Conducting stroke research with an exception from the requirement for informed consent

Stroke

Volumn 34, Issue 5, 2003, Pages 1317-1323

  Bateman, Brian T ^a   Meyers, Philip M ^a,c   Schumacher, H Christian ^b   Mangla, Sundeep ^a   Pile Spellman, John ^a  

^a Univ Hospitals of Columbia/Cornell ^*  (United States)

^b New York Presbyterian Hospital Columbia University Medical Center   (United States)

^c Milstein Hospital   (United States)

Author keywords

Ethics, medical; Informed consent; Stroke

Indexed keywords

CLINICAL RESEARCH; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; INFORMED CONSENT; LAW; MEDICAL ETHICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; STROKE;

CEREBROVASCULAR ACCIDENT; CLINICAL TRIALS; CLINICAL TRIALS DATA MONITORING COMMITTEES; CONSCIOUSNESS DISORDERS; EMERGENCIES; FINANCING, GOVERNMENT; HEALTH POLICY; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PRACTICE GUIDELINES; RESEARCH SUPPORT; SOCIETIES, MEDICAL; SPEECH DISORDERS; THIRD-PARTY CONSENT; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0038304315     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.STR.0000065230.00053.B4     Document Type: Review

References (62)

1. American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Tex: American Heart Association; 2001.
2. Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999;30:2523.
3. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
4. Connors JJ, Wojak JC. Current directions in emergency stroke therapy. In: Connors JJ, Wojak JC, eds. Interventional Neuroradiology: Strategies and Practical Techniques. New York, NY: WB Saunders Co; 1999: 629-634.
5. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F, for the PROACT Investigators. Intra-arterial prourokinase for acute ischemic stroke: the PROACT II Study: a randomized controlled trial. JAMA. 1999;282: 2003-2011.
6. Ronning OM, Guldvog B. Stroke units versus general medical wards, I: twelve- and eighteen-month survival: a randomized, controlled trial. Stroke. 1998;29:58-62.
7. Glader E-L, Stegmayr B, Johansson L, Hulter-Asberg K, Wester PO. Differences in long-term outcome between patients treated in stroke units and in general wards: a 2-year follow-up of stroke patients in Sweden. Stroke. 2001;32:2124-2130.
8. National Stroke Association. Recognizing stroke symptoms. Available at: www.stroke.org/recog.cfm. Accessed August 1, 2002.
9. Saver R. Critical care research and informed consent. North Carol Law Rev. 1996;75:205-271.
10. Federal Register. 51497-51531 (1996).
11. Menasche A. FDA revises informed consent regulations for emergency research. IRB. 1995;17:19-21.
12. Marwick C. Research in emergency circumstances. JAMA. 1995;273: 687-688.
13. 45 CFR §46.101(a).
14. Olson CM. The letter or the spirit: consent for research in CPR. JAMA. 1994;271:1445-1447.
15. 45 CFR §46.103(a).
16. 45 CFR §46.102(i).
17. 45 CFR §46.116(d).
18. Abramson NS, Meisel A, Safar P. Deferred consent: a new approach for resuscitation research on comatose patients. JAMA. 1986;255: 2466-2471.
19. Levine R. Research in emergency settings: the role of deferred consent. JAMA. 1995;273:1300-1302.
20. 21 CFR §50.23(a)(1)-(4).
21. Fost N. Waived consent for emergency research. Am J Law Med. 1998; 24:163-183.
22. Fost N, Robertson JA. Case study: deferring consent with incompetent patients in an intensive care unit. IRB. 1980;2:5-6.
23. Ellis GB. Report: Informed Consent - Legally Effective and Prospectively Obtained. Washington, DC: Office of Protection From Research Risks; 1993.
24. 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;273:1283-1287.
25. Federal Register. 49085-49103 (1995).
26. 21 CFR §50.24(a).
27. 21 CFR §50.24(a)(1).
28. Thrift AG, Dewey HM, Macdonell RA, McNeil JJ, Donnan GA. Incidence of the major stroke subtypes: initial findings from the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2001;32: 1732-1738.
29. Sacco RL, Wolf PA, Kannel WB, McNamara PM. Survival and recurrence following stroke: the Framingham Study. Stroke. 1982;13: 290-295.
30. Kolominsky-Rabas PL, Sarti C, Heuschmann PU, Graf C, Siemonsen S, Neundoerfer B, Katalinic A, Lang E, Gassmann KG, von Stockert TR. A prospective community-based study of stroke in Germany: the Erlangen Stroke Project (ESPro): incidence and case fatality at 1, 3, and 12 months. Stroke. 1998;29:2501-2506.
31. 21 CFR §50.24(a)(2)(i)-(iii).
32. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994.
33. Muir KW. Multicenter Acute Stroke Trial-Italy. Lancet. 1996;347:391. Letter.
34. Slyer H. Ethical challenges in stroke research. Stroke. 1998;29: 1725-1729.
35. Janofsky JS, McCarthy RJ, Folstein MF. The Hopkins Competency Assessment Test; a brief method for evaluating patients' capacity to give informed consent. Hosp Community Psychiatry. 1992;43:132-136.
36. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48:1415-1419.
37. NY State Consolidated Laws, Article 24-A, §2442.
38. NY State Consolidated Laws, Article 29-C.
39. 21 CFR §50.24(a)(3)(i)-(iii).
40. 21 CFR §50.24(a)(7)(i).
41. Levine RJ. RE Proposed Rule, Protection of Human Subjects; Informed Consent, 21 CFR Part 50, et al, Federal Register, September 21, 1995 [Docket No. 95N-0158]. IRB. 1995;17:21-22.
42. 21 CFR §50.24(a)(4).
43. US Food and Drug Administration. Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators: 1998 Update. Washington, DC: US Food and Drug Administration; 1998.
44. 21 CFR §50.24(a)(5).
45. US Department of Health and Human Services, Food and Drug Administration. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements For Emergency Research. Washington, DC: US Dept of Health and Human Services, Food and Drug Administration; 2000. Draft guidance.
46. 21 CFR §50.24(a)(6).
47. 21 CFR §50.24(a)(7)(i)-(ii).
48. Adams JG, Wegener J. Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann Emerg Med. 1999;33:218-223.
49. Santora TA, Cowell V, Trooskin SZ. Working through the public disclosure process mandated by use of 21 CFR 50.24 (exception to informed consent): guidelines for success. J Trauma. 1998;45:907-913.
50. 21 CFR §50.24(a)(7)(iii).
51. 21 CFR §50.24(a)(7)(iv).
52. Lewis RJ, Berry DA, Cryer H III, Fost N, Krome R, Wahington GR, Houghton J, Blue JW, Bechhofer R, Cook T, Fisher M. Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing waiver of prospective informed consent: the diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial. Ann Emerg Med. 2001;38:397-404.
53. 21 CFR §50.24(a)(7)(v).
54. 21 CFR §50.3.
55. 21 CFR §50.24(b).
56. 21 CFR §50.24(d).
57. 21 CFR §312.20(c).
58. The Nuremberg Code. JAMA. 1997;276:1691.
59. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects [reprinted]. JAMA. 2000; 284:3043-3045.
60. US Department of Health, Education, and Welfare. Protection of human subjects: Belmont Report - ethical principles and guidelines for the protection of human subjects of research. Federal Register. 1979;44: 23192-23197.
61. Kolata G. Ban on medical experiments without consent is relaxed. New York Times. November 5, 1996:sect Al.
62. Abramson NS, Safar P, for the Brain Resuscitation Clinical Trial II Study Group. Deferred consent: use in clinical resuscitation research. Ann Emerg Med. 1990;19:781-784.