Contextualizing the Informed Consent Process in Vaccine Trials in Developing Countries

Abstract

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.

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

“…In many instances in these settings, the ICD is written in English or the corresponding official language of the country and, for illiterate participants, it is verbally interpreted by trained study staff during the consent process using their spoken language. 9 Consent of illiterate participants is also supported by the presence of a literate impartial witness who should be present throughout the discussion to attest that the information discussed is consistent with the ICD and the process follows internationally acceptable ethical standards. The literate witness should be independent of the trial and should read and translate any written information supplied to the potential participant.…”

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine

“…Investigators and their research teams ensured a sound approach for informed consent process using the above-mentioned process. Such elements have emerged in the literature as proven approaches for the process of informed consent [ 6 , 7 , 9 , 10 ]. The success of the informed consent process still required the investigators' continued transparency, confidentiality, and respect of the participant in the implementation of these tools, while ensuring a thorough documentation of each informed consent.…”