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In Bloomberg Law, Health Care Attorney Addresses Delay in Harmonizing Human Research Rules

Practices: Health Care, Life Sciences, Clinical Research, Digital Health, FDA Regulatory

Capital Insights.

In a Bloomberg Law article published on Dec. 13, health care associate David Peloquin (Boston) discusses the delay in implementation of harmonization to the revised Common Rule on human subjects research and U.S. Food and Drug Administration regulations on human subjects research. Navigating the parallel and sometimes conflicting rules complicates research on new drugs and medical devices.

Mr. Peloquin explains that while the FDA’s guidance has helped to streamline oversight for researchers in certain areas, such as informed consent and waivers thereof, institutions still face different requirements for Common Rule-regulated research and another for FDA-regulated research with respect to certain topics such as expedited review procedures.

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