Abstract
Objective—To explore the opinions of unpaid healthy volunteers on the payment of research subjects.
Design—Prospective cohort.
Setting—Southern Alberta, Canada.
Participants—Medically eligible persons responding to recruiting advertisements for a randomised vaccine trial were invited to take part in a study of informed consent at the point at which they formally consented or refused trial participation. Of 72 invited, 67 (62 trial consenters, 5 trial refusers) returned questionnaires at baseline and 54 at follow-up.
Outcome measures—Proportions of persons who agreed or disagreed with three close-ended statements on the payment of research subjects; themes and categories identified by content analysis of responses to an open-ended question.
Results—A minority (43.3%) agreed with paying either patient or healthy volunteer participants. Opinions did not change over time. Participants' comments addressed: benefits and drawbacks to research participation; benefits and drawbacks to paying research participants; conditions under which payment of research subjects would be acceptable, and the nature of acceptable recognition. Acceptable conditions were to improve problematic recruitment, to reimburse costs, and to recognise participants, particularly for their time investment. Both non-monetary and monetary recognition of volunteers were thought to be appropriate.
Conclusions—Most unpaid volunteers disagreed with paying research participants. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs. (Journal of Medical Ethics 2000;26:126–130)
Key Words: Ethics, medical • human experimentation • clinical trials • voluntary workers
Full Text
The Full Text of this article is available as a PDF (95.3 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Aby J. S., Pheley A. M., Steinberg P. Motivation for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Ann Allergy Asthma Immunol. 1996 Apr;76(4):348–354. doi: 10.1016/S1081-1206(10)60036-1. [DOI] [PubMed] [Google Scholar]
- Bigorra J., Baños J. E. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443–446. doi: 10.1007/BF02336681. [DOI] [PubMed] [Google Scholar]
- Darragh A., Kenny M., Lambe R., Brick I. Sudden death of a volunteer. Lancet. 1985 Jan 12;1(8420):93–94. doi: 10.1016/s0140-6736(85)91977-4. [DOI] [PubMed] [Google Scholar]
- De Castro Leonardo D. Exploitation in the use of human subjects for medical experimentation: a re-examination of basic issues. Bioethics. 1995 Jul;9(3-4):259–268. doi: 10.1111/j.1467-8519.1995.tb00360.x. [DOI] [PubMed] [Google Scholar]
- Hassar M., Pocelinko R., Weintraub M., Nelson D., Thomas G., Lasagna L. Free-living volunteer's motivations and attitudes toward pharmacologic studies in man. Clin Pharmacol Ther. 1977 May;21(5):515–519. doi: 10.1002/cpt1977215515. [DOI] [PubMed] [Google Scholar]
- Rudy E. B., Estok P. J., Kerr M. E., Menzel L. Research incentives: money versus gifts. Nurs Res. 1994 Jul-Aug;43(4):253–255. doi: 10.1097/00006199-199407000-00012. [DOI] [PubMed] [Google Scholar]
- Searight H. R., Miller C. K. Remembering and interpreting informed consent: a qualitative study of drug trial participants. J Am Board Fam Pract. 1996 Jan-Feb;9(1):14–22. [PubMed] [Google Scholar]
- Vere D. W. Payments to healthy volunteers--ethical problems. Br J Clin Pharmacol. 1991 Aug;32(2):141–142. doi: 10.1111/j.1365-2125.1991.tb03872.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Whinnery J. E. Motivational analysis of human volunteers for centrifuge acceleration research. Aviat Space Environ Med. 1982 Oct;53(10):1017–1020. [PubMed] [Google Scholar]
- van Gelderen C. E., Savelkoul T. J., van Dokkum W., Meulenbelt J. Motives and perception of healthy volunteers who participate in experiments. Eur J Clin Pharmacol. 1993;45(1):15–21. doi: 10.1007/BF00315344. [DOI] [PubMed] [Google Scholar]