Proposed Change in Regulations for Human Research

Officials say that an effort to reinforce safety and decrease red tape, which can impede studies, has led the government to propose changes in the rules governing research involving human subjects.

The vast alterations in the research atmosphere featuring new attributes such as genomics studies using patients’ DNA samples, Internet use, and a rising dependence on studies that take place at many sites concurrently have made it imperative to deal with these changes, say officials.

In a telephone news conference on Friday, deputy director of the National Institutes of Health, Kathy Hudson, said: “These are the first substantial changes that have been made to the rules governing human subjects in decades, so this is really quite a historic moment.”

Changes in rules are expected to cover topics such as the informed consent provided by research participants and the institutional review boards that supervise research at universities and hospitals. The rule which became popular as the Common Rule was initially drawn up by the Department of Health and Human Services in the 1970s and ’80s followed the acceptance of the system by 14 other federal agencies and departments in 1991.

However, some experts were of the opinion that it had become too cumbersome.

A professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years, Dr. Robert J. Levine, said: “It’s a terrible drag on getting good research done.” Despite the fact that the government’s lengthy proposal was not systematically reviewed by him, he said that he was optimistic about what he had seen.

The process is still being established. Specific rules will be formulated in the next 60 days after a public comment regarding the possible changes described by the Government; subsequently, specific rules will be formulated and again sent out for comment.

Earlier in January, President Obama’s executive order called upon agencies to discard needless regulations, and the government remarked that its proposal was in tune with the order. However, some of the proposed changes would add regulation.

According to one change, the coverage of the rules would be extended to all studies conducted at institutions funded by any of the 15 federal agencies that are governed by the Common Rule. For instance, if a university is receiving grants from National Institutes of Health, then even a study paid for by a drug company that is being conducted at that same university paid would be covered by the rules.

Although that would include more medical research, there was no clarity on whether the rules would govern those trials funded by drug companies and conducted at individual physicians’ offices.
According to another proposed change, single institutional review boards would be permitted to supervise studies conducted at multiple sites.

At present, there could be long delays in approvals because the institutional review boards at each location must individually endorse a trial. Federal officials are of the opinion that oversight can actually be strengthened by having a single reviewer who is truly accountable for its decisions apart from eliminating redundancy and delays.
Compared with risks to participants in medical studies, studies involving surveys or other social science research wherein the risks to participants are usually minimal are expected to be made less cumbersome, according to other proposed changes.

Associate director for science at the White House Office of Science and Technology Policy, Carl Wieman, said that given all the required consent, it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher. “You’re not doing anything here except watching people,” he said.

Another probable change would involve obtaining consent from donors of blood, DNA, or tissue samples before the use of those samples in subsequent research. Currently, samples can often be used for further research without consent if the identity of the donor cannot be determined. However, Dr. Hudson of the health institutes said that biological specimens are “inherently identifiable” using modern techniques of DNA sequencing. So the proposal would necessitate a mandatory consent.