Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information

Journal of Medical Ethics

Volumn 31, Issue 11, 2005, Pages 674-678

  Eriksson, S ^a   Helgesson, Gert ^a  

^a UPPSALA UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ATTITUDE; CLINICAL STUDY; COMPREHENSION; HUMAN; INFORMED CONSENT; PRIVACY; RESEARCH ETHICS; RESEARCH SUBJECT; RESPONSIBILITY; TRUST;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

BIOMEDICAL RESEARCH; HUMANS; INFORMATION DISSEMINATION; MOTIVATION; PATIENT EDUCATION; PATIENT PARTICIPATION; PRIVACY; QUESTIONNAIRES; SOCIAL RESPONSIBILITY; SOCIAL VALUES; TIME FACTORS; TRUST;

EID: 28244461469     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2004.009753     Document Type: Article

References (22)

1. Giardello FM, Brensinger MS, Petersen GM, et al. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. N Engl J Med 1997;336:823-7.
2. Daugherty CK. Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. J Clin Oncol 1999;17:1601-17.
3. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 2001;93:139-46.
4. Stolt UG, Helgesson G, Liss P-E, et al. Information and informed consent in a longitudinal screening involving children: a questionnaire survey. Eur J Hum Genet 2005;13:376-83.
5. Brown RF, Butow PN, Butt DG, et al. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Soc Sci Med 2004;58:379-90.
6. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003;348:721-6.
7. Freeman WL. Making research consent forms informative and understandable: the experience of the Indian Health Service. Camb Q Healthc Ethics 1994;3:510-21.
8. Montgomery C, Lydon A, Lloyd K. Patients may not understand enough to give their informed consent. BMJ 1997;314:1482.
9. Holmes-Rovner M, Wills CE. Improving informed consent; insights from behavioral decision research. Med Care 2002;40(Suppl):V30-V38.
10. Edwards SA, Lilford RJ, Braunholtz DA, et al. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess 1998;2(15).
11. Kuczewski MG, Marshall P. The decision dynamics of clinical research; the context and ace of informed consent. Med Care 2002;40(Suppl):V45-V54.
12. Getz KA. Informed consent process: a survey of subjects assesses strengths and weaknesses. Appl Clin Trials 2002;11:30-6.
13. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med 2004;164:2201-4.
14. Clarke S. Informed consent in medicine in comparison with consent in other areas of human activity. Southern Journal of Philosophy 2001;34:169-87.
15. Doyal L. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997;314:1107-11.
16. Miller SM. Monitoring versus blunting styles of coping with cancer influence the information patients want and need about their disease. Cancer 1995;76:167-77.
17. Lidz CW, Appelbaum PS, Grisso T, et al. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004;58:1689-97.
18. Freedman B. The validity of ignorant consent to medical research. IRB 1982;4(2):1-5.
19. Hansson MG. Balancing the quality of consent. J Med Ethics 1998;24:182-7.
20. Edwards SJL, Lilford RJ, Braunholtz DA, et al. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess 1998;2(15):16.
21. Lantos J. The "inclusion benefit" in clinical trials. J Pediatr 1999;134:130-1.
22. Chalmers I, Lindley RI. Double standards on informed consent to treatment. In: Doyal L, Tobias JS, eds. Informed consent in medical research. London: BMJ Books, 2001:266-75.