Did You Know:
The HRPP has a consultation service to provide individual or group consultation to researchers.
We can work with you
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
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)