Panel Calls for Explicit Rules on Human Subjects Research

Some significant updates are in store for the federal rules governing human subjects research, and the National Research Council (NRC) is trying to ensure those changes include clear, sensible requirements for social and behavioral studies.

A special NRC committee, chaired by APS Past President Susan Fiske, has completed a report recommending more clarity in the regulatory updates to the so-called Common Rule, the baseline standard of ethics for government-funded research involving human subjects.

“We need more explicit definitions,” Fiske explained during a January 30 public briefing on the NRC committee’s report. “Regulations have to be clear. If you have a lot of room for interpretation, regulators go all over the place.”

First proposed in 2011 by the US Department of Health and Human Services (HHS), the Common Rule revisions are designed to extend protections to people more effectively while simultaneously easing the oversight and paperwork requirements for scientists.

The NRC committee says that one clear category should be “not-human-subjects research,” which would explicitly include the use of pre-existing research and nonresearch data collected from publicly available resources. Much data is in fact public, even when it contains personally identifiable information, the report contends.

“The biggest implication of this is publicly available information is ‘not-human-subjects research,’ as long as the individual had no reasonable expectation of privacy,” Fiske said at the briefing.

Another of the major components of the proposed rule changes is the creation of an “excused” category for low-risk research, including educational tests, surveys, focus groups, and familiar procedures. That designation would lighten the scrutiny required by Institutional Review Boards that oversee government-funded scientific studies.

HHS also “should make clear in the revised regulations that excused research includes research that has no more than minimal risk, even if the information being gathered addresses questions about human subjects’ physical or psychological well-being” and “should explicitly address the relationship between the consent of human subjects and excused research, with consent required in all excused research that directly involves human subjects through interaction or intervention,” the report states. The report discusses lowering the burden of excessive consent documents in such research.

The NRC committee also addressed data-protection components of the Common Rule revisions. It said that even in the case of excused research, scientists should register the study and file a data-protection plan.

“These plans need to be calibrated to the type and level of informational risk in order to avoid inadvertent disclosure and to reduce the level of any potential risk to no more than minimal,” the report says.

After HHS considers public feedback on its proposals, it will make changes where appropriate before publishing a final rule in the Federal Register with a specific date upon which the rule becomes effective and enforceable.

The NRC committee’s complete report, along with the webcast of the January 30 public briefing, are available at the National Academy of Sciences website.