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Government News
Research Regulation Changes Could Make Process More User Friendly
Psychiatric News
Volume 46 Number 17 page 4-4

The Department of Health and Human Services' proposed changes to the "Common Rule" governing human research aim to accomplish the following:

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  • Establish for all of the U.S. sites in a multisite study a single Institutional Review Board (IRB) of record. Under the current Common Rule, an IRB at each institution involved in a study has to approve the research.

  • Tailor administrative and reporting requirements to the level of risk to humans involved in biomedical research and expand the number of trials that can be expedited without IRB oversight.

  • Provide greater specificity about how consent forms should be written and what information they should contain, so they can be shorter and more user friendly.

  • Establish a single Web site where adverse events can be reported electronically, thus meeting all federal reporting requirements, with the resulting data being stored in a single database and reporting requirements across federal agencies harmonized. 4_2.inline-graphic-1.gif

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