In developed countries, the informed consent process depends primarily on documents approved by local Institutional Review Boards (IRBs) and on the participants'signatures, to indicate they have read and understood the document. The two essential goals of informed consent are first, to ensure that participants are fully and fairly informed, and second, to ensure that consent is given freely. Unfortunately, the informed consent process often fails to achieve these goals in developing countries because the participants have limited or no literacy and limited experience with western medicine. The goal of this proposal is to develop informed consent strategies which are as effective for persons in developing countries with limited or no literacy (who have limited experience with western medicine) as they are for educated individuals in the U.S. This issue is relevant to health research in the broadest sense, because individuals with limited literacy who have limited experience with western medicine are also present in the U.S. (New Orleans, Houston, New York, Los Angeles).
The specific aims of this proposal are to: 1] develop strategies to assess the understanding of a study protocol by potential participants and their acceptance of the informed consent process, and 2] use those strategies to compare the understanding of participants based on the information they have received (videotape presentation prepared in collaboration with the Institute of Languages in Bamako vs. the conventional paraphrased translation of the study protocol) and to compare the acceptance of a new consent procedure (oral consent based on discussion with a study representative and a traditional Malian intermediary that is documented with a video recorder) to the conventional consent (based on """"""""signing,"""""""" placing an """"""""X"""""""" or a thumbprint on a document the participant cannot read). If successful, this proposal will permit the development of similar strategies at other overseas and domestic sites - based on key informant interviews and focus groups to ensure that the strategies selected are consistent with local cultural beliefs and patterns. Thus, this approach also has the potential to be valuable in inner city environments where limited literacy and limited experience with western medicine are common. By departing from the current reliance on written documentation, this approach offers an opportunity to refocus on the essential elements of informed consent: that the participants be fully and fairly informed, and that consent be given freely.
Because informed consent depends on written documents, it often fails because of illiteracy in developing countries. This proposal uses a videotape to present the study protocol visually and in dialect, and a new consent procedure based on recording the consent transaction between the subject, study representative and traditional Malian intermediary with a video camera. It then compares the effectiveness of the videotape presentation to the conventional presentation (paraphrased translation of the study protocol by a staff member) and the acceptance of the new consent procedure to the acceptance of the conventional consent procedure (placing an """"""""X"""""""" or a thumbprint on the consent document).
| Koita, Ousmane A; Murphy, Robert L; Fongoro, Saharé et al. (2016) Clinical Research and the Training of Host Country Investigators: Essential Health Priorities for Disease-Endemic Regions. Am J Trop Med Hyg 94:253-7 |
| Krogstad, Donald J; Diop, Samba; Diallo, Amadou et al. (2010) Informed consent in international research: the rationale for different approaches. Am J Trop Med Hyg 83:743-7 |
