Human Research Protection Program

Tip of the Month

Did You Know:

The HRPP has a consultation service to provide individual or group consultation to researchers.

We can work with you

• as you develop your protocol application
• to answer questions about submissions to the IRB
• to help with special considerations, such as research with vulnerable populations
• to assist in understanding federal regulations, state laws and Yale policies and procedures that affect human subjects research

Staff can meet with you at the HRPP office, at your office, or at a location that is convenient for you.

To request a consultation, please e-mail us

Announcements

• New IRB Members! The HRPP is pleased to announce the addition of the following members to the committees. We applaud these individuals for their willingness to join our ranks and thank them for their shared commitment to the protection of human subjects in research.
  • HIC I: Karen Conway, BSN, MBA (Oncology), Diana Irizarry, RN (Nursing Oncology), Martha Luther, BSN, MSPH (GYN Oncology), Jill Shellow, JD (Law), Tara Sanft, MD (Medical Oncology)
  • HIC II: Amenuve Bekui, MD (Internal Medicine/Epidemiology)
  • HIC III: Vali Gazula, PhD (Neuroscience), Erica Giles, BS (Medical Student)
  • HIC IV: Mary-Jane Hogan, MD (Pediatric Hematology/Oncology)

• 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.

• 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 or contact YCCI at 203.785.3482)

Last revised April 3, 2013