Recently proposed changes to legal and ethical guidelines governing human subjects research image

Journal of Law and the Biosciences, Vol. 3, Issue 1 (April 1, 2016)
Emily Largent (Student Fellow Alumna)


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From the article:

In recent months, updates have been proposed to two important documents in human subjects research oversight: the Federal Policy for the Protection of Human Subjects or ‘Common Rule’ and the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines for Biomedical Research (hereafter, ‘CIOMS Guidelines’). The two proposals have garnered significant attention within the research community because, if finalized, they would be the first major revisions to these documents since 1991 and 2002, respectively. Moreover, they include substantive changes that could have far-reaching effects on the conduct of human subjects research.

Human subjects research—research in which human beings are the subjects of study—is governed by ‘a series of international codes, national legislation, and agency regulations. The regulatory framework has evolved over time, often shifting in the aftermath of tragedy’ and scandal. Consequently, there is a tendency to emphasize some ethical requirements while overlooking others. Additionally, research itself is evolving, and guidelines may offer incomplete guidance (or no guidance), for example, in the face of advances in medicine or new methods of conducting research. As a result, the regulatory framework must continually evolve. Even understanding this, one might reasonably ask: Why are changes being proposed now? [...]

bioethics health law policy human subjects research regulation