Waiver of Informed Consent Requirement
Waiver of the consent requirement may be applied in certain circumstances where no foreseeable harm is expected to result from the study or when permitted by law, federal regulations, or if an ethical review committee has approved the non-disclosure of certain information.
Besides studies with minimal risk, waivers of consent may be obtained in a military setting. According to 10 USC 980, the United States Code for the Armed Forces, Limitations on the Use of Humans as Experimental Subjects, a waiver of advanced informed consent may be granted by the Secretary of Defense if a research project would:
- Directly benefit subjects.
- Advance the development of a medical product necessary to the military.
- Be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA.
Read more about this topic: Informed Consent
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