BETHESDA, MD — This summer, HHS announced a proposal to improve the rules governing the protection of human research subjects — a system usually referred to as the Common Rule, which has been in place since 1991. While the proposed changes are wide-ranging, some critics question whether the revisions go far enough or do anything to better protect human subjects.
In July, a notice of proposed rulemaking (ANPRM) was published
in the Federal Register, laying out proposed changes and soliciting comments from the research community. Those proposals, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” included revisions to risk-based protection rules.
HHS is proposing to no longer keep Institutional Review Board (IRB) reviews going once a study has reached the data-examination phase. Also, while there now are categories of studies, such as surveys that are exempt from a review, HHS is proposing those studies be held to a data-protection standard and officially tracked by the agency.
The ANPRM also targets informed consent forms, which have been heavily criticized as being too technical, too lengthy and with no highlighting of the important points that a research subject should know. HHS is proposing to prescribe appropriate content as well as dictate appropriate length, because some consent forms can be as long as 50 pages.
HHS also proposes an overhaul of how multisite studies are reviewed. Currently, a domestic multisite study could be reviewed by dozens or hundreds of IRBs, with no clear evidence that more IRB reviews bring added protection. HHS proposes to have a single IRB of record for all domestic, multisite studies.
The agency also proposes that all federally funded human research fall under the Common Rule. Six categories of research currently are exempt: research in education settings involving educational practices; research involving educational tests if the subjects are elected officials and if federal status requires confidentiality; research involving the collection of existing data; research designed to study public benefit or service programs; and taste and food quality evaluation and consumer acceptance studies.
All such studies that receive federal funding would be held to Common Rule regulations if the proposal becomes law.
The proposal also tackles “regulatory harmonization.” After the Common Rule was adopted in 1991, each federal agency was allowed to create its own set of additional guidance regarding human subject protection. Consequently, each federal agency has differing guidelines, which sometimes conflict with each other. The ANPRM would require consistency of regulations across the federal government.