Challenges of Ethical Clearance in International Health Policy and Social Sciences Research: Experiences and Recommendations from a Multi-Country Research Programme

By Edwards, Nancy; Viehbeck, Sarah et al. | Public Health Reviews; Rennes, January 1, 2012 | Go to article overview

Challenges of Ethical Clearance in International Health Policy and Social Sciences Research: Experiences and Recommendations from a Multi-Country Research Programme


Edwards, Nancy, Viehbeck, Sarah, Hämäläinen, Riitta-Maija, Rus, Diana, Skovgaard, Thomas, van de Goor, Ien, Valente, Adriana, Syed, Ahmed, Aro, Arja R., Public Health Reviews; Rennes


INTRODUCTION

Navigating ethics review requirements and processes is not straightforward, particularly when a mix of sequential projects, each with different leaders from multiple countries, is being undertaken for a funded programme of research. There are some useful published guidelines describing underlying principles that should be considered and pragmatic approaches that could be followed in seeking ethics approval for international research.1,2 However, most of these have originated in the domains of biomedical and clinical research. Thus, they do not consider structures for and normative practices of ethics reviews for health policy and social sciences research at either institutional- or country-levels. This is an important gap that needs to be addressed in order to ensure good research ethics practices in these international programmes. The purpose of this paper is to explore research ethics requirements for countries involved in social science and/or health policy research programmes and to provide recommendations for seeking ethics approval in situations where requirements differ among countries.

International Ethics Review Guidelines

Expectations of and requirements for ethics reviews are driven in part by international guidelines and agreements, including for example, the regularly updated World Medical Association's Helsinki Declaration.1 This internationally accepted standard spells out ethical principles for medical research with human subjects and directs authors to consider relevant "ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards".1(p.2) Helsinki Committees or Institutional Review Boards are now required in many countries and may be a requirement for research grant applications or for publishing results in peer-reviewed journals. However, as noted above, the implementation of such approaches is highly variable. Its primary focus has been medical personnel who are engaged in research on the "causes, development and effects of diseases"1(p.1) with the aim of improving "preventive, diagnostic and therapeutic interventions (methods, procedures and treatments)".1(p.1)

The World Health Organization document entitled Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)3 includes epidemiological, social, and psychological investigations. Other guidelines exist specifically for epidemiological research, including observational studies.4 Such guidance covers issues related not only to physical harm and benefits of research to humans, but also to social dimensions such as privacy concerns and informed consent. The uptake of these guidelines has been reinforced by journal editors, who have agreed through the World Association of Medical Editors, that the documentation of ethics review is a condition for publishing empirical studies.5 However, little guidance seems to be available regarding the nature of ethics documentation that is acceptable to journals, particularly for teams conducting multi-jurisdictional research.

An example of public health-specific guidance came from the Nuffield Council on Bioethics in its Public Health: Ethical Issues Report in 2007.6 This report provides an overall ethical framework for public health interventions and exemplifies the framework through case studies of public health issues.

Among these documents, there is variability in what constitutes research and the extent to which applied health and social sciences research is within scope of ethics review processes. Furthermore, there are inconsistencies in definitions of research subjects (e.g., patients versus organizational decision-makers, policy-makers or leaders) and interventions (e.g., medical, educational, organizational or policy).

Ethics and EC-Funded Research: The Case of REPOPA

This paper evolved from the context of a multi-country, European Commission (EC)-funded international programme: Research into Policy to enhance Physical Activity (REPOPA). …

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