Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience

Boga, Mwanamvua; Davies, Alun; Kamuya, Dorcas; Kinyanjui, Samson; Kivaya, Ester; Kombe, Francis; Lang, Trudie; Marsh, Vicki; Mbete, Bibi; Mlamba, Albert; Molyneux, Sassy; Mulupi, Stephen; Mwalukore, Salim

doi:10.1371/journal.pmed.1001089

Cited by 44 publications

(45 citation statements)

References 13 publications

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“…The FEAST trial training and supportive supervision processes, including for consent, were greatly appreciated by staff, and are essential in all research settings given that frontline staff are constantly making ethically important decisions [14], [30]. Our data suggests that supportive supervision needs to be constant, and to be seeking out and responding continuously to challenges and areas lacking clarity as they arise.…”

Section: Discussionmentioning

confidence: 97%

“…Interactive training methods drew upon trainees’ knowledge and experience to contribute ideas for handling potential field scenarios, within an institutionally agreed consent SOP [14]. The time required for verbal assent was generally 2–5 minutes and could be obtained at the bedside, even whilst other aspects of emergency care were being administered (e.g.…”

Section: Introductionmentioning

confidence: 99%

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‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

et al. 2013

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ObjectiveTo document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future.MethodsA social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya.FindingsOverall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal.ConclusionWhile the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach.

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Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

et al. 2013

Self Cite

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“…All research carried out at the centre is reviewed by local, national scientific and independent ethical review committees, and where applicable external review committees. Additional mechanisms to strengthen communication and consent include a dedicated communication and consent committee, review and support of study specific community engagement plans, and locally designed informed consent templates …”

Section: Introductionmentioning

confidence: 99%

Evolving Friendships and Shifting Ethical Dilemmas: Fieldworkers’ Experiences in a Short Term Community Based Study in Kenya

Kamuya¹,

Theobald²,

Munywoki³

et al. 2013

Developing World Bioethics

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Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes.

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“…The above example also illustrates the importance of informed consent being real rather than merely fulfilling statutory requirements 10. A lengthy document may convey less information than a short one, especially if participants are illiterate and the material must be read to them.…”

Section: Who Chooses What Will Be Studied and How A Trial Will Be Desmentioning

confidence: 99%

Practical issues in relation to clinical trials in children in low-income countries: experience from the front line

et al. 2012

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Clinical trials in children in resource-poor environments are essential for local health policy and practice to be relevant and evidence based. Research must be ethical, appropriate, relevant and of good quality. It should, where possible, benefit the subjects studied,the clinical, scientific and support staff involved, and the service and academic institutions of the host country. The challenge for researchers and their sponsors is to maximise such benefits while avoiding the many possible pitfalls.

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Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience

Abstract: Samson Muchina Kinyanjui and colleagues from the KEMRI-Wellcome Trust Research Programme discuss how they modified their informed consent processes by taking into account local social, cultural, and economic contexts in the design and administration of consent forms.

Cited by 44 publications

References 13 publications

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

Evolving Friendships and Shifting Ethical Dilemmas: Fieldworkers’ Experiences in a Short Term Community Based Study in Kenya

Practical issues in relation to clinical trials in children in low-income countries: experience from the front line

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