The controversy over emergency research: A review of the issues and suggestions for a resolution

American Journal of Respiratory and Critical Care Medicine

Volumn 153, Issue 2, 1996, Pages 499-506

  Karlawish, Jason H T ^a,b   Hall, Jesse B ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b MC 6098 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CRITICAL ILLNESS; EMERGENCY MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY;

EID: 0030033668     PISSN: 1073449X     EISSN: None     Source Type: Journal    
DOI: 10.1164/ajrccm.153.2.8564087     Document Type: Short Survey

References (42)

1. Biros, M. H., R. J. Lewis, C. M. Olson, J. E. Runge, R. O. Cummins, and N. Fost. 1995. Informed consent in emergency research: consensus statement from the coalition conference of acute resuscitation and critical care researchers. J.A.M.A. 273:1283-1287.
2. Prentice, E. D., D. L. Antonson, L. G. Leibrock, T. K. Kelso, and T. D. Sears. 1993. IRB review of phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury. IRB: Review of Human Subjects Research. 15:1-7.
3. Spivey, W. H., N. S. Abramson, K. V. Iserson, C. R. MacKay, and M. P. Cohen. 1991. Informed consent for biomedical research in acute care medicine. Ann. Emerg. Med. 20:1251-1265.
4. Marwick, C. 1995. Medical news and perspectives: research in emergency circumstances. J.A.M.A. 273:687-688.
5. Food and Drug Administration and National Institutes of Health. January 1995. Transcript of Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances, 9-10 January 1995. (HFI-35). Freedom of Information Office, Food and Drug Administration, rm 12A-16, 5600 Fishers Lane, Rockville, MD 20857 (hereafter referred to as FDA/NIH Public Forum. 9 January 1995).
6. FDA/NIH Public Forum. 9 January 1995. Case Study Summaries. (HFI-35) Freedom of Information Office, Food and Drug Administration, Rockville, MD.
7. Office of Protection from Research Risks. Department of Health and Human Services. 1991. Common Rule, 45 CFR 46 Federal Policy for the Protection of Human Subjects; Notices and Rules. Federal Register. 56:28003-28032 (hereafter referred to as OPRR. 1991. 45 CFR 46).
8. Faden, R., and T. Beauchamp. 1986. A History and Theory of Informed Consent. Oxford University Press, New York. 200-232.
9. Porter, J. P. 1991. The federal policy for the protection of human subjects. IRB: Review of Human Subjects Research. 13:8-9.
10. Food and Drug Administration. 1991. Rules and Regulations 21 CFR 50. Federal Register. 56(117):28003-28032 (hereafter referred to as FDA. 1991. 21 CFR 50).
11. OPRR. 1991. 45 CFR 46. 116 2d.
12. FDA. 1991. 21 CFR 50. 23a-c.
13. Prentice, E. D., D. C. Antonson, L. G. Leibrock, T. K. Kelso, and T. D. Sears. 1994. An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirement. IRB: Review of Human Subjects Research. 16:16-18.
14. Levine, R. J. 1991. Deferred consent. Control Clin. Trials 12:546-550.
15. Abramson, N. S., A. Meisel, and P. Safar. 1986. Deferred Consent: a new approach for resuscitation research on comatose patients. J.A.M.A. 225:2466-2471.
16. OPRR. 1991. 45 CFR 46. 102i.
17. Ellis, G. B. FDA/NIH Public Forum. 9 January 1995. 49-57.
18. U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1977. Transcript of the proceedings of the 30th meeting. 13 May 1977. National Reference Center for Bioethics Literature, Kennedy Institute, Georgetown University, Washington, DC. 20057-21065.
19. McCarthy, C. R. 1995. To be or not to be: waiving informed consent in emergency research. Kennedy Inst. Ethics J. 5:155-162.
20. McCartney, J. J. 1978. Research in children: national commission says 'Yes, If....'. Hastings Cent. Rep. 8:26-31.
21. Department of Health, Education, and Welfare. Office of the Secretary. 1979. 45 CFR 46: proposed regulations amending basic HEW policy for protection of human research subjects. Federal Register. 44:47688-47698.
22. Department of Health and Human Services. Office of the Secretary. 1981. 45 CFR 46: final regulations amending basic HHS policy for the protection of human research subjects. Federal Register. 46:8387.
23. OPRR. 1991. 45 CFR 46. 405.
24. Department of Health and Human Services. Office of the Secretary. 1981. 45 CFR 46: final regulations amending basic HHS policy for the protection of human research subjects. Federal Register. 46:8373.
25. Kopelman, L. 1981. Estimating risk in human research. Clin. Res. 29:1-8.
26. Freedman, B., A. Fuks, and C. Weijer. 1993. In loco patients: minimal risk as an ethical threshold for research upon children. Hastings Cent. Rep. 23:13-19.
27. Department of Health and Human Services. Office of the Secretary. 1981. 45 CFR 46: final regulations amending basic HHS policy for the protection of human research subjects. Federal Register. 46:8378.
28. Lynn, F. M. 1987. OSHA's carcinogens standard: round one on risk assessment models and assumptions. In B. B. Johnson and V. T. Covello, editors. The Social and Cultural Construction of Risk. D. Reider Publishing Co., Holland. 345-358.
29. Cranor, C. F. 1990. Some moral issues in risk assessment. Ethics 101: 123-143.
30. Weinberg, A. M. 1972. Science and trans-science. Minerva 10:209-222.
31. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Federal Register. 44:23192-23197.
32. Levine, R. J. 1995. Research in emergency situations: the role of deferred consent. J.A.M.A. 273:1300-1302.
33. Freedman, B. 1987. Equipoise and the ethics of clinical research. N. Engl. J. Med. 317:141-145.
34. Faden, R., and T. Beauchamp. 1986. A History and Theory of Informed Consent. Oxford University Press, New York. 235-268.
35. Miller, B. L. 1988. Philosophical, ethical and legal aspects of resuscitation medicine: deferred consent and justification of resuscitation research. Crit. Care Med. 16:1059-1062.
36. Beauchamp, T. L., and J. F. Childress. 1994. Principles of Biomedical Ethics. Oxford University Press, New York. 171-173.
37. Seckler, A. B., D. E. Meier, M. Mulvihill, and B. E. Cammer Paris. 1991. Substituted judgment: how accurate are proxy predictions? Ann. Intern. Med. 115:289-294.
38. Sulmasy, D. P., K. Haller, and P. B. Terry. 1994. More talk, less paper: predicting the accuracy of substituted judgments. Am. J. Med. 96:432-438.
39. Beauchamp, T. L., and J. F. Childress. 1994. Principles of Biomedical Ethics. Oxford University Press, New York. 178-181.
40. FDA/NIH Public Forum. 9 January 1995. Case Study Summaries. (HFI-35). Freedom of Information Office, Food and Drug Administration, Rockville, MD.
41. Beauchamp, T. L., and J. F. Childress. 1994. Principles of Biomedical Ethics. Oxford University Press, New York. 328.
42. Department of Health and Human Services, Food and Drug Administration. 1992.21 CFR 314 and 601: new drug, antibiotic, and biological drug product regulations; accelerated approval; Final Rule. Federal Register. 57:58942-58960.