OHRP offers guidance on review of trial web sites
Clarifications welcomed by many
In late September, OHRP issued guidance concerning IRB review of clinical trial web sites. The guidance, which can be viewed at OHRP’s web site, states that IRB review is required when information on a clinical trial web site includes more information than the study title, the purpose of the study, the protocol summary, basic eligibility criteria, study site locations, and how to get more information on the study.
Among the additional information the guidance points to as necessitating IRB review are descriptions of risks and potential benefits, and solicitation of "identifiable information."
In reviewing any risk or benefit information, the guidance says the IRBs should try to ensure it is presented in "a balanced and fair manner." IRBs should also review incentives being offered and determine whether they could cloud a potential subject’s judgment. The guidance also notes that eligibility questions that solicit information that could link answers to the respondent require IRB review. Additionally, the IRB should review plans for maintaining confidentiality of that information and ensure that the web site includes explanations of how that information will be used. In most cases, informed consent is required if any personal information is going to be collected.
Lastly, the guidance notes that IRBs do not have to review clinical trial web sites that include only directory listings and basic information about clinical trials.
"One area that is a potential gap is the approval by central IRBs of advertisement materials for markets in which there are one or more local IRBs — who has jurisdiction?" says Robert "Skip" Nelson, MD, PhD, associate professor at the University of Pennsylvania and physician at the Children’s Hospital of Philadelphia.
"An individual in Philadelphia, for example, could go to the web site, and then be referred to the local investigator. The local IRB has jurisdiction over that investigator but may have never seen nor approved the web site. Even if the local investigator knew of the site and told the local IRB, the web site may have been reviewed and approved by the central IRB. All is well if everyone agrees, but what should happen if the local IRB disagrees with the central IRB? Who wins? Should the local IRB tell the local investigator to not use the site? Refuse referrals? Disapprove the study?"
Nelson’s solution is that the local IRB would provide input to the central IRB, which can then take the advice at their discretion.
This kind of conflict can be completely avoided if local and central IRBs communicate well, says Erin Thacker, MS, CIP, lead administrator of New England IRB in Wellesley, MA. "I would hope that a local IRB would call us if there was a problem," she says, or better yet, that the two organizations would talk about web site content before it goes live.
The guidance in general is not going to change what New England IRB does in most cases — primarily because most of the studies they do are conducted under FDA regulations. "Those requirements say pretty much the same things about clinical listings," she says. "These are a little bit more specific when it comes to confidentiality issues, though." This clarification is welcomed, though, not least because some unnecessary paperwork will be eliminated, she says. Thacker will not have to approve the most general web sites.
Felix Gyi, PharmD, MBA, CIP, chief executive officer of Chesapeake Research Review in Columbia, MD, says another positive aspect of the guidance is that it takes the potential for interpretation out of one aspect of the IRB’s work. "There was a presumption that anything that had to do with research had to be reviewed," says Gyi, who also serves on the Secretary of Health and Human Services’ advisory community on human research protection. "Whenever you get official guidance on something, you eliminate individual interpretation." He also notes that guidance means no one will have to search through all the letters of determination to find out whether this issue has come up for any IRB.
In late September, OHRP issued guidance concerning IRB review of clinical trial web sites. The guidance, which can be viewed at OHRPs web site, states that IRB review is required when information on a clinical trial web site includes more information than the study title, the purpose of the study, the protocol summary, basic eligibility criteria, study site locations, and how to get more information on the study.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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