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Supported decision-making can advance clinical research participation for people with disabilities

Clinical research often excludes people with disabilities who have impaired decisional capacity, but they can be included through supported decision-making, where their decisions can be assisted by designated supporters of their choosing. This will promote equitable access to research.

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References

  1. Feldman, M. A. et al. J. Intellect. Disabil. Res. 58, 800–809 (2014).

    Article  CAS  PubMed  Google Scholar 

  2. Friesen, P. et al. Am. J. Bioeth. https://doi.org/10.1080/15265161.2022.2063434 1–14 (2022).

  3. Shogren, K. A. et al. Educ. Train. Autism Dev. Disabil. 52, 144–157 (2017).

    Google Scholar 

  4. United Nations Convention on the Rights of Persons with Disabilities (CRPD): Article 12 – Equal Recognition Before the Law; https://go.nature.com/3fh6kUc (UN, accessed 1 September 2022).

  5. Stein, M. A. et al. Mental Health, Legal Capacity, and Human Rights (Cambridge Univ. Press, 2021).

  6. Vásquez Encalada, A. et al. Int. J. Environ. Res. Public Health 18, 5204 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  7. Implementing Supported Decision-Making: Developments Across Europe and the Role of National Human Rights Institutions (ENNHRI, MHE, 2020).

  8. In Your State; https://go.nature.com/3BQPyTD (NRC-SDM, accessed 1 September 2022).

  9. Bard, J. S. JLPA 6, 489–560 (2021).

    Google Scholar 

  10. Howell, B. M. et al. in Research Involving Participants with Cognitive Disability and Difference: Ethics, Autonomy, Inclusion, and Innovation (eds Cascio, M. A. & Racine, E.) Ch. 3. (Oxford Univ. Press, 2019).

  11. Office for Human Research Protections. US Code of Federal Regulations on the Protection of Human Subjects (45 CFR 46); https://go.nature.com/3yl1Rq4 (US HHS, 2018).

  12. Subcommittee on Inclusion of Individuals with Impaired Decision-making in Research: Recommendation 6 https://go.nature.com/3r1Z7Kf (SACHRP, 2009).

  13. Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and Sponsors (US FDA, 2014).

  14. Section 504 of the Rehabilitation Act 29 U.S.C. 794 (US Government, 2022).

  15. Americans with Disabilities Act U.S.C. 12101 (US Government, 2022).

  16. The Right to Make Choices: International Laws and Decision-Making by People with Disabilities (ASAN, 2016).

  17. U.S. Supported Decision-Making Laws; https://go.nature.com/3LGpQ8K (CPR, 1 September 2022).

  18. Supported Decision-Making Act: Delaware Code 16 9401A–9410A (Delaware, 2022).

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B.C.S., W.D.P. and B.E.B. wrote the original draft. All authors were responsible for conceptualization, review and editing.

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Correspondence to Benjamin C. Silverman.

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Competing interests

A.N. received consulting fees from CareSource, Inclusa and the Department of Health and Human Services Office for Civil Rights. The analysis presented here was not developed as part of his duties for any of these entities, including the Department of Health and Human Services, and the research, analysis, findings and conclusions were not reviewed by them and do not necessarily represent their views. D.H.S. received consulting fees as an external advisor to the Takeda Pharmaceuticals Ethics Advisory Council.

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Silverman, B.C., Ne’eman, A., Strauss, D.H. et al. Supported decision-making can advance clinical research participation for people with disabilities. Nat Med 28, 2250–2253 (2022). https://doi.org/10.1038/s41591-022-02035-3

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