HHS and 15 other agencies issued proposed updates Wednesday to what is known as the Common Rule, created to protect human research subjects. The updates, which include clearer consent rules for the reuse of stored blood or tissue in new research unrelated to their original use, come on the eve of President Barack Obama's ambitious Precision Medicine Initiative that may involve as many as 1 million volunteer subjects.
The Common Rule, established in 1991, addresses the ethics, oversight and transparency related to biomedical research involving human subjects. The agencies began overhauling the regulations in response to the increasingly expanded and sophisticated ways biospecimens can be analyzed, as well as in response to the collection of digital health records.
Adil Shamoo, professor of biochemistry and molecular biology at the University of Maryland and chairman of the medical ethics subcommittee of the Defense Health Board, said pressure to make changes to the Common Rule came after ethical concerns about misconduct and inappropriate consent of human research subjects came to light.
One of the proposed changes would require participant consent for future use of donated biospecimens. Researchers now can use leftover samples by simply stripping them of any personal identifying information.
Shamoo said he believes the most important change requires the policy to be extended to cover all clinical trials, regardless of whether they are government or privately funded.
He added that he favors using centralized institutional review boards (IRBs), but cautioned that a centralized IRB should be associated with a university, and the university should conduct the reviewing process in a professional manner, and not by overworked faculty members. In a large clinical trial with numerous IRBs, the current system requires every IRB to approve research protocols, Shamoo said. That makes no sense and is a waste of resources, he said, as IRBs are local with varying sets of rules.
“I don't believe in large bureaucracies,” he said.
But not everyone agrees with the rule using a single IRB for cooperative research. That rule would inappropriately mandate that only one IRB may review clinical trials conducted at multiple institutions, including trials that involve dozens or hundreds of sites, said Dr. Michael Carome, director of the health research group at not-for-profit advocacy group Public Citizen. “IRBs review human research to ensure it is ethical and complies with regulations,” Carome said in a statement.
Shamoo also advocates for the proposed rule that surveys and low-risk research shouldn't require IRBs, and only highly intrusive research should be reviewed by an IRB. But Carome said the proposed rule is based on the assumption that reducing the time and effort IRBs spend reviewing low-risk research will allow them to spend more time reviewing higher-risk research. “But HHS offers no evidence to back this up,” Carome said.
It is more likely that IRBs, many of which feel overburdened, will spend the same amount of time and effort reviewing moderate- and high-risk research, with no enhanced protections for research subjects, Carome said. Without additional, specific requirements for higher-risk research, human subjects will continue to remain at risk, he said.
The Common Rule changes are subject to a 90-day comment period before being finalized.
The White House has proposed spending $215 million on research to accelerate biomedical discoveries. A $130 million grant to the National Institutes of Health would fund a voluntary national research cohort of 1 million or more volunteers to participate in the research.
