The federal government plans to overhaul the rules for conducting research with human subjects with the aim of bringing the regulations in line with the realities of research in the 21st century.
Officials at the Department of Health and Human Services published the advanced notice of proposed rule making on human subjects’ research in the Federal Register on July 26. The proposal seeks public comment on a series of possible changes, from relying on a single institutional review board for multi-center studies to simplifying informed consent forms. This is the first time the regulations on human subjects’ research, known as the Common Rule, have been updated since 1991.
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MULTIMEDIA: Cells were taken from Henrietta Lacks, a cervical cancer patient at Johns Hopkins 60 years ago when there were no established informed consent rules. HeLa cells multiplied and have been used for research worldwide.
While the Common Rule was a landmark development in the protection of research participants, those rules were developed during a "simpler time," Dr. Howard Koh, assistant secretary for health at HHS, said during a briefing with reporters on June 22. Twenty years later, human subjects’ research includes a variety of new areas such as genomics and behavioral and social science research, as well as studies utilizing the Internet and large-scale data networks.
"These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," he said.
With that in mind, HHS is proposing to offer greater protection to study participants in several ways, such as:
• Giving participants the right to say whether researchers can use their biospecimens in future research.
• Helping researchers to craft informed consent forms that are easier to understand.
• Making data security and information protections uniform across all studies that involve potentially identifiable patient information.
• Developing a more systematic approach to collecting adverse event data from ongoing studies.
Officials also aim to ease regulatory burdens for researchers in the following ways:
• Designing review requirements to match the risk posed to research subjects.
• Ensuring that any guidance issued by the federal government is consistent across departments.
• Allowing research at multiple sites to be overseen by a single institutional review board.
HHS also seeks to expand the reach of the regulation by extending it to all studies conducted by institutions that receive federal funding for human subjects’ research from a Common Rule agency.
The proposal is being well-received in the research community. Mary Woolley, president and CEO of Research!America, a not-for-profit organization that advocates for public and private funding of medical research, said the proposal would benefit both patients and researchers because it streamlines some of the process while adding patient protections.
"We’re going to speed the conduct of research and thus speed the day when we have more and more personalized medicine based on research that is going to save lives and save money," she said.
Dr. Holly A. Taylor, Ph.D., a core faculty member of the Berman Institute of Bioethics at the Johns Hopkins University, Baltimore, praised the regulation’s focus on improving the informed consent process.
Dr. Taylor, who has conducted her own research on informed consent, said she agrees with HHS that, in many cases, the forms have become too long and complex for patients to understand. She urged the agency to work with investigators, who aren’t trained to write for a consumer audience, on rewriting the forms. It will be important for the government to tell investigators not just what to include in the form but how to do it, she said. "Given where we started, having a form like this was a really great idea. But there are ways now that it is sort of defeating its own purpose," she said.
Comments on the advance notice of proposed rule making will be accepted at www.regulations.gov until 5 p.m. ET on Sept. 26; instructions on how to do so can be found here.