by Claire Carbary

Common Rule Changes – Making Sense of the Proposal for Excluded Research

Institution Bulletin vol. 5, issue 4

One of the major changes outlined in the Notice of Proposed Rule Making (NPRM) is the creation of a new section of the regulations describing activities that would be “excluded” from the requirements of the Common Rule. The intent of this change is to provide clarity about what activities should be considered research, and therefore, covered by the Common Rule. In addition, the proposal would limit the application of the Common Rule to certain research activities considered to be “low-risk” — that is, they do not entail physical risk, and both the probability and magnitude of other risks, once required protections are applied, are hypothesized to be low.[1]

Importantly, the NPRM notes that there is no proposal outlining how decisions will be made for determining whether a research activity is eligible for exclusion. Furthermore, the proposal is based on the assumption that all investigators will be able to accurately determine whether the proposed activity is outside the scope of the Common Rule. The NPRM requests that stakeholders consider whether the benefits associated with reducing the delay for researchers are countervailed by potential increases in risk of harm.

Kinetiq, the technology and consulting division of Quorum Review has prepared a summary of the new Excluded Categories under the proposed rule with corresponding explanations for how each Excluded Category impacts existing Exempt Categories where applicable.


[1] NPRM, p. 53950.

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