Medical malpractice lawsuits are a common domain among plaintiff’s attorneys in clinical care. While human subjects research does contain some parallels to clinical care, litigation in clinical trials has stemmed from an array of legal claims including lack of informed consent, products liability, fraud, battery, infliction of emotional distress, breach of patients’ rights protected by state law, violation of federal regulations, and violation of civil rights protected under the constitution.1 Layering on top of the actual claims is the breadth of individuals and institutions against which lawsuits have been commenced. Cases have been brought against universities, academic medical centers, hospital systems, investigators, clinical trial sponsors, institutional review board (IRB) members, and bioethicists.2,3
Private sector funding associated with clinical trials has been growing at an astounding pace,4 consequently growing in relevance to the careers of investigators. Legal challenges have also increasingly contoured the discourse surrounding research and clinical trial design, conduct, integrity, and safety. This chapter identifies context and considerations in conducting clinical trials with a focus on the role of the investigator and highlights areas in which lawsuits can arise.
The complex regulatory, ethical, professional, and scientific backdrop
Various regulations and practice standards apply to investigators and other stakeholders of clinical trials depending upon what is being investigated, who is funding the activity, and the populations being studied. Research supported by US federal funds, such as that funded by the National Institutes of Health (NIH), is generally subject to the “Common Rule.” The Common Rule is a generic reference to a shared policy on human subject protections among several federal agencies.5,6 US Food and Drug Administration (FDA) oversight is applicable when there is a clinical investigation of a test article (an investigational drug or device) or data regarding a product are intended for submission to the FDA.7,8 Beyond regulatory provisions, FDA has adopted the Good Clinical Practice (GCP) transnational quality standards provided by the International Conference on Harmonization (ICH-GCP) as nonbinding guidance.9,10
Both federal regulations and ICH-GCP require protections be in place for any individual enrolling in a clinical trial. For example, federal regulations require that an ethics committee, referred to in the United States as an IRB, review all research involving human subjects against core research ethics tenants and regulation. This includes the obligation to obtain informed consent, a topic discussed later in this chapter.11,12 Because many individuals enroll in oncology trials when other clinical alternatives have failed, the experimental drug is often viewed by the human subject (and sometimes the investigator) as another treatment option. Evaluation of this “therapeutic misconception” is part of the ethics review because, without appropriate safeguards, it may lead to individuals agreeing to take on greater risks than they would otherwise accept.
Investigators often carry both clinical care and research responsibilities, ...