Update to Common Rule could impact research on human subjects

Enacted in 1991, the Common Rule was a way to standardize participant protection in research programs.
Enacted in 1991, the Common Rule was a way to standardize participant protection in research programs. | File photo

The United States recently updated the Common Rule, a federal regulation that supports research involving human subjects.

"A lot of residency projects involve the retrospective analysis of health records, and the Common Rule would apply to those records — more specifically, your institution's implementation of the Common Rule," said Wesley Byerly, the associate vice president for research, research integrity, and regulatory affairs for UConn Health in Farmington, Connecticut.

Enacted in 1991, the Common Rule was a way to standardize participant protection in research programs across the country. The new update is the first since 2005. The main focus of the update is to help participants by making informed consent easier and making consent forms more readable.

"There's been a lot of discussion in the research community about the complexity and length of consent forms. And part of the revisions are targeted at trying to assist in making consent forms more readable and, hopefully, less lengthy," Byerly said. "Most academic institutions have developed their own templates to help individuals in constructing consent forms that meet the requirements for the Common Rule and other institution-specific requirements. The revision will require institutions to take a look at how their current consent form templates are structured."

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American Society of Health-System Pharmacists 7272 Wisconsin Ave Bethesda, MD 20814

University of Connecticut 261 Glenbrook Rd Mansfield, CT 06269