Answer:
Recently there has been a dramatic expansion in research conducted in low- and middle-income countries, as well as research ethics committees (RECs) in these countries.
RECs in low- and middle-income countries have little experience overseeing human rights research and may be subject to government control or influence that may favor the interests of the state over the interests of individual research participants.
Many human rights investigators are trained in disciplines with ethical codes and professional norms, but do not typically engage RECs nor see human rights documentation as research, and they tend to view REC approval as counterproductive to the protection of research participants.
Case studies of human rights research can provide important lessons on navigating conflicts of interest posed by some local (i.e., in country) RECs.
Expanding the use of community engagement and developing strong ethical operating principles can help ensure that individuals and researchers are protected in human rights research and investigations.
Background
Human rights violations play an important role as determinants of, or structural barriers to, health [1]–[6]. Research, investigation, and documentation focused on human rights have led to the development of rights-based interventions [7],[8] and the promotion of human rights in the core strategies of international health organizations [9],[10].
At the same time, health and human rights investigations raise complex ethical and methodological challenges [11]. Key questions have emerged about the roles of ethical review and research ethics committees (RECs) when criminalized or marginalized populations are part of research or program efforts [12],[13]. Human rights researchers may also follow ethical codes and professional norms such as those of journalists or lawyers, for example, but these do not typically engage RECs and may in fact define their work differently than biomedical or epidemiologic definitions of “research” [14]–[16]. Furthermore, members of local (i.e., in country) RECs may have conflicts of interest when state actors have a role in or supervision over RECs and can exert their influence to limit the scope of or impede investigations into human rights abuses.
In some circumstances, interests other than ensuring the sound protection of research participants may come to dominate the decisions that RECs make, including whether they agree to review the research and/or allow the research to be conducted at all. Researchers aware of these decision-making processes may “self censor” the focus of their research or choose to conduct research elsewhere. As increasing amounts of research are conducted on the impact of human rights on health, more attention is needed on the roles of RECs and researchers to ensure genuine protection of the individuals involved in human rights investigations.
Here we present examples of how human rights researchers can address complex ethical challenges by building the capacity of community-based organizations representing vulnerable populations and by adopting ethical operating principles. We illustrate our policy proposals using case studies of research involving men who have sex with men (MSM) in Africa, ethnic minorities in Myanmar, and individuals in compulsory drug treatment centers in Asia.
Human Participant Protections
The protection of participants in health-related research has evolved into a well-articulated international framework supported by normative documents, conventions, and, in growing numbers of jurisdictions, laws. Key among these are the World Medical Association's 1964 Declaration of Helsinki [17], the US Department of Health and Human Services Belmont Report and regulations for the protection of research participants [18],[19], the Council for International Organizations of Medical Sciences international ethical guidelines [20], and the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (http://www.ich.org/). All of these guidelines require prior review of research by an REC before research can be implemented. More recently, the World Health Organization published standards for such committees outlining key requirements for their structure, governance, and review standards [21].
Over the last ten years, there has been extraordinary growth in the numbers of RECs in low- and middle-income countries (LMICs). As new committees in LMICs have emerged, many countries have adopted a structure whereby local committees, affiliated with specific research institutions or organizations, are supported by a national committee. The national committee is in charge of creating policies, providing oversight, and, in some cases, performing an additional, final review.
