Conducting research on the critically ill: An ethical perspective

Minerva Anestesiologica

Volumn 75, Issue 7-8, 2009, Pages 443-446

  Whetstine, L M ^a  

^a WALSH UNIVERSITY   (United States)

Author keywords

Anesthesia; Critical illness; Ethics

Indexed keywords

ANESTHESIA; CRITICALLY ILL PATIENT; INTENSIVE CARE UNIT; MEDICAL ETHICS; MEDICAL RESEARCH; NOTE;

CRITICAL ILLNESS; ETHICS, RESEARCH; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; INFORMED CONSENT; MORALS; UNITED STATES;

EID: 69149093249     PISSN: 03759393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (31)

1. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research. JAMA 2004;292:1593-1601 (Pubitemid 39314966)
2. Michalopoulos A, Bliziotis IA, Rizos M, Falagas M. Worldwide research productivity in critical care medicine. Crit Care 2005;9:R258-R265.
3. Truog R. Will ethical requirements bring critical cate research to a halt? Intensive Care Med 2005:31:338-344
4. American Thoracic Society Documents. The ethical conduct of clinical research involving critically ill patients in the United States and Canada. Am J Respir Crit Care Med 2004; 170: 1375-1384
5. Luce John M. Research ethics and consent in the intensive care unit: ethical, legal and organizational issues in the intensive care unit. Curr Opin Crit Care 2003;9:540-544
6. Huang DT, Hadian M. Bench to bedside review: Human subjects research-are more standards needed? Crit Care 2006:10:244.
7. National Institutes of Health Regulations and Ethical Guidelines. http://ohsr.od.nih.gov/guidelines/belmont.html
8. Wendler D, Grady C. What should research participants understand to understand they are participants in research? Bioethics 2008;22:203-208
9. Rincon HG, Granados M, Unutzer J, Gomez M, Duran R, Badiel M et al. Prevalence, detection and treatment of anxiety, depression, and delirium in the adult critical care unit. Psychosomatics 2001;42:391-396 (Pubitemid 33032111)
10. Pun B, Ely E. The importance of diagnosing and managing ICU delirium. Chest 2007:132:624-636 (Pubitemid 47282398)
11. Bigatello LM, George E, Hurford WE. Ethical considerations for research in critically ill patients. Crit Care Med 2003:31(3 Suppl):S178-81. (Pubitemid 36379564)
12. Nelson JE, Tandon N, Mercado AF, Camhi SL, Ely EW, Morrison RS. Brain dysfunction: another burden for the chronically critically ill. Arch Intern Med 2006;166:1993-1999 (Pubitemid 44537180)
13. Pandharipande P, Jackson J, Ely EW. Delirium: acute cognitive dysfunction in the critically ill. Curr Opin Crit Care 2005;11:360-368 (Pubitemid 41248311)
14. Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: an under-recognized syndrome of organ dysfunction. Semin Respir Crit Care Med 2001;22:115-126
15. Silverman HJ. Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Care Med 1996;154:582-586
16. Chenaud C, Merlani P, Luyasu S, Ricou B. Informed consent for research obtained during the intensive care unit stay. Crit Care 2006;10:R170. (Pubitemid 46322002)
17. Coleman CH, Bouësseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 2008;28;9:6.
18. Lemaire F, Brun-Buisson C. Are institutional review boards effective in safeguarding patents in intensive care units? Curr Opin Anaesthesiol 2000;13:195-201.
19. http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf
20. Chenaud C, Merlani P, Ricou B. Informed consent for research in ICU obtained before ICU admission. Intensive Care Med 2005;32:439-444
21. Silverman HJ, Lemaire F. Ethics and research in critical care. Intensive Care Med 2006;32:1697-1705
22. Richmond TS, Ulrich C. Ethical issues of recruitment and enrollment of critically ill and injured patients for research. AACN Adv Crit Care 2007;18:352-355
23. Luce JM. Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 2003:31(3 Suppl):S153-60.
24. Saver RS. Critical care research and informed consent. North Carol Law Rev 1996;75:205-271
25. Harvey SE, Elbourne D, Ashcroft J, Jones CM, Rowan K. Informed consent in clinical trials in critical care: experience from PAC-man study. Intensive Care Med 2006:32:2002-25. (Pubitemid 44833116)
26. Lemaire F. The inability to consent in critical care research: emergency or impairment of cognitive function. Intensive Care Med 2006;32:1930-1932 (Pubitemid 44833103)
27. Weijer C. The ethical analysis of risk. J Law Med Ethics 2000;28:344-361
28. Wicclair MR. Informed consent and research involving the newly dead. Kennedy Inst Ethics J 2002;12:351-372
29. http://www.hhs.gov/ohrp/humansubjects/guidance/ 45cfr46.htm.
30. Deutsch E. Clinical studies in the intensive care unit: ethical and legal aspects. Law Rev 1997:27:259-272
31. Ishikawa H, Yano E. Patient health literacy and participation in the health care process. Health Expect 2008;11:113-122 (Pubitemid 351725003)