Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of Reality.

ABSTRACT: A central principle of bioethics is "subject autonomy," the acknowledgement of the primacy of the informed consent of the subject of research. Autonomy requires informed consent - the assurance that the research participant is informed about the possible risks and benefits of the research. In fact, informed consent is difficult when a single drug is being tested, although subjects have a baseline understanding of the testing of a pharmacological agent and the understanding that they can stop taking the drug if there were an adverse event. However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within

SUBMITTER: Anderson AJ 

PROVIDER: S-EPMC5435227 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature