Research on the cognitively impaired: Lessons and warnings from the emergency research debate

Journal of the American Geriatrics Society

Volumn 45, Issue 4, 1997, Pages 474-481

  Karlawish, Jason H T ^a,b   Sachs, Greg A ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIOXIDANT; NERVE GROWTH FACTOR; SUPEROXIDE DISMUTASE MACROGOL;

AGED; ALZHEIMER DISEASE; CHRONIC DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL; COGNITIVE DEFECT; EMERGENCY TREATMENT; FAMILY COUNSELING; FOOD AND DRUG ADMINISTRATION; GERIATRIC PATIENT; HEAD INJURY; HUMAN; INFORMED CONSENT; INTRACEREBROVENTRICULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MEDICAL DECISION MAKING; MEDICAL ETHICS; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT INDICATION;

EID: 0030938502     PISSN: 00028614     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1532-5415.1997.tb05174.x     Document Type: Review

References (65)

1. Prentice ED, Antonson DL, Leibrock LG et al. IRB review of phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury. IRB: Rev Hum Subj Res 1993;15:1-7.
2. Olson L. NGF and the treatment of Alzheimer's disease. Exp Neurol 1993;124:5-15.
3. McCarthy CR. To be or not to be: Waiving informed consent in emergency research. Kennedy Inst Ethics J 1995;5:155-162.
4. Karlawish JHT, Hall JB. The controversy over emergency research: A review of the issues and suggestions for a resolution. Am J Respir Crit Care Med 1996;153:499-506.
5. Biros MH, Lewis RJ, Olson CM et al. Informed consent in emergency research: Consensus statement from the coalition conference of acute resuscitation and critical care researchers. JAMA 1995;273:283-1287.
6. Spivey WH, Abramson NS, Iserson KV et al. Informed consent for biomedical research in acute care medicine. Ann Emerg Med 1991;20:1251-1265.
7. Transcript of Food and Drug Administration and National Institutes of Health Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances, 9-10 January 1995.
8. Levine RJ. Research in emergency situations: The role of deferred consent. JAMA 1995;273:1300-1302.
9. Protection of Human Subjects; Informed Consent; Proposed Rule. Federal Register 1995;60:49085-49103.
10. Olson CM. The letter or the spirit: Consent for research in CPR (editorial). JAMA 1994;271:1445-1447.
11. DeRenzo E. Surrogate decision making for severely cognitively impaired research subjects: The continuing debate. Camb Q Healthcare Ethics 1994;3:539-548.
12. Dresser R. Mentally disabled research subjects: The enduring policy issues. JAMA. 1996;276:67-72.
13. Sachs GA, Cassel CK. Biomedical research involving older human subjects. Law Med Health Care 1990;18:234-243.
14. American College of Physicians. Cognitively impaired subjects (position paper). Ann Intern Med 1989;111:843-848.
15. High DM. Research with Alzheimer's disease subjects: Informed consent and proxy decision making. J Am Geriatr Soc 1992;40:950-957.
16. Glass KC, Somerville MA. Informed consent to medical research on persons with Alzheimer's disease: Ethical and legal parameters. In: Berg JM, Karlinsky H, Lowy FH, eds. Alzheimer's Disease Research: Ethical and Legal Issues. Toronto: Carswell, 1991, pp 30-59.
17. Melnick VL, Dubler NN, Weisbard A, Butler R. Clinical research in senile dementia of the Alzheimer's type: Suggested guidelines addressing ethical and legal issues. In: Melnick VL, Dubler NN, eds. Alzheimer's Dementia: Dilemmas in Clinical Research. Clifton, NJ: Humana Press, 1985, pp 295-308.
18. Fletcher JC, Dommel Jr. W, Cowell DD. Consent to research with impaired human subjects. IRB: Rev Hum Subj Res 1985;7:1-6.
19. Gauthier S, Bouchard R, Lamontagne A et al. Tetrahydroaminoacridine-lecithin combination treatment in patients with intermediate-stage Alzheimer's disease. N Engl J Med 1990;322:1272-1276.
20. Farlow M, Gracon SI, Hershey LA et al. A controlled trial of tacrine in Alzheimer's disease. JAMA 1992;268:2523-2529.
21. Davis KL, Thai LJ, Gamzu ER et al. A double-blind, placebo-controlled multicenter study of tacrine for Alzheimer's disease. N Engl J Med 1992;327:1253-1259.
22. Knapp MJ, Knopman DS, Solomon PR et al. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA 1994;271:985-991.
23. Summers WK, Viesselman JO, Marsh GM, Candelora K. Use of THA in treatment of Alzheimer-like dementia: Pilot study of twelve patients. Biol Psychiatry 1981;16:145-153.
24. Summers WK, Majovski LV, Marsh GM et al. Oral tetrahydroaminoacridine in long-term treatment of senile dementia, Alzheimer type. N Engl J Med 1986;315:1241-1245.
25. T.D. et al. vs New York Office of Mental Health, New York City, No. 5136/91 (S.C., A.D., order issued 18 January 1996).
26. Department of Health and Human Services, Common Rule, 45 CFR 46. Federal Policy for the Protection of Human Subjects; Notices and Rules. Federal Register 1991;56:28003-28032.
27. Food and Drug Administration Rules and Regulations 21 CFR 50. Federal Register 1991;56:28003-28032.
28. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Federal Register 1979;44:23192-23197.
29. Department of Health, Education and Welfare, Office of the Secretary. Proposed regulations on research involving those institutionalized as mentally disabled. Federal Register 1978 17;43:53950-53956.
30. Lishman WA. The history of research into dementia and its relationship to current concepts. Huppert FA, Brayne C, O'Connor DW, eds. Dementia and Normal Aging. Cambridge: Cambridge University Press, 1994, pp 41-56.
31. Hall JK. Exclusion of pregnant women from research protocols: Unethical and illegal. IRB: Rev Hum Subj Res 1995;17:1-4.
32. Fox P. From senility to Alzheimer's disease: The rise of the Alzheimer's disease movement. Milbank Q 1989;67:58-102.
33. 45 CFR 46.116.
34. 45 CFR 46.116 2(d).
35. Lurie KG, Shultz JJ, Callaham ML et al. Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest. JAMA 1994;271:1405-1411.
36. Marek L. Ethical dilemma in the ER: Experiment on patients? Chicago Tribune, May 23, 1994, sect. 1:1, 9.
37. AP Wire Service. Panel questions rules on trauma research. The New York Times, April 24, 1994, sect. 1:26.
38. Winslow R. FDA halts test on device that shows promise for victims of cardiac arrest. The Wall Street Journal, May 11, 1994, sect. B:8.
39. Levine RJ. Deferred consent. Control Clin Trials 1991;12:546-550.
40. Abramson NS, Meisel A, Safar P. Deferred consent: A new approach for resuscitation research on comatose patients. JAMA 1986;255:2466-2471.
41. Miller BL. Philosophical, ethical and legal aspects of resuscitation medicine: Deferred consent and justification of resuscitation research. Crit Care Med 1988;16:1059-1062.
42. Faden R, Beauchamp T. A History and Theory of Informed Consent. New York: Oxford University Press, 1986, pp 274-297.
43. 45 CFR 46.102 (c).
44. Menikoff JA, Sachs GA, Siegler M. Beyond advance directives: Health care surrogate laws. N Engl J Med 1992;327:1165-1169.
45. 45 CFR 46.102 2(i).
46. 21 CFR 50.3(n).
47. 21 CFR 50.24 (a)(1).
48. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145.
49. Protection of Human Subjects; Informed Consent; Proposed Rule. Federal Register 1995;60:49093.
50. Protection of Human Subjects; Informed Consent; Proposed Rule. Fed Regist 1995;60:49095.
51. Sunderland T, Tariot PN, Cohen RM et al. Anticholinergic sensitivity in patients with dementia of the Alzheimer type and age-matched controls. Arch Gen Psychiatry 1987;44:418-426.
52. Cutler NR, Murphy MF, Nash RJ et al. Clinical safety, tolerance, and plasma levels of the oral anticholinesterase 1,2,3,4-tetrahydro-9-aminoacridin-1-oL-maleate (HP 029) in Alzheimer's disease: Preliminary findings. J Clin Pharmacol 1990;30:556-561.
53. Antuono PG. Effectiveness and safety of velnacrine for the treatment of Alzheimer's disease: A double-blind, placebo-controlled study. Mentane study group. Arch Intern Med 1995;155:1766-1772.
54. Dysken MW, Mendels J, LeWitt P et al. Milacemide: A placebo-controlled study in senile dementia of the Alzheimer type. J Am Geriatr Soc 1992;40:503-506.
55. Sachs GA. Advance consent for dementia research. Alzheimer Dis Assoc Disord 1994;8(suppl):19-27.
56. Miller BL. Autonomy and proxy consent. In: Melnick VL, Dubler NN, eds. Alzheimer's Dementia: Dilemmas in Clinical Research. Clifton, NJ: Humana Press, 1985, pp 239-263.
57. Seckler AB, Meier DE, Mulvihill M, Cammer Paris BE. Substituted judgment: How accurate are proxy predictions? Ann Intern Med 1991;115:92-98.
58. Sulmasy DP, Haller K, Terry PB. More talk, less paper: Predicting the accuracy of substituted judgments. Am J Med 1994;96:432-438.
59. Sachs GA, Stocking CB, Stern R et al. Ethics of dementia research: Informed consent and proxy consent. Clin Res 1994;42:403-412.
60. Martin DK, Meslin EM, Kohut N, Singer PA. The incommensurability of research risks and benefits: Practical help for research ethics committees. IRB: Rev Hum Subj Res 1995;17:8-10.
61. Epstein S. The construction of lay activism and the forging of credibility in the form of clinical trials. Sci Technol Hum Values 1995;20:408-437.
62. Dyer AR. Assessment of competence to give informed consent. In: Melnick VL, Dubler NN, eds. Alzheimer's Dementia: Dilemmas in Clinical Research. Clifton, NJ: Humana Press, 1985, pp 227-237.
63. Katz J. Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimetnation Process. New York: Russell Sage Foundation, 1972, pp 9-65.
64. Department of Health and Human Services, Office of the Secretary. 45 CFR Part 46, Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects. Federal Register 1981;46:8386-8391.
65. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Implementing Human Research Regulations: The Adequacy and Unifotmity of Federal Rules and Their Implementation. Washington, DC: U.S. Government Printing Office, 1983.