Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments

Bull, Susan; Farsides, Bobbie; Tekola‐Ayele, Fasil

doi:10.1525/jer.2012.7.1.37

Cited by 45 publications

(52 citation statements)

References 55 publications

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“…When we began this research, we expected low literacy to be one of the factors hindering comprehension at the time of consent to participate in genomic research. However, based on the analysis of our data understanding of the concepts in genomic research dependent more on the methods used to communicate the information [22]. These results were similar to those of a study conducted in Gambia and Bangladesh [10,23,24].…”

Section: Discussionsupporting

confidence: 83%

A qualitative study on aspects of consent for genomic research in communities with low literacy

Bukini

Mbekenga²,

Nkya

et al. 2020

Preprint

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Background: Low literacy of study participants in Sub Saharan Africa has been associated with poor comprehension during consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. Aim: The aim of this study was to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension. Methods: Using qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes. Results: Findings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension. Conclusion: The quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies.

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Section: Discussionsupporting

confidence: 83%

A qualitative study on aspects of consent for genomic research in communities with low literacy

Bukini

Mbekenga²,

Nkya

et al. 2020

Preprint

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“…Guidance and regulation on research ethics requires that consent to research must be appropriately informed if it is to be valid [1, 2, 31]. While there is some consensus about core topics that should be covered in all recruitment processes, researchers are required to determine how much information about each of these core topics should be provided, and how to support understanding of the information on a study by study basis [8, 32]. The limited empirical research into developing consent processes for genomic research suggests that promoting participants’ understanding that they are enrolled in genetic or genomic research and the implications of such enrollment can present challenges in a number of African settings [10, 12-15, 17, 18].…”

Section: Discussionmentioning

confidence: 99%

Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali

et al. 2015

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BackgroundObtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. It aimed to inform best practices in recruiting participants into genomic research.MethodsA qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software.ResultsParticipants’ parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand.ConclusionsThis study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-015-0035-7) contains supplementary material, which is available to authorized users.

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“…Surveys were carried out in the study area, during which In-Depth Interviews (IDIs) and Focus Group Discussions (FGDs) were conducted. These were done using semi-structured interview guides adapted from a rapid assessment method validated in The Gambia [ 22 , 23 ] and Ethiopia [ 5 ]. Three different interview guides were developed for IDIs and used as follows: one for health workers, one for researchers and the last one for community members, community leaders, and non-government organisation (NGO) members.…”

Section: Methodsmentioning

confidence: 99%

“…Rapid ethical assessment is a brief qualitative intervention designed to map the ethical terrain of a research setting prior to recruitment of participants. It has been proposed as one means of improving the consent process in research-naïve settings [ 22 , 23 ]. Rapid ethical assessment was carried out in Ethiopia prior to a genetic study to investigate the genetic basis of podoconiosis [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Perceptions of consent, permission structures and approaches to the community: a rapid ethical assessment performed in North West Cameroon

et al. 2014

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BackgroundUnderstanding local contextual factors is important when conducting international collaborative studies in low-income country settings. Rapid ethical assessment (a brief qualitative intervention designed to map the ethical terrain of a research setting prior to recruitment of participants), has been used in a range of research-naïve settings. We used rapid ethical assessment to explore ethical issues and challenges associated with approaching communities and gaining informed consent in North West Cameroon.MethodsThis qualitative study was carried out in two health districts in the North West Region of Cameroon between February and April 2012. Eleven focus group discussions (with a total of 107 participants) were carried out among adult community members, while 72 in-depth interviews included health workers, non-government organisation staff and local community leaders. Data were collected in English and pidgin, translated where necessary into English, transcribed and coded following themes.ResultsMany community members had some understanding of informed consent, probably through exposure to agricultural research in the past. Participants described a centralised permission-giving structure in their communities, though there was evidence of some subversion of these structures by the educated young and by women. Several acceptable routes for approaching the communities were outlined, all including the health centre and the Fon (traditional leader). The importance of time spent in sensitizing the community and explaining information was stressed.ConclusionsRespondents held relatively sophisticated understanding of consent and were able to outline the structures of permission-giving in the community. Although the structures are unique to these communities, the role of certain trusted groups is common to several other communities in Kenya and Ethiopia explored using similar techniques. The information gained through Rapid Ethical Assessment will form an important guide for future studies in North West Cameroon.

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Tailoring Information Provision and Consent Processes to Research Contexts: The Value of Rapid Assessments

Cited by 45 publications

References 55 publications

A qualitative study on aspects of consent for genomic research in communities with low literacy

A qualitative study on aspects of consent for genomic research in communities with low literacy

Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali

Perceptions of consent, permission structures and approaches to the community: a rapid ethical assessment performed in North West Cameroon

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