Full IRB Review
Research protocols requiring review by the full board are those that involve greater than minimal risk to human participants. Common examples of research requiring full board review are studies involving prisoners, persons with undocumented status, research on illegal activities, incarcerated youth, among others. Whether a proposed research protocol will require full board review depends on the nature and context of the particular study. The level of review is determined by the HSPP/IRB, not by the investigators. In addition, some studies may begin review by one or two members (expedited review), but may be referred to the convened IRB at the discretion of the reviewer(s).
The full board meets about once a month, but approval may require modifications and subsequent review(s) by the convened IRB or by designated members. Researchers should allow sufficient time for the pre-review process to ensure that submission materials are adequate for IRB review. Only complete and consistent submission materials will be assigned to a meeting agenda for review, and the agendas are closed one week to 10 days prior to each meeting.
If your research may involve greater than minimal risk to subjects, you are advised to submit the study well before you intend to begin their research - our recommendation is six months prior to the planned start of the research. Communication with the HSPP manager can also ensure the timeliness of this process.
The DHHS Office of Human Research Protections dictates the procedures for convened IRB meetings. The content of the meeting minutes is also regulated by federal codes and guidelines, as well as institutional standards. Refer to the HSPP Policies & Procedures and reviewer worksheets and checklists for detailed information on the IRB review process and the criteria for approval.
Convened IRB meetings are closed to the public. Researchers and outside consultants may be asked to participate in IRB discussions of specific studies, but only IRB members and authorized HSPP staff can be present in the room for votes on determinations.
Possible Outcomes of a Full Board Review
There are several possible determinations that may be made for proposed research that is reviewed by the convened IRB:
- The Board may vote to approve the proposed research when all criteria for approval are met. The IRB must also determine an interval for continuing review. Most approvals are granted for one year at a time. The investigators are responsible for submitting for continuing or final review of the research to ensure that this IRB approval does not lapse.
- The Board may determine that modifications to the proposed research protocol are required to secure approval and will outline those specific modifications for the investigators. Individual IRB members and/or HSPP staff are designated to review the modifications, when received, to determine whether the researchers have made the required changes.
- The Board can decide to defer the proposed research when the study does not qualify for approval or minor modifications and will make recommendations that might make the protocol approvable. Once further information and/or revised research materials are received from the researchers, the study is assigned to the next available IRB meeting for subsequent review.
- The Board may vote to disapprove proposed research and will provide the Principal Investigator with their reasoning for this decision. If a study is disapproved, the investigators may appeal this decision or modify their protocol and submit for a new IRB review. Please be aware that no one at the institution, including the administration, deans, or department chairs, can override an IRB decision to disapprove a proposed study.
In general, continuing reviews and amendments to studies originally approved by a convened IRB must also be reviewed and approved in the same manner. However, the IRB may determine at some point that a specific study may be handled through the expedited process - depending on the risks to participants and the current status of the research.
Please be advised that the quality and clarity of any proposed research materials submitted to the IRB will affect the board's ability to assess risks to participants and to make a determination in a timely manner. Researchers who are developing study proposals that may involve greater than minimal risk to participants are encouraged to actively seek guidance and information from the HSPP prior to submission to avoid unnecessary delays in the review process.
HSPP staff will help facilitate the IRB review process and send appropriate correspondence to the Principal Investigator via IRBNet of any determination made by the IRB. The HSPP staff can offer guidance and assistance on the IRB review process and requirements. Please contact the HSPP with any questions or concerns at email@example.com.