IRB review not mandatory for listings on the Internet
Some question whether sites are recruitment tools
It’s as simple as typing in an Internet URL, entering a few keywords, and hitting return — across any person’s computer screen comes a nationwide listing of clinical trials under way at various research institutions.
Some sites even offer matching services — on the site CenterWatch.com, for example, interested potential subjects can enter their criteria and are e-mailed lists of trials for which they might be eligible as research subjects.
Could use of these listing services be considered recruitment? And if so, should investigators and/or corporate research sponsors get IRB approval before posting information about their research on these sites?
What is a recruitment tool?
A recruitment tool is defined as any message that is intended to be seen or heard by prospective research subjects for the purpose of informing them about the existence of a study, Goebel specifies. This could include both advertisements for the trial and listings placed on Internet sites. Messages that are not considered recruitment tools are newspaper, radio, television interview or stories that are not advertisements.
"Advertisements are generally paid for; whereas, news stories are the interview or articles prepared by reporters," he says. "Any person may exercise his or her First Amendment rights also without control or approval by the IRB."
According to the FDA guidance, IRBs should review the content of any advertisements directed at potential participants because the FDA considers the advertisement to be the beginning of the initial informed consent process, and it is necessary to ensure that the ad doesn’t contain elements that unduly promise a cure or effective treatment or otherwise coerce the individual to enter the study, he notes. But given the current limited content of most on-line trial listings, it is unlikely that they will violate this standard, he concludes.
As long as the listings contain only the basic information about the trial and where it is being conducted — and make no claim of a possible cure or effective treatment — they are not recruitment tools and not subject to IRB approval, says Paul W. Goebel, CIP, vice president of the Columbia, MD-based Chesapeake Research Review Inc. and former chief of the institutional review branch of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Goebel, a member of IRB Advisor’s editorial board, helped develop the FDA’s regulations governing the conduct of research trials.
The FDA information sheet, "Recruiting Study Subjects," details what comprises a study recruitment tool and what items are subject to IRB review. The sheet can be found on the administration’s web site at www.fda.gov/oc/ohrt/irbs/toc4.html.
"When the postings do not contain a claim of certainty of cure or effective treatment, no IRB is necessary," he points out. "The posting can accurately describe the purpose of the research, e.g., to determine whether XYZ is safe and effective for the treatment of __.’ The sponsor or other entity doing the posting should be guided by the purpose outlined in the protocol for the study."
IRBs should review postings that exceed the bare-bones information, though this is not required, he adds.
"The FDA guidance states: When the opportunity to add additional descriptive information is not precluded by the site’s database system, IRB review and approval may assure that the additional information does not promise or imply a certainty of cure or other benefit beyond what is contained in the protocol or informed consent document," Goebel says.
Potential for abuse?
That information was news to Casey Bush, research regulatory specialist at Legacy Health System in Portland, OR.
He was surprised to learn from some study coordinators that corporate sponsors were advising them to post information about clinical trials, not only on Centerwatch and ClinicalTrials.gov (the site maintained by the National Institutes of Health) but also on sites sponsored by pharmaceutical companies and web sites devoted to specific diseases or conditions — and they were specifying to the coordinators that IRB approval was not required.
"I was amazed that they could do this," he states. "I really thought this was an issue for IRB review. At first, they wanted to put the information on general sites like CenterWatch and ClinicalTrials.gov, but the sponsor extrapolated that to wanting to post it on specific sites, like psoriasis.com, etc. They specifically told our coordinators that they did not need to take it to the IRB for approval. But once you put a listing on a web site for say, a diabetes support group, for example, that seemed like direct advertising."
At Legacy, research staff frequently take calls from people who have combed through Internet sites and simply know that research is conducted there, and they call up wanting to volunteer, Bush says.
"We don’t even get many participants via the Internet. We are a hospital system, and we only do studies on people who have conditions that we treat in our system," he explains. "We are listed on CenterWatch mainly because it allows companies to know we are here and are conducting trials, it’s not done with the intent of getting participants."
He is concerned that the lack of review of Internet postings may mean that people who hear about the research this way may not be afforded the same protections.
For example, IRBs typically approve the text and scripts for radio and print advertising, and at the same time, review how the potential participant who sees the advertisement will contact the research entity, what kind of information they will be provided about the trial, and how much information the researchers are allowed to collect and keep from the initial callers, he states. The same may not be true of the on-line list announcements, he notes.
No cause for concern
The FDA considered such listings when developing their guidance but decided that most databases used by these sites only allowed the input of basic trial information, says Goebel.
"The practical reality is that it is relatively easy to obtain IRB review before a notice is posted on a web site. The problem is, it will usually not be the IRB of record for all the sites of a multisite study," he explains. "These IRBs will generally not have the authority to change or remove web postings. When the posting is limited to basic information about the research project, little or no protection would be added by IRB review."
Using the large number of postings on ClinicalTrails.gov as a guide, it was decided that IRB review was not necessary. However, the FDA did reserve the right to require IRB approval if postings changed and resulted in prospective subjects being unduly influenced to participate in the research project, he adds.
As for placement on disease-specific sites, such as a support group for people living with a specific condition, Goebel says the only criteria for judgment remains the content of the listing — not its location.
"As long as only the basic information is included, I can see no difference between a general site and a disease-specific site."