Making a national donor research program a reality: Concepts for operationalizing a system

American Journal of Transplantation - Tập 19 - Trang 2686-2691 - 2019
Richard B. Freeman1,2
1Dell Medical School, University of Texas at Austin, Austin, Texas
2McCombs School of Business, University of Texas Austin, Austin, Texas

Tài liệu tham khảo

2017 Rodrigue, 2016, Deceased donor intervention research: a survey of transplant surgeons, organ procurement professionals and institutional review board members, Am J Transplant., 16, 278, 10.1111/ajt.13482 Abt, 2013, Challenge to research and innovation to optimize deceased donor organ quality and quantity, Am J Transplant., 13, 1400, 10.1111/ajt.12243 Glazier, 2015, A framework for conducting deceased donor research in the United States, Transplantation., 99, 2252, 10.1097/TP.0000000000000841 45 CFR 46. https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML. Accessed May 2, 2019. DeVita, 2007, Caring for organs or for patients? Ethical concerns about the Uniform Anatomical Gift Act (2006), Ann Intern Med., 147, 876, 10.7326/0003-4819-147-12-200712180-00008 Wicclair, 2002, Informed consent and research involving the newly dead, Kennedy Inst Ethics J., 12, 351, 10.1353/ken.2002.0028 Volk, 2014, Pilot test of a patient decision aid about liver transplant organ quality, Liver Transpl., 20, 850, 10.1002/lt.23882 Niemann, 2015, Therapeutic hypothermia in deceased organ donors and kidney-graft function, NEJM., 373, 405, 10.1056/NEJMoa1501969 Winkler, 2015, The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multi-site IRB review and oversight, Clin Transl Sci., 8, 57, 10.1111/cts.12202 Final NIH policy on the use of a single institutional review board for multi-site research. available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html Accessed December 19, 2017. Flynn, 2013, Using central IRBs for multicenter clinical trials in the United States, PLoS ONE., 8, e54999, 10.1371/journal.pone.0054999 Freeman, 2009, Transplantation risks and the real world: what does “high risk” really mean?, Am J Transplant., 9, 23, 10.1111/j.1600-6143.2008.02476.x