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Federal Guidance on IRB Review of Clinical Trial WebsitesWebsites that provide information on clinical trials-and that may serve as study recruitment tools-are increasingly prevalent on the Internet. In September 2005, the Office for Human Research Protections (OHRP) issued new guidance that highlights under what conditions an IRB must review a sponsor's or researcher's clinical trial website. Earlier guidance for the review of clinical trail websites stated that review by an IRB was required only if the materials were not limited to basic trial information. Basic trial information was outlined as "...title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information." According to the new guidance, clinical trial websites that describe risks and benefits or solicit identifiable information should be considered to contain more than basic information. Such websites, therefore, require IRB review. The guidance reiterates that IRBs have the responsibility to review risks and benefits mentioned in websites to ensure they are presented in a manner which is both fair and balanced. The guidance also specifically calls out the need for IRBs to review the incentives, if any, being offered to potential participants. An IRB needs to ensure that incentives are not being offered that would unduly coerce participants into a study. Offering significant monetary or non-monetary benefits could potentially affect a prospective participant's decision to enter a study, so an IRB must ascertain whether or not proposed levels of compensation are acceptable. Some clinical trial websites also request viewers to submit answers to eligibility questions, which may contain private information. The guidance states that IRBs should ensure websites using such a mechanism explain how the information being submitted may be used, and also review the plan for maintaining the confidentiality of the information collected. Quorum Review's policy is consistent with this guidance. If a website is being used to recruit participants for a study under Quorum's oversight, and if that website includes more than basic trial information, Quorum IRB must review it. Please see our Guide to Recruitment and Participant Study Materials, located at http://www.quorumreview.com/investigators_general.asp, under the General Forms and Guidelines section, for more detailed guidance. Or contact us for additional information. To read more on the September 2005 OHRP guidance, please visit http://www.hhs.gov/ohrp/policy/clinicaltrials.html. |
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