Tailoring Consent to Context: Designing an Appropriate Consent Process for a Biomedical Study in a Low Income Setting

Abstract

BackgroundCurrently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia.Methodology/Principal FindingsWe adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent.ConclusionsResearchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis.

Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

“…The mean ± SD, CS achieved by the participants was 13.4 ± 2.9; median 14 (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20). The highest correct responses were obtained for questions on background details (38%).…”

“…In one such study, 13 discussions were conducted with podoconiosis patients and nonpatients in the community, fieldworkers, researchers, staff of the local nongovernmental organization (NGO), working on prevention and treatment of podoconiosis and community leaders. The extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research.…”

Assessment of the understanding of informed consent including participants’ experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research

“…Participant satisfaction with the consent process is also a desirable outcome. The consenting physician or researcher should endeavour to convey the information to the fullest extent, both orally and/or in writing, in a manner and language which is appropriate and tailored to each individual's level of understanding 6 . However, it has been long argued that the informed consent process is often reduced to a simple recitation of the contents of the written document -participant information leaflet/sheet.…”

Views of dental professionals and dental patients in Jos, Nigeria concerning the need for informed consent prior participation in dental clinical research

“…For example, the information sheets and consent forms borrowed from developed countries may contain technical concepts not familiar to research participants in developing countries. [13] It may be too sparse or too complicated, or research participants may not be given a satisfactory opportunity to ask questions and have their personal worries and interests addressed. [14] Religious and cultural hindrances as well as low socio-economic status of the people is also a challenge to passing adequate information to the patients or research subjects.…”

“…[16] Though the research participant, as a lay person, is unlikely to understand fully the scientifi c basis and needs for Informed Consent in a specifi c research endeavor as opposed to the researcher or a medical expert, there are differential perspectives between lay people and investigators (Clinicians) regarding the relative importance or need of certain disclosed elements of the informed consent. [13,17] This study therefore aimed to identify the views of dental patients and dental professionals in Jos, Nigeria toward their knowledge and perceived need for Informed Consent prior participation in dental clinical research.…”