An influential federal panel is calling on the White House to kill a proposal that would revise regulations for medical research volunteers, according to NPR.
The regulations, known as the Common Rule, were established decades ago to ensure medical research is conducted ethically and human participants are protected. However, the rules haven't been updated in nearly 25 years, so HHS proposed a major revision last year. However, the agency's proposal has sparked major criticism.
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The proposal is "marred by omissions, the absence of essential elements and a lack of clarity," according to the National Academies of Sciences, Engineering and Medicine, NPR reported. The conclusion is part of a 283-page report released Wednesday.
Some critics say the proposed revisions are too vague, complex and confusing. One especially controversial change would require researchers to get explicit consent from patients before using their blood or tissue for research, according to the report. Many researchers believe this requirement would create unnecessary red tape and significantly encumber research.
Instead of the proposed changes, the report recommends the president should appoint an independent national commission based on the President's Commission for the Study of Ethical Problems in Medicine and Biomedical/Behavioral Research and start over in revising the regulations, according to the report.