Dataset Information

Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

ABSTRACT:

Background

Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent.

Methods

A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial.

Results

For most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents' willingness to have their child included in the trial made them develop active strategies to achieve this purpose.

Discussion

In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process.

SUBMITTER: Pare Toe L

PROVIDER: S-EPMC3829938 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

Paré Toe Lea L Ravinetto Raffaella M RM Dierickx Susan S Gryseels Charlotte C Tinto Halidou H Rouamba Noèl N Diallo Ibrahim I Cissao Yacouba Y Bayala Korotimi K Hausmann Susanna S Muela Joan J D'Alessandro Umberto U Peeters Grietens Koen K

PloS one 20131115 11

<h4>Background</h4>Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent.<h4>Methods</h4>A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carr ...[more]

PMID: 24260484

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Project description:BackgroundEthical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts.MethodsStudy staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed.ResultsICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24-42). Median ICAT scores were 80% (IQR: 67-93) for comprehension and 89% (IQR: 78-100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials.ConclusionsParticipants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.

Project description:BackgroundProviding understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients' autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.MethodsWe searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.ResultsOur search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes.ConclusionsDigital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

Project description:BACKGROUND:Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice. MATERIALS AND METHODS:We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220. RESULTS:Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or "mature minor" status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach. CONCLUSIONS:The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

Project description:Evidence is emerging from rigorous evaluations about the effectiveness of nutrition-sensitive agriculture programmes in improving nutritional outcomes. Additional evidence can elucidate how different programme components and pathways contribute and can be optimized for impact. The International Food Policy Research Institute, with Helen Keller International, designed a comprehensive framework to evaluate the delivery, utilization, and impact of Helen Keller International's enhanced homestead food production programme in Burkina Faso. After 18 months of implementation, a process evaluation was conducted to examine programme impact pathways, using key informant and semistructured interviews with implementing agents and beneficiaries, and with residents of control communities. Data were analyzed by International Food Policy Research Institute and reviewed with project managers and partners through multiple workshops to identify opportunities to strengthen implementation. Findings illuminated gaps between intended and actual delivery schemes, including input constraints, knowledge gaps among community agents in agriculture and young child nutrition practices, and lower than expected activity by community volunteers. In response, staff developed measures to overcome water constraints and expand vegetable and poultry production, retrained volunteers in certain techniques of food production and counselling for nutrition behaviour change, added small incentives to motivate volunteers, and shaped both immediate and long-term changes to the programme model. Working closely with International Food Policy Research Institute on the evaluation activities also expanded the repertoire of research methods and skills of Helen Keller International staff. Process evaluation can strengthen programme delivery, utilization, and design. Collaboration between researchers and implementers can improve programme effectiveness, project staff capacity, and advance delivery science.

Dataset Information

Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

Background

Methods

Results

Discussion

Publications

Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

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