The Division of Medical
Ethics and Humanities

Howard Mann M.D.

Program Associate Division of Medical Ethics LDS Hospital & Department of Medicine - University of Utah School of Medicine Salt Lake City, Utah Correspondence: Department of Radiology 1A71 University Hospital 50 North Medical Drive Salt Lake City, Utah 84132-1140 E-mail address: Howard.Mann@hsc.utah.edu.

Current Appointments

• Associate Professor of Radiology, Department of Radiology, University of Utah School of Medicine
• Adjunct Associate Professor of Internal Medicine, University of Utah School of Medicine
• Institutional Review Board, University of Utah School of Medicine

Background in Biomedical and Research Ethics

• Member, LDS Hospital Bioethics Committee, 1992-1999
• Co-chairman, LDS Hospital Bioethics Committee, June 1994-December 1997
• Member, Institutional Review Board, IHC Urban Central Region, May 1994-March 2001
• Chairman, Institutional Review Board, IHC Urban Central Region, August 1999-March 2001

Current initiatives, guidance documents, presentations, and courses in research ethics

• ASSERT: A Standard for the Scientific and Ethical Review of Trials (http://www.assert-statement.org/) This initiative is directed at the review and monitoring of randomized clinical trials by research ethics committees.
• Uncertainty and equipoise in clinical trials: considerations for investigators, IRBs, physicians and patients. Department of Internal Medicine Grand Rounds lecture. December 2002.
• Responsible conduct of human subjects research - a course for clinical investigators.

Selected publications related to research ethics

1. Mann, H. The role of research ethics committees in the public dissemination of clinical trial results.Lancet 2002; 360:406-408
2. Mann, H. Patient recruitment and therapeutic beneficence in randomized controlled clinical trials. Open Peer Commentary. American Journal of Bioethics 2002: 2:35-6.
3. Mann, H. Alteplase for stroke. Uncertainty remains about efficacy (Letter) BMJ 2002;324:1581
4. Mann, H. Disclosure in research ethics. (Letter) Canad Med Assoc Journ 2002; 6:167
5. Mann, H. Institutional review board reform (Letter) NEJM 2002; 347:1285
6. Mann, H. Clinical trial protocols:agreements between the FDA and industrial sponsors. Lancet 2002; 360:1345-1346.
7. Mann, H. Trial participants need to be informed of uncertainty principle. (Letter) BMJ 2002; 325:1363
8. Mann H, Djulbegovic B. Off-study availability of investigational treatments. (Letter) Lancet 2003; 361:1302
9. Mann H, Djulbegovic B. Choosing a control intervention for a randomised clinical trial. BioMed Central (BMC). Medical Research Methodology 2003;3:7 (http://www.biomedcentral.com/1471-2288/3/7)
10. Mann H, Djulbegovic B, Gold PB. Equipoise in clinical trials. (Letter) J. Law, Med & Ethics 2003; 31(1):5-6
11. Mann, H. Publication of Full Reports of Clinical Trials. (Letter) Journal of Clinical Oncology 2003; 21:4254-4255
12. Mann, H. Ethics of research involving vulnerable populations. (Letter) Lancet 2003; 362:1857
13. Mann H, Djulbegovic B. Clinical equipose and the therapeutic misconception (Letter) Hasting's Center Report. September-October, 2003.
14. Mann H. Sham surgery in randomized trials : additional requirements should be satisfied. American Journal of Bioethics 2003; 3(4):5-7.
15. Mann H, Djulbegovic B. Biases due to differences in the treatments selected for comparison (comparator bias). James Lind Library (www.jameslindlibrary.org).
16. Mann, H. Controversial choice of a control intervention in a trial of ventilator therapy in ARDS: standard of care arguments in a randomized controlled trial J Med Ethics 2005; 31: 548- 553.
17. Mann H, London AJ, Mann J. Equipoise in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Trial : a critical appraisal. Clinical Trials 2005; 2: 233-243.
18. Mann H. Book review : Readings in the ethical and regulatory aspects of clinical research. American Journal of Bioethics 2005; 5: 72-74
19. Mann H, Shamoo AE. A call for a centralized national human research protections system. Accountability in Research 2006; 13(1): 1-9.
20. 20. Mann H. How confidential trial negotiations and agreements between the Food and Drug Administration and Sponsors marginalize local IRBs, and what to do about it. American Journal of Bioethics 2006;6(3): 22-23

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