New Rules by the Dept. of Health & Human Services will impact human research studies.

HHS Considers New Rules for Human Research

By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 23, 2011

WASHINGTON -- The Department of Health and Human Services has announced it is planning to change its rules on research involving human study participants. One piece of the plan -- announced Friday in an advance notice of proposed rule making -- would require researchers to get participants' consent to having biospecimens, such as blood, used in studies other than the one in which they are enrolled. Specimens collected for one study may find their way into dozens of others. Under a law known as the Common Rule -- which governs human research at 17 federal agencies and offices -- sharing of biospecimens is a legitimate practice because the specimen is considered "deidentified" from the person to whom it belongs. However, with relatively recent scientific advances -- think DNA testing -- a person's tissue, blood, and other bodily fluids actually hold the key to a person's identity and therefore can't be "unidentified." The proposed rule "acknowledges that biospecimens are inherently identifiable," explained Kathy Hudson, PhD, deputy director for Science, Outreach, and Policy at the National Institutes of Health (NIH) in a Friday call with reporters. Another major change in the proposed rules would require all institutions that receive any federal funding to follow federal guidelines for research involving human participants. Currently, if an institution is not receiving grant money from the federal government for a particular study, and the study isn't part of the FDA approval process, the institution does not have to abide by the federal government's rule on human research for that study. But under the proposal, if any branch of the institution receives any money at all from the federal government for research, then all research performed at the institution would have to abide by the federal rules, even if investigators don't have a federal grant for the particular study in question. According to HHS, about two-thirds of all universities have agreed to follow the federal human research rules, and one-third have not. Most of the other proposed rules announced Friday would pertain to making the research trial process faster and more streamlined. For instance, in large, multi-centered studies performed at a number of universities, each institution generally needs to clear the study protocol with its institutional review board, or IRB. In the case of a large study, that can be an extremely time-consuming process. An HHS official recalled one case in which so much time went by after the researchers submitted their proposed study to various IRBs, that the staff at several of the IRBs turned over and the new staff wanted to start over with the review. The whole study was eventually canned, said Carl Wieman, PhD, associate director for science in the White House Office of Science and Technology Policy. Under the new proposal, approval of a single IRB (likely chosen by the drug company funding the study) would suffice in the case of multi-center trials, ostensibly allowing study sites to begin enrolling patients more quickly. "Being able to shrink the time from having a protocol in hand and being able to recruit patients is key," Hudson said. Another key provision to speed up studies: Researchers who are conducting a study that is very unlikely to pose any sort of harm to participants would not have to go before an IRB every year to update the board on the progress of the research. The rule also proposes to update the process and forms used for informed consent, and to implement a uniform and more efficient approach to collecting and analyzing data on adverse events observed in clinical trials. The basis for the Common Rule dates back to a the 1978 "Belmont Report," which was prompted by the infamous Tuskegee syphilis study, in which impoverished African-American sharecroppers in Alabama who had syphilis were enrolled in a study to monitor the natural progress of syphilis. They were given free medical care, meals, and burial insurance, and never told they had syphilis. 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 no harm" while maximizing research benefits and minimizing risks to the subject. The proposed rule was published in the Federal Register and the government will be accepting comments on it for 60 days.