What To Expect at an IRB Meeting Einstein IRB Members come from a diverse community of physicians, researchers, clinicians, nurses, pharmacists, physical therapists (among other members of the medical community), engineers, lawyers, and non-scientists. We rely on their combined expertise and hard work to ensure that we are engaging in the responsible conduct of research. The following are resources that are useful for understanding and conducting an IRB review. Sequence of Events at IRB Meetings The format for discussion of protocols at the full board committee meeting is not set by federal regulations or guidance documents. Thus, IRBs are able to develop a routine that works for their institution and membership. What follows is a basic order of Einstein IRB meetings: The meeting starts with review and approval of the minutes from the previous meeting. The Chair reminds members about the IRB member Conflict of Interest Policy and asks if any conflicts exist among those present. The Chair or assigned IRB members present progress report submissions to update the board on the status of the studies, and votes are taken to renew their approval periods. The board reviews each initial submission as follows: The primary reviewer presents a BRIEF summary of the study. The Board members should have already read the protocol, so there is no need to for the primary reviewer to re-explain. The primary reviewer presents ALL major problems/questions. The secondary reviewer focuses on the consent form. The secondary reviewer does not need to repeat what was already discussed. If there are no additional issues, they may state so. Specific minor revisions (including mention of minor consent revisions) do not need to be discussed. Reviewers can simply note that minor consent changes will be forwarded to the analyst. Controversial issues are discussed, one by one. The statistician reviewer provides comments. Investigators are generally invited to participate in the discussion about their study, though they must leave before the IRB calls for a vote. The Chair states and/or confirms the regulatory findings (e.g., 45 CFR 46.111 approval criteria, vulnerable population criteria, IND/IDE status, HIPAA waiver). The chair ends the discussion and calls for a vote to approve, accept with contingencies, table, or disapprove. The Chair or assigned IRB members present amendments to previously-approved studies if any, and votes are taken. An ideal environment is one that promotes an open discussion and encourages all members to express their views in a warm atmosphere, and all IRB members participate in identifying and discussing the issues. There is no formula for this process so it is essential that the IRB Chair manage this aspect of the meeting. The Chair determines when all of the important issues have been raised, declares the discussion over, and calls for the vote. Questions of regulatory or policy matters are often addressed by the Chair or IRB Director as IRB members are not expected to be as expert in these areas. Voting Options at Meetings Approved: The study meets the regulatory criteria for IRB approval as defined by 45 CFR 46.111 and/or 21 CFR 56.111. The application has secured approval, thus the investigator is not required to make changes to the protocol or IRB application. IRB approval is valid for one year, unless the committee designates a shorter period due to higher levels of risk. An approval letter is sent to the investigator. The consent documents (if any) are stamped with the IRB approval dates. The investigator may start enrolling subjects. Approved Pending: A study may be “approved pending” if only non-substantive changes are necessary to gain final approval. Examples of such minor non-substantive requested changes include: Confirmation of specific assumptions or understandings on the part of the IRB regarding how the research will be conducted (e.g., confirmation that the research excludes children); Submission of additional documentation (e.g., certificate of ethics training); Directed language changes to protocol or informed consent documents; or Directed changes to protocol or informed consent documents along with clearly stated parameters that the changes must satisfy. If a study is “approved pending,” the investigator’s response to the requests does not need to go back to the full board for approval. Rather, it can be done via “expedited” review. Deferred: A study may be deferred because of substantive changes requested by the committee, or other issues related to the criteria for approval. The investigator’s response to the requested changes will come back to the full board for review. Disapproved: A study may be disapproved if the magnitude and/or number of concerns, questions, and problems are such that an “approved pending” or “deferred” decision are inappropriate. In contrast to deferral, which implies that the study may be approvable pending substantive changes, disapproval of research should be reserved for when the board cannot reasonably imagine revising the study in such a way that the benefits outweigh the risks. Tabled: A study may be tabled if the IRB determines that it does not have enough information to vote on a study. Recuse: If an IRB member is listed in a study under IRB review or has any other conflict of interest, they may not participate in the initial or continuing review of the study (or an amendment) except to provide information requested by the IRB. The IRB member must leave the room (e.g. “recuse” themselves for the discussion and vote). The meeting minutes will reflect this. The chair requests IRB members with a conflict of interest to leave the room and not participate in the vote or discussion. Conflicts of interest include financial interest, active participation in the trial as principal investigator or co-investigator, or any other issue for which the member feels his or her vote could be potentially conflicted. Abstain: If an IRB member does not have a “conflict” but is unable to vote (e.g., left the room during discussion, does not comprehend the study or the issues) the member may “abstain” from voting. A vote to “abstain” will be included as part of the voting quorum. The meeting minutes will reflect this.