Research Regulation Changes Could Make Process More User Friendly
The Department of Health and Human Services' proposed changes to the "Common Rule" governing human research aim to accomplish the following:
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.
