OHRP ISSUES GUIDANCE TO IRB FOR REVIEW OF TRIAL WEBSITES

The Office of Human Research Protections (OHRP) has issued guidance to institutional review boards (IRBs) for reviewing information provided on clinical trial websites. Because websites are commonly used by investigators and institutions to recruit research subjects, the information provided constitutes the earliest components of the informed consent process, according to the guidance document.

Although websites use a different medium than traditional print or broadcast advertisements to recruit subjects, the requirements are the same, OHRP states in the guidance. IRB approval and review is required when information posted on a clinical trial website goes beyond basic descriptive information. That basic descriptive information includes: study title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and contact information for the study site.

"IRBs should pay particular attention to risk and potential benefit information to ensure it is presented in a balanced and fair manner," OHRP's guidance states. "The information presented should not mislead, for example, by promising benefits or implying a benefit beyond that potentially provided by the research."

IRBs should also assess the types of incentives being offered to prospective subjects, stressing that monetary and non-monetary incentives influence a potential subject's decision to participate in research.

Some clinical trial websites ask viewers to answer questions regarding eligibility for a specific clinical trial and identifiable private information that might be collected via the website. The guidance clarifies that IRBs should review plans for protecting the confidentiality of private information and should ensure that the website clearly explains how identifiable private information might be used.

The guidance document stems from a May 2002 HHS Office of Inspector General report, "Clinical Trial Websites: A Promising Tool to Foster Informed Consent," which recommended OHRP provide further guidance to IRBs clarifying that risk and benefit information in trial listings on websites is subject to IRB review and approval, and requiring IRBs to review any prescreening used for specific trials.

For more information, visit http://www.hhs.gov/ohrp/policy/clinicaltrials.html (http://www.hhs.gov/ohrp/policy/clinicaltrials.html).