Whether a drug company has a duty to stop a clinical study and refer a participant to medical care when it is aware the participant is suffering from a life-threatening condition

QUESTION PRESENTED According to the National Institutes of Health, there are currently over 3,000 on-going clinical drug trials in the United States which are either currently active or currently recruiting test subjects. It is also estimated that 19 million Americans participate as test subjects in clinical research trials every year.” Numerous ethical codes, including the Nuremberg Code, developed after the human experimentation atrocities in World War II, the Belmont Report, issued by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Declaration of Helsinki, developed by an international consortium of researchers, and federal regulations, including 21 C.F.R. § 312.50 and 21 C.F.R. § 312.56, all emphasize the importance of protecting the health and safety of clinical trial test subjects as a paramount consideration in every research endeavor. The question presented is: Whether a drug company which is medically monitoring the participants of its drug study has a duty under federal regulations to exercise 1. See, https:// +subjectsGentry most recently accessed on July 5, 2018. 2. Seutti, Clinical Trials Do Go Wrong: How Many Human Subjects Are Injured By Scientific Research Each Year?, Innovation, 2/5/16 (available at accessed on July 5, 2018. u its independent power to stop a clinical study and refer a participant to medical care when it is aware that the participant is suffering from a life-threatening medical condition making him or her unsuitable to participate in the study or whether, as the California Court of Appeal, Second Appellate District, Division Five held, the study sponsor has no obligation to intervene even when it is aware that the clinical investigator it hired to conduct the clinical trial has failed to exercise reasonable care in making decisions about the enrollment of the test subject and has maintained the test subject in the study despite clear evidence of the test subject’s failing health.