Disclosure of Information to Potential Subjects on Research Recruitment Web Sites
Klitzman, Robert, Albala, Ilene, Siragusa, Joseph, Patel, Jignasha, Appelbaum, Paul S., IRB: Ethics & Human Research
Recruitment practices in clinical research may be changing rapidly as use of the Internet grows. Last year, 73% of Americans were reported to be using the Internet. (1) Yet despite the developing influence of the Internet as a tool for reaching potential subjects, few systematic studies have been conducted that explore how individuals are recruited via the Internet for research studies or what type of information clinical trial Web sites provide to prospective research participants.
In 2002, the Department of Health and Human Services' (DHHS) Office of Inspector General (OIG) examined 22 Web sites--federal sites, third-party sites, location-specific sites, sponsor-specific sites, and others--that listed a total of 110 clinical trials. Of these 22 sites, 21 explained the importance of informed consent, and 16 described the role of Institutional Review Boards (IRBs). However, of the 110 trials listed, only 29 mentioned potential research benefits, while none mentioned potential risks. Some Web sites provided misleading information (e.g., referring to "new drug treatments" rather than "experimental" or "unproven drugs"). Of note, this 2002 report did not describe how the particular Web sites within each category were chosen.
Based on its review, the OIG recommended that the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) provide guidance to IRBs concerning clinical trial Web sites; that risk and benefit information be balanced and subject to IRB review; that use of voluntary standards by Web sites be facilitated; and that Web sites be reviewed periodically by independent bodies. Subsequently, in September 2005, the OHRP issued a report, "Guidance on Institutional Review Board Review of Clinical Trial Websites," that stated:
When information posted on a clinical trial website goes beyond directory listings with basic descriptive information, such information is considered part of the informed consent process and thus requires IRB review and approval. Basic descriptive information includes: study title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the study site for further information. Information exceeding such basic listing information includes descriptions of clinical trial risks and potential benefits. ... IRBs should pay particular attention to risk and potential benefit information to ensure it is presented in a balanced and fair manner. ... IRBs reviewing clinical trial Web sites also should assess the types of incentives, if any, being offered to prospective subjects. Monetary and non-monetary incentives (e.g., access to services or programs) can create undue influence on a potential subject's decision about participation. (2)
Even before the OHRP issued its guidance, the FDA had provided essentially the same guidance for IRB review of clinical trial Web sites. In 1998, the FDA noted in its document, "Guidance for Institutional Review Boards and Clinical Investigators," that
IRB review and approval may assure that ... additional information does not promise or imply a certainty of cure or other benefit beyond what is contained in the protocol and the informed consent document. (3)
The FDA has also pointed out that it "considers direct advertising for study subjects to be the start of the informed consent and subject selection process," (4) and the OHRP has said that "in some cases, the information provided on these [clinical trial] websites may constitute the earliest components of the informed consent process." (5)
Clearly, this regulatory guidance is important, yet the degree to which trial sponsors, Principal Investigators (PIs), and IRBs follow FDA and OHRP guidance has not been examined. …