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.
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.
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.
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:
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.
(Research that does not involve biomedical procedures)
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.
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.
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:
View Ohio State’s FWA (#00006378)
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:
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.
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:
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.
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.
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:
Those designated to be a primary or secondary reviewer of the research will also review:
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.
Plan on spending several hours reading materials and preparing your reviews. Some helpful hints about preparation follow:
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.
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.
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.
The following procedures will be used for each study reviewed (new submission, continuing review, event report, or amendment):
In their motion, the primary reviewer should propose:
Study risk level is defined as either minimal risk or greater than minimal risk. Please use the following general guidance to make a determination:
The IRB has determined that all criteria for approval have been met, as follows:
When applicable, the IRB has:
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.
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.
Risks of the procedures outweigh any potential benefit to be gained and/or the proposed research is inconsistent with HRPP policies.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Article ID: 76
Created: August 28, 2024
Last Updated: September 23, 2024
Online URL: https://ohiostateresearch.knowledgebase.co/article/information-for-irb-members-76.html