HHS Proposes Revised Rules Governing Human Medical Research

The Department of Health and Human Services (HHS) plans to revise the Common Ruleregulations that facilitate how human research is conducted that have been in place since 1991.  “This regulatory review effort is primarily about enhancing protections for human subjects,” HHS assistant secretary for health Howard K. Koh, M.D., MPH, said.  “The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

One challenge involves participant consent regarding how bio-specimens are used.  Under current rules, bio-specimens — such as blood and other bodily fluids that are collected for a particular study — may be used in other studies without clear permission from the person to whom it belongs under the assumption that the specimen is “de-identified” from the subject.  The latest advances in genetic and DNA testing now make these specimens “inherently identifiable,” said Kathy Hudson, PhD, deputy director for Science, Outreach, and Policy at the National Institutes of Health (NIH).  If the proposed changes are adopted, researchers must get participants’ consent to use bio-specimens in studies other than the one in which they were initially provided.

“I think this will really have quite a significant response from the research community,” said Heather Pierce, an official with the Association of American Medical Colleges.  “I think it will be seen as moving human-research oversight into the 21st century.”  The Common Rule defines a single set of requirements for informed consent, ethical oversight and human-subject protection at 15 federal departments and agencies, such as the NIH, the Department of Defense and the U.S. Agency for International Development.  The rule also must be obeyed in research funded by those agencies but performed at other locations, such as at universities and medical schools.

Under the revisions, the Common Rule will apply to all research at institutions that receive funding from any of the 15 federal agencies.  This even covers studies funded by other sources, such as drug companies or private foundations.  The impact will be to capture nearly all the biomedical experiments that are not already covered.  The rule also will require that a single “institutional review board” oversee studies of subjects at multiple hospitals and clinics (as is typical with most big clinical trials of drugs and procedures).  At present, each hospital’s board usually reviews the experimental protocol and makes suggestions — a process that researchers describe as onerous and government overseers find confusing.

A dedicated website will be created where all “adverse events” from clinical studies will be reported.  Currently,, notification of such problems is sent to multiple agencies on varying schedules.  The creation of a one-stop-shopping database will be more efficient and has the potential to increase the likelihood of catching rare and severe complications more quickly.  Volunteers in studies in which biological material, such as blood or tissue, is collected will be asked to 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 any donor information or identification.  The concept of “anonymity” has changed in an age of relatively inexpensive and easy gene sequencing.  “This acknowledges that with today’s technology that bio-specimens are inherently identifiable,” Hudson said.  Acquiring permission to use their specimens — including DNA — in future research “expresses a very high level of respect to those research participants.”

The roots of the Common Rules date from the 1978 Belmont Report”, which resulted from the disastrous Tuskegee syphilis study which was conducted over a 40-year time period between 1932 and 1972.  African-American sharecroppers in Alabama entered a program to study syphilis’ natural progression.  The volunteers were given free medial care, meals and burial insurance – although they were never told that they had been infected with the dread disease.

According to Emily P. Walker on MedPage Today, “The Belmont report laid the ethical framework for the government’s stance on human research and includes principles such as treating all participants with courtesy and respect, allowing for informed consent, and adhering to the philosophy of ‘do not harm” while maximizing research benefits and minimizing risks to the subject.”

The proposed alterations have been posted on the Federal Register; comments will be accepted over a 60-day period.

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