Ethical considerations in consenting critically ill patients for bedside clinical care and research

Journal of Intensive Care Medicine

Volumn 30, Issue 3, 2015, Pages 141-150

  Rincon, Fred ^a   Lee, Kiwon ^b  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b EAST TEXAS MEDICAL CENTER   (United States)

Author keywords

decisional capacity; informed consent; surrogate

Indexed keywords

CLINICAL RESEARCH; COMPREHENSION; CRITICALLY ILL PATIENT; HUMAN; INFORMED CONSENT; INTENSIVE CARE UNIT; INTERPERSONAL COMMUNICATION; LIVING WILL; MEDICAL CARE; MEDICAL ETHICS; MENTAL CAPACITY; PATIENT DECISION MAKING; PRIORITY JOURNAL; REVIEW; STANDARD;

EID: 84964284197     PISSN: 08850666     EISSN: 15251489     Source Type: Journal    
DOI: 10.1177/0885066613503279     Document Type: Review

References (61)

1. The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research. http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed July 20, 2011.
2. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed July 20, 2011.
3. Annas GJ, Grodin MA. The Nazi doctors and the Nuremberg Code: relevance for modern medical research. Med War. 1990 ; 6 (2). 120-123
4. Frenkel DA. Human experimentation: codes of ethics. Leg Med Q. 1977 ; 1 (1). 7-14
5. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research. consensus statement from the coalition conference of acute resuscitation and critical care researchers. JAMA. 1995 ; 273 (16). 1283-1287
6. Silverman HJ, Lemaire F. Ethics and research in critical care. Intensive Care Med. 2006 ; 32 (11). 1697-1705
7. Moreno JD. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Vol II. Rockville, Maryland: National Bioethics Advisory Commission ; 1999: 52-57.
8. Levine RJ. Research in emergency situations. the role of deferred consent. JAMA. 1995 ; 273 (16). 1300-1302
9. Beecher HK. Ethics and clinical research. N Engl J Med. 1966 ; 274 (24). 1354-1360
10. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent - why are its goals imperfectly realized?. N E J Med. 1980 ; 302 (16). 896-900
11. Meisel A, Roth LH. What we do and do not know about informed consent. JAMA. 1981 ; 246 (21). 2473-2477
12. Goldman J, Katz MD. Inconsistency and institutional review boards. JAMA. 1982 ; 248 (2). 197-202
13. Silverman HJ. Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Crit Care Med. 1996 ; 154 (3 pt 1). 582-586
14. Beauchamp TL, Childress JF Principles of Biomedical Ethics. New York: Oxford University Press ; 2009 :
15. Schloendorff v Society of New York Hospitals. 1914;211 NY 125, 105NE 92.
16. Salgo v Leland Stanford Jr: Board of Trustees. 1957;317 PZA 170.
17. Cobbs v Grant. 1972;8 Cal 3d 229; 502P:2d 1.
18. Paulus SM. Bouvia v. Superior Court. Issues Law Med. 1986 ; 2 (1). 63-68
19. Smith HL. Myocardial infarction - Case studies of ethics in the consent situation. Soc Sci Med. 1974 ; 8 (7). 399-404
20. Ockene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the thrombolysis in myocardial infarction (TIMI - phase I) trial. Clin Res. 1991 ; 39 (1). 13-17
21. Lynoe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991 ; 303 (6803). 610-613
22. Cassell EJ, Leon AC, Kaufman SG. Preliminary evidence of impaired thinking in sick patients. Ann Int Med. 2001 ; 134 (12). 1120-1123
23. Shimm DS, Spece RG. Industry reimbursement for entering patients into clinical trials: legal and ethical issues. Ann Intern Med. 1991 ; 115 (2). 148-151
24. Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry. 1982 ; 39 (8). 951-958
25. Akinsanya J, Diggory P, Heitz E, Jones V. Assessing capacity and obtaining consent for thrombolysis for acute stroke. Clin Med. 2009 ; 9 (3). 239-241
26. White-Bateman SR, Schumacher HC, Sacco RL, Appelbaum PS. Consent for intravenous thrombolysis in acute stroke: review and future directions. Arch Neurol. 2007 ; 64 (6). 785-792
27. Appelbaum PS, Grisso T.. The MacArthur treatment competence study. I: mental illness and competence to consent to treatment. Law Hum Behav. 1995 ; 19 (2). 105-126
28. Grisso T, Appelbaum PS, Mulvey EP, Fletcher K.. The MacArthur treatment competence study. II: measures of abilities related to competence to consent to treatment. Law Hum Behav. 1995 ; 19 (2). 127-148
29. Grisso T, Appelbaum PS. The MacArthur treatment competence study. III: abilities of patients to consent to psychiatric and medical treatments. Law Hum Behav. 1995 ; 19 (2). 149-174
30. Stein J. The ethics of advance directives: a rehabilitation perspective. Am J Phys Rehabil. 2003 ; 82 (2). 152-157
31. Ciccone A. Consent to thrombolysis in acute ischaemic stroke: from trial to practice. Lancet Neurol. 2003 ; 2 (6). 375-378
32. Thrombolysis for acute ischemic stroke: the problem of consent. Neurolo Sci. 2001 ; 22 (5). 339-351
33. Chiu D, Peterson L, Elkind MS, Rosand J, Gerber LM, Silverstein MD. Comparison of outcomes after intracerebral hemorrhage and ischemic stroke. J Stroke Cerebrovasc Dis. 2010 ; 19 (3). 225-229
34. Suhl J, Simons P, Reedy T, Garrick T. Myth of substituted judgment. surrogate decision making regarding life support is unreliable. Arch Int Med. 1994 ; 154 (1). 90-96
35. Kummer HB, Thompson DR Critical Care Ethics. Mount Prospect, IL: Society of Critical Care Medicine ; 2009 :
36. Seckler AB, Meier DE, Mulvihill M, Paris BE. Substituted judgment: how accurate are proxy predictions?. Ann Int Med. 1991 ; 115 (2). 92-98
37. Fleck LM, Hayes OW. Ethics and consent to treat issues in acute stroke therapy. Emerg Med Clin North Am. 2002 ; 20 (3). 703-715
38. Kopelman LM. The best interests standard for incompetent or incapacitated persons of all ages. The Journal of law, medicine & ethics: a journal of the American Society of Law, Medicine & Ethics. 2007 ; 35 (1). 187-196
39. Kottow M. The battering of informed consent. J Med Ethics. 2004 ; 30 (6). 565-569
40. Louw SJ, Keeble JA. Stroke medicine-ethical and legal considerations. Age Ageing. 2002 ; 31 (suppl 3). 31-35
41. MillerTE. New York Adopts Broad Changes To Law on Treatment Decisions. The New York Law Journal. March 29, 201020120;243(58).
42. American Medical Association Council on Ethical and Judicial Affairs. http://www.ama-assn.org/resources/doc/code-medical-ethics/8081a.pdf. Accessed July 20, 2011.
43. American academy of pediatrics. Pediatrics. 1995 ; 95 (2). 314-317
44. Luce JM. Is the concept of informed consent applicable to clinical research involving critically ill patients?. Crit Care Med. 2003 ; 31 (3 suppl). S153 - S160
45. Karlawish JH, Hall JB. The controversy over emergency research. a review of the issues and suggestions for a resolution. Am J Respir Crit Care Med. 1996 ; 153 (2). 499-506
46. Department of Health and Human Services Rules and Regulations. Protection of Human Subjects. Title 45, CFR, PArt 46, 116d: General requirements for informed consent. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116. Accessed April 15, 2012.
47. Sulmasy DP, Haller K, Terry PB. More talk, less paper: predicting the accuracy of substituted judgments. Am J Med. 1994 ; 96 (5). 432-438
48. Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research?. Chest. 2001 ; 119 (2). 603-612
49. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995 ; 13 (5). 1062-1072
50. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001 ; 358 (9295). 1772-1777
51. Abramson NS, Meisel A, Safar P. Deferred consent. a new approach for resuscitation research on comatose patients. JAMA. 1986 ; 255 (18). 2466-2471
52. Final Rules. Title 21, Code of Federal Regulations. Part 50:24. Federal Register. 1996 ; 61 (192). 51497-51531
53. Lotjonen S. Medical research in clinical emergency settings in Europe. J Med Ethics. 2002 ; 28 (3). 183-187
54. Lemaire F, Bion J, Blanco J, et al. The European union directive on clinical research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med. 2005 ; 31 (3). 476-479
55. Cone DC, O'Connor RE. Are US informed consent requirements driving resuscitation research overseas?. Resuscitation. 2005 ; 66 (2). 141-148
56. Mosesso VN, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the public access defibrillation (PAD) trial experience. Resuscitation. 2004 ; 61 (1). 29-36
57. Lemaire F. Emergency research: only possible if consent is waived?. Curr Opin Crit Care. 2007 ; 13 (2). 122-125
58. Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials?. N Engl J Med. 1999 ; 340 (10). 804-807
59. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987 ; 317 (3). 141-145
60. Franklin C, Rosenbloom B. Proposing a new standard to establish medical competence for the purpose of critical care intervention. Crit Care Med. 2000 ; 28 (8). 3035-3038
61. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000 ; 283 (20). 2701-2711