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THE COMMITEE ON HUMAN RESEARCH

FREQUENTLY ASKED QUESTIONS ABOUT LISTING CHR APPROVED STUDIES ON A SEARCHABLE WEB SITE FOR THE PUBLIC

1. Why should I list my study on these type of sites?

Many departments find it useful to maintain lists of current studies on their websites in order to keep patients informed of potential research opportunities. Making your study available to the public in this fashion is optional.

However, as many of you know, all investigators who perform a clinical trial must by law ensure that the trial is registered on a government website called ClinicalTrials.gov. Additional information can be found at Office of Research News, Vol. 8, No. 2.

2. Should I include the posted text in my CHR application?

Only if the information is to be posted on another website that does not have a published policy consistent with FDA Guidance below. In that case please also identify the web site.

3. Do I need CHR approval for these listings?

The CHR is required to review and approve advertisements for research. However the FDA has published guidance that "IRB review and approval of listings of clinical trials on the internet would provide no additional safeguard and is not required when the system format limits the information provided to basic trial information, such as: the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information." CHR review and approval is still required for flyers, posters, radio and TV advertisements, and letters sent to potential subjects.