Research involving cognitively impaired adults

New England Journal of Medicine

Volumn 348, Issue 14, 2003, Pages 1389-1392

  Karlawish, Jason H T ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT RESPIRATORY DISTRESS SYNDROME; AGITATION; ARTIFICIAL VENTILATION; ATELECTASIS; BAROTRAUMA; CAREGIVER; COGNITIVE DEFECT; COMPETENCE; CRITICAL ILLNESS; CUSTODY; DECISION MAKING; DYSPNEA; HEART CATHETERIZATION; HUMAN; INFORMED CONSENT; INTENSIVE CARE; LAW; LUNG INJURY; MEDICAL ETHICS; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

CLINICAL TRIALS; ETHICS, RESEARCH; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; ORGANIZATIONAL POLICY; RISK ASSESSMENT; THIRD-PARTY CONSENT; UNITED STATES;

EID: 0037417244     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMsb030172     Document Type: Review

References (38)

1. Drazen JM. Controlling research trials. N Engl J Med 2003;348: 1377-80.
2. Steinbrook R. How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 2003;348:1393-401.
3. OHRP compliance activities: determination letters: 2002. OHRP investigation of a multicenter, double-blind, placebo controlled study of estrogen replacement therapy in patients with mild to moderate Alzheimer's disease. Rockville, Md.: Office for Human Research Protections, 2003. (Accessed March 3, 2003, at http://ohrp.osophs. dhhs.gov/detrm_letrs/lindex.htm.)
4. Seeman BT. Lung study that includes Harborview too risky, government says. Seattle Times. December 12, 2002:A25.
5. Department of Health and Human Services. Common rule, 45 CFR 46. Federal policy for the protection of human subjects; notices and rules. Fed Regist 1991;56:28003-32.
6. Department of Health, Education, and Welfare. Protection of human subjects: proposed regulations on research involving those institutionalized as mentally disabled. Fed Regist 1978;43:53950-6.
7. American College of Physicians. Cognitively impaired subjects. Ann Intern Med 1989;111:843-8.
8. Clinical research in senile dementia of the Alzheimer's type: suggested guidelines addressing the ethical and legal issues. In: Melnick VL, Dubler N, Weisbard A, Butler RN. Alzheimer's dementia: dilemmas in clinical research. Clifton, N.J.: Humana Press, 1985:295-310.
9. Fletcher JC, Dommel FW Jr, Cowell DD. Consent to research with impaired human subjects: a trial policy for the intramural programs of the National Institutes of Health. IRB 1985;7(6):1-6.
10. Research involving persons with mental disorders that may affect their decisionmaking capacity. Vol. 1: Report and recommendations. Rockville, Md.: National Bioethics Advisory Commission, December 1998:88.
11. Making judgments about patients' competence. In: Grisso T, Appelbaum PS. Assessing competence to consent to treatment: a guide for physicians and other health professionals. New York: Oxford University Press, 1998:127-48.
12. Appelbaum PS, Grisso T. MacArthur competence assessment tool for clinical research. Sarasota, Fla.: Professional Resource Press, 2001.
13. Kim SYH, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 2001;158:712-7.
14. Karlawish JHT, Casarett DJ, James BD. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc 2002;50:2019-24.
15. Erb TO, Schulman SR, Sugarman J. Permission and assent for clinical research in pediatric anesthesia. Anesth Analg 2002;94: 1155-60.
16. Breitbart W, Marotta R, Platt MM, et al. A double-blind trial of haloperidol, chlorpromazine, and lorazepam in the treatment of delirium in hospitalized AIDS patients. Am J Psychiatry 1996;153:231-7.
17. Sandham JD, Hull RD, Brant RF, et al. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med 2003;348:5-14.
18. Dresser R. Advance directives in dementia research: promoting autonomy and protecting subjects. IRB 2001;23(1):1-6.
19. OHRP compliance activities: determination letters: 2002. OHRP investigation of a multi-center, phase II/III, randomized, doubleblind placebo-controlled trial of lisofylline and controlled ventilation in patients with acute lung injury and acute respiratory distress syndrome. Rockville, Md.: Office for Human Research Protections, 2003. (Accessed March 3, 2003, at http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm.)
20. Carome MA. Human research subject protections under Multiple Project Assurance (MPA) M-1115. Rockville, Md.: Office for Human Research Protections, 2002. (Accessed March 3, 2003, at http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/jan02m.pdf.)
21. Idem. Human research subject protections under Multiple Project Assurance (MPA) M-1025. Rockville, Md.: Office for Human Research Protections, 2003. (Accessed March 3, 2003, at http://ohrp.osophs. dhhs.gov/detrm_letrs/YR02/jan02n.pdf.)
22. Surrogate consent in the absence of an advance directive. Chicago: American Bar Association, 2001.
23. An act to amend Section 24178 of the Health and Safety Code, relating to health. Sacramento: State of California, 2002.
24. Karlawish JHT, Casarett D, Klocinksi J, Sankar P. How do AD patients and their caregivers decide whether to enroll in a clinical trial? Neurology 2001;56:789-92.
25. Warren JW, Sobal J, Tenney JH, et al. Informed consent by proxy: an issue in research with elderly patients. N Engl J Med 1986;315: 1124-8.
26. Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001;119: 603-12.
27. Sehgal A, Galbraith A, Chesney M, Schoenfeld P, Charles G, Lo B. How strictly do dialysis patients want their advance directive followed? JAMA 1992;267:59-63.
28. Wendler D, Martinez RA, Fairdough D, Sunderland T, Emanuel E. Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. Am J Psychiatry 2002; 159:585-91.
29. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995;13:1062-72. [Erratum, J Clin Oncol 1995;13:2476.]
30. Assessing risks and potential benefits and evaluating vulnerability. In: Ethical and policy issues in research involving human participants. Vol. 1. Report and recommendations of the National Bioethics Advisory Commission. Bethesda, Md.: National Bioethics Advisory Commission, August 2001:69-96.
31. Weijer C. The ethical analysis of risk. J Law Med Ethics 2000;28: 344-61.
32. The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301-8.
33. Freedman B. Scientific value and validity as ethical requirements for research: a proposed explication. IRB 1987;9(6):7-10.
34. Casarett DJ, Karlawish JHT, Moreno JD. A taxonomy of value in clinical research. IRB 2002;24(6):1-6.
35. 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.
36. 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. Fed Regist 1979;44:23192-7.
37. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
38. Charney DS, Innis RB, Nestler EJ. New requirements for manuscripts submitted to Biological Psychiatry: informed consent and protection of subjects. Biol Psychiatry 1999;46:1007-8.