The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on informed consent. The module accompanies the Bioethics Commission’s two-volume report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1) and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The new Gray Matters module adds to the informed consent resources already produced by the Bioethics Commission. Additional materials on informed consent include a background module and four report-specific modules that accompany the Bioethics Commission reports Ethically Impossible: STD Research in Guatemala from 1946 to 1948, Privacy and Progress in Whole Genome Sequencing, Safeguarding Children: Pediatric Medical Countermeasure Research, and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings. Other topics covered by the Bioethics Commission’s educational modules include research design, privacy, community engagement, compensation for research-related injury, and vulnerable populations.
The Informed Consent in Gray Matters module provides a brief introduction to the concept of consent capacity; elaborates an ethical justification for responsibly including individuals with impaired consent capacity in neuroscience research; describes the current regulatory framework regarding human subjects research involving participants with impaired consent capacity; and describes additional ethical safeguards to protect vulnerable populations, including adults with impaired consent capacity.
All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.