The federal government on Friday proposed sweeping revisions to rules governing scientific research involving human subjects with the intent of extending protections to a larger number of people while simultaneously streamlining the oversight and paperwork required of scientists.
The proposed changes would be the first in two decades to the “Common Rule” that governs nearly all human-subject research financed by American taxpayers. The changes would try to address features of the research landscape that were uncommon 20 years ago, such as the proliferation of clinical experiments conducted at multiple sites; the growth of research by drug companies; and the collection of biological specimens for permanent archiving.
“These proposals are designed to modernize, simplify and strengthen the current system,” said Howard K. Koh, an assistant secretary of the Department of Health and Human Services.
The changes, which can be revised after 60 days of comment by the public, got an early warm welcome .
“I think this will really have quite a significant response from the research community,” said Heather Pierce, an official at the Association of American Medical Colleges, whose members include 135 U.S. and 17 Canadian medical schools, and more than 400 teaching hospitals. “I think it will be seen as moving human-research oversight into the 21st century.”
The Common Rule lays out a single set of requirements for informed consent, ethical oversight and human-subject protection at 15 federal departments and agencies, such as the National Institutes of Health, the Department of Defense and the U.S. Agency for International Development. The rule must also be followed in research funded by those agencies but done elsewhere, such as at universities and medical schools.
Under the proposed changes, the Common Rule would cover all research at institutions that get money from one of the 15 federal agencies, even studies paid for entirely by other sources, such as drug companies or private foundations. The effect would be to capture nearly all the biomedical experiments not already covered.
The rule would also require that a single “institutional review board” oversee a study that enrolls subjects at many hospitals and clinics (as is the case with most big clinical trials of drugs and procedures). Currently, each hospital’s board generally reviews the experimental protocol and makes suggestions — a process that researchers call burdensome and government overseers find confusing.
However, boards in foreign countries would still review proposals for research enrolling their own citizens because, according to an HHS document, “it might be difficult for an IRB in the U.S. to adequately evaluate local conditions in a foreign country that could play an important role on the ethical evaluation of the study.”
The proposal would also exempt from board review research that involves surveys and interviews that poses little or no risk to people — a change expected to be especially welcomed by social scientists. The revisions intend to make the consent forms that lay out a study’s risks and possible benefits clearer, shorter and more standardized.
Friday’s announcement acknowledges the revolution in computer information technology and in understanding the human genome that’ has marked the last 20 years of medical research.
A single Web site would be created where all “adverse events” from clinical studies would have to be reported. Today, notification of such problems is sent to various agencies on different schedules. Having a single database would not only be more efficient, it might increase the chance of catching rare and severe complications more quickly.
Volunteers in studies in which biological material, such as blood or tissue, is collected would be asked whether they agree to have the material used in future research. Today, archived blood can be studied long after collection as long as researchers strip it of information that identifies the donor. But the concept of “anonymity” has changed in an era of cheap and easy gene sequencing.
“This acknowledges that with today’s technology that biospecimens are inherently identifiable,” said Kathy Hudson, a deputy director at the NIH.
Asking permission to use their specimens — including their DNA — in future research “expresses a very high level of respect to those research participants,” she said.