Recommendations to the IRB review process in preparation of xenotransplantation clinical trials
Corresponding Author
Daniel J. Hurst
Department of Family and Community Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
Correspondence
Daniel J. Hurst, Department of Family and Community Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.
Email: [email protected]
Search for more papers by this authorLuz A. Padilla
Department of Epidemiology, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorChristine Trani
Clinical Research Unit, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA
Search for more papers by this authorAdam McClintock
The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid K. C. Cooper
UAB Xenotransplantation Program, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorWendy Walters
The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorJames Hunter
Anesthesiology and Perioperative Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid Eckhoff
Division of Transplantation, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid Cleveland
Department of Surgery, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorWayne Paris
Department of Social Work, Abilene Christian University, Abilene, TX, USA
Search for more papers by this authorCorresponding Author
Daniel J. Hurst
Department of Family and Community Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
Correspondence
Daniel J. Hurst, Department of Family and Community Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.
Email: [email protected]
Search for more papers by this authorLuz A. Padilla
Department of Epidemiology, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorChristine Trani
Clinical Research Unit, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA
Search for more papers by this authorAdam McClintock
The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid K. C. Cooper
UAB Xenotransplantation Program, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorWendy Walters
The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorJames Hunter
Anesthesiology and Perioperative Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid Eckhoff
Division of Transplantation, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorDavid Cleveland
Department of Surgery, The University of Alabama at Birmingham, Birmingham, AL, USA
Search for more papers by this authorWayne Paris
Department of Social Work, Abilene Christian University, Abilene, TX, USA
Search for more papers by this author
REFERENCES
- 1Denner J, Tonjes RR. Infection barriers to successful xenotransplantation focusing on porcine endogenous retroviruses. Clin Microbiol Rev. 2012; 25(2): 318-343.
- 2Levine RJ. Ethics and Regulation of Clinical Research, 2nd edn. New Haven, CT: Yale University Press; 1988.
- 3Jonsen AR, Veatch RM, Walters L. Source Book in Bioethics: A Documentary History. Washington, DC: Georgetown University Press; 1998.
- 4 US Food and Drug Administration. Guidance for Institutional Review Boards and Clinical Investigators. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions. Published 1998. Accessed February 28, 2020.
- 5 PRIM&R. 2015 Webinar: Practical and Effective Approaches To Educate IRB Members. https://www.primr.org/webinars/april2015/. Published 2015. Accessed February 28, 2020.
- 6Pence GE. Medical Ethics: Accounts of Ground-Breaking Cases, 8th edn. New York City, NY: McGraw Hill; 2017.
- 7The NIH Report of Its Review of the Baby Fae Case. IRB: Ethics & Human Research. 1986; 8(2): 1-4.
10.2307/3564157 Google Scholar
- 8 US Food and Drug Administration. Clinical trials guidance documents. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents. Updated 25 March 2019. Accessed August 20, 2019.
- 9 National Institutes of Health. Recombinant DNA Advisory Committee. https://osp.od.nih.gov/biotechnology/recombinant-dna-advisory-committee/. Accessed January 18, 2020.
- 10Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF. Summary statement of the Asilomar conference on recombinant DNA molecules. Proc Natl Acad Sci USA. 1975; 72(6): 1981-1984.
- 11Wivel NA. Historical perspectives pertaining to the NIH Recombinant DNA Advisory Committee. Hum Gene Ther. 2014; 25(1): 19-24.
- 12 NIH. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf. Published 2019. Accessed February 28, 2020.
- 13 Recombinant DNA Research; Request for Public Comment on “Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols”. In: NIH, ed. Vol 50 Federal Register 1985: 2940-2945.
- 14Savulescu J. Harm, ethics committees and the gene therapy death. J Med Ethics. 2001; 27(3): 148-150.
- 15 Oversight of gene transfer research. In: RN Lenzi, BM Altevogt, LO Gostin, eds . Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: National Academies Press; 2014: 42-76. https://www.ncbi.nlm.nih.gov/pubmed/24354033
- 16 NIH. Final action under the NIH guidelines for research involving recombinant or synthetic nucleic acid molecules (NIH guidelines). Federal Register. 2016; 81(55): 15316.
- 17Baltimore D Asilomar. https://osp.od.nih.gov/wp-content/uploads/Session_I_Keynote_Baltimore.pdf. Published 2017. Accessed November 10, 2019.
- 18 National Institutes of Health. Introducing the NExTRAC. https://osp.od.nih.gov/2019/04/24/introducing-the-nextrac/. Accessed February 28, 2020.
- 19 NIH. Charter: Novel and Exceptional Technology and Research Advisory Committee. https://osp.od.nih.gov/wp-content/uploads/NExTRAC_Charter.pdf. Published 2019. Accessed November 10, 2019.
- 20 Nuffield Council on Bioethics. Animal-to-Human Transplants: the ethics of xenotransplantation. Nuffield Council on Bioethics; 1996.
- 21Tallacchini M. Defining an appropriate ethical, social and regulatory framework for clinical xenotransplantation. Curr Opin Organ Transplant. 2008; 13: 159-164.
- 22 US Department of Health and Human Services. PHS guideline on infectious disease issues in xenotransplantation. 2001.
- 23McGregor CGA, Takeuchi Y, Scobie L, Byrne G. PERVading strategies and infectious risk for clinical xenotransplantation. Xenotransplantation. 2018; 25(4):e12402.
- 24 The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Accessed November 15, 2019.
- 25Spillman MA, Sade RM. Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required. J Law Med Ethics. 2007; 35(2): 265-272.
- 26McConnell T. The inalienable right to withdraw from research. J Law Med Ethics. 2010; 38(4): 840-846.
- 27Hurst DJ, Padillia A, Walters W, et al. Pediatric xenotransplantation clinical trials and the right to withdraw. J Med Ethics.2019. https://doi.org/10.1136/medethics-2019-105668
- 28 Institute of Medicine Committee on Xenograft Transplantation: Ethical Issues and Public Policy, Xenotransplantation: Science, Ethics, and Public Policy. Washington, DC: National Academies Press; 1996. https://www.ncbi.nlm.nih.gov/books/NBK45532/ Accessed February 28, 2020.
- 29Cooper DKC, Wijkstrom M, Hariharan S, et al. Selection of patients for initial clinical trials of solid organ xenotransplantation. Transplantation. 2017; 101(7): 1551-1558.
- 30Gonzalez JG. Ethical and regulatory issues for clinical trials in xenotransplantation. Methods Mol Biol. 2012; 885: 281-305.
- 31Segedi M, Dhani G, Ng VL, Grant D. Living donors for fulminant hepatic failure in children. In: RA Greenberg, AM Goldberg, D Rodríguez-Arias, eds. Ethical Issues in Pediatric Organ Transplantation. Switzerland: Springer; 2016: 34-36.
10.1007/978-3-319-29185-7_2 Google Scholar
- 32Oliva M, Singh TP, Gauvreau K, Vanderpluym CJ, Bastardi HJ, Almond CS. Impact of medication non-adherence on survival after pediatric heart transplantation in the U.S.A. J Heart Lung Transplant. 2013; 32(9): 881-888.
- 33Shellmer DA, Dabbs AD, Dew MA. Medical adherence in pediatric organ transplantation: what are the next steps? Curr Opin Organ Transplant. 2011; 16(5): 509-514.
- 34Anderson EE, Solomon S, Heitman E, et al. Research ethics education for community-engaged research: a review and research agenda. J Empir Res Hum Res Ethics. 2012; 7(2): 3-19.
- 35 WHO. The Changsha Communiqué. Paper presented at: First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials 2008; Changsha, China.
- 36 US Department of Health and Human Services. Source animal, product, preclinical, and clinical issues concerning the use of Xenotransplantation products in humans: guidance for industry. 2016.
- 37 World Health Organization. Second WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials. 2011. https://www.who.int/transplantation/xeno/report2nd_global_consultation_xtx.pdf?ua=1. Accessed February 28, 2020.
- 38Hawthorne WJ, Cowan PJ, Buhler LH, et al. Third WHO global consultation on regulatory requirements for xenotransplantation clinical trials, Changsha, Hunan, China December 12–14, 2018: "The 2018 Changsha Communique" The 10-Year anniversary of the international consultation on xenotransplantation. Xenotransplantation. 2019; 26(2):e12513.
- 39 World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Transplantation. 2010; 90(3): 229-233.
- 40Sykes M, d’Apice A, Sandrin M. Position paper of the ethics committee of the international xenotransplantation association. Transplantation. 2004; 78(8): 1101-1107.
- 41Porter KM, Danis M, Taylor HA, Cho MK, Wilfond BS, Wilfond BS; Clinical Research Ethics Consultation Collaborative Repository G. The emergence of clinical research ethics consultation: insights from a national collaborative. Am J Bioeth. 2018; 18(1): 39-45.