OHRP offers primer on IRB procedures
Written procedures should cover seven main areas
One of the most frequent requests that the Office for Human Research Protections (OHRP) receives is for guidance and clarification regarding what should be included in an IRB’s written procedures. To help institutions develop or refine their IRB procedures, OHRP produced a guide that summarizes the relevant regulatory requirements of which IRBs should be aware. IRB Advisor has provided a condensed version of their document below.
IRBs should start with developing procedures for seven main areas required under HHS regulations:
- conducting initial review of research;
- continuing review of research;
- reporting its findings and actions to investigators and the institution;
- determining which projects require review more often than annually;
- determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review;
- ensuring prompt reporting to the IRB of proposed changes in a research activity;
- ensuring prompt reporting of any unanticipated problems involving risks to subjects or others; any serious or continuing noncompliance with federal regulations or IRB rulings; suspension or termination of IRB approval.
IRB procedures should be step-by-step
According to OHRP, written IRB procedures should provide a step-by-step description of how each of the seven main areas will be conducted. Specifically, procedures should include:
— Description of the review process, including steps for initiating protocol changes or directions for reporting problem related to risks or noncompliance.
— Lists of documents that should be distributed to primary reviewers and IRB members.
— Details of any process (e.g., a subcommittee procedure) that may be used to supplement the IRB’s oversight.
— Schedule of when documents should be distributed prior to IRB meetings.
— Possible actions that could be taken by the IRB for protocols undergoing initial or continuing review.
— Description of how expedited review is conducted and how expedited approval actions are communicated to all IRB members.
— Description of the procedures for a) communicating to investigators regarding proposed research and any modifications or clarifications; and b) reviewing and acting upon investigators’ responses.
— Description of which institutional office(s) and official(s) are notified of IRB findings and actions and how notification to each is accomplished.
Other procedures should include:
— Description of who is responsible for further review and approval or disapproval of research that is approved by the IRB.
— Specific procedure for how the IRB determines which protocols require review more often than annually, (e.g., an IRB may set a shorter approval period for high-risk protocols or protocols with a high risk/potential-benefit ratio).
— Specific procedure for how the IRB determines which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review.
— Description of what steps are taken to ensure that investigators do not implement any protocol changes without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects.
— Description of who is responsible for promptly reporting problems involving risks to subjects or others, continuing noncompliance, and any suspension or termination of IRB approval. Should also include a description of the required time frame for accomplishing the reporting requirements.
— Possible actions that could be taken by the IRB in response to reports of unanticipated problems involving risks to subjects or others or of serious or continuing noncompliance.
Meetings, reviews, etc. also need procedures
The guide also lists the following specific areas that will require procedures:
- meetings;
- initial review materials;
- continuing review materials;
- IRB review in emergency situations;
- conditional approvals;
- conflicts of interest;
- initial and continuing expedited review;
- inclusion of women and minorities in research.
Documentation and record keeping should include:
— IRB protocol record, which is simply a document containing all written procedures;
— Minutes of IRB meetings, including deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB; and the vote on all IRB actions including the number of members voting for, against, and abstaining.
— Documentation of findings. When approving a procedure that does not contain all elements of informed consent, the IRB must explain the procedure and justify why the informed consent process should be altered.
— Documentation of risk and approval period. IRBs must determine which protocols require continuing review more often than annually, as appropriate to the degree of risk. OHRP recommends that the minutes of IRB meetings clearly reflect these determinations regarding risk and approval period (review interval).
— Retention of IRB records. IRB records should be retained for at least three years, and records relating to research that is conducted are retained for at least three years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner.
— Procedures for determining exemptions. OHRP recommends that institutions adopt clear procedures under which the IRB determines whether proposed research is exempt from the human subjects regulations.
— Informed-consent documents: Approval and expiration dates. OHRP recommends that IRBs affix the approval and expiration dates to all approved informed-consent documents and stipulate that copies of these dated documents must be used in obtaining consent. This procedure helps ensure that only the current, IRB-approved informed-consent documents are presented to subjects and serves as a reminder to the investigators of the need for continuing review.
Finally, institutions may wish to consider including additional pertinent information in their written IRB procedures, such as: a) important definitions (e.g., the definition of research, human subject, and minimal risk); b) a description of procedures for implementing other relevant federal regulations that apply to human subject research (e.g., FDA and HIPAA regulations); c) procedures for selecting and appointing the IRB chairperson and members in order to satisfy the requirements of Department of Health and Human Services regulations at 45 CFR 46.107; d) procedures for training and educating IRB members and staff and investigators; e) a description of the required elements of informed consent and criteria for waiving or altering these requirements; and f) procedures for ensuring that the IRB possesses sufficient knowledge of the local research context.
To obtain a copy of the complete nine-page guide, visit OHRP’s web site at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/wirbproc.pdf.
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