HHS Plans Overhaul of Human Research Subject Protections

HHS last week proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials.

The reforms, detailed in a 519-page notice of proposed rulemaking, would reduce the length of informed consent forms and give more details about aspects of the research that could influence a person’s decision to participate. And they would increase transparency around consent forms by requiring that they be posted for public scrutiny.

For the first time, informed consent would be required for secondary research with a biospecimen, although this could be obtained on a broad basis and not for each specific study. Waivers of consent for research involving biospecimens would be granted in rare circumstances, HHS says.

The proposal also calls for a single IRB to oversee all U.S. sites of a multisite trial, and encourages the use of unaffiliated IRBs.

Another change would eliminate requirements for conducting continuing reviews of studies, such as ones undergoing expedited review or involving only observational follow-up.

The proposal also would extend HHS protections to all clinical trials conducted at federally funded institutions to comply with HHS protections, regardless of their funding source. The provision is meant to cover privately funded trials that currently aren’t subject to any human subject rules and specifically excludes FDA-regulated studies.

Sponsors of drug clinical trials are subject to the FDA’s clinical trial regulations, 21 CFR 50. If a trial receives federal funds, it must also comply with HHS’ Common Rule, 45 CFR 46.

The reforms — slated for publication in the Sept. 8 Federal Register — are the first since the Common Rule was encapsulated in the 1991 revision to 45 CFR 46. The Common Rule initially took effect in 1981. Many of the reforms were included in an advanced notice of public rulemaking issued in 2011.

Comments are due by Dec. 7 to Docket Number HHS-OPHS-2015-0008. Read the NPRM here: www.fdanews.com/9-15-HHS-NPRM.pdf. — Jonathon Shacat