Summary of FDA and DHHS Stipulations for Research Conducted With an Exception From Informed Consent

  1. The human subjects are in a life-threatening situation, available treatments are unproved or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized, placebo-controlled investigations, is necessary to determine the safety and efficacy of particular interventions.

  2. Obtaining informed consent is not feasible because

    1. The subjects will not be able to give their informed consent as a result of their medical condition

    2. The intervention involved in the research must be administered before consent from the subjects' legally authorized representatives is feasible

    3. There is no reasonable way to identify prospectively the individuals who are likely to become eligible for participation in the research

  3. Participation in the research holds the prospect of direct benefit because

    1. Subjects are in a life-threatening situation that necessitates intervention

    2. Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects

    3. Risks associated with the research are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity

  4. The research could not practicably be carried out without the waiver.

  5. The research protocol defines the potential therapeutic window, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time.

  6. The IRB has reviewed and approved informed consent documents to be used in the cases when informed consent from the subject or his or her representative is feasible.

  7. Additional protections will be provided, including at least

    1. Consultation with representatives of the community in which the research will be conducted and from which the subjects will be drawn

    2. Public disclosure to the communities in which the research will take place and from which the subjects will be drawn

    3. Public disclosure at the completion of the investigation of the study results, including demographic characteristics of the research population

    4. Establishment of an independent data-monitoring committee

    5. The investigator has committed, if feasible, to attempting to contact, within the therapeutic window, a family member of the subject and asking whether he or she objects to the subject's participation in the research