Resource Center: Consent in Treatment and Research

Decency LLC maintains a list of resources related to issues of consent in healthcare. Scroll below or search the site to find more information on these topics.

The hope is to continue to update and expand this list over time. Last update: September 21, 2023.

Please feel welcome to reach out and report broken links if information has become outdated. If you are interested in historical information, you can try pasting the outdated link into the search engine here at https://web.archive.org/, which may be able to return snapshots of the linked page on different dates in the past.


Note:

This page can be a starting point for understanding what kinds of resources exist in any given topic area.

Although this information is compiled by DLLC, the company does not have a relationship to the cited sources, has not “vetted” the sources, and is not recommending their use.

DLLC is not a law firm, does not take on legal clients, and is not able to provide advice or tailor guidance to any specific case.

The information and opinions on this site do not include legal advice or the advice of a licensed healthcare provider.

 

Current Sections

  • 21st Century Cures—Implications for Consent

  • Consent Forms

  • Disabilities and Decision-Making

  • Human Rights and Healthcare

  • Informed Consent in the Code of Federal Regulations

  • Institutional Review Boards (IRBs)

  • Language Access and Consent

  • Patients’ Rights

  • The Research Process

  • What Is Informed Consent?

  • What Does It Mean to “Waive” Informed Consent?

 

21st Century Cures—Implications for Consent

How did 21st Century Cures change informed consent requirements in clinical research? Link (2019): https://www.anjusoftware.com/about/all-news/insights/21st-century-cures-act#:~:text=The%20Cures%20Act%20will%20help,explains%20healthcare%20attorney%20Bonnie%20Scott

 

Consent Forms

About the legal status of consent forms in research (2013), link: https://academic.oup.com/medlaw/article/21/3/371/936340

 

Disabilities and Decision-Making

About supported decision making (2019), link: https://www.ndrn.org/resource/supported-decision-making-and-health-care/

 

Human Rights and Healthcare

Human Rights Watch commentary on CARE courts, link: https://www.hrw.org/news/2022/06/14/human-rights-watchs-opposition-care-court-sb-1338

 

Informed Consent in the Code of Federal Regulations

Link here to regulations regarding “Informed Consent of Human Subjects” in the Code of Federal Regulations: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-B

 

Institutional Review Boards (IRBs)

Link here to regulations regarding “Institutional Review Boards” (IRBs) in the Code of Federal Regulations: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56

Link here to “Guidance for Institutional Review Boards and Clinical Investigators” from the FDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions

 

Language Access and Consent

Information on translation and informed consent forms, link: https://www.languagescientific.com/6-things-to-know-about-translating-informed-consent-forms-2/#:~:text=Informed%20Consent%20Form%20Translations%20Must,written%20clearly%20in%20plain%20language

U.S. government guidance on informed consent of individuals who do not speak English (1995), link: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html

 

Patients’ Rights

42 CFR § 482.13 - Condition of participation: Patient's rights.

About the right to refuse treatment (2015), link: https://www.findlaw.com/legalblogs/personal-injury/do-you-have-the-right-to-refuse-medical-treatment/?DCMP=cfeatures%2F#:~:text=To%20the%20extent%20permitted%20by,at%20the%20end%20of%20life

 

The Research Process

The National Institute for Health Research provides a “Research ToolKit” here: https://ntdendrontoolkit.weebly.com/15-who-conducts-research.html

Find information on clinical trial requirements here, from the University of Nevada, Reno: https://www.unr.edu/research-integrity/human-research/researchers-affiliates/clinical/regulatory/requirements

Find guidance here from Hawai’i Pacific Health on clinical trial participation: https://www.hawaiipacifichealth.org/services/clinical-trials/

 

What Is Informed Consent?

Information from the American Medical Association on informed consent, link: https://www.ama-assn.org/delivering-care/ethics/informed-consent

 

What Does It Mean to “Waive” Informed Consent?

One Midwestern hospital system provides information here on what it means to waive informed consent, link: https://www.mclaren.org/uploads/Public/Documents/waiverofinformedconsentrequirements.pdf

Information from the FDA on waiver or alteration of informed consent, link: https://www.fda.gov/files/about%20fda/published/IRB-Waiver-or-Alteration-of-Informed-Consent-for-Clinical-Investigations-Involving-No-More-Than-Minimal-Risk-to-Human-Subjects---Printer-Friendly.pdf