IRB casts a dissenting vote. If the quorum is lost at any time during the meeting, the IRB may not take further actions unless a quorum is restored.
The ORRP and IRB leadership work together to prepare and finalize the meeting minutes. The IRB chair will review and approve the minutes within five working days following the convened meeting. Within three working days of receiving the approved minutes, the ORRP staff will send correspondence to the PI documenting the Board's actions.
Studies that meet specific regulatory criteria may be reviewed outside the convened IRB meeting through expedited or designated review.
A single IRB member will review each submission that qualifies for expedited review. The reviewer may approve the research, request modifications, or refer the research to the convened IRB for review, but may not disapprove the research.
Only administrative and editorial amendments and continuing review applications that meet the requirements for designated review may be reviewed outside of the convened IRB meeting.
Some human subjects research may be exempt from IRB review. At Ohio State, investigators may not make this determination. ORRP staff review applications for exemption to determine whether the proposed research meets the regulatory requirements for exemption.
IRB members have legal protections should they be named in a lawsuit:
Last updated: May 14, 2025
Article ID: 76
Created: August 28, 2024
Last Updated: July 1, 2025
Online URL: https://ohiostateresearch.knowledgebase.co/article/information-for-irb-members-76.html