HHS rules aim to protect clinical trial participants

HHS rules aim to protect clinical trial participants
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The Obama administration finalized new rules Wednesday to better protect people who voluntarily participate in federally funded clinical trials.

The rule from the Department of Health and Human Services (HHS) and 15 other government agencies updates the 1991 regulations to require participants be given consent forms that clearly explain up front the purpose of the research, the risks involved and any alternative treatments that might be beneficial. 

The HHS removed a provision it first proposed in 2015 requiring researchers to get a patient’s consent before using their non-identified biospecimens such as blood, plasma and urine, and decided in the final rule only to cover federally funded clinical trials. 


“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” Dr. Jerry Menikoff, director of the HHS Office for Human Research Protections, said in a news release.

“We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.”

The final rule is set to take effect on Jan. 19, 2018.