Aiming to improve medical care, researchers are proposing new ways to study treatments in ?real-world? settings, like the hospital or doctor?s office. These studies, sometimes called ?pragmatic trials,? often compare treatments that patients might receive in usual care, although the care any particular patient might receive as part of the study is determined through random assignment, like flipping a coin. For these types of studies, sometimes the usual processes for obtaining the informed consent of the patient for research participation is bypassed. For example, a doctor conducting the research might tell the patient about the study after the patient was provided care and ask if the researchers could study the patient?s medical record to see how effective the care was. Another example would be when a person entering a hospital might sign a form agreeing that some parts of the patient?s care would be a determined by a research study but that the patient would not be asked to consent to specific changes in their care as long as they were in the scope of this general consent form. Proponents of these newer consent approaches for pragmatic trials emphasize the similarity between research and clinical practice when patients receive usual care treatments, even if chosen by random selection. There is a lot of debate among ethicists about whether these changes to the usually strict informed consent requirements for research are appropriate. Our research team has noticed a gap in these discussions. Rarely do they consider what a court might say if a research participant brought a lawsuit about their participation in research without the usual methods of consent. Based on our expertise and preliminary research, we believe that the common law, the body of law developed through decisions of courts, such as tort or contract law, would have something important to say about these newer approaches to consent. Our study will research and analyze legal cases to determine how common law principles and the ethics underlying them relate to informed consent in innovative research designs like ?usual care? studies (Aim 1) and develop a framework for incorporating ethical underpinnings of common law principles to guide design and review or innovative research and to more completely inform future policy and practice (Aim 2). Results from this research carry great value for the CTSA network hubs as they train translational scientists seeking ways to overcome barriers in the translation process and support innovations to discover, develop and disseminate more treatments to more patients more quickly.

Public Health Relevance

Clinical researchers sometimes design research studies in different ways which change the way participants are invited to consent for the research. Results from this proposed research carry great value for the public as it will use lessons from the common law to provide more complete ethical and legal guidance to translational scientists seeking innovative ways to discover, develop and disseminate more treatments to more patients more quickly according to NCATS mission.

National Institute of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Linked Specialized Center Cooperative Agreement (UL1)
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Zhang, Xinzhi
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University of Virginia
Schools of Medicine
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