US officials are laying the groundwork to overhaul human research protections for the first time in twenty years. Today, the US Department of Health and Human Services (HHS) released seven proposed ways to update the guidelines. The proposals will be open for public comment for the next 60 days.
In 1991, the federal government brought 15 different departments and agencies together under the umbrella of the ‘Common Rule’, a set of regulations that govern federally funded human-subjects research. But technological advances since then have changed how such research is conducted. “These regulations were developed in a simpler time,” said HHS assistant secretary for Health Howard Koh at a press conference today. Twenty years ago, many clinical studies were carried out at a single institution, he noted. Biological specimens that did not have identifying information explicitly associated with them were considered safely anonymous. And the Internet was not the widely used research tool that it is today, particularly for social and behavioural science surveys.
“These changes have raised questions regarding the effectiveness of the current regulatory framework,” Koh said.
With this in mind, HHS has released an “Advance Notice of Proposed Rulemaking” to solicit public comment on ways to update the regulations. Included along the seven proposals are: a requirement to establish mandatory data security standards, the extension of federal regulations to apply to all research conducted at US institutions receiving support from any of the 15 Common Rule agencies, and the use of a single ethics committee of record for multi-site studies. (Look here for a complete listing of all seven.)
Current Common Rule regulations apply only to studies that are funded by any of the 15 member agencies. (The US Food and Drug Administration has its own guidelines for human subjects research.) Only about 2/3 of institutions have voluntarily agreed to apply Common Rule regulations and accept federal oversight on all of the studies carried out within their walls regardless of funding source, said Jerry Menikoff, director of HHS’s Office for Human Subjects Research. “So currently somebody walking into a major research center probably doesn’t know whether that’s one of the 2/3 that has said we are subject to federal oversight on all of our studies,” he said. The proposal to apply the Common Rule more broadly – to institutions that receive federal funds, rather than merely to individual studies – could provide more assurance to patients.
HHS is also proposing a change to how consent is granted for research involving biological samples, such as blood or organ biopsies. Currently, it is assumed that if there is no identifying information – such as a subject’s name or social security number – attached to the sample, it is anonymous and can be used for research without explicit permission from the donor. That anonymity can no longer be assured, said Kathy Hudson, deputy director for science outreach and policy at the National Institutes of Health. “With today’s technologies, biospecimens are inherently identifiable,” she said. As a result, the department is proposing that individuals donating samples to a specific study would be presented with a separate consent form governing the use of that sample in subsequent biomedical research.
Other proposed changes could streamline the approval process for human subjects research. At present, research proposals are reviewed by ethics committees called Institutional Review Boards. Often each institution participating in a study will have its own review board, meaning that a large, multi-center clinical trial that includes dozens of hospitals would have to gain approval from dozens of review boards. Instead, the HHS is proposing that one committee be designated the review board of record for a particular study. Individual institutions could conduct their own review if they chose, but the responsibility for ensuring an ethical study will fall on a single, designated committee.