Information for IRB Members

The Ohio State’s Institutional Review Boards (IRB) work closely with investigators and the university to help ensure the safety and welfare of the individuals participating in human subject research. Currently, Ohio State investigators are conducting more than 6,000 projects that involve human participants.

Your appointment letter is very important. Your signed copy provided within DocuSign is the official record documenting your acceptance of the IRB member role on behalf of the university.

IRB Member Roles

Your primary responsibility as an IRB member is to help protect the rights and welfare of research participants. Most members are Ohio State faculty members who are knowledgeable about science and research methods. Other Board members are Ohio State staff and/or non-affiliated community volunteers.

Members are appointed to ensure each Board contains a variety of expertise and diversity. All members have an equal vote. Please do not hesitate to give your comments during the Committee discussions. Each member brings a special set of skills and insights that are important for a thorough IRB review. It is important that all members actively participate.

There are faculty members from a variety of disciplines on each IRB. Diverse expertise is needed to evaluate a wide variety of research studies. When a study has not been reviewed for scientific merit before the IRB meeting, the scientist members on the committee must evaluate the study plan. The IRB must know that the scientific question is important and that the proposed study design can yield the information required to answer the research question. If the IRB determines there is a major study design flaw, the IRB would be concerned that the investigator would not be able to answer the study question. As a result, the IRB could not approve the research since the study risks would outweigh the potential benefits (new knowledge) to be gained.

The IRB members must also reflect racial, gender, and cultural diversity. This is desired to promote sensitivity to community attitudes and respect for the Board’s decisions. Some members also have specific advocacy roles (e.g., prisoners and children involved in research). For others, their primary concern is in non-scientific areas. Non-scientist members provide very important checks to determine if study materials and consent forms are in a language that will be understandable to potential study participants. The role of the non-scientist is so critical that there is a regulatory requirement for a non-scientist to be present at each convened IRB meeting.

Whenever possible, each IRB member has an alternate. This is done to reduce the frequency of meetings that members must attend. It also helps to ensure that sufficient members are available to reach the required meeting quorums. Although some members are officially designated as alternates, all members have equal voting privileges. If for some reason a member and his/her alternate wish to attend the same meeting, only one member of the team can vote on an action.

Education

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 are given the Institutional Review Board Member Handbook which you should also find very helpful as you perform your reviews.

New IRB members must complete a web-based Collaborative Institutional Training Initiative (CITI) human subjects protection training course before serving as reviewers. The CITI course is comprehensive and includes information on ethical principles and regulatory requirements. National experts developed the course with funding from the National Institutes of Health. It is considered a state-of-the-art course and is currently used by thousands of institutions and organizations worldwide. Please inform staff of your course completion. Details on the required training are found here.

As an IRB member, you will also receive periodic updates. The IRB Chairs and Vice Chairs also attend local, regional, and national conferences to help the Boards stay current on human subjects protections issues.

Administrative Support

The Enterprise for Research, Innovation and Knowledge's Office of Responsible Research Practices staff provides support to the university review committees. The staff members are pleased to assist you in your role as an IRB member. Your primary contact will be with the IRB analysts. Please do not hesitate to contact an analyst if you ever have any questions or concerns.

The staff will:

work closely with the investigators and with the IRBs
pre-review the submissions for completeness before placing them on an IRB meeting agenda
answer investigators’ questions and assign studies to the most appropriate IRB
attend the IRB meetings to provide regulatory guidance, prepare IRB meeting minutes, and forward IRB correspondence to investigators
work with IRB leadership to develop quality improvement initiatives and to investigate allegations of non-compliance with human subjects requirements
conduct post-approval monitoring to ensure compliance with IRB-approved studies

Learn more about IRB and Ohio State human subjects research policies, IRB member rosters and meeting dates, and other regulatory guidance.

Ohio State Institutional Review Boards

The university has three internal IRBs. A listing of the Boards and the current leadership follows.

The staff monitors Board assignments to ensure that the IRB with the most applicable expertise reviews the research. The staff may change a study’s Board assignment if IRB members have significant conflicts of interest.

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

Interim Chair - Jennifer Vaughn, Associate Professor, Hematology
Vice Chair - Alison Neal, Director, Comprehensive Cancer Center
Vice Chair - Julie Rice-Weimer, Lead Nurse Clinical Research Coordinator, Nationwide Children's Hospital
Vice Chair - Mary "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

Research (clinical trials) that is industry-sponsored, and not designed by Ohio State researchers is reviewed by an independent IRB (e.g., WIRB-Copernicus Group IRB, Advarra) unless the 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. The following university committees have specific responsibilities as mandated by federal regulations, state law, and university policies.

Clinical Scientific Review Committee (CSRC) - cancer-related activities
Institutional Biosafety Committee (IBC) - gene manipulation, infectious agents, toxins
Maternal-Fetal Welfare Committee - pregnant women and fetuses
Human Subject Radiation Committee - radioactive drugs or research exposure to external radiation
Privacy Board - studies that are 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). Each organization conducting human subjects research must have an assurance filed with the federal Office for Human Research Protections (OHRP). 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; and
human subjects research will be limited to locations for which the university has authority and oversight responsibility.

View Ohio State’s FWA (#00006378)

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:

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

Some limited use of non-Ohio State facilities is permitted for research activities; however, the facilities and the personnel at the non-Ohio State sites must not be “engaged” in the research activities.

Guidance

Engagement of Institutions in Human Subjects Research (HHS)
Ohio State investigator tools for collaborative research
Questions may also be directed to an IRB analyst

Since Ohio State is automatically "engaged" in human subjects research whenever it receives a direct federal grant, generally the Ohio State IRB must review and approve research whenever an Ohio State faculty member receives a federal grant. This is required even if there will be no human subjects activities at any Ohio State sites. In some situations, IRB review may be ceded to a collaborating institution through the use of an IRB Authorization Agreement facilitated by ERIK responsible research practices staff.

If a principal investigator proposes:

Limited use of another institution’s facilities (e.g., schools, nursing homes, businesses) for research activities that do not engage the facility or the facility personnel in the research, the IRB should require the investigator to submit letter(s) of support from the institution(s).
More than limited use of the outside facilities or involvement by individuals who are not Ohio State employees or students (that would engage them in the research activities), the IRB should ask the investigator to provide documentation that there are arrangements in place for IRB oversight.

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; however, the teams may split their coverage as best fits their schedule. While it is recognized that both members might occasionally be unavailable for a meeting, this should be rare. Researchers (including students on graduation timelines) count on all IRB meetings being held as scheduled.

If a member is unable to attend a scheduled meeting, the member should first contact their alternate to determine if their alternate can attend an additional meeting or trade scheduled meeting dates. The member that has initiated the schedule change must inform the IRB analyst of their team’s plan for meeting coverage with as much advance notice as possible so materials can be properly posted. Should the university close for severe weather or other emergencies, e-mail notifications will be provided with instructions regarding meeting cancellations.

Meeting Logistics

Schedule and Location

Please refer to your Board’s specific schedule for meeting dates. Meetings are held every two or three weeks and usually last from two to three hours.

Advance Materials

Approximately 6 days before each convened meeting, the analyst will notify you via email that meeting materials are posted in Teams. The material will include an agenda and information about all the studies the Committee will consider. The member’s convened folder will contain reviewer sheets and a research proposal for your assigned studies and other detailed information as applicable (e.g., grant proposal, consent documents, drug information). Specific meeting contents are described below.

For new studies or those undergoing continuing review, all IRB members review the following:

IRB application summarizing the research;
informed consent and assent documents, as applicable;
questionnaires to be used for data collection (e.g., questionnaires, interview questions, or assessment scales); and
recruitment materials, including any advertisements to be seen or heard by potential participants.

Those designated to be a primary or secondary reviewer of the research will also review:

The complete copy of the research proposal;
a complete copy of the sponsor’s protocol or grant application for externally funded applications, as appropriate; and
copies of the applicable drug/device information for research involving medications or devices.

Please notify the IRB analyst if you are missing any materials.

The complete IRB file and minutes from previous reviews are also available to all IRB members before and during the convened meeting upon request.

Preparing for the Meeting

Plan on spending several hours reading materials and preparing your reviews. Some helpful hints about preparation follow:

Begin by reviewing the meeting agenda. Look for your name to determine to which studies you have been assigned. These materials are your priority; start by reviewing them. You may be assigned to review a new study, an ongoing study that is due for a continuing review, an amendment, or an event report.
Many studies are reviewed during a convened IRB meeting; however, some IRB submissions may qualify for expedited review (which means they are reviewed outside of the meeting by one or more IRB members designated by the Chair). New members are not assigned to perform expedited reviews on the medical IRBs.
The primary reviewer should prepare a short summary for each of their assigned studies. The summary should emphasize the procedures, risks, benefits, and consent process. Try to be concise and avoid giving excessive study details as each Board member receives a research summary and consent form in their materials.
Remember that the IRB member’s job is to help protect the rights and welfare of research participants. As you review your materials, look for problems and unanswered issues, but also try to suggest solutions. It is most helpful if you can come to the meeting ready to recommend specific modifications that the IRB can require the investigator to make.
The primary reviewer is encouraged to contact the principal investigator to resolve questions in advance of the meeting. The secondary reviewer should also be prepared to fill in (give a verbal summary of the study) if the primary reviewer is unexpectedly absent.
At times, ad hoc consultants may be needed to provide additional professional expertise to assist the Committee in its review. Should you identify the need for a consultant, please contact the IRB analyst who will work with the Chair to make the necessary arrangements.
All assigned reviewers are required to complete reviewer sheets. Teams-posted reviews are preferred to avoid transcription problems; these can be uploaded prior to the meeting or by the end of the meeting day. Remember to date and note the IRB action(s) on your reviewer sheet(s), type your name, and upload the sheet in your “convened” study-specific folder.
Members should also ensure that any meeting materials are not copied or circulated. Please ensure that any printed IRB meeting materials are shredded when disposed.

Attending the Meeting

Guests

All guests will complete a confidentiality agreement. Guests may include investigators, Ohio State staff, and students. When a principal investigator (PI) is present during the convened IRB meeting, the IRB will review the application and begin a discussion of the criteria for approval, engaging the PI as appropriate. After the PI is excused, the IRB will complete discussion of any controversial issues until resolution prior to voting.

Meeting Agenda

The Chair will call the meeting to order and will usually follow the prepared agenda. Sometimes when there are conflicts of interest or other schedule conflicts, agendas must be rearranged. Ongoing research (i.e., continuing reviews, amendments, and event reports) is usually discussed before new studies. This is done to avoid lapses in IRB approval and research interruptions should the IRB not be able to complete its entire agenda.

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 of interest are excused from the meeting but may be asked to answer questions about the study should any arise during the discussion. The member must leave the meeting prior to final discussion and voting. The name of the Board member with a conflicting interest is recorded in the IRB meeting minutes.

Chairs and Vice Chairs with conflicts of interest will not conduct those discussions and are absent from the meeting as described above.

Study Reviews and Discussions

The following procedures will be used for each study reviewed (new submission, continuing review, event report, or amendment):

Members must disclose any potential/actual conflicts of interests and excuse themselves from discussion and voting on applicable submission reviews;
the primary reviewer will read their review emphasizing issues impacting participant welfare and safety with recommendations for modifications to improve participant protections when appropriate;
the secondary reviewer will present their comments;
the discussion will be opened to the full Board, and
at the conclusion of the group discussion, the Chair will ask the primary reviewer to offer a motion.

Making a Motion

In their motion, the primary reviewer should propose:

Recommended Board action
And for new reviews,
1. the risk level associated with the study, and
2. recommended length for IRB approval (up to one year).

Risk Level

Study risk level is defined as either minimal risk or greater than minimal risk. Please use the following general guidance to make a determination:

A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during performance of routine physical and psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination.
A risk is greater than minimal when the probability and magnitude of harm or discomfort anticipated in the research are more than those encountered in daily life. Greater than minimal risk research requires ongoing monitoring by the principal investigator and IRB, and may also require monitoring by an independent safety monitor or data and safety monitoring board.
The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Additional requirements apply when the research is greater than minimal risk, particularly for vulnerable populations (children, prisoners, fetuses, adults with impaired decision-making capacity).

IRB Actions

Approval

The IRB has determined that all criteria for approval have been met, as follows:

Risks to subjects are minimized;
risks are reasonable in relation to reasonably anticipated benefits;
selection of subjects is equitable;
consent will be obtained & documented (or regulatory criteria for waiver of consent/consent documentation have been met);
proposed consent form(s) contains all the required elements ;
consent language is not exculpatory;
information is presented in a language that is understandable to potential subjects;
informed consent will be obtained from adults who are able to consent;
assent will be obtained from (adults who are unable to consent and children 14-17 years old, when applicable;)
verbal assent will be obtained from children younger than 14;
separate parental permission will be obtained for participants under 18;
confidentiality is safeguarded;
monitoring is adequate to assure subject safety and data integrity The IRB has determined whether an independent data and safety monitoring board or committee is required.

When applicable, the IRB has:

determined that regulatory criteria for inclusion of vulnerable populations have been met (additional safeguards have been included);
determined whether an IND or IDE is required if a study involves the use of investigational new drugs or devices or the investigational use of approved drugs or devices (Tools for Drugs/Tools for Devices)

Outcomes (next steps)

Investigator receives an IRB approval letter for the period specified by the board.
Letter informs the investigator of responsibilities for:
- study oversight;
- reporting serious adverse events and unanticipated problems;
- for seeking IRB approval before initiating study changes; and
- for seeking continuing IRB approval.
Research that has been approved by the IRB may be subject to further review by the Senior Vice President for Research (SVP).
If approved by the IRB but not permitted by the Senior Vice President for Research, the SVP will promptly convey notice to the investigator and the IRB Chair.

Modifications Required

The criteria for approval have been met based on the review materials and minor clarifications or explicit revisions that require simple concurrence by the investigator.

Note: The federal agency (Office for Human Research Protections – OHRP) has made findings against boards when they inappropriately approve research contingent upon substantive modifications or clarifications.

Outcomes (next steps)

The chair designates an IRB member who will subsequently review the investigator responses under expedited procedures outside the convened meeting.
The reviewer approves the revised research study on behalf of the IRB.
Research may not begin until the IRB member indicates that the required modifications have been made.

Deferral

The criteria for approval have not been met. Additional information including substantive changes to the research proposal, consent form(s), application, or other materials is required before the board can make a determination.

Outcomes (next steps)

Investigators are notified of deficiencies.
One or more members of the IRB may be appointed to discuss the deferral with the principal investigator.
After revising the protocol and/or consent form(s), the investigator will resubmit their response to the ERIK responsible research practices staff.
The application is then scheduled for re-review at a convened meeting of the appropriate IRB.
The IRB may request that the investigator attend the convened IRB meeting at which the revised study will be reviewed.
If the changes are approved, an approval letter that will document the approval period is sent to the investigator by the staff.

Disapproval

Risks of the procedures outweigh any potential benefit to be gained and/or the proposed research is inconsistent with HRPP policies.

Outcomes (next steps)

ERIK responsible research practices staff notifies the principal investigator by letter of the reasons for disapproval.
The principal investigator will be given an opportunity to respond in person or in writing.
No research may be initiated without approval of the designated IRB.
The board’s vote is final.
Neither the Senior Vice President for Research or any other office or official of the institution may approve a research activity that the IRB has disapproved.

Length of IRB Approval

The IRB may approve research for up to one year. The approval period should be appropriate to the degree of risk and the Committee may set a shorter approval period (i.e., more often than annually) for high or unusual risk studies or studies with a high risk/benefit ratio.

Examples of research that may require more frequent review include “novel” research (e.g., gene manipulation), Phase I studies, or projects conducted by investigators who have previously failed to comply with the requirements of the IRB. The approval period will be documented in the IRB meeting minutes.

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 toward the meeting quorum. The IRB member and their alternate may not both vote at the same meeting.

Members may vote for or against the motion or may choose to abstain from the vote. Only one action is voted on at a time.

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 (e.g., loss of members through absence or abstention), the IRB may not take further actions unless and until a quorum is restored.

Following the Meeting

The ERIK responsible research practices staff and IRB leadership work together to prepare and finalize the meeting minutes. Standard turnaround times have been developed to try to ensure prompt preparation of investigator correspondence.

The staff will write the meeting minutes and the IRB Chair, Vice Chair, or member chairing the meeting will review and approve the minutes within five working days following the convened meeting. Within three working days of receiving the approved minutes, the staff will send correspondence to the PI documenting the Board’s actions. When modifications are required, the staff will pre-review investigator responses and will forward complete responses to the designated IRB reviewer.

Reviews Performed Outside the Convened Meeting

Studies that meet specific regulatory criteria may be reviewed outside the convened IRB meeting. This is defined as expedited review. The IRB Chair designates the IRB members who may perform expedited reviews. The IRB members are notified of expedited reviews in the Teams Archives Folder.

New Studies

The IRB Chair designates members with an appropriate level of experience to conduct these types of reviews. A single IRB member will review each submission. Reviews are posted on a weekly basis. The reviewer should contact the IRB analyst immediately if they feel the research does not qualify for expedited review or if they are unable to complete and return their review within one week.

The reviewer may approve the research, request modifications, or refer the research to the convened IRB for review, but may not disapprove the research. The reviewer must document the specific research category(ies) under which the research qualifies for expedited review. Completed reviewer sheets should be uploaded to Teams.

Investigator Responses to IRB Required Modifications

The analyst will post investigator responses and revised supporting documents for the designated modifications reviewer. The reviewer should ensure that the investigator has made all the modifications requested by the Board. Reviewers are asked to limit their review to the Board’s specific requests.

Continuing Reviews and Amendments

Only administrative and editorial amendments and continuing review applications that meet the requirements for expedited review may be reviewed outside of the convened IRB meeting. The Chair delegates these responsibilities to a limited number of experienced IRB members who have undergone additional training. The expedited reviewer may approve the research, request modifications, or refer the research to the convened IRB for review but may not disapprove the research.

Exempt Research

Some human subjects research may be exempt from review by the IRB. At Ohio State, investigators may not make this determination. ERIK responsible research practices staff review applications for exemption to determine whether the proposed research meets the regulatory requirements for exemption.

IRB Member Protections

Because the IRB can deal with contentious issues, there is always a possibility that the university or individual members of the IRB may be named in a lawsuit. In those instances, IRB members have often asked whether they have legal protections. As discussed below, the answer is yes, but the specific protections depend on your status with the university.

University employees have qualified immunity to suit for actions taken within the course and scope of employment as long as they are acting in good faith and in a reasonable manner generally. For employees who serve on the IRB, such service becomes part of their university duties, so they are covered by such immunity should they be named in a suit.

IRB members who are not employees are not formally entitled to state employee immunity but may have some similar protections as appointees to the board. And, regardless, all volunteer members are covered under the university’s general liability insurance policy for their service on the board in furtherance of Ohio State’s mission to support research initiatives as long as they are acting within the scope of their IRB responsibilities in good faith and in a reasonable manner.