Why IRB Reviewers Ask Those Questions

It's not unusual for a protocol submitted to the IRB to be deferred with a request for information or a stipulation to make specific changes as a condition for approval.

The 111 Criteria. In order to approve a protocol, IRB members conducting a review at a convened meeting or using expedited procedures must make seven determinations, which are listed in the federal regulations for protection of human subjects at 45 CFR 46.111. Simply put, applications are deferred because they don't contain the information that reviewers need to make the required determinations. These determinations, known as the "111 criteria", are as follows:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 


(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

 

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. 


(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116. 


(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117. 


(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. 


(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.


The Checklist. IRB members use exhaustive (and exhausting!) checklists to assist in making determinations for each of the 111 criteria. The main checklist, in a slightly edited format, can be accessed by following this link:

203 Checklist

Special Checklists. IRB members use additional checklists when a protocol involves special populations of research subjects, such as pregnant women, children, or involves an unusual situations such as alteration of the consent process.


Updated 5/24/17


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