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The Legal Landscape for Supported Decision-Making in the United States and its Application to Clinical Research

Published online by Cambridge University Press:  26 March 2026

Nina A. Kohn ,
Megan S. Wright  and
Robert D. Dinerstein
Nina A. Kohn*
Affiliation:
College of Law, Syracuse University, United States Law School, Yale University, United States
Megan S. Wright
Affiliation:
Penn State, United States
Robert D. Dinerstein
Affiliation:
American University, United States
*
Corresponding author: Nina A. Kohn; Email: nakohn@syr.edu
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Abstract

Supported decision-making is rapidly gaining attention as an alternative to guardianship and other forms of surrogate decision-making for people with cognitive disabilities. This article provides an overview of the legal status of supported decision-making in the United States, with particular attention to how states are recognizing supported decision-making in different legal contexts. It then explores how the law of supported decision-making applies to clinical research. It explains that although federal research regulations and guidance do not explicitly address formal supported decision-making, individuals may use supported decision-making to make decisions about participating in clinical research and researchers may be required to allow such use under federal laws that protect against disability discrimination. It then concludes by considering legal barriers to greater use of supported decision-making and how these barriers might be overcome.

Keywords

Supported decision-makingclinical researchsurrogate decision-making

Information

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , First View , pp. 1 - 9
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NoDerivatives licence (http://creativecommons.org/licenses/by-nd/4.0), which permits re-use, distribution, and reproduction in any medium, provided that no alterations are made and the original article is properly cited.
Copyright
© The Author(s), 2026. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

Introduction

Supported decision-making is a process by which individuals make decisions with help from other people. Such decision-making help may include gathering information, identifying and thinking through options, or communicating a decision to third parties.Reference Pan, Dinerstein and Wendler 1

Supported decision-making has long occurred in the shadow of the law. However, in recent years, inspired in part by the UN Convention on the Rights of Persons with Disabilities,Reference McDonald 2 there has been a push for legal recognition of supported decision-making relationships. Such relationships are seen as an alternative to guardianship, and a way to ensure that individuals with cognitive disabilities are able to make their own decisions and have these decisions recognized by others. As a result, a growing list of countries and many US states have enacted statutes giving legal effect to supported decision-making agreements. In addition, some states have recognized supported decision-making relationships in other ways. For example, a growing number of states have statutes or court decisions recognizing supported decision-making as an alternative to guardianship, and some now explicitly limit guardianship to situations where supported decision-making would not meet a person’s needs. Similarly, Delaware and Utah recently adopted legislation that gives decision-making supporters priority as health care surrogate decision-makers for persons who cannot make decisions even with support.

The increasing legal recognition of supported decision-making has the potential to impact a wide range of activities, including clinical research. With that in mind, this article provides an overview of the legal status of supported decision-making in the US that shows both how the law recognizes supported decision-making and how it creates barriers to it. It then addresses how the law of supported decision-making applies in the context of clinical research. It explains that although federal research regulations and guidance do not explicitly address formal supported decision-making, it is legally permissible for individuals to use supported decision-making to make decisions about participating in clinical research. Furthermore, allowing decisions about participation in clinical research to be made using supported decision-making may be required by federal laws that protect against disability discrimination. The article concludes by considering legal barriers to greater use of supported decision-making and how these barriers might be overcome.

Legal Recognition of Supported Decision-Making

States provide legal recognition of supported decision-making through statutes that grant formal legal status to supported decision-making agreements, through reforms to guardianship and conservatorship law, and through a variety of other statutory innovations recognizing the importance and validity of decisions made using support. This section provides an overview of the ways states’ laws recognize supported decision-making. 3 It begins with a discussion of legal recognition of supported decision-making agreements, a topic previously explored by our lead author in a 2021 article in the Harvard Journal of Legislation. Reference Kohn 4 After building on that prior work by providing an updated account of the extent and potential impact of statutory recognition of supported decision-making agreements, it moves on to discussions of recognition of supported decision-making in guardianship law and health law.

Legal Recognition of Supported Decision-Making Agreements

The most common way states’ laws have recognized supported decision-making is by adopting statutes that give formal legal status to supported decision-making agreements. Texas became the first state in the US to do so when, in 2015, it enacted the Texas Supported Decision-Making Act, 5 which gives formal legal recognition to agreements entered into between individuals seeking support (“principals”) and people they have selected to provide decision-making support (“supporters”). 6 States quickly followed Texas’ lead; by late 2024, eighteen states and the District of Columbia had enacted supported decision-making-specific statutes. 7 In these states, when individuals make a formal supported decision-making agreement, that agreement creates certain legal rights and duties that the state will recognize.

As part of this legal recognition, many states have authorized a form that individuals can use to create a supported decision-making agreement. 8 Forms commonly describe what supported decision-making is; list the parties to the agreement (the principal and their appointed supporter or supporters); list decisions for which the principal may request decision-making assistance (e.g., managing finances, identifying housing, making medical decisions, etc.); clarify the role of the supporter (decision-assister, not decision-maker); contain an option to release protected health, educational, or other information; include signatures of the principal, supporter(s), and witnesses; provide a warning to third parties to report suspected abuse, neglect, or exploitation of the principal; and add a note about the limitation of liability for third parties who rely on the agreement in good faith.Reference Wright 9 Aside from providing options for the principal to select or not, the forms also typically provide for other customization (e.g., providing space for parties to write in additional information). Some states only provide legal recognition to supported decision-making agreements that substantially comply with this form, 10 and others require them to be “not inconsistent” with the form. 11

Statutes that recognize supported decision-making agreements typically encourage third parties to rely on supported decision-making agreements by providing immunity from liability or professional discipline for doing so to individuals who rely on a supported decision-making agreement or who act on a decision actually or allegedly made in accordance with supported decision-making. 12

Such statutes also encourage individuals to formally accept a supporter role. One way they do so is to provide supporters “legal status.” For example, some states grant the supporter legal standing to enforce a decision made by the individual without the individual’s involvement or consent to such enforcement. 13 Another way they advance this goal is by protecting the supporter from claims that might be brought by the individual being supported. For example, states may explicitly limit the degree of care the supporter is required to use. 14 One state — North Dakota — explicitly provides supporters immunity for negligence claims brought by the individual being supported. 15 These provisions are significant because without explicit statutory limitation, whether a court would find a supporter to have fiduciary obligations to the principal would likely be a matter of fact.

Supported decision-making is defended as empowering persons with cognitive disabilities; 16 however, as prior work by the lead author has also recognized,Reference Kohn 17 legislation giving supported decision-making agreements legal effect in US states may not always benefit individuals with cognitive disabilities. As discussed above, principals may lose the right to hold supporters accountable for conduct that would otherwise give rise to liability. Additionally, states often restrict the way in which the principal may revoke the agreement, 18 likely in an effort to increase the chances that third parties are on notice of when they may no longer rely on an agreement. States also limit the privacy rights of the individuals being supported by requiring others to disclose otherwise confidential information about the individuals 19 (e.g., by requiring people who would not otherwise be mandatory reporters of abuse to report suspected abuse or exploitation of a principal).Reference Kohn 20

In contrast, legal recognition of supported decision-making agreements may provide individuals with disabilities with few new legal rights. 21 The only new right typically granted to the individual is the right to have their information kept confidential by supporters. 22 Only a few states impose a fiduciary level of care on the supporter, 23 whereas many do the opposite.

That said, in practice, such statutes may allow people to realize the rights they already had. A statute stating that individuals with disabilities may use support to make decisions, 24 and that those decisions are valid, is a way of communicating this fact and a way to avoid guardianship or other substitute decision-making. And it may thus be a way to counter misinformation and stereotypes that cause individuals, including physicians and researchers, not to respect the decisions of persons with cognitive impairments. Statutes that formally recognize supported decision-making as a legitimate decision-making modality may thus enable the exercise of autonomy by individuals with disabilities because of its effect on third parties’ willingness to respect the decisions of this population, including in the clinical research context.

Thus, state statutes that recognize the role of supported decision-making in facilitating legal capacity, including those that give formal legal recognition to supported decision-making agreements, are often seen as rights-granting although technically they may be, at most, rights-facilitating. But further empirical research is needed to know if supported decision-making law and practice achieves the hopes of its advocates that it will enable, not prevent, individuals with disabilities from exercising agency. 25

Legal Recognition of Supported Decision-Making in Guardianship Law

States are increasingly recognizing, and giving legal effect to, supported decision-making relationships in their statutory law governing guardianship.Reference Martinis 26 Consistent with the Uniform Guardianship, Conservatorship, and Other Protective Arrangements Act, 27 some states’ guardianship laws now explicitly prohibit imposition of a guardianship or conservatorship if supported decision-making would meet an individual’s needs. 28 Notably, this statutory law is accompanied by a growing body of court decisions recognizing that supported decision-making is an alternative to guardianship even in the absence of a formal supported decision-making agreement. 29

A handful of states have also recognized supported decision-making in their guardianship statutes by requiring supporters to be given notice of a proceeding for guardianship or conservatorship, 30 or allowing individuals to utilize supported decision-making when defending against guardianship or conservatorship. 31

Another way states recognize supported decision-making in guardianship-related statutes is by requiring dissemination of information about supported decision-making to potential guardianship petitioners. 32 For example, Indiana recognizes supported decision-making in the special education context, requiring a discussion of supported decision-making in lieu of guardianship in certain case conference committee meetings for students receiving special education. And the District of Columbia specifically recognizes supported decision-making as a decision-making alternative in lieu of guardianship for students receiving special education who turn 18 years old. 33

Legal Recognition of Supported Decision-Making in Health Law

State healthcare decision-making laws can also give legal effect to supported decision-making. For example, in the past several years, many states have recognized supported decision-making in the context of organ transplantation decision-making, with an eye to making transplantation more accessible to users of supported decision-making. 34

States are also incorporating supported decision-making into general medical decision-making law. For example, Delaware and Utah recognize supported decision-making in the context of healthcare decision-making. 35 First, they recognize that an individual has capacity to make a healthcare decision even if they require support to do so. 36 Second, they give persons who have provided a patient with decision-making support priority for acting as a healthcare surrogate if a patient lacks capacity and has not appointed an agent to make healthcare decisions. 37 Third, they give decision-making supporters the right to object to a determination that the patient lacks capacity to make a healthcare decision, thus triggering the need for a second opinion before a surrogate can make decisions for the patient. 38

Notably, the approach taken by Delaware and Utah is likely to be followed elsewhere as its approach is based on the Uniform Health Care Decisions Act, adopted by the Uniform Law Commission in 2023. 39 In September 2024, Delaware became the first state to adopt the Act, thus bringing this embrace of supported decision-making to that state’s healthcare decisions law. Utah followed suit in March 2025. At present, the Act is under serious consideration in other states. It may just be a matter of time before this embrace of supported decision-making becomes widespread in the healthcare decisions context, and because of the close association between medical and clinical research decisions, the clinical research context as well.

The Law of Supported Decision-Making in Clinical Research

There has been recent scholarly interest in how supported decision-making could be used in clinical research.Reference Wright, Cascio and Racine 40 This section discusses how the consent process for participating in clinical research is currently regulated, and how the relevant regulations apply to individuals with cognitive disabilities. It then shows how supported decision-making laws can interact with federal regulations governing clinical research. To do so, it looks at one area of clinical research: clinical trials regulated by the federal Food and Drug Administration (FDA). It then discusses roles for supported decision-making in clinical research.

The Role of Supported Decision-Making in Clinical Research: FDA Clinical Trials as a Case Study

In the United States, the FDA is responsible for regulating many clinical trials of drugs, biologics, and medical devices. With limited exceptions, informed consent from research participants or their “legally authorized representative” (LAR) is required in FDA-regulated clinical trials. 41 An LAR is “an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.” 42

To ensure consent is informed, the consent documents and conversation must be in language understandable to the prospective subject or their LAR. 43 Regulations also direct that, during the informed consent process, care be taken to minimize coercion and undue influence to ensure that participation in clinical research is voluntary. 44 Informed consent documents and discussions thus must include information that the research participant can “discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.” 45 Institutional Review Boards (IRBs) must also ensure that additional protections be included for clinical research involving vulnerable subject populations. 46

Federal regulations do not bar individuals with cognitive disabilities from participating in clinical research, but obtaining informed consent is required prior to their participation. 47 The FDA does not explicitly discuss a role for supported decision-making in the informed consent process. However, it implicitly recognizes a role for it in a couple of different ways.

First, the FDA recommends that the investigators and IRBs modify the informed consent process and build in additional safeguards for research participants with impaired decision-making abilities, including involving a “subject advocate or trusted family member/friend to assist when sharing information about the clinical investigation” to “enhance consent capacity.” 48 Although the term “supporter” is not used, a “trusted family member/friend” can be viewed as a supporter in this context.

Second, FDA guidance references other published recommendations that note that the informed consent process can be modified so that the subject is more likely to achieve capacity to consent, and one recommended modification is involving individuals trusted by the prospective participant. 49 It can be inferred from the cross-references in FDA guidance that a clinical trial participant could achieve consent capacity by using supported decision-making (whether formal or informal), even though these recommendations do not make specific reference to supported decision-making, or specify how or what types of assistance would be provided to the participant during a capacity assessment process.

The FDA’s approach, however, stops far short of suggesting that the use of supported decision-making will always render individuals able to consent to participation in clinicial trials. The FDA recognizes that some individuals will not be able to participate in decisions about clinical trial participation, and, in these instances, “consent to research by an LAR is an acceptable alternative under FDA’s regulations.” 50 But the FDA also acknowledges that other individuals with cognitive impairments

may be able to appoint an LAR, define the limits of their own research participation, or remain actively involved in the decision to enroll and remain enrolled in the research. As such, individuals with impaired consent capacity should be included in the process of consent to the extent possible and consistent with their desires and abilities. In a situation in which a prospective subject is capable of providing informed consent at the onset of a clinical investigation but is expected to become less capable of providing continued consent as the research progresses (e.g., a long-term clinical trial for Alzheimer’s), consideration should be given at the start of the trial to having subjects designate an individual to serve as their LAR once the subjects’ conditions warrant it. 51

From a review of federal regulations and FDA guidance, one can infer that the FDA would accept integrating supported decision-making into clinical trials for research participants who could benefit from it. That is, the FDA would likely view an individual who uses supported decision-making as capable of providing consent to participation in a clinical trial if the individual is ultimately able to achieve (either with or without support) the level of understanding and appreciation required to be deemed capable of giving consent.Reference Segal, Howard and Wendler 52 And indeed, such a view is consistent with other laws requiring reasonable accommodations for individuals with disabilities to fully participate in society, as we discuss later in the article.

A Role for Supported Decision-Making in Clinical Research

There are many potential applications of supported decision-making for clinical research. To understand the range of these applications, it may be useful to think about the temporal dimensions of a clinical research study and how supported decision-making may be used at different points of the research by an adult with a cognitive disability eligible for and interested in clinical research participation.

Supported decision-making can help an individual decide whether to participate in clinical research. Supporters may help identify clinical research opportunities that may be relevant and of interest to the principal. Supporters may also help the principal respond to recruitment for clinical research participation. Principals may also engage in deliberation with their supporters about whether to pursue clinical research participation or request their supporters’ assistance in obtaining more information about participation. The form of this assistance is not governed by federal regulations, but instead by the terms of the agreement or understanding between the principal and supporter.

Principals may also want those supporting them to assist throughout the informed consent process, including before they agree to participate in clinical research and throughout the course of their participation as circumstances or information change. 53 Notably, this type of assistance is permissible under current FDA guidance and matches FDA recommendations about modifying the consent process for individuals with impaired cognition. Moreover, not only is this assistance permissible under FDA guidance, researchers may be required to facilitate supported decision-making as a reasonable accommodation for participants with disabilities under other disability rights laws governing the clinical research enterprise, such as the Rehabilitation Act of 1973 that applies to federally funded research. 54

In addition, principals may seek assistance with complying with the clinical research protocol, communicating with investigators throughout the trial (especially if trial endpoints rely on participant reports), and communicating with the research team after their participation has concluded. Principals may also want supporters’ assistance in withdrawing consent or leaving the research project.

Finally, supporters may at some point in the research process act as an LAR. This is permissible under federal regulations if it is permissible under state law (which may sometimes not be clear). 55 One way a supporter could become an LAR would be for the principal (if the principal has sufficient capacity to do so) to appoint the supporter as their agent under a power of attorney for healthcare (also called a “health care proxy”). When acting as an agent, the supporter could provide informed consent on behalf of the research participant who no longer has capacity to make decisions even when provided with decision-making support.Reference Wright 56 That said, if the clinical research does not have a health benefit for the principal, state law might not actually permit the agent to consent. 57

Addressing Legal Barriers to the Use of Supported Decision-Making

As this article has shown, the law is increasingly embracing supported decision-making. Even in the clinical research context, where there has yet to be explicit statutory or regulatory recognition of supported decision-making, the law permits — and may even demand — its use. This is because clinical research is not governed solely by federal research regulations, but also by the Americans with Disabilities Act (ADA) and the Rehabilitation Act of 1973. The ADA requires both public (under Title II) and private (under Title III) hospitals and healthcare providers to provide reasonable modifications and accommodations for individuals with disabilities so that such persons have equal access to provided services, 58 which can include clinical trials. Furthermore, Section 504 of the Rehabilitation Act of 1973 prohibits recipients of federal financial assistance, 59 which often pays for clinical trials,Reference Boyle 60 from discriminating against persons with disabilities, including by failing to provide them with reasonable accomodations. Supported decision-making can be considered a “reasonable accommodation” or a way to ensure equal participation under these laws.Reference Wright 61

Yet the law still has a long way to go in helping achieve the potential of supported decision-making. For example, although current FDA regulations and guidance implicitly recognize a role for supported decision-making in clinical trials, it would be beneficial for the FDA to issue explicit guidance recognizing the ways supported decision-making can be incorporated into clinical trials so that investigators and IRBs are aware of the role it can and should play in this context.

Indeed, fully realizing the potential of supported decision-making will require dismantling legal barriers to its use. One barrier occurs when the law equates legal capacity with the ability to make decisions independently; people who need assistance in making decisions may be denied legal capacity despite their ability to make decisions with support. Another barrier occurs when individuals are permitted to equate capacity with the ability to make decisions without support. For example, if clinical researchers equate capacity to consent to research with capacity to consent to research without support (which the law does not in fact require), they may end up denying individuals who use support access to clinical research and its attendant benefits.

Thus, fulfilling the potential of supported decision-making will require integrating it into the law of decision-making, such that individuals are not denied legal capacity simply because they use support to make decisions. Some states are leading the way by beginning to integrate supported decision-making into existing legal systems (e.g., advance directives, guardianship law, organ donation). But there is a long way to go. Many states have either not recognized supported decision-making, or merely given legal effect to formal supported decision-making agreements and not also to informal arrangements. Even those states that have begun integrating supported decision-making into existing legal systems have yet to fully reform their law to ensure that people are not found to lack capacity to make a legal decision simply because they use support to do so.

The law of legal capacity, however, is not the only legal barrier to supported decision-making. Legal protections designed to protect individuals’ privacy and autonomy can also create a barrier to supported decision-making because they make it harder for supporters to obtain the information they need to help decision-making. Individuals utilizing supported decision-making will often be doing so because they need help obtaining and understanding decision-relevant information (such as bank statements to inform financial decisions, or lab results to make healthcare decisions). For example, an individual considering whether to participate in clinical research may benefit from a supporter obtaining a wide variety of information: information about the individual’s current health and planned treatment, information about the clinical trial and its risks, and information about the individual’s financial situation and the potential impact of participation on the individual’s finances. The supporter’s efficacy may depend on their ability to readily assemble and process information from such diverse sources.

One benefit of entering into a supported decision-making agreement in some states is that the agreement can be used to give the supporter the authority that the principal would have to access health information. However, not all individuals who wish to use support in making decisions will want to enter into a formal supported decision-making agreement. They may prefer less formality or may not like the duties and limitations associated with a formal agreement.

To facilitate the use of supported decision-making, while still protecting individual privacy and autonomy, states should consider creating a form that individuals can use to grant a supporter the right to access personal information on their behalf from a wide variety of sources, 62 even if they have not chosen to enter into a broader supported decision-making agreement. To be sure, individuals being supported can grant their supporters the right to access information by providing consent to share personal information (e.g., by signing a medical provider’s “HIPAA waiver,” authorizing sharing of information using forms or systems provided by a financial institution, or appointing the supporter as an agent through a power of attorney for finances or healthcare). 63 However, doing so is often time-consuming and — at least where the individual does not have a legally recognized supported decision-making agreement — must be done separately for each source of information. A single, state-sanctioned, and publicly available form would reduce the cost of obtaining information, and thus reduce the cost of supporting a decision-maker.

Conclusion

Supported decision-making can enable people who would otherwise be unable to make contemporaneous decisions for themselves to do so, and help other people reach better decisions than they might without support. As this article has cataloged, states are increasingly recognizing supported decision-making both by enacting statutes that give formal legal recognition to supported decision-making agreements, and by amending other laws to recognize the role that supported decision-making can play in supporting self-determination. Further legal reforms, including updated regulations and regulatory guidance pertaining to clinical research, could help to further realize the benefits of supported decision-making. For example, we recommend that the FDA promulgate explicit guidance on how supported decision-making can be incorporated into clinical trials so that investigators and IRBs are aware of this possibility. However, even without such reforms, clinical researchers can and should foster more inclusive research by integrating supported decision-making into their practices, including during informed consent discussions with participants with cognitive impairments.

Disclosures

Nina A. Kohn and Robert D. Dinerstein received consulting fees from the NIH All of Us Research Program (through a grantee, the American Association on Health and Disability) for consulting on incorporating supported decision-making in research protocols.

References

Supported decision-making is only one form of decision-making assistance and may be used in combination with other forms of decision-making assistance (for example, in combination with decision-making aids that present information in a way that clearly explains options). Pan, Cf. Shen, Dinerstein, Robert, and Wendler, David, “Using Supported Decision-Making to Promote Value-Aligned Research Participation,” Journal of Law, Medicine & Ethics 54, supp. 2 (2026): in this issue.Google Scholar
G.A. Res. 61/106, art. 12, Convention on the Rights of Persons with Disabilities (Dec. 13, 2006). See also McDonald, Katherine et al., “Adults with Intellectual Disability and Consent to Precision Medicine Research: Using Supported Decision-Making to Facilitate First-Person Consent,” Journal of Law, Medicine & Ethics 54, supp. 2 (2026): https://doi.org/10.1017/jme.2025.10196 (discussing CRPD and surveying supported decision-making laws).Google Scholar
Federal laws may also recognize supported decision-making. See later section describing the Americans with Disabilities Act and the Rehabilitation Act of 1973.Google Scholar
See Kohn, Nina A., “Legislating Supported Decision-Making,” Harvard Journal on Legislation 58 (2021): 313–356.Google Scholar
See Supported Decision-Making Agreement Act, Tex. Est. Code Ann. § 1357.001–.102 (West 2024).Google Scholar
Sometimes, other terms are used for the participants in supported decision-making. For example, many advocates of supported decision-making prefer the term “decision-maker” over “principal,” as this emphasizes the individual’s agency.Google Scholar
As of October 2024, the following statutes had been adopted: Supported Decision-Making Agreements, Ala. Code §§ 26-1B-1–10 (2024); Supported Decision-Making Agreements Act, Alaska Stat. Ann. § 13.56.010–.195 (West 2024); Supported Decision-Making Agreements, Ariz. Rev. Stat. Ann. §§ 14-5721–22 (2024); Supported Decisionmaking, Cal. Welf. & Inst. Code §§ 21000–21008 (West 2024); Supported Decision-Making Agreements for Adults with a Disability, Colo. Rev. Stat. Ann. §§ 15-14-801–06 (West 2024); Supported Decision-Making Act, Del. Code. Ann. tit. 16, §§ 9401a–9410a (West 2024); Supported Decision-Making Agreements, D.C. Code Ann. § 7-2131–2134 (West 2024); Supported Decision-Making Agreement Act, 755 Ill. Comp. Stat. Ann. §§ 9/1–99 (West 2024); Supported Decision Making, Ind. Code Ann. §§ 29-3-14-1–13. (West 2024); Supported Decisionmaking Agreement Act, La. Stat. Ann. §§ 4261–64 (2024); Supported Decision Making, Md. Code Ann. Est. & Trusts § 18-101–09 (West 2024); Supported Decision-Making Act, Nev. Rev. Stat. Ann. § 162c.010–.300 (West 2024); Supported Decision-Making, N.H. Rev. Stat. Ann. §§ 464-D:1–16 (2024); Supported Decision-Making, N.Y. Mental Hyg. Law § 82.01–.15 (McKinney 2024); Supported Decisionmaking Agreements, N.D. Cent. Code Ann. § 30.1-36-01 to 30.1-36-08 (West 2024); Supported Decision-Making Act, 42 R.I. Gen. Laws Ann. §§ 42-66.13-1–10 (West 2024); Supported Decision-Making Agreement Act, Tex. Est. Code Ann. § 1357.001–.102 (West 2024); Uniform Guardianship, Conservatorship, and Other Protective Agreements Act, Wash. Rev. Code Ann. § 11.130.001–.915 (West 2024); Supported Decision-Making Agreements, Wis. Stat. Ann. § 52.01–.32 (West 2024).Google Scholar
See Ala. Code § 26-1B-4 (2024); Alaska Stat. Ann. § 13.56.180 (West 2024); Ariz. Rev. Stat. Ann. § 14-5722 (2024); D.C. Code Ann. § 7-2132 (West 2024); 755 Ill. Comp. Stat. Ann. § 9/50 (West 2024); N.H. Rev. Stat. Ann. § 464-D:16 (2024); R.I. Gen. Laws Ann. § 42-66.13-10 (West 2024); Tex. Est. Code Ann. § 1357.056 (West 2024); Wash. Rev. Code Ann. § 11.130.745 (West 2024); Wis. Stat. Ann. § 52.20 (West 2024).Google Scholar
See Wright, Megan S., “Dementia, Autonomy, and Supported Healthcare Decisionmaking,” Maryland Law Review 79, no. 2 (2020): 257–324 (describing supported decision-making agreement forms). The templates provided by states vary significantly. A template that complies with Texas’ supported decision-making statute is two pages whereas a template provided by Virginia is 23 pages. Compare “Supported Decision-Making Agreement,” Texas Council for Developmental Disabilities, https://tcdd.texas.gov/wp-content/uploads/2021/08/Supported-Decision-Making-Agreement-Oct15.pdf (last visited September 20, 2025) with “Commonwealth of Virginia: Supported Decision-Making Agreement,” Virginia Department of Behavioral Health and Developmental Services, https://dbhds.virginia.gov/wp-content/uploads/2023/03/Virginia-SDM-Agreement-fillable-Updated-March-2023.pdf (last visited September 20, 2025).Google Scholar
See Alaska Stat. Ann. § 13.56.180 (West 2024); Ariz. Rev. Stat. Ann. § 14-5722 (2024); D.C. Code Ann. § 7-2132 (West 2024); 755 Ill. Comp. Stat. Ann. § 9/50 (West 2024); R.I. Gen. Laws Ann. § 42-66.13-10 (West 2024); Tex. Est. Code Ann. § 1357.056 (West 2024); Wash. Rev. Code Ann. § 11.130.745 (West 2024); Wis. Stat. Ann. § 52.20 (West 2024).Google Scholar
See, e.g., 42 R.I. Gen. Laws Ann. § 42-66.13-10 (2024 West); N.H. Rev. Stat. Ann. § 464-D:16 (2024).Google Scholar
Ala. Code § 26-1B-9 (2024) (stating that a third party who in good faith relies on an authorization in an agreement and has not otherwise acted in a manner that amounts to fraud, misrepresentation, recklessness or willful or wanton misconduct is not subject to discipline for unprofessional conduct); Alaska Stat. Ann. § 13.56.140 (West 2024) (stating that third parties are not civilly or criminally liable and have not engaged in professional misconduct for relying in good faith on an agreement assumed to be valid); Colo. Rev. Stat. Ann. § 15-14-806 (West 2024) (stating that a third party shall rely on an agreement and is not subject to criminal or civil liability nor discipline for professional misconduct for acting in good faith and in reliance on the agreement); D.C. Code Ann. § 7-2133(e) (West 2024) (stating that third parties are not civilly or criminally liable and have not engaged in professional misconduct for acts done in good faith and in reasonable reliance on an agreement); Ind. Code Ann. §§ 29-3-14-10; 29-3-14-11 (West 2024) (stating that a third party may rely on an agreement unless the third party has actual knowledge that the agreement not valid, and is not criminally or civilly liable or subject to professional discipline for good faith reliance on or rejection of an agreement); Nev. Rev. Stat. Ann. § 162C.320 (West 2024) (stating that persons who rely on an agreement in good faith, without actual knowledge that it is void, invalidated, or terminated, are protected from all liability and discipline for giving effect to the agreement or from “following the direction of a supporter named in the supported decision-making agreement”); N.Y. Mental Hyg. Law § 82.12 (McKinney 2024) (stating that a third party is not subject to criminal or civil liability and shall not be determined to have engaged in professional misconduct for an action done in good faith and in reliance on a decision made pursuant to a valid agreement, and that health care providers are immune from actions alleging that the decision-maker lacked capacity to provide informed consent unless they had actual knowledge or notice that the decision-maker had revoked the agreement or that the supporter was committing abuse or exploitation with respect to the decision to grant consent); N.D. Cent. Code Ann. § 30.1-36-08 (West 2024) (making third parties immune from civil or criminal liability or professional misconduct for relying in good faith on a supported decision-making agreement); Tex. Est. Code Ann. § 1357.101(b) (West 2024) (making third parties immune from civil or criminal liability or professional misconduct for acts done in good faith and in reliance on a supported decision-making agreement); Wash. Rev. Code Ann. § 11.130.750 (West 2024) (stating that third parties shall rely on agreements and are not subject to criminal or civil liability nor considered to have engaged in professional misconduct for acting in good faith and in reliance on an agreement); Wis. Stat. Ann. § 52.30 (West 2024) (making third parties who are not health care providers immune from criminal liability, civil liability, and professional discipline if they rely in good faith on a supported decision-making agreement).Google Scholar
See Alaska Stat. Ann. § 13.56.130 (West 2024) (providing for the supporter to independently enforce the principal’s decision); Del. Code. Ann. Tit. 16, § 9407A (West 2024) (providing for the supporter to independently enforce the principal’s decision); 755 Ill. Comp. Stat. Ann. § 9/60 (West 2024) (providing that a supporter may independently enforce a decision); Nev. Rev. Stat. Ann. § 162C.310 (West 2024) (providing that the supporter may independently enforce a decision); N.H. Rev. Stat. Ann. § 464-D:11 (2024) (providing that a supporter may independently enforce a decision); R.I. Gen. Laws Ann. § 42-66.13-7 (West 2024) (providing that a supporter may independently enforce a decision).Google Scholar
Alaska Stat. Ann. § 13.56.090 (West 2024) (adopting an ordinary care standard: “A supporter shall act with the care, competence, and diligence ordinarily exercised by individuals in similar circumstances.”); Ariz. Rev. Stat. Ann. § 14-5722 (2024) (imposing a duty to act in good faith, with loyalty to the decision-maker, and without self-interest or conflicts of interest); Colo. Rev. Stat. Ann. § 15-14-804 (West 2024) (prohibiting the supporter from using information obtained for the purposes of assisting the adult with making a decision from using the information for anything other than the specific purposes requested by the adult); Del. Code. Ann. tit. 16, § 9406A(d) (West 2024) (requiring supporters to use the “care, competence, and diligence ordinarily exercised by individuals in similar circumstances,” taking into account special skills or expertise); 755 Ill. Comp. Stat. Ann. § 9/30 (West 2024) (requiring a supporter to “act with the care, competence, and diligence ordinarily exercised by an individual in a similar circumstance, with due regard to the possession of, or lack of, special skills or expertise”); Ind. Code Ann. § 29-3-14-11 (West 2024) (stating that supporters are not liable if they “perform[ed] supported decision making in good faith”); La. Stat. Ann. § 4261.203 (2024) (requiring a supporter act in the adult’s best interest and not in his or her opinion of the adult’s best interests and to act honestly, diligently, and in good faith, within the scope of the agreement, avoiding conflicts of interest); Md. Code Ann. Est. & Trusts § 18-105 (West 2024) (providing that a supporter shall act honestly, diligently and in good faith within the authority given in the agreement and avoid conflicts of interest); N.Y. Mental Hyg. Law § 82.05 (McKinney 2024) (requiring a supporter to act honestly, diligently, and in good faith, within the scope of the agreement, and avoiding conflicts of interest); N.D. Cent. Code Ann. § 30.1-36-03 (West 2024) (making a supporter not liable for acts performed as a supporter in good faith “unless the supporter has been recklessly or grossly negligent or has intentionally committed misconduct”); R.I. Gen. Laws Ann. § 42-66.13-6 (West 2024) (requiring the supporter to use “care, competence, and diligence ordinarily exercised by individuals in similar circumstances”); Wash. Rev. Code Ann. § 11.130.735 (West 2024) (requiring only that the supporter keep any information obtained for the purposes of assisting the adult with making a decision privileged and confidential and protected from unauthorized use); Wis. Stat. Ann. § 52.30(8) (West 2024) (“A supporter acting in the context of a valid supported decision-making agreement is immune from civil liability for his or her acts or omissions in performing duties as the supporter if he or she performs the duties in good faith, in conformance with the supported decision-making agreement or document of the adult with a functional impairment, and with the degree and prudence that an ordinarily prudent person exercises in his or her own affairs.”).Google Scholar
N.D. Cent. Code Ann. § 30.1-36-03 (West 2024) (“A supporter is not liable to the named individual and has not engaged in professional misconduct for acts performed as a supporter in good faith unless the supporter has been recklessly or grossly negligent or has intentionally committed misconduct.”).Google Scholar
See generally Wright, “Dementia, Autonomy, and Supported Healthcare Decisionmaking.”Google Scholar
See Kohn, “Legislating Supported Decision-Making” (discussing these concerns at greater length); Kohn, Nina A., “Realizing Supported Decision-Making: What It Does—and Does Not—Require,” The American Journal of Bioethics 21 (2021): 37–40 (raising concerns about the over-formalization of supported decision-making).CrossRefGoogle ScholarPubMed
Ala. Code § 26-1B-7 (2024) (requiring the individual revoke in writing and provide notice to each supporter); Alaska Stat. Ann. § 13.56.080 (West 2024) (requiring the individual to terminate the agreement in the presence of two witnesses or have the termination notarized; in addition, the supporter must be notified in person, by certified mail, or by electronic means); Ariz. Rev. Stat. Ann. § 14-5722 (2024) (requiring written termination); Cal. Welf. & Inst. Code § 21006 (West 2024) (requiring oral or written notice of termination to all parties to the agreement); Colo. Rev. Stat. Ann. § 15-14-803 (West 2024) (requiring oral or written notice of termination to all parties to the agreement); 755 Ill. Comp. Stat. Ann. § 9/70 (West 2024) (providing the individual must either destroy the agreement, revoke the agreement in writing, or, if revoking verbally must do so in the presence of two witnesses); Ind. Code Ann. §§ 29-3-14-1–13 (West 2024) (requiring revocation be in writing with a copy provided to each supporter); La. Stat. Ann. § 4261.206 (2024) (requiring the individual revoke in writing and provide a copy to each supporter); Nev. Rev. Stat. Ann. § 162C.200 (West 2024) (allowing for oral termination but requires notice to other parties); N.H. Rev. Stat. Ann. § 464-D:8 (2024) (requiring either written notice to all supporters or oral expression of intent to revoke in the presence of two witnesses); N.D. Cent. Code Ann. § 30.1-36-05 (West 2024) (allowing for multiple ways to terminate but requiring notice to supporters); R.I. Gen. Laws Ann. § 42-66.13-5 (West 2024) (requiring the individual to provide notice to supporters in writing); Wis. Stat. Ann. § 52.14 (West 2024) (providing the individual must destroy the agreement, provide written revocation, or, revoke orally in the presence of two witnesses).Google Scholar
Ala. Code § 26-1B-10 (2024) (requiring any person in receipt of an agreement or aware of its existence who has reasonable belief that the principal is being abused, neglected or exploited to report the suspicion, not explicitly indicating that the supporter be the suspected abuser); Ariz. Rev. Stat. Ann. § 14-5722 (2024) (requiring any person in receipt of an agreement or aware of its existence who has cause to believe that the principal is being abused, neglected or exploited by the supporter report the suspicion); Colo. Rev. Stat. Ann. § 15-14-805 (West 2024) (requiring any mandated reporter relying on an agreement that has cause to believe the decision maker is being mistreated by a supporter to report the suspected mistreatment to adult protective services); 755 Ill. Comp. Stat. Ann. § 9/65 (West 2024) (requiring any person in receipt of an agreement or aware of its existence who has cause to believe that the principal is being abused, neglected or exploited by the supporter report the suspicion); Ind. Code Ann. § 29-3-14-13 (West 2024) (stating that a person who knows of the agreement or receives a copy of it must report if the person reasonably believes that the individual is being abused, exploited, or neglected, even if the supporter is the not the suspected perpetrator); La. Stat. Ann. § 4261.302 (2024) (requiring any person who receives or is aware of an agreement to report any suspicion of abuse, neglect or exploitation of the decision maker by a supporter to adult protective services or law enforcement); N.H. Rev. Stat. Ann. § 464-D:14 (2024) (requiring persons in receipt of an agreement or aware of its existence to promptly report if they have cause to believe that the principal has been abused, neglected, or exploited by the supporter); N.Y. Mental Hyg. Law § 82.14 (McKinney 2024) (stating that any person in receipt of an agreement who has cause to believe the principal is being abused, coerced, or exploited by a supporter may report it to adult protective services, but does not require it unless they otherwise have a duty imposed by law); R.I. Gen. Laws. Ann. § 42-66.13-9 (West 2024) (stating that any person who is aware of an agreement or receives a copy of it must report abuse, neglect, or exploitation); Tex. Est. Code Ann. § 1357.102 (West 2024) (requiring a person who receives a copy of the agreement or is aware of its existence to report alleged abuse, neglect, or exploitation by the supporter); Wash. Rev. Code Ann. § 11.130.755 (West 2024) (requiring that any person in receipt of an agreement who has cause to believe “a vulnerable adult”, not limited to the principal, is being abused, abandoned, or neglected, including self-neglect, or exploited by the supporter shall report their belief to the Department of Social Services, except where the person is exempted from reporting due to a confidential relationship).Google Scholar
For a discussion of mandatory reporting requirements that are not specific to those in supported decision-making relationships, see Kohn, Nina A. et al, “Mandated Reporting of Elder Abuse: An Evaluation & Call to Action,” Elder Law Journal 33, no. 1 (2025): 167–222 (noting that most states only require certain categories of people to report abuse).Google Scholar
Accord Kohn, “Legislating Supported Decision-Making,” Kohn, “Realizing Supported Decision-Making: What It Does—and Does Not—Require.”Google Scholar
See Alaska Stat. Ann. § 13.56.120 (West 2024) (supporter required to keep information confidential and to protect it “from unauthorized use, access, or disclosure” and to “dispose of it properly when appropriate”); Del. Code. Ann. tit. 16, § 9409A (West 2024) (supporter must keep information collected on behalf of an individual privileged and confidential and properly dispose of when appropriate); Nev. Rev. Stat. Ann. § 162C.220 (West 2024) (supporter must keep information collected on behalf of an individual privileged and confidential, protect it against unauthorized access, use or disclosure, and properly dispose of it when appropriate); N.D. Cent. Code Ann. § 30.1-36-06 (West 2024) (supporter may not allow unauthorized access, use or disclosure of confidential information unless the supported person directed otherwise); R.I. Gen. Laws Ann. § 42-66.13-8(b) (West 2024) (supporter required to keep information obtained on behalf of the individual privileged and confidential); Tex. Est. Code Ann. § 1357.054 (West 2024) (supporter shall insure personal information that the supporter helped obtain or access is kept privileged and confidential and not subject to unauthorized access, use, or disclosure).Google Scholar
Notably, Indiana’s statute strongly implies that the supporter is a fiduciary as it deems the relationship to be one of “trust and confidence” and requires the supporter to “act honestly, diligently, and in good faith” and “avoid conflicts of interest.” However, that statute effectively negates the duty by then making the supporter immune from liability if the supporter “perform[ed] supported decision making in good faith.” Compare Ind. Code Ann. § 29-3-14-5 (West 2024), with Ind. Code Ann. § 29-3-14-11 (West 2024).Google Scholar
See Wright, “Dementia, Autonomy, and Supported Healthcare Decisionmaking,” at 298 (discussing supported decision-making laws’ grant of capacity as applied to patients with dementia).Google Scholar
While there are a growing number of anecdotal reports of supported decision-making being used with success, there is not yet a robust evidence base either showing its efficacy or what factors or practices are associated with its efficacy.Google Scholar
See also Martinis, Jonathan et al., “State Guardianship Laws and Supported Decision-Making in the United States After Ross and Ross v. Hatch: Analysis and Implications for Research, Policy, Education, and Advocacy,” Journal of Disability Policy Studies 34, no. 1 (2021): 8–16 (discussing states’ growing recognition of supported decision-making as an alternative to guardianship).CrossRefGoogle Scholar
Under this Act, a court may only appoint a guardian for an adult if the court finds by clear and convincing evidence that “the respondent lacks the ability to meet essential requirements for physical health, safety, or self-care because the respondent is unable to receive and evaluate information or make or communicate decisions, even with appropriate supportive services, technological assistance, or supported decision making.” Unif. Guardianship, Conservatorship, and Other Protective Proceedings Act § 301(a)(1)(A) (Nat’l Conference of Comm’rs on Unif. State Laws 2017) (emphasis added) [hereinafter UGCOPPA].Google Scholar
See, for example, Tex. Est. Code Ann.§ 1101.101(a)(1)(D)–(E) (West 2024) (prohibiting courts from appointing a guardian for an adult if alternatives to guardianship, including supports and services, that would avoid the need for the appointment of a guardian “have been considered and determined not to be feasible” and defining such alternatives as including supported decision-making); Me. St. t. 18-C §§ 5-301(A)(1); 5-502(1)(2024) (prohibiting appointment of a guardian or conservator unless there is clear and convincing evidence that less restrictive alternatives, including supported decision-making, would not meet respondents’ needs).Google Scholar
See, e.g., Matter of Grace, 176 N.Y.S. 3d 450 (2022) (finding that a guardianship was inappropriate for a respondent with intellectual disability because she received care in a group home and had “caring and capable siblings, including Petitioner, who can support her decision making without the need for a guardianship”); In re Estate of Caitlin, 2017 NYLJ LEXIS 714 (N.Y. Sur. 2017) (dismissing a petition for guardianship because it was in respondent’s best interest to “maintain [her] legal right to make personal decisions about her own affairs, while providing her with the necessary assistance to make those decisions in a supported decision making framework,” which was already in place). See also, Ross and Ross v. Hatch, No. CWF120000426P-03 (Va. Cir. Ct. August 27, 2012) (recognizing value of supported decision-making but concluding that respondent needed temporary guardianship for one year and directing guardians to prepare respondent for supported decision-making by the end of that year) and id., August 2, 2013 (final order vacating guardianship in favor of supported decision-making). The Jenny Hatch case was the earliest known US case in which an individual successfully advocated a guardianship should be terminated because supported decision-making would meet the individual’s needs. See Martinis et al., “State Guardianship Laws and Supported Decision-Making” (explaining the background and implications of the Hatch case). One of this article’s co-authors (Dinerstein) testified as an expert witness on supported decision-making in the Hatch case.Google Scholar
See Wash. Rev. Code Ann. § 11.130.270 (West 2024) (requiring notice to any “person known to have routinely assisted the respondent with decision making during the six months immediately before the filing of the petition”); Me. Rev. Stat. Ann. tit. 18-C §5-302 (West 2024) (requiring notice to any “person known to have routinely assisted the respondent with decision making during the six months immediately before the filing of the petition”).Google ScholarGoogle Scholar
Me. Rev. Stat. Ann. tit. 18-C § 5-301 (West 2024) (providing that a court may only appoint a guardian for an adult when it finds by clear and convincing evidence that supported decision-making does not provide adequate protection); Md. Code Ann. Est. & Trusts § 13-705 (West 2024) (requiring the finding of clear and convincing evidence that no less restrictive form of intervention, including supported decision-making, is available before appointing a guardian of the person); Minn. Stat. Ann. §524.5-310 (West 2024) (requiring the court “make specific findings particular to the respondent why less restrictive alternatives do not work,” including supported-decision making, prior to appointment of a guardian); Mont. Code Ann. § 72-5-316 (West 2024) (stating that the court may appoint a guardian when it is satisfied that the identified needs of the person cannot be met by a less restrictive alternative, including supported decision-making); N.D. Cent. Code Ann. § 30.1-28-04 (requiring the court only appoint a guardian after finding clear and convincing evidence that guardianship is the least restrictive form of intervention consistent with the ability of the ward for self-care); R.I. Gen. Laws Ann. § 33-15-47 (West 2024) (requiring supported-decision making to have been explored and deemed inappropriate as a less restrictive alternative prior to petitioning for appointment of a guardian); Wash. Rev. Code Ann. § 11.130.265 (West 2024) (requiring clear and convincing evidence that supported decision-making has not been sufficient to meet the essential needs of the respondent); Wis. Stat. Ann. § 54.10 (West 2024) (requiring clear and convincing evidence that that individual’s needs cannot be met through less restrictive means, including supported decision-making, prior to the appointment of a guardian).Google Scholar
Cal. Prob. Code § 1836(a)(1), (3), (A) (West 2024).Google Scholar
Ind. Code Ann. § 20-35-6-4(b) (2024); DC Code §38-2571.01 et seq. (2025)Google Scholar
See Al. St. § 22-19-202(7) & 203(d) (2025) (defining supported decision-making and requiring covered entities to “implement … supported decision-making services as necessary to ensure that a qualified individual is not denied services, including transplantation-related counseling, information, coverage, or treatment, unless the covered entity can demonstrate that implementation of the accommodations would fundamentally alter the nature of the services being offered or would result in an undue burden”); Ar. St. § 20-14-903(b)(2) (making it impermissible for a covered entity to require independent decision-making if the patient has a supportive network); Ga. St. § 31-1-24(C) (2025) (recognizing supported decision-making and prohibiting depriorization for organ transplantation of those who cannot independently comply with posttransplant medical requirements if they have “the necessary support system to assist”); Ks. St. § 65-3276 (2025) (requiring that for the purposes of determining whether people meet transplantation requirements persons not be discriminated against for using supported decision-making); Ms. St. § 43-6-255 (2025) (requiring that for the purposes of determining whether people meet transplantation requirements, persons not be discriminated against for using supported decision-making); Nev. St. § 460.160(3)(c) (2025) (requiring communication with decision-making supporters and prohibiting deprioritization of people for organ transplantation on the grounds that they cannot independently comply with postransplantation requirements if they could with assistance); N.C. St. § 130A-414.2 (2025) (requiring that for the purposes of determining whether people meet transplantation requirements, persons not be discriminated against for using supported decision-making); Oh. St. § 2108.36 (2025) (requiring that for the purposes of determining whether people meet transplantation requirements. persons not be discriminated against for using supported decision-making, and prohibiting deprioritization of people for organ transplantation on the grounds that they cannot independently comply with postransplantation requirements if they could with assistance); Va. St. § 32.1-297.2 (2025) (requiring that for the purposes of determining whether people meet transplantation requirements, persons not be discriminated against for using supported decision-making).Google Scholar
This provision can be found in Delaware Senate Bill 309 (84 Del. Laws 467 (2024)), signed into law in December 2024, and Utah Senate Bill 134 (S.B. 134, 2025 Gen. Sess. (Utah 2025)), signed into law in March 2025.Google Scholar
84 Del. Laws 467 (2024) and S.B. 134, 2025 Gen. Sess. (Utah 2025).Google Scholar
84 Del. Laws 467 (2024) and S.B. 134, 2025 Gen. Sess. (Utah 2025).Google Scholar
84 Del. Laws 467 (2024) and S.B. 134, 2025 Gen. Sess. (Utah 2025).Google Scholar
Unif. Health Care Decisions Act §3(a)(1), 5, 12(b)(7) (Nat’l Conference of Comm’rs on Unif. State Laws 2023).Google Scholar
See Wright, Megan S., “Who Decides? Legal Changes to Facilitate Inclusion of Participants with Impaired Cognition in Research,” in Research Involving Participants with Cognitive Disability and Difference: Ethics, Autonomy, Inclusion, and Innovation, ed. Cascio, Ariel & Racine, Eric, (Oxford University Press, 2019): 15–26; Benjamin C. Silverman et al., “Supported Decision-Making Can Advance Clinical Research Participation for People with Disabilities,” Nature Medicine 28, no. 11 (2022): 2250–2253; David Wender and Scott Y.H. Kim, “Implementing Supported Decision Making in Clinical Research,” International Journal of Geriatric Psychiatry (2023).Google Scholar
21 C.F.R. § 50.20, 50.25 (2023); see also Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Food and Drug Administration Office of Clinical Policy, August 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent (interpreting regulations) [hereinafter, “FDA, Informed Consent”]. See informed consent exceptions at 21 C.F.R. § 50.22 (2023); 21 C.F.R. § 50.23 (2025); C.F.R. §50.24 (2025).Google Scholar
21 CFR § 50.3(1) (2025); see also FDA, Informed Consent, at 53 (noting that this is “determined by State and local law. Where applicable law exists to determine who is authorized to serve as an LAR to consent to an individual’s participation in research, consent must be obtained from an LAR in accordance with this law.”).Google Scholar
21 C.F.R. § 50.20 (2025).CrossRefGoogle Scholar
21 C.F.R. § 50.20 (2025); 21 C.F.R. § 50.25(a)(8) (205).10.1097/01.NPR.0000000000000380CrossRefGoogle Scholar
21 C.F.R. § 50.25(a)(8) (2025).Google Scholar
21 C.F.R. § 56.111(b) (2025); see also FDA, Informed Consent, at 30–31 (interpreting regulations on IRB responsibilities). Federal regulations governing human subjects research specify some populations (e.g., children) as vulnerable and set forth safeguards and standards for research conducted with these populations. Although individuals with cognitive disabilities are referred to as “vulnerable” in the regulations, they do not receive similar, in-depth regulatory treatment. Directives on conducting research with individuals with cognitive disabilities are primarily found in agency guidance and policies interpreting the regulations.Google Scholar
The FDA has issued guidance about “enrolling adult subjects with impaired consent capacity” that states:Google ScholarGoogle ScholarGoogle ScholarGoogle Scholar
FDA, Informed Consent, at 52–53. Other recommendations include assessing capacity prior to enrollment and throughout the trial (and using independent assessors and documenting the results); including waiting periods; testing for participant understanding of the trial; requesting subject assent and LAR consent; involving the LAR throughout the study; using third parties to monitor the consent process; emphasizing voluntariness and the subject’s ability to leave the study at any time; and simplifying information.Google Scholar
FDA, Informed Consent, at 52; Grants and Funding, “Research Involving Individuals with Questionable Capacity to Consent,” National Institutes of Health, November 2009, https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/policies-and-regulations/vulnerable-populations/questionable-capacity (last visited September 21, 2025); Secretary’s Advisory Committee on Human Research Protections (SACHRP), Attachment: Recommendations Regarding Research Involving Individuals with Impaired Decision-making, U.S. Department of Health & Human Services, July 15, 2009 (last visited September 21, 2025), https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2009-july-15-letter-attachment/index.html.Google Scholar
FDA, Informed Consent, at 53–54 (“Additionally, the LAR should be consulted to make decisions on behalf of the subject and to assure that any such decisions are in the subject’s best interest throughout the duration of the subject’s participation in the clinical investigation.”).Google Scholar
FDA, Informed Consent, at 53–54.Google Scholar
FDA, Informed Consent, at 51–54. For an argument that the principal should have expanded authority to make decisions to participate in clinical research even when they do not attain full capacity with decisional support and a surrogate may need to provide ultimate consent, see Segal, Aaron, Howard, Dana, and Wendler, David, “Supported Decision-Making and the Inclusion of People Who Lack Decisional Capacity in Greater than Minimal Risk Research,” Journal of Law, Medicine & Ethics 54, supp. 2 (2026): forthcoming.Google Scholar
Principals may be able to demand that their supporter is present during informed consent discussions. This demand may have legal force via the supported decision-making agreement (i.e., directive for third parties to rely on the agreement) or as a “reasonable accommodation” under the Americans with Disabilities Act.Google Scholar
This is discussed in the next section of this article.Google Scholar
Wright, “Who Decides?,” at 19–20; NIH, “Research Involving Individuals with Questionable Capacity to Consent.”Google Scholar
NIH, “Research Involving Individuals with Questionable Capacity to Consent”; see also Wright, Megan S., “Planning for Cognitive Decline: Combining Formal Supported Decision-Making Agreements and Healthcare Power of Attorney,” Health Matrix: The Journal of Law-Medicine 35, no. 1 (2025): 225–244.Google Scholar
This is an evolving area of the law and a full discussion of the authority of a healthcare agent to consent to clinical research is beyond the scope of this article.Google Scholar
42 U.S.C. § 12101–12213 (2025).Google Scholar
Rehabilitation Act of 1973, Pub. L. No. 93-112, 87 Stat. 355 (codified as amended in scattered sections of 29 U.S.C. § 700-796). Indeed, the FDA recognizes this separate legal obligation in their guidance document on informed consent. FDA, Informed Consent, at 51, note 80 (“FDA strongly encourages stakeholders to ensure that informed consent documents are accessible to individuals with disabilities. To the extent an organization receives Federal financial assistance from HHS, the organization must comply with the Rehabilitation Act of 1973.”).Google Scholar
Boyle, Patrick, “What’s at Stake When Clinical Trials Research Gets Cut,” AAMC, April 24, 2025, https://www.aamc.org/news/whats-stake-when-clinical-trials-research-gets-cut (last visited September 21, 2025) (“The NIH [is] the primary funder of medical research in the United States.”).Google Scholar
See Wright, “Dementia, Autonomy, and Supported Healthcare Decisionmaking,” at 305; Wright, Megan S., “Dementia, Healthcare Decision Making, and Disability Law,” Journal of Law, Medicine & Ethics 47, no. 4 supplement (2019): 25–33; Alison Barkoff, “A Federal Policy and Legal Framework to Help Address Health Disparities Experienced by People with Intellectual and Other Cognitive Disabilities: Clinical Research and Supported Decision-Making,” Journal of Law, Medicine & Ethics 54, supp. 2 (2026): https://doi.org/10.1017/jme.2025.10201 (discussing recent 504 regulations and inclusion of clinical research as a place where reasonable accommodations are required).Google ScholarPubMed
See Kohn, “Legislating Supported Decision-Making.”Google Scholar
In some states, a person who has been named as a supporter pursuant to a formal supported decision-making agreement automatically has access to the individual’s personal health information; in others, this access must be specifically granted.Google Scholar