HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS REGISTER		Author Keyword(s) Vol Page [Advanced]

This Article Full Text Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this link to a friend Similar articles in this journal Similar articles in PubMed Add article to my folders Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Moodley, K Articles by Myer, L Search for Related Content PubMed PubMed Citation Articles by Moodley, K Articles by Myer, L

Informed consent and participant perceptions of influenza vaccine trials in South Africa

¹ Bioethics Unit, Centre for Applied Ethics and Department of Family Medicine and Primary Care, Faculty of Health Sciences, University of Stellenbosch, South Africa
² Department of Family Medicine and Primary Care, University of Stellenbosch, South Africa
³ School of Public Health and Family Medicine, University of Cape Town, South Africa

Correspondence to:
Prof K Moodley
Bioethics Unit—Tygerberg Division, PO Box 19063, Tygerberg 7505, South Africa; km{at}sun.ac.za Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.

Method: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration.

Results: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication.

Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.

Keywords: informed consent; randomised control trials; participant comprehension; participant recall; placebos; random allocation

This article has been cited by other articles:

				A T Barnett, I Crandon, J F Lindo, G Gordon-Strachan, D Robinson, and D Ranglin An assessment of the process of informed consent at the University Hospital of the West Indies J. Med. Ethics, May 1, 2008; 34(5): 344 - 347. [Abstract] [Full Text] [PDF]

				Z Hill, C Tawiah-Agyemang, S Odei-Danso, and B Kirkwood Informed consent in Ghana: what do participants really understand? J. Med. Ethics, January 1, 2008; 34(1): 48 - 53. [Abstract] [Full Text] [PDF]