Proposed Rules Would Boost Human Research Protections

Proposed rules would boost protection for individuals who participate in human research studies. (Image: NIH)

Proposed changes to US oversight of human research would extend existing protections to studies not receiving federal funding and offer individuals more control over how their tissues are used in research, according to Department of Health and Human Services (DHHS) officials who unveiled the proposal during a press briefing today.

The proposal aims to update the “Common Rule” of medical ethics regarding participants in human research, which was last established in 1991. “These regulations were developed at a simpler time,” said DHHS Assistant Secretary for Health Howard K. Koh, MD, MPH, during the briefing. He explained that in the past 20 years, huge changes occurring in research have rendered the regulations out of date. Larger, more complex multicenter studies have become more common as have studies funded by private entities. Additionally, advances in genomics, expanded use of the Internet in research, and more study of behavioral issues have raised new concerns.

Currently, human research that is not federally funded or subject to oversight by the US Food and Drug Administration (FDA) is exempt from the Common Rule. For example, studies comparing surgical techniques may currently escape scrutiny if they do not involve an FDA-regulated product and are not being funded by the National Institutes of Health (NIH) or another federal agency. To prevent such gaps, the new rule would require any institution receiving any federal funds to submit to oversight of human studies.

“Participants in human research should know they are covered by the same protections regardless of the stream of funding,” said NIH Deputy Director for Science Outreach and Policy Kathy Hudson, PhD, at the briefing.

The proposed rule also addresses privacy concerns raised by advances in genomics. Currently, researchers may use biospecimens collected from participants in previous research for future studies without consent as long as information that could identify the individual such as their name is removed from the containers. But Hudson notes “with today’s technology, biospecimens are inherently identifiable.” So the new rules would require that individuals be given the opportunity to decline such future use of their specimens.

Other recommended changes would help to streamline the research process such as requiring multisite clinical studies to have centralized oversight of patient safety and ethical conduct, harmonizing research data protection requirements with the requirements of the Health Insurance Portability and Accountability Act, and matching the level of oversight for a study with the level of risk the study poses to participants.

Categories: Evidence-Based Medicine, Genetics, Human Rights, Internet, Medical Ethics