In November 2010, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) published new continuing review guidance for institutional review boards (IRBs). The new guidance (roughly 40+ pages) is more detailed, and gives IRBs an opportunity to use the new information to fit their institutional needs, as long as they satisfy the regulatory requirements set forth in 45 CFR 46.
It is important to note that the recommendations are directed toward research that is conducted or supported by Health and Human Services (HHS). However, many institutions apply the guidance to other research as well. The guidance indicates that continuing review should be similar to the initial review, applying the same guidelines throughout the process. However, we also read that:
When conducting continuing review, the IRB should start with the working presumption that the research, as previously approved, does satisfy all of the above criteria. The IRB should focus on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects.
Thus, during continuing review, IRBs should determine if any information provided by the researcher will alter the initial assessment. In addition, OHRP guidance states that IRB reviewers should pay particular attention to the following four aspects of the research:
- Risk assessment and monitoring;
- Adequacy of the process for obtaining informed consent;
- Investigator and institutional issues; and
- Research progress.
The guidance goes on to provide examples of these four aspects, indicating what kinds of documents the IRB reviewer should evaluate. Some sections discuss what should be included in an institutions’ standard operating procedures, the review process, and approval dating procedures. One critical section (OHRP Guidance on IRB Continuing Review of Research, November 10, 2010, Section C(7)) may result in changes to IRB procedures.
The guidance later states that, “an IRB administrator or staff member who is also an experienced member of the IRB may be designated by the IRB chairperson to conduct continuing review of research under an expedited review procedure.” So it’s not prohibited for staff to review continuing review submissions, but OHRP wants to ensure that the person is a member of the IRB and has the qualifications to conduct the review. Thus, if you have IRB staff that are not IRB members, but reviewing continuing review submissions, you will want to discuss this information with your institution to determine the next steps.
I have found the information in the new guidance to be helpful in assessing our continuing review process. We will be assessing our procedures in the near future to ensure that we’re aligned with these recommendations. Will your institution be using this guidance, as well?