A Community-Driven Framework to Prioritize the Use of Donated Human Biological Materials in the Context of HIV Cure-Related Research at the End of Life
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Abstract
Initiated in 2017 after extensive community engagement, the Last Gift program enrolls altruistic volunteers willing to donate their cells and tissues at the end of life to allow studies on HIV reservoir dynamics across anatomical sites. As the Last Gift team received tissue requests outside the scope of HIV cure research, we noticed the absence of guiding frameworks to help prioritize the use of altruistically donated human biological materials. In this commentary, we present a proposed framework for prioritizing the use of donated human biological materials within and outside the end-of-life (EOL) HIV cure research context, using the Last Gift study as an example. First, we discuss regulatory and policy considerations, and highlight key ethical values to guide prioritization decisions. Second, we present our prioritization framework and share some of our experiences prioritizing requests for donated human biological materials within and outside EOL HIV cure research.
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References
1. Palella FJ, Jr., Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998;338(13):853-60. doi: 10.1056/NEJM199803263381301. PubMed PMID: 9516219.
2. Brown B, Marg L, Cabral A, Didero M, Christensen C, Taylor J, Subica A. Community-Driven Health Priorities for Healthy Aging With HIV. J Assoc Nurses AIDS Care. 2019;30(1):119-28. doi: 10.1097/JNC.0000000000000042. PubMed PMID: 30586089.
3. Goodkin K, Kompella S, Kendell SF. End-of-Life Care and Bereavement Issues in Human Immunodeficiency Virus-AIDS. Nurs Clin North Am. 2018;53(1):123-35. doi: 10.1016/j.cnur.2017.10.010. PubMed PMID: 29362056; PMCID: PMC5837059.
4. Perry KE, Dubé K, Concha-Garcia S, Patel H, Kaytes A, Taylor J, Javadi SS, Mathur K, Lo M, Brown B, Sauceda JA, Wohl DA, Little S, Hendrickx S, Rawlings SA, Smith DM, Gianella S. “My Death Will Not [Be] in Vain”: Testimonials from Last Gift Rapid Research Autopsy Study Participants Living with HIV at the End of Life. AIDS Res Hum Retroviruses. 2020;36(12):1071-82. Epub 20200624. doi: 10.1089/AID.2020.0020. PubMed PMID: 32449625; PMCID: PMC7703253.
5. Gianella S, Taylor J, Brown TR, Kaytes A, Achim CL, Moore DJ, Little SJ, Ellis RJ, Smith DM. Can research at the end of life be a useful tool to advance HIV cure? AIDS. 2017;31(1):1-4. doi: 10.1097/QAD.0000000000001300. PubMed PMID: 27755112; PMCID: PMC5137789.
6. Lessard D, Dubé K, Bilodeau M, Keeler P, Margolese S, Rosenes R, Sinyavskaya L, Durand M, Benko E, Kovacs C, Guerlotte C, Tharao W, Arnold K, Masching R, Taylor D, Sousa J, Ostrowski M, Taylor J, Kaytes A, Smith D, Gianella S, Chomont N, Angel JB, Routy JP, Cohen EA, Lebouche B, Costiniuk CT. Willingness of Older Canadians with HIV to Participate in HIV Cure Research Near and After the End of Life: A Mixed-Method Study. AIDS Res Hum Retroviruses. 2022;38(8):670-82. Epub 20220728. doi: 10.1089/AID.2022.0006. PubMed PMID: 35778845; PMCID: PMC9483839.
7. Prakash K, Gianella S, Dubé K, Taylor J, Lee G, Smith DM. Willingness to participate in HIV research at the end of life (EOL). PLoS One. 2018;13(7):e0199670. Epub 20180723. doi: 10.1371/journal.pone.0199670. PubMed PMID: 30036365; PMCID: PMC6056048.
8. Rawlings SA, Layman L, Smith D, Scott B, Ignacio C, Porrachia M, Concha-Garcia S, Hendrickx S, Kaytes A, Taylor J, Gianella S. Performing rapid autopsy for the interrogation of HIV reservoirs. AIDS. 2020;34(7):1089-92. doi: 10.1097/QAD.0000000000002546. PubMed PMID: 32287073; PMCID: PMC7780881.
9. Chaillon A, Gianella S, Dellicour S, Rawlings SA, Schlub TE, De Oliveira MF, Ignacio C, Porrachia M, Vrancken B, Smith DM. HIV persists throughout deep tissues with repopulation from multiple anatomical sources. J Clin Invest. 2020;130(4):1699-712. doi: 10.1172/JCI134815. PubMed PMID: 31910162; PMCID: PMC7108926.
10. Rawlings SA, Chaillon A, Smith D, Gianella S. Scale up rapid research autopsies for tissue immunology. Nature. 2021;595(7867):352. doi: 10.1038/d41586-021-01887-y. PubMed PMID: 34257439.
11. Pentz RD, Cohen CB, Wicclair M, DeVita MA, Flamm AL, Youngner SJ, Hamric AB, McCabe MS, Glover JJ, Kittiko WJ, Kinlaw K, Keller J, Asch A, Kavanagh JJ, Arap W. Ethics guidelines for research with the recently dead. Nat Med. 2005;11(11):1145-9. doi: 10.1038/nm1105-1145. PubMed PMID: 16270065.
12. Opportunities for Organ Donor Intervention Research [Internet]. NASEM; 2020. Available from: https://nap.nationalacademies.org/catalog/24884/opportunities-for-organ-donor-intervention-research-saving-lives-by-improving.
13. Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects [Internet]. US Department of Health and Human Services; 2014. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
14. Glazier AK, Heffernan KG, Rodrigue JR. A Framework for Conducting Deceased Donor Research in the United States. Transplantation. 2015;99(11):2252-7. doi: 10.1097/TP.0000000000000841. PubMed PMID: 26244717.
15. Revised Uniform Anatomical Gift Act [Internet]. National Conference of Commissioners on Uniform State Laws; 2006 1-60]. Available from: https://wcmea.com/wp-content/uploads/2020/01/Uniform-Anatomical-Gift-Act.pdf.
16. Commercial Use of Human Biological Materials: American Medical Association. Available from: https://code-medical-ethics.ama-assn.org/ethics-opinions/commercial-use-human-biological-materials#:~:text=Human%20biological%20materials%20%20and%20their,accordance%20with%20lawful%20contractual%20agreements.
17. The HIPAA Privacy Rule [Internet]. Department of Health and Human Services; [updated March 31, 2022; cited 2023 March]. Available from: https://www.hhs.gov/hipaa/for-professionals/privacy/index.html.
18. UCLA suspends its Willed Body Program [Internet]. CNN.com; Wednesday, March 10, 2004. Available from: https://edition.cnn.com/2004/LAW/03/09/ucla.cadaver.suit/index.html.
19. Dubé K, Gianella S, Concha-Garcia S, Little SJ, Kaytes A, Taylor J, Mathur K, Javadi S, Nathan A, Patel H, Luter S, Philpott-Jones S, Brown B, Smith D. Ethical considerations for HIV cure-related research at the end of life. BMC Med Ethics. 2018;19(1):83. Epub 20181020. doi: 10.1186/s12910-018-0321-2. PubMed PMID: 30342507; PMCID: PMC6196016.
20. Kanazawa J, Rawlings SA, Hendrickx S, Gianella S, Concha-Garcia S, Taylor J, Kaytes A, Patel H, Ndukwe S, Little SJ, Smith D, Dubé K. Lessons learned from the Last Gift study: ethical and practical challenges faced while conducting HIV cure-related research at the end of life. J Med Ethics. 2023;49(5):305-10. Epub 20220622. doi: 10.1136/medethics-2021-107512. PubMed PMID: 35732421; PMCID: PMC9772357.
21. Danielson MM, Dubé K. Michael’s Testimonial. Ann Intern Med. 2018;169(5):349. doi: 10.7326/M18-1719. PubMed PMID: 30178018.
22. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [Internet]. Department of Health, Education, and Welfare; April 18, 1979 [Notice of Report for Public Comment]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html.
23. Gordon EJ. Informed consent for living donation: a review of key empirical studies, ethical challenges and future research. Am J Transplant. 2012;12(9):2273-80. Epub 20120517. doi: 10.1111/j.1600-6143.2012.04102.x. PubMed PMID: 22594620.
24. Riggs PK, Chaillon A, Jiang G, Letendre SL, Tang Y, Taylor J, Kaytes A, Smith DM, Dubé K, Gianella S. Lessons for Understanding Central Nervous System HIV Reservoirs from the Last Gift Program. Curr HIV/AIDS Rep. 2022;19(6):566-79. Epub 20221019. doi: 10.1007/s11904-022-00628-8. PubMed PMID: 36260191; PMCID: PMC9580451.
25. Foster C. Dignity and the ownership and use of body parts. Camb Q Healthc Ethics. 2014;23(4):417-30. Epub 20140717. doi: 10.1017/S0963180114000097. PubMed PMID: 25032711.
26. Strong CW, Shafer T. Donation of bodily material for medicine and research. BMJ. 2011;343:d6839. Epub 20111026. doi: 10.1136/bmj.d6839. PubMed PMID: 22031927.
27. Freeman RB, Bernat JL. Ethical issues in organ transplantation. Prog Cardiovasc Dis. 2012;55(3):282-9. doi: 10.1016/j.pcad.2012.08.005. PubMed PMID: 23217432.
28. Beauchamp TL CJ. Principles of Biomedical Ethics. 8 ed: Oxford University Press; 2019. 512 p.
29. Joffe S, Miller FG. Bench to bedside: mapping the moral terrain of clinical research. Hastings Cent Rep. 2008;38(2):30-42. doi: 10.1353/hcr.2008.0019. PubMed PMID: 18457227.
30. Dubé K, Perry KE, Mathur K, Lo M, Javadi SS, Patel H, Concha-Garcia S, Taylor J, Kaytes A, Dee L, Campbell D, Kanazawa J, Smith D, Gianella S, Auerbach JD, Saberi P, Sauceda JA. Altruism: Scoping review of the literature and future directions for HIV cure-related research. J Virus Erad. 2020;6(4):100008. Epub 20200825. doi: 10.1016/j.jve.2020.100008. PubMed PMID: 33294210; PMCID: PMC7695811.
31. Rosenbaum L. Altruism in Extremis - The Evolving Ethics of Organ Donation. N Engl J Med. 2020;382(6):493-6. doi: 10.1056/NEJMp2000048. PubMed PMID: 32023370.
32. Dubé K, Patel H, Concha-Garcia S, Perry KE, Mathur K, Javadi SS, Taylor J, Kaytes A, Brown B, Sauceda JA, Little S, Hendrickx S, Rawlings SA, Smith DM, Gianella S. Perceptions of Next-of-Kin/Loved Ones About Last Gift Rapid Research Autopsy Study Enrolling People with HIV/AIDS at the End of Life: A Qualitative Interview Study. AIDS Res Hum Retroviruses. 2020;36(12):1033-46. Epub 20200625. doi: 10.1089/AID.2020.0025. PubMed PMID: 32449624; PMCID: PMC7703245.
33. Javadi SS, Mathur K, Concha-Garcia S, Patel H, Perry KE, Lo M, Taylor J, Kaytes A, Little S, Gianella S, Smith D, Dubé K. Attitudes and perceptions of next-of-kin/loved ones toward end-of-life HIV cure-related research: A qualitative focus group study in Southern California. PLoS One. 2021;16(5):e0250882. Epub 20210507. doi: 10.1371/journal.pone.0250882. PubMed PMID: 33961653; PMCID: PMC8104928.
34. Perry KE, Taylor J, Patel H, Javadi SS, Mathur K, Kaytes A, Concha-Garcia S, Little S, Smith D, Gianella S, Dubé K. “[It] is now my responsibility to fulfill that wish:” Clinical and rapid autopsy staff members’ experiences and perceptions of HIV reservoir research at the end of life. PLoS One. 2020;15(11):e0242420. Epub 20201118. doi: 10.1371/journal.pone.0242420. PubMed PMID: 33206710; PMCID: PMC7673534.
35. Wendler D, Dickert N. The consent process for cadaveric organ procurement: how does it work? How can it be improved? JAMA. 2001;285(3):329-33. doi: 10.1001/jama.285.3.329. PubMed PMID: 11176844.
36. Kanazawa J, Gianella S, Concha-Garcia S, Taylor J, Kaytes A, Christensen C, Patel H, Ndukwe S, Rawlings S, Hendrickx S, Little S, Brown B, Smith D, Dubé K. Ethical and practical considerations for interventional HIV cure-related research at the end-of-life: A qualitative study with key stakeholders in the United States. PLoS One. 2021;16(7):e0254148. Epub 20210716. doi: 10.1371/journal.pone.0254148. PubMed PMID: 34270612; PMCID: PMC8284787.
37. Pope TM. Legal briefing: organ donation and allocation. J Clin Ethics. 2010;21(3):243-63. PubMed PMID: 21089996.
38. Wang C, Schlub TE, Yu WH, Tan CS, Stefic K, Gianella S, Smith DM, Lauffenburger DA, Chaillon A, Julg B. Landscape of Human Immunodeficiency Virus Neutralization Susceptibilities Across Tissue Reservoirs. Clin Infect Dis. 2022;75(8):1342-50. doi: 10.1093/cid/ciac164. PubMed PMID: 35234862; PMCID: PMC9555844.
39. Lang ME, Bird CE. Understanding and Addressing the Common Roots of Racial Health Disparities: The Case of Cardiovascular Disease and HIV/AIDS in African Americans. Health Matrix Clevel. 2015;25:109-38. PubMed PMID: 29485842.
40. Sangaramoorthy T, Jamison A, Dyer T. Older African Americans and the HIV Care Continuum: A Systematic Review of the Literature, 2003-2018. AIDS Behav. 2019;23(4):973-83. doi: 10.1007/s10461-018-2354-4. PubMed PMID: 30519903; PMCID: PMC6459701.
41. Goodkin K, Heckman T, Siegel K, Linsk N, Khamis I, Lee D, Lecusay R, Poindexter CC, Mason SJ, Suarez P, Eisdorfer C. “Putting a face” on HIV infection/AIDS in older adults: a psychosocial context. J Acquir Immune Defic Syndr. 2003;33 Suppl 2:S171-84. PubMed PMID: 12853867.
42. Rhoades N, Mendoza N, Jankeel A, Sureshchandra S, Alvarez AD, Doratt B, Heidari O, Hagan R, Brown B, Scheibel S, Marbley T, Taylor J, Messaoudi I. Altered Immunity and Microbial Dysbiosis in Aged Individuals With Long-Term Controlled HIV Infection. Front Immunol. 2019;10:463. Epub 20190312. doi: 10.3389/fimmu.2019.00463. PubMed PMID: 30915086; PMCID: PMC6423162.
43. Marg LZ, Heidari O, Taylor J, Marbley C, Scheibel S, Hagan R, Messaoudi I, Mendoza N, Brown B. A Multidimensional Assessment of Successful Aging Among Older People Living with HIV in Palm Springs, California. AIDS Res Hum Retroviruses. 2019;35(11-12):1174-80. Epub 20190925. doi: 10.1089/AID.2019.0048. PubMed PMID: 31441322.