Ropes & Gray attorneys David Peloquin
, and Mark Barnes
, along with Barbara Bierer, M.D., Harvard Medical School, recently co-authored an article that appeared in Bloomberg BNA Life Sciences Law & Industry Report
discussing the recent revisions to the Common Rule, the set of federal regulations governing the conduct of research involving human subjects. In the article, the Ropes & Gray attorneys summarize the key provisions of the final rule, describe the major changes from the proposed rule, and identify the important new requirements established by the final rule. The revisions to the Common Rule will have implications for a wide range of clinical research stakeholders in the life sciences and health care industries, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, institutional review boards, contract research organizations, laboratories, and tissue banks.