Elsevier

Social Science & Medicine

Volume 59, Issue 12, December 2004, Pages 2547-2559
Social Science & Medicine

Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast

https://doi.org/10.1016/j.socscimed.2004.03.037Get rights and content

Abstract

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the ‘subjects’ of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.

Introduction

The application of voluntary informed consent is often taken as synonymous with conducting ethically sound clinical research. The difficulties of achieving genuine informed consent in practice are widely recognised, particularly where research involves children, and in settings where investigators have significantly different educational and socio-cultural backgrounds to study participants (Silverman, 1989; Kuczewski & Marshall, 2002; Lidz & Appelbaum, 2002; Smyth & Weindling, 1999). Nevertheless, most guidelines continue to recommend informed consent in these situations, and the majority of ethical committees retain it as a key requirement (CIOMS, 2002; World Medical Association; Nuffield Council of Bioethics, 2002). Adaptations that are supported or recommended include preceding individual consent with community level consultation and permission, and—where the majority of potential participants cannot read or write—alternative methods of documenting the individual informed consent process (for example through audio or video tape as opposed to signatures).

This study contributes to a small body of empirical work exploring perceptions, understanding and appropriateness of informed consent processes for research in low-income settings (Fitzgerald, Marotte, Verdier, Johnson, & Pape, 2002; Leach, Greenwood, Manneh, Dibba, & Mulholland, 1999; Lynoe, Hyder, Chowdhury, & Ekstrom, 2001; Preziosi, Yam, Ndiaye, Simaga, & Simondon, 1997; Sanwal, Kumar, Sahni, & Nundy, 1996). Carried out in and around a research centre where thousands of people sign consent for a diverse range of hospital- and field-based studies every year, it was designed to answer several questions:

  • 1.

    Do community members support the notion of individual informed consent for different types of research?

  • 2.

    Do parents understand what they are consenting their children to be involved in?

  • 3.

    What are community members’ principal concerns regarding on-going field and clinical (research) activities?

In this paper, we focus on parents’ understanding of studies that they have consented themselves (or more commonly in our setting, their children) to be involved in, and the informational and psycho-social factors that explain the findings. Community members’ concerns are discussed where they shed light on these issues.

A number of major challenges to obtaining truly informed consent are highlighted. Given that the study was initiated and supported by a group who already had a well-developed interest in issues of research ethics and communication, it is highly unlikely that these problems are purely local. The paper's conclusions and recommendations, while specific to the study setting, are therefore expected to be relevant to a wide audience.

Section snippets

Study setting

A programme of collaborative research involving the Kenyan Medical Research Institute (KEMRI) and the Wellcome Trust was established in Kilifi District, on the Kenyan Coast, in 1989. The District has amongst the highest rates of poverty, the lowest rates of literacy and the largest gender differentials in rates of education and hours of work in the country. The research centre (or ‘Unit’) has grown steadily over the years: it now employs 296 staff and has achieved a strong international

Study methods

The principal approach to exploring informed consent (i.e. ‘the consent study’) was the use of three ‘research case studies’, each of which was a study that had been approved locally, nationally and internationally, and was on-going at the time of the consent study. Research case study details are presented in Table 1 (Rows 1–5). The consent study methods included informal and semi-structured interviews with researchers, fieldworkers (FWs) and community members, and structured observations of

Findings and discussion

We begin with a brief overview of the way in which the Unit's activities are described by the general community. This provides some context for the key findings regarding understanding of case studies A–C, and for the links between understandings, consent/refusal, and community concerns. In subsequent sections the reasons behind these findings are explored, and the implications discussed.

Community views of the unit activities—overview

Descriptions of the Unit's work were overwhelmingly positive. Almost everybody had heard of the institution; describing it as a good quality hospital, or as an aid organisation working in the area because the population suffers from ill-health, is poor, and needs help. Particularly appreciated appeared to be: the distribution of bednets (part of an ITBN trial); following up children ‘even into our homes’ (studies with field follow-ups or cohort studies); the ‘miraculous’ handling of children

Understanding of case studies

Case study data suggest that community members’ descriptions of the Unit as a health service or aid organisation relate to the way in which research messages reached study participants or parents in the first place, as opposed to information having been forgotten.

Case study A

Primary reasons for consenting appeared to relate to study benefits rather than altruistic motives or a desire to contribute to an improved global understanding about a major public health problem. Only two households refused to join the study from the outset, in both cases reporting that they were relatively wealthy and would gain little. Three quarters (78%) of those interviewed after the survey said they could not or would not have refused the blood sample, usually because of the study

Case study A

As noted above, the precise use of the research blood samples was often unclear to children and their parents. In some cases this was only of vague interest, with potential concerns minimised by constant interaction with research staff and trust in the Unit's objectives. However, in many cases questions about when (individual-level) results would be given and concerns about blood use and volume suggested a desire to know more and that explanations were not clear enough for the majority.

Factors behind understandings

The data presented suggest that research messages were lost in the researcher–communicator–parent chain in both community-based and in-patient studies. Here, we consider how and why this happened in relation to three inter-related themes: issues relating to the concept and terminology for research, unit-community power relations, and the role of communicators.

Conclusions and recommendations

Our research suggests that the majority of community members and study participants appreciate the Unit's field and ward-based activities, but that this appreciation is based on a perception that the Unit's primary aim is health service provision or assistance as opposed to research. This understanding is the result of a number of inter-related factors, including conceptual and terminology complications (linked to lack of access for many to scientific information from external sources); the

Acknowledgements

This research was funded by The Wellcome Trust, UK and supported by the Kenyan Medical Research Institute. We thank the researchers and fieldworkers who volunteered their studies to be included as case studies. Without their genuine interest and concern, this work would not have been possible. Thanks also to Ben Mrimi, Esther Yaa, Richard Rimba, and Marice Matumbo who organised and held numerous discussions, and to the many research Unit and hospital staff members, community members and parents

References (25)

  • A. Haaland et al.

    Introducing Health Workers for ChangeFrom transformation theory to health systems in developing countries

    Health Policy and Planning

    (1991)
  • C.S. Harth et al.

    Parental perceptions and attitudes about informed consent in clinical research involving children

    Social Science and Medicine

    (1995)
  • Cited by (0)

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