{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T15:42:12Z","timestamp":1785426132884,"version":"3.56.0"},"reference-count":44,"publisher":"Cambridge University Press (CUP)","issue":"S2","license":[{"start":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T00:00:00Z","timestamp":1779926400000},"content-version":"unspecified","delay-in-days":147,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2026]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    We advocate for a change in the way individuals with cognitive impairment are enrolled in\n                    <jats:italic>minimal risk clinical research.<\/jats:italic>\n                    We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participants retain some interest in decision-making as well as the ability to express a decision. In these cases, we argue that the common practice whereby researchers either obtain consent from the individual or consent from a surrogate and assent from the individual, is ethically unnecessary. Instead, a process of facilitated decision-making based on SDM (supported decision-making) should be employed. Although it is possible that this process of facilitation will enable some individuals to make a capacitated choice who would not otherwise have done so, this should not be a requirement of getting to choose. In those cases where a would-be participant, despite support, fails to make a capacitated choice, the individual should still have the final say about participation. In this respect, our proposal deviates from standard practice. However, we argue that our proposal offers participants as much ethical protection as the more common procedures involving surrogates.\n                  <\/jats:p>","DOI":"10.1017\/jme.2025.10192","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T07:48:36Z","timestamp":1779954516000},"page":"94-102","source":"Crossref","is-referenced-by-count":1,"title":["Replacing Surrogate Decision-Making with Supported Decision-Making for Minimal Risk Research"],"prefix":"10.1017","volume":"54","author":[{"given":"Jennifer","family":"Hawkins","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00py81415","id-type":"ROR","asserted-by":"publisher"}],"name":"Duke University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4015-2248","authenticated-orcid":false,"given":"Aaron Eli","family":"Segal","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/052em3f88","id-type":"ROR","asserted-by":"publisher"}],"name":"Kansas City University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Wendler","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"National Institutes of Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Howard","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00c01js51","id-type":"ROR","asserted-by":"publisher"}],"name":"The Ohio State University Wexner Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,5,28]]},"reference":[{"key":"S1073110525101927_r35","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1016\/j.jpeds.2011.05.034","article-title":"How best to define the concept of minimal risk","volume":"159","author":"Westra","year":"2011","journal-title":"The Journal of Pediatrics"},{"key":"S1073110525101927_r38","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1186\/s40504-016-0036-4","article-title":"The moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate","volume":"12","author":"De Vries","year":"2016","journal-title":"Life Sciences, Society and Policy"},{"key":"S1073110525101927_r9","doi-asserted-by":"crossref","first-page":"2250","DOI":"10.1038\/s41591-022-02035-3","article-title":"Supported Decision-Making Can Advance Clinical Research Participation for People with Disabilities","volume":"28","author":"Silverman","year":"2022","journal-title":"Nature Medicine"},{"key":"S1073110525101927_r15","doi-asserted-by":"crossref","unstructured":"15. While it is known that there are variations in the way IRBs interpret minimal risk, for the most part, IRBs are cautious. However, even some of the more inclusive and slightly less cautious interpretations of minimal risk that we are aware of strike us as compatible with the spirit of our proposal. For the variability of how IRB members interpret minimal risk, see: Shah, Seema et al., \u201cHow do institutional review boards apply the federal risk and benefit standards for pediatric research?,\u201d JAMA 291, no. 4 (2004): 476\u201382. https:\/\/doi.org\/10.1001\/jama.291.4.476.","DOI":"10.1001\/jama.291.4.476"},{"key":"S1073110525101927_r42","unstructured":"42. Moreover, there are going to be situations where one may feel respected, but the manner in which they are treated (either without their knowledge or without their understanding) betrays a lack of respect. In such situations, treating others in ways that are generally understood to express respect is important regardless of uptake."},{"key":"S1073110525101927_r25","first-page":"63","volume-title":"Principles of Biomedical Ethics","author":"Beauchamp","year":"2001"},{"key":"S1073110525101927_r33","unstructured":"33. This is a common assumption. See, for example, SACHRP, \u201cRecommendations Regarding Research,\u201d Recommendation 4, which states \u201cConsent to research by the legally authorized representative (LAR) stands in for the consent by the prospective research participant, but it is not fully equivalent to consent by the participant him or herself. Therefore, when the participant is unable to protect his or her interests through the process of consent, additional protections or safeguards at the level of IRB review are required.\u201d"},{"key":"S1073110525101927_r22","volume-title":"The Stanford Encyclopedia of Philosophy","author":"Eyal","year":"2019"},{"key":"S1073110525101927_r26","unstructured":"26. Beauchamp and Childress, Principles: 63."},{"key":"S1073110525101927_r19","unstructured":"19. Here we note a difference between how we envision SDM to work in minimal risk research and how SDM may work in more than minimal risk research. As some of us (AS, DW, DH) discuss elsewhere, in more than minimal risk research, the potential participant\u2019s decision may not be final depending on the other risks and benefits of research participation. See Segal et al., \u201cSupported Decision-Making and the Inclusion of People who Lack Decisional Capacity in Greater Than Minimal Risk Research.\u201d"},{"key":"S1073110525101927_r18","unstructured":"18. Supporters may use a variety of methods to help someone understand and think about a decision \u2014 many kinds of decisional aids are available. A variety of tools and ideas for supported decision-making for different types of decisions can be found at https:\/\/supporteddecisionmaking.org\/resource-library\/."},{"key":"S1073110525101927_r16","unstructured":"16. Some impaired individuals may not be capable of trust or of maintaining trusting relationships. However, we assume that most individuals with the basic capacities mentioned earlier as necessary for implementing our proposal would have such an ability. The more pressing problem is that some individuals, though capable of trust and of forming trusting relationships, simply fail to have someone they actually trust who is available to fill the role of supporter. Our proposal is not that having such a person in the role of supporter be a requirement. We merely mean to suggest that any participant who has someone they trust be encouraged to have that person as a supporter. If no such person exists or is available, this should not automatically be a barrier to inclusion, though it should prompt careful consideration of how best to support the individual and whether it is necessary to identify a supporter for them."},{"key":"S1073110525101927_r12","unstructured":"12. This is different from the proposal some of us (AS, DW, DH) make for SDM in research involving more than minimal risk. Segal et al., \u201cSupported Decision-Making and the Inclusion of People who Lack Decisional Capacity in Greater Than Minimal Risk Research.\u201d 1\u20138. There, due to the elevated risks of research participation, it is argued that while the potential participant may not wield full decisional authority over whether to participate in research, they retain some decisional authority, and deference is owed to their actual choices in some situations, even if the supporter would not have made a similar decision through the process of surrogate decision-making."},{"key":"S1073110525101927_r11","unstructured":"11. See note 9."},{"key":"S1073110525101927_r17","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1017\/jme.2025.10202","article-title":"The Legal Landscape for Supported Decision-Making in the United States","volume":"54","author":"Kohn","year":"2026","journal-title":"Journal of Law, Medicine and Ethics"},{"key":"S1073110525101927_r34","unstructured":"34. As some of us (AS, DW, DH) argue in Segal et al., \u201cSupported Decision-Making and the Inclusion of People who Lack Decisional Capacity in Greater Than Minimal Risk Research.\u201d 1\u20138"},{"key":"S1073110525101927_r4","doi-asserted-by":"crossref","first-page":"474","DOI":"10.1186\/s13063-019-3603-1","article-title":"Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK","volume":"20","author":"Shepherd","year":"2019","journal-title":"Trials"},{"key":"S1073110525101927_r1","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1111\/jir.12091","article-title":"Where are Persons with Intellectual Disabilities in Medical Research? A Survey of Published Clinical Trials","volume":"58","author":"Feldman","year":"2014","journal-title":"Journal of Intellectual Disability Research"},{"key":"S1073110525101927_r5","unstructured":"5. Zur, \u201cProtected from Harm\u201d; Wisner et al., \u201cPregnant Women Therapeutic Orphans\u201d; Mastroianni et al., \u201cWomen and Health Research\u201d; Shirkey, \u201cTherapeutic Orphans,\u201d; Thake and Lowry, \u201cSystematic Review\u201d; Feldman et al., \u201cWhere are persons with intellectual disabilities?\u201d"},{"key":"S1073110525101927_r39","unstructured":"39. 45 C.F.R. \u00a7 46.116(f) (2025)."},{"key":"S1073110525101927_r32","unstructured":"32. Kim, Evaluation of Capacity: 15\u201316; Buchanan and Brock, Deciding for Others; Grisso and Appelbaum, Assessing Competence: 12\u201314."},{"key":"S1073110525101927_r29","unstructured":"29. 45 C.F.R. \u00a7 46.111(a)(2) (2025)."},{"key":"S1073110525101927_r7","doi-asserted-by":"crossref","first-page":"514","DOI":"10.7326\/0003-4819-135-7-200110020-00011","article-title":"Core Safeguards for Clinical Research with Adults Who are Unable to Consent","volume":"135","author":"Wendler","year":"2001","journal-title":"Annals of Internal Medicine"},{"key":"S1073110525101927_r3","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1002\/wps.20776","article-title":"Pregnant women are still therapeutic orphans","volume":"19","author":"Wisner","year":"2020","journal-title":"World Psychiatry"},{"key":"S1073110525101927_r2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1017\/jme.2025.10190","article-title":"Supported Decision-Making and the Inclusion of People who Lack Decisional Capacity in Greater Than Minimal Risk Research","volume":"54","author":"Segal","year":"2026","journal-title":"Journal of Law, Medicine and Ethics"},{"key":"S1073110525101927_r27","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1093\/oso\/9780195103724.001.0001","volume-title":"Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals","author":"Grisso","year":"1998"},{"key":"S1073110525101927_r21","doi-asserted-by":"crossref","first-page":"2701","DOI":"10.1001\/jama.283.20.2701","article-title":"What Makes Clinical Research Ethical?","volume":"283","author":"Emanuel","year":"2000","journal-title":"JAMA"},{"key":"S1073110525101927_r40","doi-asserted-by":"crossref","first-page":"795","DOI":"10.1086\/233946","article-title":"Appearing Respectful. The Moral Significance of Manners","volume":"109","author":"Buss","year":"1999","journal-title":"Ethics"},{"key":"S1073110525101927_r31","unstructured":"31. We assume that decision-making capacity is decision-relative and ought to be assessed that way. So, it is quite possible that someone capable of making one decision may be incapable of making another."},{"key":"S1073110525101927_r13","unstructured":"13. Here, and in the next sentence, we refer to the basic cognitive requirements that are part of what is known as \u201cthe four-abilities model\u201d of decision-making capacity. While not universally used, it is widely used, and many of the other forms of assessment resemble it closely in terms of its focus on basic cognitive capacities that underwrite making choices that align with one\u2019s ends. The four-abilities model was developed by Paul Appelbaum, Thomas Grisso, and their colleagues. Two clear expositions of how the model is intended to work are: Thomas Grisso and Paul S. Appelbaum, The Assessment of Decision-Making Capacity: A Guide for Physicians and Other Healthcare Professionals (Oxford University Press, 1998); Scott Y. H. Kim, Evaluation of Capacity to Consent to Treatment and Research (Oxford University Press, 2010)."},{"key":"#cr-split#-S1073110525101927_r6.1","unstructured":"6. US Federal regulations allow that adults unable to consent for themselves may be included in research if a surrogate decision-maker decides for them. But beyond that, they do not give much in the way of specific direction. However, various other guidance documents address research with adults unable to consent and defend the need to assess decisional capacity whenever it is anticipated that some participating individuals will lack decision-making capacity. See, e.g. (1) The Secretary's Advisory Committee on Human Research Protections (SACHRP), Recommendations Regarding Research Involving Individuals with Impaired Decision-Making, Recommendation 3(b)(i) (U.S. Department of Health & Human Services, March 4, 2009) https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2009-july-15-letter-attachment\/index.html"},{"key":"#cr-split#-S1073110525101927_r6.2","unstructured":"(2) Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-related Research Involving Humans (Council for International Organizations of Medical Sciences, 2016), ISBN 978-929036088-9, https:\/\/cioms.ch\/publications\/product\/international-ethical-guidelines-for-health-related-research-involving-humans\/."},{"key":"S1073110525101927_r28","unstructured":"28. 45 C.F.R. \u00a7 46.111(a)(2) (2025)."},{"key":"S1073110525101927_r8","first-page":"8","article-title":"Implementing Legal Capacity Under Article 12 of the UN Convention on the Rights of Persons with Disabilities","volume":"19","author":"Dinerstein","year":"2012","journal-title":"Human Rights Brief"},{"key":"S1073110525101927_r30","unstructured":"30. Kim, Evaluation of Capacity: 15\u201316; Buchanan and Brock, Deciding for Others; Grisso and Appelbaum, Assessing Competence: 12\u201314."},{"key":"S1073110525101927_r36","unstructured":"36. 45 C.F.R. \u00a7 46.102(j) (2025)."},{"key":"S1073110525101927_r37","unstructured":"37. We have so far been discussing minimal risk research. But it is also worth pausing briefly to note the risks associated with consent itself. In short, there is always a small risk that a consent process may not suffice to get people to decide not to participate who, for one reason or another, ought not to participate. For example, in ordinary research with individuals who have decision-making capacity, it is always possible that a person will consent to participation in research, despite the fact that her own idiosyncratic preferences and values mean she will find participation distressing and perhaps even harmful. This could happen, for example, if the individual is idiosyncratic in certain ways, but does not pay close attention to the information given in the consent process. However, if the consent process has been well-thought out and well-conducted, the risk of that happening should be extremely low. Our claim is that if our proposal is implemented, the risk that a cognitively impaired person would be enrolled in research that harms her (as opposed to merely imposing a burden) is also extremely low, and indeed, as low as such risks generally are in well-conducted clinical research."},{"key":"S1073110525101927_r14","unstructured":"14. 45 C.F.R. \u00a7 46.102(j) (2025)."},{"key":"S1073110525101927_r41","volume-title":"Essay Concerning Human Understanding","author":"Locke","year":"1694"},{"key":"S1073110525101927_r43","unstructured":"43. We do not mean that such individuals are not owed respect. Rather, our point is that \u201crespect\u201d can mean different things and require different things of us in different contexts. We are here talking about a concrete ethical requirement to treat people in ways that communicate to them that they are taken seriously and valued. Our point is just that a communicative requirement of this sort does not apply to people who cannot receive the message."},{"key":"S1073110525101927_r20","unstructured":"20. In addition to what we discuss here, there are often issues about ongoing consent. Our proposal could be applied here as well and would simplify this process since there is no need to assess decision-making capacity, only the need to engage the participant periodically in an SDM process. Here, for simplicity, we have focused on enrollment."},{"key":"S1073110525101927_r24","doi-asserted-by":"crossref","DOI":"10.1017\/CBO9781139171946","volume-title":"Deciding for Others: The Ethics of Surrogate Decision-Making","author":"Buchanan","year":"1990"},{"key":"S1073110525101927_r10","unstructured":"10. Implementing our suggestion would require a change to the common rule, since current regulations require surrogate consent from individuals who lack decisional capacity. Our argument is intended as a moral argument for why such a change would be a good change to make."},{"key":"S1073110525101927_r23","first-page":"238","volume-title":"A History and Theory of Informed Consent","author":"Faden","year":"1986"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110525101927","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T07:26:08Z","timestamp":1780903568000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110525101927\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026]]},"references-count":44,"journal-issue":{"issue":"S2","published-print":{"date-parts":[[2026]]}},"alternative-id":["S1073110525101927"],"URL":"https:\/\/doi.org\/10.1017\/jme.2025.10192","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026]]}}}