Here’s the relevant passage in full:
The framework for this chapter’s recommendations follows from the fundamental point that the Common Rule was intended to apply to human-subjects research specifically in the biomedical, behavioral, and social sciences. From that perspective, the Common Rule does not apply to scientific research that does not meet the definition of human-subjects research. Also, it does not apply to scholarly or investigative activities that are not conventionally considered to be scientific research, even if they involve interaction with people.
Recommendation 2.2: HHS should revise the Federal Regulations to clarify that many forms of scholarship that are widely labeled “research” should be considered as “not human- subjects research” because they are not covered by the intent or spirit of the term “human-subjects research” (see Box 2-3).
Guidance Recommended: OHRP should provide guidance offering examples of forms of scholarship that conventionally fall outside of the definition of human-subjects research, which could help researchers and IRBs in determining whether research activities would be considered as not human-subjects research. For example, historians or nonfiction writers speaking to sources about particular events, or organizations collecting information about preferred benefits packages or studying internal process improvement (that is, self-study) are not engaged in human-subjects research, and such activities are not intended to be covered by 45 C.F.R. § 46.
Scholarship outside the definition of human-subjects research
1. Interviews with individuals for the purpose of establishing a historical record or supplementing extant historical records (e.g., biographical scholarship)
2. Personal observation and note taking preparatory to composition (e.g., fiction writing, memoir, and related creative or expressive writing) (p. 32)
Unfortunately, the report does not specifically address journalism and folklore, which could have been easily added to this list.
It’s worth noting the justification for this recommendation: “the Common Rule was intended to apply to human-subjects research specifically in the biomedical, behavioral, and social sciences.” Thus, the NRC committee has avoided any hairsplitting about generalizability, and has instead adopted an originalist stance, opposing the ever-widening scope of the Common Rule.
The report could have taken this analysis further by noting that the statute on which the Common Rule is allegedly based, the National Research Act of 1974, covers only biomedical and behavioral, not social research.
If we were really serious about the intent of the law, we would restrict regulations to the scope authorized by Congress.