Recommendations to the IRB review process in preparation of xenotransplantation clinical trials

Author:

Hurst Daniel J.1ORCID,Padilla Luz A.2,Trani Christine3,McClintock Adam4,Cooper David K. C.5ORCID,Walters Wendy4,Hunter James6,Eckhoff David7,Cleveland David8,Paris Wayne9

Affiliation:

1. Department of Family and Community Medicine The University of Alabama at Birmingham Birmingham AL USA

2. Department of Epidemiology The University of Alabama at Birmingham Birmingham AL USA

3. Clinical Research Unit, Abramson Cancer Center University of Pennsylvania Philadelphia PA USA

4. The University of Alabama at Birmingham Birmingham AL USA

5. UAB Xenotransplantation Program The University of Alabama at Birmingham Birmingham AL USA

6. Anesthesiology and Perioperative Medicine The University of Alabama at Birmingham Birmingham AL USA

7. Division of Transplantation The University of Alabama at Birmingham Birmingham AL USA

8. Department of Surgery The University of Alabama at Birmingham Birmingham AL USA

9. Department of Social Work Abilene Christian University Abilene TX USA

Publisher

Wiley

Subject

Transplantation,Immunology

Reference41 articles.

1. Infection Barriers to Successful Xenotransplantation Focusing on Porcine Endogenous Retroviruses

2. 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.

3. PRIM&R.2015Webinar: Practical and Effective Approaches To Educate IRB Members.https://www.primr.org/webinars/april2015/. Published 2015. Accessed February 28 2020.

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