Anant Bhan

Grand Challenges in Global Health: Engaging Civil Society Organizations in Biomedical Research in Developing Countries

The authors discuss the different types of civil society organizations, their role in biomedical research, and the advantages and challenges of working with them.

Evaluating community engagement in global health research: the need for metrics

BackgroundCommunity engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.DiscussionWe describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work in other health related research. Next, we review the scholarly literature regarding community engagement, outlining the diverse ethical goals ascribed to it. We then discuss practical guidelines that have been issued regarding community engagement. There is a lack of consensus regarding the ethical goals and approaches for community engagement, and an associated lack of indicators and metrics for evaluating success in achieving stated goals. To address these gaps we outline a framework for developing indicators for evaluating the contribution of community engagement to ethical goals in health research.SummaryThere is a critical need to enhance efforts in evaluating community engagement to ensure that the work on the ground reflects the intentions expressed in the guidelines, and to investigate the contribution of specific community engagement practices for making research responsive to community needs and concerns. Evaluation mechanisms should be built into community engagement practices to guide best practices in community engagement and their replication across diverse health research settings.

A comparison of online versus on-site training in health research methodology: a randomized study.

AbstractBackgroundDistance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses.MethodsSubjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline.ResultsBaseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14).ConclusionOn-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

Improving Ethical Review of Research Involving Incentives for Health Promotion

Alex London and colleagues propose new ethical frameworks for evaluating the risks associated with research in which financial or other incentives are used to promote healthy behavior.

Grand challenges in global health : ethical, social, and cultural issues based on key informant perspectives.

The authors interviewed key informants from the developing world and the Grand Challenges investigators to explore their ethical, social, and cultural concerns about the program.

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Highlights • Placebo controls may be acceptable even when an efficacious vaccine exists, in the following four possible situations:• When developing a locally affordable vaccine.• When evaluating the local safety and efficacy of an existing vaccine.• When testing a new vaccine when an existing vaccine is not considered appropriate locally.• When determining the local burden of disease.

Addressing Ethical, Social, and Cultural Issues in Global Health Research

Summary The purpose of this paper is to encourage reflection among the global health research community and the research ethics community about how a wide range of ethical, social, and cultural (ESC) influences on the conduct, success, and impact of global health research can best be addressed by consultation services in research ethics (CSRE). We draw on lessons we have learned during our experiences with the ESC Program of the Grand Challenges in Global Health initiative to propose key features of CSRE that may prove useful for those designing or implementing similar programs.

India’s new policy to protect research participants

Urgent need to deal with its unintended consequences

Diagnosis of drug-resistant TB and provision of second-line TB treatment in India: some ethical considerations.

BACKGROUND The GeneXpert® MTB/RIF (hereinafter Xpert) test has demonstrated sensitive detection of tuberculosis (TB) and Rifampicin resistance directly from untreated sputum in less than two hours. India is currently drafting the third phase of its Revised National Tuberculosis Control Programme (RNTCP). This process provides the countrys health authorities with an ideal opportunity to revolutionise TB management in the country. The RNTCP is currently conducting a multi-site demonstration study to gather operational evidence to scale up the Xpert test under Indian programme conditions. DISCUSSION With the impending publication of RNTCPs third phase, we consider the obligations of Indias RNTCP in the light of the World Health Organizations Guidance on ethics of tuberculosis prevention, care and control, published in November 2010. SUMMARY India is ethically obliged to phase-in the nationwide deployment of Xpert, a generic equivalent, or a quality lower-cost molecular diagnostic alternative, preferably made in India, as soon as reasonably possible. Further, India is ethically obliged to provide those diagnosed with first-line drug resistance universal access to second-line TB drugs. Doing so will reduce Indias morbidity and mortality associated with diagnostic delay, dropout, and mistreatment of TB, and help stem the countrys growing TB crisis.

Organ donation, discrimination after death, anti-vaccination sentiments, and tuberculosis management.

John Coggon, Bill Madden, Tina Cockburn, Cameron Stewart, Jerome Amir Singh, Anant Bhan, Ross E. Upshur and Bernadette Richards