Information for IRB Members

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.

Administrative Support

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:

• Pre-reviewing submissions for completeness
• Answering investigators' questions
• Assigning studies to appropriate IRBs
• Attending IRB meetings to provide regulatory guidance
• Preparing IRB meeting minutes
• Conducting post-approval monitoring

Visit the human subjects page for policies, guidance, and IRB member rosters.

Ohio State Institutional Review Boards

The university has three internal IRBs:

Behavioral & Social Sciences IRB

(Research that does not involve biomedical procedures)

• Chair - Daniel Strunk, Professor, Clinical Psychology
• Vice Chair - Jesse Fox, Associate Professor, Communication
• Vice Chair - Gerald Kosicki, Associate Professor, Communication

Biomedical Sciences IRB

• Chair - Karla Zadnik, Professor, College of Optometry
• Vice Chair - Alison Neal, Director, Comprehensive Cancer Center
• Vice Chair - Julie Rice-Weimer, Lead Nurse Clinical Research Coordinator, Nationwide Children's Hospital
• Vice Chair - Claire Such, Physical Therapist, Sports Medicine/Ambulatory Rehabilitation

Cancer IRB

• Chair - Susan Colace, Associate Professor, Pediatric Hematology/Oncology/BMT
• Vice Chair - Julia Cooper, Assistant Professor, Human Genetics

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.

Other Review Committees

For some types of research, other institutional committee approvals are also required:

• Clinical Scientific Review Committee (CSRC) - cancer-related activities
• Institutional Biosafety Committee (IBC) - gene manipulation, infectious agents, toxins
• Human Subject Radiation Committee - radioactive drugs or research exposure to external radiation
• Privacy Board - studies that are ceded for external IRB review or exempt from IRB review and involve protected health information (PHI) (HIPAA compliance)

Assurance for Human Subjects Research

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:

• All non-exempt human subjects research will be reviewed and approved by the IRB before it is undertaken
• Legally effective informed consent or a consent waiver will be obtained for all human subjects research
• Written procedures for human subjects protections will be followed
• Serious non-compliance with human subjects requirements will be reported to OHRP
• Sufficient IRB resources will be provided
• IRB members, researchers, and research support staff will receive human subjects training
• Human subjects research will be limited to locations for which the university has authority and oversight responsibility

Research Performance Sites

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:

1. Intervene or interact with living individuals for research purposes
2. Obtain individually identifiable private information for research purposes
3. Receive a direct federal grant to support human subjects research

IRB Meeting Attendance

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.

Meeting Logistics

Schedules / Locations

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.

Advance Materials

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:

1. Huron SmartForm
2. Research protocol highlighting regulatory criteria
3. Informed consent and assent documents
4. Instruments to be used for data collection
5. Recruitment materials

Primary or secondary reviewers also review:

1. Complete copy of the research protocol and accompanying appendices
2. Complete copy of the sponsor's protocol or grant application for externally funded applications
3. Copies of the drug/device information, as applicable

Preparing for the Meeting

Plan on spending several hours reading materials and preparing your reviews.

Helpful preparation hints:

1. Begin by reviewing the meeting agenda and look for your assignments
2. Check for conflicts of interest that will necessitate reassignment
3. Primary reviewers should prepare a short summary emphasizing procedures, risks, benefits, and consent process
4. Look for problems and suggest solutions
5. Primary reviewers are encouraged to contact the principal investigator to resolve questions in advance
6. Contact the IRB analyst if you need an ad hoc consultant
7. Complete the Huron review activity to submit reviewer comments prior to the meeting
8. Ensure that meeting materials are not circulated and are properly disposed of (shredded)

Attending the Meeting

Guests

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.

Disclosing Conflicts of Interest

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.

Study Reviews and Discussions

The following procedures will be used for each submission reviewed:

1. Members must disclose conflicts and excuse themselves from discussion and voting
2. Primary reviewer presents their review emphasizing participant welfare and safety
3. Secondary reviewer presents their comments
4. Discussion is opened to the full Board
5. Chair asks the primary reviewer to offer a motion

Making a Motion

In their motion, the primary reviewer should propose:

1. Recommended Board action
2. For new reviews:
   • The risk level associated with the study
   • Recommended length for IRB approval (up to one year)

Risk Level

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 Actions

Table with IRB actions, requirements and outcomes

IRB Action	Requirements	Outcomes
APPROVAL	All criteria for approval have been met, including: Risks to subjects are minimized Risks are reasonable in relation to anticipated benefits Selection of subjects is equitable Consent will be obtained & documented Consent forms contain required elements Confidentiality is safeguarded Monitoring is adequate	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.

Voting

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.

Following the Meeting

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.

Reviews Performed Outside the Convened Meeting

Studies that meet specific regulatory criteria may be reviewed outside the convened IRB meeting through expedited or designated review.

New Studies

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.

Continuing Reviews & Amendments

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.

Exempt Research

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 Member Protections

IRB members have legal protections should they be named in a lawsuit:

• University employees have qualified immunity for actions taken within the course and scope of employment as long as they are acting in good faith and in a reasonable manner.
• Non-employee IRB members may have some similar protections as appointees to the board and are covered under the university's general liability insurance policy for their service on the board.

Last updated: May 14, 2025