Human Research Protection Program

Announcements

• Mandatory Clinical Trials Registration Information FDA/ICMJE

  Effective March 7, 2012, the FDA has mandated the following language in all consent documents for Phase II or III controlled clinical trials with FDA oversight, or controlled trials with health outcomes of an FDA regulated device:

  A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

  The HIC has incorporated this language into our informed consent and compound authorization templates, available on the forms page, available on the forms page.

  Please also note: Registration of clinical trials is now also a requirement of ICMJE for manuscripts submitted to biomedical journals.

  (For more information on registering clinical trials, including whether your trial must be registered, see the YCCI webpage, see the YCCI webpage or contact YCCI at 203.785.3482)

• Are you a physician or physician scientist interested in serving on a biomedical IRB? Click here for information.
• Interested in serving on a social/behavioral/educational IRB? Click here for information.
• Investigators and Research staff: See an important announcement concerning approval notations and validation dates.
• NEW HRPP DIRECTOR: Jan L Hewett, B.S.N, J.D., has accepted the position of Director of Yale’s Human Research Protection Program, beginning March 1, 2012. Ms. Hewett comes to Yale from the University of Michigan, where she has served as Director, Medical School Institutional Review Board for Human Subjects Research, since 2006. She brings to Yale not only her IRB experience, but experience as well as a Senior Grants and Contracts Officer, Research & Technology Development Services at Georgetown University, and Supervisor of Research Operations at the Lombardi Cancer Center at Georgetown, where she also served as a clinical research nurse specialist in oncology, and clinical research nurse coordinator in clinical pharmacology. She has served as consumer representative member of the FDA Nonprescription Drugs Advisory Committee, and has presented nationally for Public Responsibility in Medicine and Research (PRIM&R), the National Comprehensive Cancer Network (NCCN) IRB Directors Forum, the Annual FDA Inspections Summit, and the Association for the Accreditation of Human Research Protections Programs (AAHRPP). Trained as a nurse in her native Australia, Ms. Hewett received her B.S.N. from Georgetown University School of Nursing and her J.D. from the University of Michigan Law School. She is co-author on a number of peer reviewed articles in the areas of medical law, research results, and IRB function.
• Effective January 18, 2012, the HRPP has revised our procedure for Certificates of Confidentiality. Revisions to the procedure are available here.
• (October 26, 2011) The Office for Human Research Protections (OHRP) has issued a notice of proposed changes to federal human research protection regulations, requesting comments from the research community. Click here to see the notice, and here to view Yale’s response.
• Investigators and Research staff: See the announcement regarding continuing education.