Editing Informed consent (section)

==Waiver of requirement==
{{Globalize|section|US|date=December 2022}}
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.<ref>{{cite web |author=Council for International Organization of Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 |title=International Ethical Guidelines for Biomedical Research Involving Human Subjects |url=http://www.cioms.ch/publications/layout_guide2002.pdf |url-status=dead |archive-url=https://web.archive.org/web/20100823205120/http://www.cioms.ch/publications/layout_guide2002.pdf |archive-date=2010-08-23 }}</ref>

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:<ref>{{cite journal|last1=McManus, J.|author2=S. G. Mehta |title=Informed consent and ethical issues in military medical research|journal=Academic Emergency Medicine|year=2005|volume=12|issue=11|pages=1120–1126|doi=10.1111/j.1553-2712.2005.tb00839.x|pmid=16264083|first1=J|display-authors=etal|doi-access=free}}</ref>
# directly benefit subjects
# advance the development of a medical product necessary to the military and
# be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver) including those pertinent to the FDA.

While informed consent is a basic right and should be carried out effectively, if a patient is incapacitated due to injury or illness, it is still important that patients benefit from emergency experimentation.<ref name="Baren">{{cite web|last=Baren|first=Jill|title=Informed Consent to Human Experimentation|url=http://www.credoreference.com/entry/sppbioeth/unique_aspects_of_informed_consent_in_emergency_research|publisher=Springer Publishing Company|access-date=26 September 2013}}</ref>{{better source needed|date=January 2023}} The Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) joined{{when|date=January 2023}} to create federal guidelines to permit emergency research, without informed consent.<ref name="Baren"/> However, they{{who|date=January 2023}} can only proceed with the research if they obtain a waiver of informed consent (WIC) or an emergency exception from informed consent (EFIC).<ref name="Baren"/>

===21st Century Cures Act===
The [[21st Century Cures Act]] enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."<ref>{{cite web |url=https://www.govinfo.gov/content/pkg/PLAW-114publ255/pdf/PLAW-114publ255.pdf |title=PUBLIC LAW 114–255—DEC. 13, 2016 130 STAT. 1033 |website=www.govinfo.gov}}</ref>