临床研究与生物伦理学杂志

抽象的

Contextualizing the Informed Consent Process in Vaccine Trials in Developing Countries

Saidu Yauba, Odutola Aderonke, Jafali James, Ogundare Olatunde, Worwui Archibald, Sey Gibbi1, Thomas Vivat, Stanley-Batchilly Elizabeth Afolabi Mohammed, Idoko Olubukola, Owolabi Olumuyiwa and Ota Martin OC.

Introduction: Most sponsors of clinical trials in Africa propose the use of complicated informed consenting procedures as in developed countries, including the translation of informed consent forms into local languages. Although well intentioned, this practice may be irrelevant and of no added value in settings where local languages are only spoken but not written. Recognizing this challenge, the ethics committee in The Gambia recommend a consent procedure that takes into account these local realities. The objective of this paper was to assess the effectiveness of this new procedure in conveying key trial information among participants in a vaccine trial in The Gambia.
Methods: Consent was obtained from 1200 parents using the new procedure. Comprehension was then assessed using a tool that contained questions on key aspects of the trial.
Results: Although the majority of respondents had no formal education, almost all of them had a sound understanding of the trial. Variables such as age, gender, education, ethnicity and occupation had minimal effect on comprehension.
Discussion and Conclusion: Our data suggest that the new consent procedure is effective in conveying key research information to research participants. The procedure is promising in that it has eliminated the need for repeatedly translating and back-translating informed consents. It also guarantees that the study team expresses research concepts in the same way.