"Substantive IRB Review" & News

With all of the attention and increased oversight of IRBs, it is essential that organizations ensure that all IRB review is "substantive". In the past, and all to often even now, IRBs have used what could be called the "sniff test". You know when you have a container of milk in the fridge and you don't know how long it's been there, you pick it up, smell it and, if it smells OK, you drink it. Well, that's how a lot of IRBs review protocols. They look at the research and, if it's good science and they are getting consent, they approve it. That's not substantive review.

The regulations have always been very specific about what constitutes substantive review. Section 111 of the regulations (in both the Common Rule and FDA regulations) details the Criteria for IRB Approval of Research. Section 111 states: "In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied". The criteria in Section 111 include: risks are minimized, risks are reasonable in relation to benefits, subject selection is equitable, informed consent is appropriately obtained, informed consent is appropriately documented, data monitored to ensure subject safety, privacy and confidentiality are protected, and additional protections are in place for vulnerable subjects. Substantive IRB review means that each and every one of the criteria are addressed by the IRB for every review - initial review, continuing review, and review of modifications.

In addition to the 111 criteria, there are also other required determinations in the regulations, such as the criteria for waiver of consent and the use of vulnerable popultions. These too, when applicable, must be addressed by the IRB.

Most IRBs that do more than the "sniff test" sort of address the 111 criteria and other required determinations, but don't do it in a systematic way. The best way to ensure that the required determinations have been addressed is to use a review checklist which includes all of the required determinations. Many IRBs have review checklists but don't really use them. Individual reviewers should use the checklists when doing their review and the full IRB should use the checklist to guide it's discussion of the research.

Of course, as they say, "It's not good enough to do the right thing, you must also be able to demonstrate to others that you have done the right thing." It's not enough for IRBs to address the required determinations, they must also adquately document that they have addressed them. For full IRB review, the minutes should document that the IRB addressed the 111 criteria for each protocol and the other required determinations as applicable. For expedtied review, there should be a review form that documents that they are addressed and is signed by the reviewer.

By ensuring that the IRB is doing a substantive review and adequately documenting that it has been done for every review, an organization not only fulfills it's responsiblity under the regulations, but also best protects itself from outside criticism or worse.