BMC Medical Ethics
(Accessed 13 December 2014)
http://www.biomedcentral.com/bmcmedethics/content

Debate
Community engagement and the human infrastructure of global health research
Katherine F King, Pamela Kolopack, Maria W Merritt and James V Lavery
BMC Medical Ethics 2014, 15:84 doi:10.1186/1472-6939-15-84
Published: 13 December 2014
Abstract (provisional)
Background
Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement (CE) has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.
Discussion
In this paper, we propose an ethical framework for CE. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement. These relationships create an essential “human infrastructure” – a web of relationships between researchers and the stakeholder community–i.e., the diverse stakeholders who have interests in the conduct and/or outcomes of the research. Through these relationships, researchers are able to address three core ethical responsibilities: (1) identifying and managing non-obvious risks and benefits; (2) expanding respect beyond the individual to the stakeholder community; and (3) building legitimacy for the research project.
Summary
By recognizing the social and political context of biomedical research, CE offers a promising solution to many seemingly intractable challenges in global health research; however there are increasing concerns about what makes engagement meaningful. We have responded to those concerns by presenting an ethical framework for CE. This framework reflects our belief that the value of CE is realized through relationships between researchers and stakeholders, thereby advancing three distinct ethical goals. Clarity about the aims of researcher-stakeholder relationships helps to make engagement programs more meaningful, and contributes to greater clarity about when CE should be recommended or required.

Research article
Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review
Marlies van Lent, Gerard A Rongen and Henk J Out
BMC Medical Ethics 2014, 15:83 doi:10.1186/1472-6939-15-83
Published: 10 December 2014
Abstract (provisional)
Background
Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.
Methods
Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature.
Results
Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95).
Conclusions
RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.