Final Rule Issued on Human Research Protections

At long last, it happened! Just before the change in Administrations, the new rule governing research with human participants was released. In July 2011, the U.S. Department of Health and Human Services (DHHS) and White House Office of Science and Technology Policy proposed the most extensive changes to the regulations on human research protections in decades.

Although there have been changes over the years to the human research protection system, the regulations, according to the Advanced Notice of Proposed Rulemaking (ANPRM) issued in July 2011, “have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of human services research, research in the social and behavioral sciences, and research involving databases, the internet, and biological specimen repositories, and the use of advanced technologies such as genomics.”

The focus of the proposed regulatory changes was on Subpart A of 45 Code of Federal Regulations 46, known as the “Common Rule” because the regulations were also adopted by a number of federal departments and agencies.

The proposed changes attempted to address a number of concerns raised in various reports and academic papers, including:

  • Calibrating the review process to the risk of research;
  • Streamlining IRB review of multi-site studies;
  • Improving the informed consent process and forms;
  • Strengthening data protections to minimize “information” risks (e.g., medical records, genetic information);
  • Improving the monitoring and evaluation of the research oversight system; and,
  • Harmonizing federal regulation and guidance across agencies.

Since mid-July 2011, federal officials have been sifting through over 1000 comments to the ANPRM; interacting with federal science agency staff; drafting a Notice of Proposed Rulemaking; reviewing over 2100 additional comments on the proposed rule; reviewing reports from the National Academy of Sciences, Engineering, and Medicine (including Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences, chaired by FABBS Past-President, Susan Fiske); and developing a final rule. Whew!

The final rule is still being carefully reviewed by the scientific community, but it does:

  • Allow for a broader consent process (e.g., prospective consent to unspecified future research);
  • Establish new exempt categories based on risk; and,
  • Remove the requirement for continuing review of ongoing research for studies that have undergone expedited review or have completed the study intervention(s) and are only analyzing data or doing observational follow up.

Importantly, the final rule does not:

  • Require repeated consent for use of nonidentified biospecimens;
  • Adopt the proposed new concept of “excluded activities”; nor
  • Expand the rule to cover clinical trials that are not federally funded.

The new rules appear to have addressed some of the major concerns of researchers, while ensuring adequate protections for participants in research.

More changes are in store, too. The new notice also states: “…the intent is to eventually amend the other subparts of the HHS human subjects protection regulations in 45 CFR part 46 (subparts B, C, D, and E)….

Read the final regulation (see pages 111-121).
Review background information on the Final Regulation.