Federal Plan to Modernize Medical Trials’ Rules Would Be Boon to Universities

September 02, 2015

After more than four years of work, the finish line appears to be in sight for a governmentwide process to modernize the rules governing human participation in medical trials. The results appear to offer substantial benefits for many university researchers.

The U.S. Department of Health and Human Services issued a 519-page set of regulations on Wednesday, the result of work with 15 other federal departments and agencies dating to 2011. The document represents the first comprehensive overhaul of the regulations in three decades.

The revised rules would make several key policy changes. They would simplify the consent-authorization paperwork given to people who volunteer for medical studies, allow studies that involve multiple universities and trial sites to undergo just a single ethical review, and exclude from those reviews a range of low-risk uses of study subjects, such as interviews and surveys.

The changes stem from a recognition that research practices — and public expectations of what it means to participate in a medical trial — have shifted substantially since federal rules in this area were first put into effect, in 1991, said Kathy L. Hudson, deputy director for science, outreach, and policy at the National Institutes of Health, which helped lead the policy revisions.

"These aren’t rules to protect people," Ms. Hudson said, describing the government’s new way of regarding so-called human-subjects protection rules. "These are rules that can help guide the relationship between researchers and research participants, and help guide the design and conduct of research."

The rules are expected to save time and money for universities, their institutional review boards, and researchers in the social sciences, who have chafed at needing board approvals for projects that involve human subjects but pose little or no risk to them.

Redirecting Resources

Questions about the adequacy of human-subject consent forms led to tensions last year between two units of the Department of Health and Human Services — the NIH and the Office for Human Research Protections. At issue was a medical study designed to determine the proper amounts of oxygen to be given to premature babies. Previous experience had suggested that too little oxygen could increase the risk of death, while too much could lead to blindness.

Some parents whose babies suffered harm or death suggested afterward that they weren’t clear on the risks and procedures in the study. The NIH and the study’s lead institution, the University of Alabama at Birmingham, faced criticism from the OHRP, which said the experiment and its methods appeared not to have been fully explained to parents at some locations.

The proposal issued on Wednesday — with the endorsement of both NIH and OHRP leaders — intends to simplify the consent forms by requiring plain-English descriptions of expected risks and benefits, while leaving to appendixes the details that might be understood only by a lawyer.

"It puts in place a number of provisions" that make sure that the consent forms "will do a much better job in terms of informing them," said the OHRP’s director, Jerry A. Menikoff.

Improving Patient Safety

The new regulations would cover virtually all medical trials, regardless of their financial support, that are conducted at any American institution that receives federal money. But first the rules must pass through a 90-day comment period before being published in a final form. They would then take effect one year later.

Two provisions would take effect only after three years. One is the rule that would allow a single institutional review board to approve studies at multiple locations. The other is a change in procedures for handling medical specimens. That policy would forbid subsequent studies to reuse specimens without the express consent of each donor, but it would encourage making language that conveys such patient approval a standard feature of consent forms.

The lengthiness of the four-year process, which led some to predict the rules would never be finished, was due to the need to coordinate the changes through more than a dozen federal agencies and various interest groups, said Philip E. Rubin, an adjunct professor of surgery at Yale University who helped draft the rules during his earlier service at the White House's Office of Science and Technology Policy.

The final rules should improve patient safety by directing regulatory resources where they are most needed, Mr. Rubin said. "When hospitals and universities and other institutions are paying so much attention to that, then they’re not taking the time to pay attention to what they need to do, and they’re overburdened, so it’s great to see that rebalancing."

Both the Association of American Universities and the Association of American Medical Colleges have supported key elements of the changes but said they would need time to review the entire proposal before commenting on its specific provisions.

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at

Correction (9/3/2015, 11:30 a.m.): This article initially misidentified a previous employer of Philip E. Rubin, an adjunct professor of surgery at Yale University. He worked at the White House's Office of Science and Technology Policy, not the Office for Human Research Protections, an arm of the U.S. Department of Health and Human Services. The article has been updated to reflect this correction.