February 24, 2024

Concerns over proposed changes to consent in US research

The HHS is suggesting changes in the use of biospecimens, supervision of multicentre studies, and ethics oversight for trials not involving invasive interventions.

Concerns have been raised about proposed revision of  US Department of Health and Human Services (HHS) human research ethics regulations. The HHS is suggesting changes regarding the regulation of the use of biospecimens for research, the supervision of multicentre studies, and the need for ethics oversight for trials not involving invasive interventions.

Specifically, the HHS would require scientists to obtain explicit consent from patients before using their blood or tissue for research. The new protocol is designed to prevent issues like the case of Henrietta Lacks, a black woman whose tissue was used without permission in cancer research for decades.  

But a number of specialists are concerned that the new rules would add unnecessary red tape to research.

“It’s now going to be much more onerous to get this tissue that otherwise would just go in the trash,” says Dr. Luis Garza, a Johns Hopkins University dermatologist who uses foreskin from circumcisions for a variety of experiments. “It’s creating barriers for working on human tissue, which is what we need to do to solve human disease.”

Other researchers are worried about changes to regulation of multi-site studies by institutional review boards. Under the proposed rules, one centralized institutional review board could run an entire multicenter study, rather than IRBs at each location participating in oversight.

Some advocates and bioethicists worry that streamlining study reviews would undermine protections for volunteers, especially studies involving many sites. Dr Michael Carome, who heads Public Citizen’s Health Research Group, a Washington, DC-based advocacy group, says that it is unlikely one IRB can “adequately understand the local context, local ethical issues, the quality of the facilities and the credentials of the practitioners.”

Certain exemptions have also been proposed for studies that do not pose physical risks, such as projects that only involve asking subjects questions and answers in surveys and in-depth interviews.

But this change is raising fears, too. Those kinds of studies “are not physically invasive, but they may be intrusive,” Ruth Macklin, a bioethicist at the Albert Einstein College of Medicine in New York, told NPR. “There are forms of harm that are not just physical harm.”

Probing people about sensitive subjects, such as whether they’ve had an abortion or have been physically or sexually abused as children, can trigger strong emotional reactions, potentially causing psychological distress, Macklin says.

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