Monitoring and oversight in critical care research

Critical Care

Volumn 8, Issue 6, 2004, Pages 403-405

  Lavery, James V ^a   Van Laethem, Marleen L P ^a   Slutsky, Arthur S ^a  

^a ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

Critical care research; Institutional accountability; Institutional review boards; Oversight and monitoring of research; Research ethics; Research ethics board; Research ethics review; Research integrity

Indexed keywords

ADMINISTRATIVE PERSONNEL; CLINICAL PROTOCOL; CLINICAL RESEARCH; INFORMED CONSENT; INTENSIVE CARE; LEADERSHIP; MEDICAL ETHICS; MEDICAL RESEARCH; PEER REVIEW; PRIORITY JOURNAL; PROFESSIONAL STANDARD; REVIEW; RISK BENEFIT ANALYSIS;

BIOMEDICAL RESEARCH; CANADA; CLINICAL PROTOCOLS; CRITICAL CARE; ETHICS COMMITTEES, RESEARCH; HUMANS; PATIENT SELECTION; PEER REVIEW, RESEARCH;

EID: 11344274991     PISSN: 13648535     EISSN: None     Source Type: Journal    
DOI: 10.1186/cc2964     Document Type: Review

References (17)

1. King NMP: The line between clinical innovation and human experimentation. Seton Hall Law Review 2002, 32:573-582.
2. Percival T: Medical ethics; or a code of institutes and precepts adapted to the professional conduct of physicians and surgeons. 1803. In Percival's Medical Ethics. Edited by Leake CD. Baltimore: The Williams & Wilkins Company; 1927.
3. U.S. Department of Energy Openness Project: Human Radiation Experiments. Roadmap to the Project. Chapter 3. The Development of Human Subject Research Policy at DHEW, at footnote 9. [http://www.eh.doe.gov/ohre/roadmap/achre/chap3_2.html] (last accessed, September 23, 2004).
4. Kutcher G: Risk to medicine or the autonomy rights of subjects? Governing American medical research. [http://www.lse.ac.uk/collections/BIOS/docs/GeraldKutcher.pdf] (last accessed 14 July 2004).
5. Frankel MS: The development of policy guidelines governing human experimentation in the United States: a case study of public policy-making for science and technology. Ethics Sci Med 1975, 2:43-59.
6. McDonald M: Canadian governance of health research involving human subjects: is anybody minding the store? Health Law J 2001, 9:1-21.
7. Weijer C, Shapiro S. Fuks A, Glass KC, Skrutkowska M: Monitoring clinical research: an obligation unfulfilled. CMAJ 1995, 152:1973-1980.
8. Weijer C: Continuing review of research approved by Canadian research ethics boards. CMAJ 2001, 164:1305-1306.
9. McCusker J, Kruszewski Z, Lacey B, Schiff B: Monitoring clinical research: report of one hospital's experience. CMAJ 2001, 164:1321-1325.
10. Bortolussi R, Nicholson D: Auditing of clinical research ethics in children's and women's academic hospital. Clin Invest Med 2002, 25:83-88.
11. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada: Tri-council policy statement: ethical conduct for research involving humans. Ottawa: Minister of Supply and Services, 1998 (with 2000, 2002 updates). Section 1D, p 1.8. [http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm] (last accessed 14 July 2004).
12. International Conference on Harmonization: Guidelines for Good Clinical Practice. Efficacy Guidelines #6 (E6):1-55. [http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254] (last accessed September 22, 2004)
13. Koski G: Ethics, science, and oversight of critical care research: The Office for Human Research Protections. Am J Respir Crit Care Med 2004, 169:982-986.
14. Morgenweck CJ: Innovation to research: some transitional obstacles in critical care units. Crit Care Med 2003, Suppl: S172-S177.
15. Bigatello LM, George E, Hurford WE: Ethical considerations for research in critically ill patients. Crit Care Med 2003, Suppl: S178-S181.
16. Truog RD, Robinson W, Randolph A, Morris A: Is informed consent always necessary for randomized controlled trials? N Engl J Med 1999, 340:804-807.
17. Coppolino M, Ackerson L: Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001, 119:603-612.