Safety of scientific medical research a State obligation: impact of human rights litigation

Abstract Background Scientific medical research with human subjects presents risks that raise human rights concerns due to the dangers posed to the subjects’ safety, health, and life. Drawing on recent jurisprudence of European and international courts, our study highlights the value of scrutinizing medical research through the lens human rights law. Methods We analyzed recent jurisprudence of European and international human rights courts and treaty monitoring bodies dealing with disputes from the clinical reality of medical research. Our analysis drew on the Council of Europe and the UN human rights frameworks. We explored what human rights are relevant to medical research with human subjects, how to safeguard these rights, and how to foster the application of human rights to this dimension of medical law. Results Courts ruled that under human rights law, the State is the main duty-bearer in protecting research subjects and is held accountable for violating the substantive and procedural aspects of individuals’ rights. Medical research insufficiently regulated by the State may result in violating the right to life and the right to health. The State obligations stand regardless of the public or private character of the scientific research (in terms of sponsorship, organization etc.). States must fulfil their legal obligations by effectively regulating medical research, protecting the human subjects, ensuring access to justice and effective remedies for victims of rights violations, and putting in place mechanisms that prevent violations. Conclusions a. Human rights-based scrutiny of scientific medical research extends the focus beyond the subject-researcher relationship to highlight the State's obligations. b. Human rights law equips healthcare professionals to better handle concrete situations where the safety of research subjects is at risk. c. Applying a human rights framework to scientific medical research strengthens the avenues to hold the State accountable. Key messages • Courts should scrutinize the medical research infrastructure through a human rights lens and clarify what elements of medical research constitute human rights obligations. • National authorities should fulfil their obligation set in human rights law to protect research subjects and help them enforce their rights.