The Ebola epidemic demonstrated how ill-prepared the global community is for major infectious disease crises. Now an international expert group has outlined a framework for preparedness, detection, and response to future infectious-disease threats.

The Neglected Dimension of Global Security — A Framework for Countering Infectious-Disease Crises

Objective To estimate the proportion of participants in clinical trials who understand different components of informed consent. Methods Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity. Findings The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study’s purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years. Conclusion The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.

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Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

The eigenchannel method, generalizing the familiar phaseshift method, is formulated for scattering from a Hermitian short range potential. Scattering eigenchannels are defined as eigenstates of some generalized (weighted) operator spectral problem. Eigenvalues of that problem define eigenphaseshifts, the former being the negative of cotangents of the latter. Eigenchannel representations of generalized scattering states, transition operators, and Green operators are constructed. A variational approach to the method is also presented. The general theory is illustrated by applications to scattering of Schr€ odinger and Dirac particles. 2003 Elsevier Inc. All rights reserved.

On the ζ-Potential

Consent and community engagement (CE) in health research are two aspects of a single concern-that research is carried out in a respectful manner where social value is maximized. There are important overlaps and interdependencies between consent and CE; for example, CE can provide insights into how best to tailor consent to context and can be an important component of consent processes. Engaging communities can also have intrinsic and instrumental value beyond consent; for example, as a means of showing respect and identifying appropriate ways of working respectfully. In this paper we critically examine how CE and consent processes are characterized, conducted, and evaluated in diverse health research contexts, and propose a preliminary research agenda to support future learning in these critical areas.

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Consent and community engagement in diverse research contexts.

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.

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Community engagement strategies for genomic studies in Africa: a review of the literature

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.

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Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience.

Internationally, calls for feedback of findings to be made an ‘ethical imperative’ or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under the age of 5 years old on the Kenyan Coast. In our setting, feeding back of aggregate findings was an appreciated set of activities. The inclusion of individual results was important from the point of view of both participants and researchers, to reassure participants of trial safety, and to ensure that positive results were not over-interpreted and that individual level issues around blinding and control were clarified. Feedback sessions also offered an opportunity to re-evaluate and re-negotiate trial relationships and benefits, with potentially important implications for perceptions of and involvement in follow-up work for the trials and in future research. We found that feedback of findings is a complex but key step in a continuing set of social interactions between community members and research staff (particularly field staff who work at the interface with communities), and among community members themselves; a step which needs careful planning from the outset. We agree with others that individual and aggregate results need to be considered separately, and that for individual results, both the nature and value of the information, and the context, including social relationships, need to be taken into account.

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Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast

We describe a participatory action research (PAR) project aimed at initiating a schools project as a component of the wider Kenya Medical Research Institute (KEMRI)–Wellcome Trust Research Programme's (KWTRP) community engagement strategy in Kilifi. Students and teachers from three nearby secondary schools, and scientists from KWTRP, were involved in designing and implementing a set of interventions aimed at promoting school awareness of locally conducted research, and positive attitudes towards school science and health research. The project was evaluated using a mixture of pre‐ and post‐intervention surveys and discussions with teachers, students, researchers and other stakeholders throughout the duration of the project. The project did appear to fill some knowledge gaps about research and contribute to enhancing students' educational experiences, as intended. However, the project also provided a forum where teachers and students could express their concerns and question research practices, and unexpectedly promoted learning among researchers themselves. Further work is needed to learn more about the potential of school engagement to provide benefits for research institutes, individual researchers and local schools.

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Bibi Mbete

Papers

Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience.

Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast

Seeing ‘With my Own Eyes’: Strengthening Interactions between Researchers and Schools*