Institutional ethics review of clinical study agreements

Journal of Medical Ethics

Volumn 30, Issue 1, 2004, Pages 30-34

  DuVal, Gordon ^a  

^a UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL STUDY; COMPENSATION; CONFIDENTIALITY; DATA ANALYSIS; FINANCIAL MANAGEMENT; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; MEDICAL RESEARCH; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; REVIEW; SAFETY; WELFARE;

BIOETHICAL ISSUES; CLINICAL TRIALS; ETHICS COMMITTEES; ETHICS, RESEARCH; HUMANS; INDUSTRY; RESEARCH SUPPORT;

EID: 1342287944     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2003.005199     Document Type: Review

References (28)

1. Walt G, Brugha R, Haines A. Working with the private sector: the need for institutional guidelines. BMJ 2002;325:432-5.
2. Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347:1335-41.
3. Office of Human Research Protections. OHRP compliance activities: common findings and guidance # 14-"initial review materials". Washington, DC: OHRP, 2002.
4. Davidoff F. Between the lines: navigating the uncharted territory of industry sponsored research. A former medical journal editor describes how and why staff changed their policy on disclosing conflicts of interest. Health Aff (Millwood) 2002;21:235-42.
5. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.
6. Blumenthal D, Campbell EG, Anderson MS, et al. Withholding research results in academic life science. Evidence from a national survey of faculty. JAMA 1997;277:1224-8.
7. Munro AJ. Publishing the findings of clinical research. BMJ 1993;307:1340-1.
8. Naylor CD. Early Toronto experience with new standards for industry sponsored clinical research: a progress report. CMAJ 2002;166:453-6.
9. Phillips RA, Hoey J. Constraints of interest: lessons at the Hospital for Sick Children. CMAJ 1998;159:955-7.
10. Rennie D. Thyroid storm. JAMA 1997;277:1238-43.
11. Anon. A duty to publish [editorial]. Not Med 1998;10:1089.
12. Rosenberg SA. Secrecy in medical research. N Engl J Med 1996;334:392-4.
13. Nadis S. US concern grows over secrecy clauses. Nature 1999;398:359.
14. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11.
15. Bodenheimer T. Uneasy alliance - clinical investigators and the pharmaceutical industry. N Engl J Med 2000;342:1539-44.
16. Simonsen RJ. Corporate sponsored research contracts - an ethical minefield. Quintessence International 1996;27:443.
17. De Angelis CD, Drazen JM, Nicholls MG, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825-6, discussion 826-7.
18. Pharmaceutical Research and Manufacturers Association. Principles on conduct of clinical trials and communication of clinical trial results. Washington, DC: Pharmaceutical Research and Manufacturers Association, 2002.
19. American Medical Association. Fee splitting - referrals to health care facilities. Principles of medical ethics opinion E-6.03 http://www.ama-assn.org/ama/pub/category/2503.html (accessed 20 Oct 2003).
20. US Code of Federal Regulations. 45 CFR 46.
21. Hebert PC, Levin AV, Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ 2001;164:509-13.
22. Wu AW, Cavanaugh TA, McPhee SJ, et al. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med 1997;12:770-5.
23. Finkelstein D, Wu AW, Holtzman NA, et al. When a physician harms a patient by a medical error: ethical, legal, and risk management considerations. J Clin Ethics 1997;8:330-5.
24. Lievre M, Menard J, Bruckert E, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001;322:603-5.
25. Evans S, Pocock S. Societal responsibilities of clinical trial sponsors. Lack of commercial pay off is not a legitimate reason for stopping a trial. BMJ 2001;322:569-70.
26. Baird P, Downie J, Thompson J. Clinical trials and industry. Science 2002;297:2211.
27. Angell M. Is academic medicine for sale? N Engl J Med 2000;342:1516-18.
28. Angell M. The pharmaceutical industry - to whom is it accountable? N Engl J Med 2000;342:1902-4.