How to handle informed consent in longitudinal studies when participants have a limited understanding of the study

Journal of Medical Ethics

Volumn 31, Issue 11, 2005, Pages 670-673

  Helgesson, Gert ^a   Ludvigsson, J ^b   Stolt, U Gustafsson ^b  

^a UPPSALA UNIVERSITY   (Sweden)

^b LINKÖPING UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL STUDY; COMPREHENSION; DECISION MAKING; EMPIRICISM; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LONGITUDINAL STUDY; MORALITY; PATIENT PARTICIPATION; PATIENT RIGHT; PATIENT SATISFACTION; RESEARCH SUBJECT; SWEDEN;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH;

COGNITION; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; LONGITUDINAL STUDIES; MORALS; PATIENT EDUCATION; PATIENT PARTICIPATION; PATIENTS; PERSONAL AUTONOMY; TERMINOLOGY;

EID: 28244449608     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2004.009274     Document Type: Article

References (17)

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 Nat Cancer Institute 2001;93:139-46.
4. Gustafsson Stolt U, Ludvigsson J, Liss P-E, et al. Bioethical theory and practice in genetic screening for type 1 diabetes. Med Health Care Philos 2003;6:45-50.
5. Gustafsson Stolt U, Helgesson G, Liss P-E, et al. Information and informed consent in a longitudinal screening involving children: a questionnaire survey. Eur J Hum Genet 2004;13:376-83.
6. Brock D. Life and death: philosophical essays in biomedical ethics. Cambridge: Cambridge University Press, 1993, ch 1.
7. Dworkin G. The theory and practice of autonomy. New York: Cambridge University Press, 1988, especially chs 1 and 7.
8. Faden R, Beauchamp T. A history and theory of informed consent. Oxford: Oxford University Press, 1986.
9. Feinberg J. Autonomy. In: Christman J, eds. The inner citadel. Essays on individual autonomy. Oxford: Oxford University Press, 1989:27-53.
10. Meyers C. Cruel choices: Autonomy and critical care decision making. Bioethics 2004;18:104-19.
11. Stiggelbout AM, Molewijk AC, Otten W, et al. Ideals of patient autonomy in clinical decision making: a study on the development of a scale to assess patients' and physicians' views. J Med Ethics 2004;30:268-74.
12. Dahl Rendtorff J. Basic ethical principles in European bioethics and biolaw: autonomy, dignity, integrity and vulnerability-towards a foundation of bioethics and biolaw. Med Health Care Philos 2002;5:235-44 (at 243).
13. Beauchamp T, Childress R. Principles of biomedical ethics [5th ed]. New York: Oxford University Press, 2001:89-90.
14. 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 (especially 380, 383, 385).
15. O'Neill O. Autonomy and trust in bioethics. Cambridge: Cambridge University Press, 2002.
16. Hoeyer K. "Science is really needed-that's all I know": informed consent and the non-verbal practices of collecting blood for genetic research in Sweden. New Genet Soc 2003;22:198-212.
17. Busby H. Blood donation for genetic research. What can we learn from donors' narratives? In, Tutton R, Corrigan O, eds. Genetic databases: Socioethical issues in the collection and use of DNA. London: Routledge, 2004:39-56 (at A7).