Are subjects satisfied with the informed consent process? A survey of research participants

Journal of Rheumatology

Volumn 30, Issue 4, 2003, Pages 815-824

  Pope, Janet E ^a,d   Tingey, David P ^b   Arnold, J Malcolm O ^c   Hong, Paul ^a   Ouimet, Janine M ^a   Krizova, Adriana ^a  

^a Division of Rheumatology   (Canada)

^b LONDON HEALTH SCIENCES CENTRE   (Canada)

^c Division of Cardiology   (Canada)

^d ST JOSEPH S HEALTH CENTRE   (Canada)

Author keywords

Informed consent; Patient understanding; Randomized controlled trial

Indexed keywords

CELECOXIB; CIPEMASTAT; GLUCOSAMINE SULFATE; LATANOPROST; LUMIRACOXIB; PLACEBO; RAMIPRIL; ROFECOXIB; TIMOLOL MALEATE; VALDECOXIB;

ADULT; AGED; ARTICLE; CARDIOLOGY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; EDUCATION; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MEDICAL CARE; OPHTHALMOLOGY; PRIORITY JOURNAL; QUESTIONNAIRE; RHEUMATOLOGY; SELF EVALUATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

ADULT; AGED; AGED, 80 AND OVER; ATTITUDE; FEMALE; HUMANS; INFORMED CONSENT; MALE; MENTAL RECALL; MIDDLE AGED; PATIENT EDUCATION; PATIENT SATISFACTION; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS;

EID: 12444301894     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (45)

1. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent - Why are its goals imperfectly realized? N Engl J Med 1980;302:896-900.
2. Taylor KM, Kelner M. Informed consent: The physician's perspective. Soc Sci Med 1987;24:135-43.
3. Meade CD. Improving understanding of the informed consent process and document. Semin Oncol Nursing 1999;2:124-37.
4. White DR, Muss HB, Michielutte R, et al. Informed consent: Patient information forms in chemotherapy trials. Am J Clin Oncol 1984;7:183-90.
5. Meade CD, Howser DM. Consent forms: How to determine and improve their readability. Oncol Nurs Forum 1992;19:1523-8.
6. Grossman SA, Piantodosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994;12:2211-5.
7. Tarnakowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics 1990;85:58-62.
8. Lynöe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ 1991;303:610-3.
9. Gallet M, Aupetit JF, Servan E, et al. Informed consent, what information is left after a therapeutic trial? Arch Mal Coeur Vaiss 1994;87:39-45.
10. Schultz AL, Pardee GP, Ensinck JW. Are research subjects really informed? West J Med 1975;123:76-80.
11. Muss HB, White DR, Michielutte R, et al. Written informed consent in patients with breast cancer. Cancer 1979;43:1549-56.
12. Bjørn E, Rossel P, Holm S. Can the written information to research subjects be improved? An empirical study. J Med Ethics 1999;25:263-7.
13. Kruse AY, Kjaergard LL, Krogsgaard K, et al. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO Trial Group. Control Clin Trials 2000;21:223-40.
14. Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology 2001;24:595-607.
15. Featherstone K, Donovan JL. "Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomized controlled trial. Soc Sci Med 2002;55:709-19.
16. Edwards SJL, Lilford RJ, Hewison J. The ethics of randomized controlled trials from the perspectives of patients, the public and healthcare professionals. BMJ 1998;317:1209-12.
17. Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics 1996;22:227-31.
18. Dal-Re R. Clinical trial of drugs: a study of the influence of information on adverse reactions on obtaining informed consent. Med Clin Barc 1991;20:566-9.
19. Ubel PA, Merz JF, Shea J, Asch DA. How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial. J Invest Med 1997;45:561-6.
20. Yuval R, Halon DA, Merdler A, et al. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Arch Intern Med 2000;8:1142-6.
21. Agard A, Hermeren G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? Heart 2001;86:632-7.
22. Kucia AM, Horowitz JD. Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? Am Heart J 2000;140:94-7.
23. Dorantes DM, Tait AR, Naughton NN. Informed consent for obstetric anesthesia research: Factors that influence parturients' decisions to participate. Anesth Analg 2000;91:369-73.
24. Benson PR, Roth LH, Winslade WJ. Informed consent in psychiatric research: preliminary findings from an ongoing investigation. Soc Sci Med 1985;20:1331-41.
25. Stiles PG, Poythress NG, Hall A, et al. Improving understanding of research consent disclosures among persons with mental illness. Psychiatr Serv 2001;52:780-5.
26. Harth SC, Thong YH. Parental perception and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995;40:1573-7.
27. Steven PE, Pletsch PK. Ethical issues of informed consent: Mothers' experiences enrolling their children in bone marrow transplantation research. Cancer Nurs 2002;25:81-7.
28. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358:1772-7.
29. Gotay CC. Perceptions of informed consent by participants in a prostate cancer prevention study. Cancer Epidemiol Biomarkers Prev 2001;10:1097-9.
30. Snowdon C, Garcia J, Elbourne D. Reactions of participants to the results of a randomized controlled trial: exploratory study. BMJ 1998;317:21-6.
31. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997;45:1337-55.
32. Featherstone K, Donovan JL. Random allocation or allocation at random? Patients' perspective of participation in a randomized controlled trial. BMJ 1998;317:1177-80.
33. Ferguson PR. Patients' perceptions of information provided in clinical trials. J Med Ethics 2002;28:45-8.
34. Verheggen FW, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns 1998;35:111-25.
35. Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. Eur J Cancer 2000;36:2096-104.
36. Grant CH III, Cissna KN, Rosenfeld LB. Patients' perceptions of physicians' communication and outcomes of the accrual to trial process. Health Commun 2000;12:23-39.
37. Verheggen FW, Nieman FH, Reerink E, Kok GJ. Patient satisfaction with clinical trial participation. Int J Qual Health Care 1998;10:319-30.
38. Kjaergaard LL, Kruse AY, Krogsgaard K, et al. Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group. Dan Med Bull 1998;45:439-43.
39. Byrne DJ, Napier A, Cuschieri A. How informed is signed consent? BMJ 1988;296:839-40.
40. Gallagher SM. Barriers to informed consent in clinical trials. Ostomy Wound Manage 1999;45:14-6.
41. Tindall B, Forde S, Ross MW, et al. Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Patient Educ Couns 1994;24:261-6.
42. Verheggen FW, Jonkers R, Kok G. Patients' perceptions on informed consent and the quality of information disclosure in trials. Patient Educ Couns 1996;29:137-53.
43. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993;306:885-90.
44. Anon. Your baby is in a trial [editorial]. BMJ 1995;345:805-6.
45. Edwards SJL, Lilford RJ, Braunholtz DA, et al. Ethical issues in the design and conduct of randomized controlled trials. Health Technol Assess 1998;2:1-132.