For research on human proposed rule changes

The Government proposes changes in the rules for research involving human sweeping, officials say an effort that would strengthen protective measures, and at the same time may interfere with the bureaucracy, the studies.

Officials said that the changes are necessary, deal with a heavily modified research climate, its new features include genomics studies with patients DNA samples, the use of the Internet and a growing dependence on studies that take place in many locations at once.

"Which are the first significant changes that have been taken to the rules on human subjects in decades, so this is really quite a historic moment," said Kathy Hudson, Deputy Director of national institutes of health in a press conference on Friday.

Rules that issues such as the consent, the respondents must provide cover and the institutional review boards would be the changes in the, to oversee the research at universities and hospitals. First by the Department of health and human services in the 1970s and 1980s, the system was adopted by the 14 other federal agencies and departments in 1991 and became known as the general rule.

But some experts said that it had become too cumbersome.

"It is done, for getting good research a terrible drag," said Dr. Robert j. Levine, Professor of medicine and biological Ethikerin at Yale University, who directed the University institutional review board for 31 years. He said Sunday, while lengthy proposal by the Government had not thoroughly checking, he was encouraged by, what he had seen.

The process is still at an early stage. The Government has described possible changes and asked for public comment on the next 60 days; Specific rules are formulated and again sent out for comment.

The Government said its proposal in January call for agencies, weed out with President Obama executive order was compatible unnecessary provisions. But some of the proposed changes would add regulation.

A change would increase the rules cover all studies of facilities, to get the money, which have adopted the joint rule of each of the 15 federal agencies. If a University by the national institutes of health, then also a study on the financing rules the University of Heidelberg, of a plant would be covered such as through the paid.

While the more medical research would include, was not clear whether studies funded by pharmaceutical companies and individual physicians performed would be covered offices.

Another proposed change would enable to oversee a single institutional review board of studies taking place at several locations.

Needs right now, the institutional review board at each site generally support a trial which may result in long delays. Federal officials said that in addition to eliminating redundancy and delays, with actual supervision could strengthen a single editor who is really responsible for their decisions.

Other proposed changes would aim, so that it less cumbersome, surveys or other social science research, in which usually are the risks for the participants to do less than for medical studies.

Carl e. Wieman, Associate Director for Science at the White House Swiss Federal Office of science and technology policy, said it was now difficult to observe teachers and students in classrooms, to determine what makes a good teacher all required approval given. He said "You not here do anything except just people".

Another possible change would be required, donors of blood, DNA or tissue samples that would consent to give before these examples in subsequent research could be used. Now, if the identity of the donor cannot be determined, samples can be used often for further research without permission. But Dr. Hudson, who said Health Institute, that with modern DNA sequencing, are biological samples "inherently identifiable." so that the proposal would you vote required.

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