April 2006

This article provides guidance regarding the requirement of the Institutional Review Board (IRB) to review information provided to potential research subjects through clinical trial websites. It specifically focuses on describing the circumstances for which IRB review of clinical trial websites is not required.

In addition to the use of printed materials and media advertisements, it has become common practice for investigators and institutions to recruit subjects via websites. In some cases, the information provided to potential subjects constitutes the earliest form of informed consent.

However, websites may only be clearly documenting basic information about the clinical trial. According to recent guidance received from the Office for Human Research Protections (September 20, 2005) posting of basic information on a website does not require IRB review. Basic information includes:

• Title
• Purpose of the study
• Protocol summary
• Basic eligibility criteria
• Study site location(s); and
• Information for contacting the study site

Information posted on a clinical trial website that goes beyond directory listings with basic descriptive information is considered part of the informed consent process and requires IRB review and approval. Types of information that would require IRB review include but are not limited to risks and potential benefits, solicitation of identifiable information or incentives (if any) which are being offered to prospective subjects.

Clinical trial websites that provide only directory listings with basic descriptive information about clinical trials in general (as listed above) do not need review and approval by an Institutional Review Board. Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) ClinicalTrials.gov website, the NIH National Cancer Institute’s cancer clinical trials listing (Physician Data Query [PDQ]), and the government-sponsored AIDS Clinical Trials Information Service (ACTIS).

*Department of Health and Human Services, Office for Human Research Protections (2005). Guidance on Institutional Review Board Review of Clinical Trial Websites, Access date 26 March 2006. World Wide Web http://www.hhs.gov/ohrp.policy/clinicaltrials.html.

*Food and Drug Administration (Sept, 1998). IRB Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators, Access date 26 March 2006. World Wide Web http://www.fda.gov/oc/ohrt/irbs/toc4.html.