advertisements for clinical trial subjects must be approved by the IRB that reviews the clinical protocol. However, not all IRBs are proficient in discerning the difference between a balanced, scientific description of the details regarding a clinical trial, and a promotional message that makes inappropriate claims for the investigational product. Some investigators, in their zeal to quickly reach enrollment quotas, may also take it upon themselves to run clinical trial recruitment ads that are never reviewed by IRBs. These ads sometimes contain inappropriate inducements for potential study subjects. If an individual participates in a clinical study because of false expectations for clinical improvement or cure that are not met, this can open up the investigator to increased liability. Informed Consent Informed consent continues to be one of the most important but most frequently mishandled risk management issues in conducting clinical trials. Clinical investigators sometimes assume that study subjects will		not take legal action against the investigator if something goes wrong during a study. This is an erroneous assumption. Clinical trial participants do take action in some situations, and these actions may frequently include a claim that the subjects were not properly informed of the risks of participating in a study. Participation in a clinical trial is not to be equated with routine health care, and subjects may receive no direct benefit from their participation. This must be communicated very clearly, not only in any advertising that is undertaken by the clinical trial site, but also in obtaining consent from study subjects. FDA regulations require that each consent form contain certain key elements such as the benefits and risks study subjects can expect from participation in a study, as well as whom to contact for additional information or to report problems. Clinical investigators can reduce their exposure to liability by making sure that these federal requirements are met in obtaining proper informed consent. The setting in which the consent form is administered is also
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important. The potential subject should be given the opportunity to ask questions and to take some time to deliberate before making a commitment to participate in a study. An ideal situation is one in which the subject takes the study information home to review before signing, or some time elapses between the signing of the consent form and the start of the study. One type of research can pose an additional risk in this regard. If the product being tested is for an acute illness that requires immediate treatment, the study subject must be enrolled quickly when he or she presents at the health care facility with the illness. This precludes allowing the potential subject the time to deliberate on the decision to participate. In this situation, it is even more important to make sure that the consent form is clearly written to provide complete information to the potential participant. Investigator-Subject Relationship Another unique risk management issue that can come up at the study site is concerned with the relationship between the investigator and the study subject.		If the study subject's regular health care provider is the clinical investigator, the subject may agree to participate in a clinical study because of the trust relationship he or she has with the health care provider. That study subject may then feel betrayed if something goes wrong. On the other hand, an investigator who is not the study subject's regular provider may not have enough information or history about that subject to properly manage the subject's participation in the clinical study. Study personnel must be aware of the unique issues that can flow from these two very different kinds of investigator/subject relationships. This is just an overview of some of the risk management issues clinical trial sites must keep in mind in conducting research studies. A well-run clinical trial can provide significant information about a new treatment modality. Therefore, it behooves all site personnel involved to adhere to good clinical practice regulations in the conduct of research. This will preserve the integrity of the data being collected, while helping to protect study subjects from unnecessary harm.
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Madeleine M. Jester, RN, JD, is Assistant Vice President, Risk Management, for CNA HealthPro's Advanced Medical Technology, a CNA business unit headquartered in New York City. The opinions expressed in this Perspective are solely those of the author.