Abstract
Background: According to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what "adequately informed" might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in such trials feel they have been given adequate information, or whether they feel able to understand that information.
Objectives: To explore trial participants' views (i) on the amount of information provided, and (ii) of their own understanding of that information.
Design: Structured interviews of patients participating in clinical trials for the treatment of chronic medical condition.
Findings: Patients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given outwith the research setting, patients generally felt they received more information when participating in a clinical trial.
Conclusions: Researchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate.
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Selected References
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- Berry J. Local Research Ethics Committees can audit ethical standards in research. J Med Ethics. 1997 Dec;23(6):379–381. doi: 10.1136/jme.23.6.379. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Corbett F., Oldham J., Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics. 1996 Aug;22(4):227–231. doi: 10.1136/jme.22.4.227. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Edwards S. J., Lilford R. J., Hewison J. The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals. BMJ. 1998 Oct 31;317(7167):1209–1212. doi: 10.1136/bmj.317.7167.1209. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Featherstone K., Donovan J. L. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ. 1998 Oct 31;317(7167):1177–1180. doi: 10.1136/bmj.317.7167.1177. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Foëx B. A. The problem of informed consent in emergency medicine research. Emerg Med J. 2001 May;18(3):198–204. doi: 10.1136/emj.18.3.198. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Grossman S. A., Piantadosi S., Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol. 1994 Oct;12(10):2211–2215. doi: 10.1200/JCO.1994.12.10.2211. [DOI] [PubMed] [Google Scholar]
- Harth S. C., Thong Y. H. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med. 1995 Jun;40(11):1573–1577. doi: 10.1016/0277-9536(94)00412-m. [DOI] [PubMed] [Google Scholar]
- Howard J. M., DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981 Dec;2(4):287–303. doi: 10.1016/0197-2456(81)90019-2. [DOI] [PubMed] [Google Scholar]
- Lynöe N., Sandlund M., Dahlqvist G., Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991 Sep 14;303(6803):610–613. doi: 10.1136/bmj.303.6803.610. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Meade C. D., Howser D. M. Consent forms: how to determine and improve their readability. Oncol Nurs Forum. 1992 Nov-Dec;19(10):1523–1528. [PubMed] [Google Scholar]
- Murphy J., Gamble G., Sharpe N. Readability of subject information leaflets for medical research. N Z Med J. 1994 Dec 14;107(991):509–510. [PubMed] [Google Scholar]
- Olver I. N., Buchanan L., Laidlaw C., Poulton G. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol. 1995 Nov;6(9):867–870. doi: 10.1093/oxfordjournals.annonc.a059352. [DOI] [PubMed] [Google Scholar]
- Penman D. T., Holland J. C., Bahna G. F., Morrow G., Schmale A. H., Derogatis L. R., Carnrike C. L., Jr, Cherry R. Informed consent for investigational chemotherapy: patients' and physicians' perceptions. J Clin Oncol. 1984 Jul;2(7):849–855. doi: 10.1200/JCO.1984.2.7.849. [DOI] [PubMed] [Google Scholar]
- Priestley K. A., Campbell C., Valentine C. B., Denison D. M., Buller N. P. Are patient consent forms for research protocols easy to read? BMJ. 1992 Nov 21;305(6864):1263–1264. doi: 10.1136/bmj.305.6864.1263. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 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 Nov;45(9):1337–1355. doi: 10.1016/s0277-9536(97)00063-4. [DOI] [PubMed] [Google Scholar]
- Snowdon C., Garcia J., Elbourne D. Reactions of participants to the results of a randomised controlled trial: exploratory study. BMJ. 1998 Jul 4;317(7150):21–26. doi: 10.1136/bmj.317.7150.21. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Tarnowski K. J., Allen D. M., Mayhall C., Kelly P. A. Readability of pediatric biomedical research informed consent forms. Pediatrics. 1990 Jan;85(1):58–62. [PubMed] [Google Scholar]