Research in Emergency Situations: Community Consultation and Public Disclosure

Derse A. (2006). Emergency research and consent: Keeping the exception from undermining the rule. American Journal of Bioethics, 6(3), 36.

Dickert N. & Sugarman J. (2006). Community consultation: Not the problem—an important part of the solution. American Journal of Bioethics, 6(3), 26.

FDA Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research: The regulations (Title 21, Code of Federal Regulations [21 CFR] Section 50.24, and conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814) provide an exception to the requirement to obtain informed consent from each subject, or the subject's legally authorized representative, prior to enrollment in a clinical investigation. The exception applies to emergency research (1) for which an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) is in effect, (2) involving human subjects who cannot give informed consent because of their emerging, life-threatening medical condition (for which available treatments are unproven or unsatisfactory), and (3) where the intervention must be administered before informed consent from the subjects' legally authorized representative is feasible. Studies involving an exception from informed consent requirements may proceed only after a sponsor has received prior written permission from FDA, and the IRB has found and documented that specific conditions have been met.

Jacoby L. (2006). For bioethics: The role of empirical research. American Journal of Bioethics, 6(3), 58.

Marshall P. & Berg J. (2006). Protecting communities in biomedical research. American Journal of Bioethics, 6(3), 28.

Richardson L. Ragin D. Rhodes R. & Wilets I. (2006). The role of community consultation in the ethical conduct of research without consent. American Journal of Bioethics, 6(3), 33.

Schmidt T. DeIorio N. McClure K. (2006). The meaning of community consultation. American Journal of Bioethics, 6(3), 30.

Sheehan M. (2006). Is the community consultation requirement necessary? American Journal of Bioethics, 6(3), 38.