PLoS Medicine invited Joseph Millum of the Department of Bioethics, National Institutes of Health, USA, and Sandra Realpe of the Council on Health Research for Development to report on the Eighth Global Forum on Bioethics in Research.
Fostering Research Ethics Infrastructure in the Developing World/Transition Societies: A Report on the Eighth Global Forum on Bioethics in Research
Joseph Millum, Sandra Realpe
A principal line of defence against unethical health research is the oversight provided by a research ethics committee. With appropriate support, independence, and expertise it can ensure the protection of human research participants while facilitating socially beneficial research. Research ethics committees (RECs) or Institutional review Boards (IRBs) have now been established across much of the world. Nevertheless, as the amount of research conducted in the developing world and transition societies increases, concerns remain about the effectiveness of the ethical oversight these host countries currently provide. These concerns formed the focus for the eighth meeting of the Global Forum on Bioethics in Research (GFBR), which met to discuss how to foster research ethics infrastructure in the developing world and transition societies, and the ethics of mental health research.
The GFBR is a partnership of organizations with an interest in promoting ethical international health research. Its annual meetings provide a platform for discussion between the various stakeholders in health research collaborations between developing and developed countries. These include scientists and ethicists from these countries, community representatives, policy-makers, and research sponsors and funders. The meetings assist the trans-global sharing of information about building research ethics capacity, and discussion of emerging ethical issues in health research.
The eighth meeting was held on June 27–29, 2007 in Vilnius, Lithuania. Its 130 participants came from 48 different countries. Seventy per cent were from developing or transition economy countries.
Challenges in establishing research ethics infrastructure
In their keynote address, Ruth Macklin (Albert Einstein College of Medicine) and Florencia Luna (Latin American University of Social Sciences (FLACSO)) laid out the challenges they saw in establishing an effective research ethics infrastructure, and proposed actions to meet them. First, many countries lack effective regulations to govern research. International guidelines might be expected to be helpful to RECs in these cases. But the array of guidelines require considerable interpretation and provide conflicting recommendations on crucial issues. Macklin and Luna called for the harmonization of these guidelines and for a halt on the production of new guidelines. Second, ensuring adequate ethical review remains a challenge. Research institutions and government bodies should provide RECs with the needed financial and administrative support to function effectively and independently. Third, ethical research can only be assured if REC members and researchers get appropriate training in ethics. And sustainable training capacity will be achieved only by training people who can then teach research ethics. Finally, the adequacy of researchers’ consultation with participants remains an issue. Informed consent documents from industry are often focused more on avoiding legal liability than conveying information, and the consent process is frequently flawed. Further, though community involvement in research may be enjoined, it is often attempted in the most cursory manner.
The challenges for establishing an effective research ethics infrastructure vary from place to place. The panel discussion following the keynote heard presentations from Africa, China, North and Latin America, and Europe on their region’s particular challenges. The speakers emphasized the wide variation in research ethics capacity not only between but within these regions. As Douglas Wassenaar (University of KwaZulu-Natal) noted, “Africa’s capacity in training and infrastructure varies from the best to amongst the most under-resourced in the world.”
Operationalizing research ethics review
In discussion, the shortage of funding for ethical oversight was the topic most frequently raised by the participants. This shortage may reduce the ability of RECs to thoroughly review protocols and not to resort to “rubber-stamping,” it reduces the monitoring of on-going research, and it hampers REC independence. In the absence of government funding, participants were torn about whether for-profit RECs should be allowed and whether they would be practical in resource-poor settings. Some thought that alternative incentives for REC participation were needed, such as protected time or professional recognition. Another proposal was that ethics approval should be a condition for research trials to be registered through the WHO’s new trial registry portal. If prospective trial registration was then a pre-condition for publication or regulatory approval, this would be a spur to provide the resources needed for ethical review.
With regard to the conflicts of interest that emerge during research, discussants were particularly concerned about the sponsors of research paying for ethics review and recruitment payments made to researchers. In both cases, procedural precautions are needed. If sponsors are to fund ethics review, then they should not be able to pick their REC. And while payment to researchers is acceptable, it should not be directly tied to the number of subjects they recruit.
Another set of key issues concerned the acquisition and dissemination of information. To facilitate capacity building, information is needed on what research ethics capacity currently exists—including local and regional RECs, data safety monitoring boards, and ethics training programmes—and what is needed. Existing systems for research oversight would benefit from better communication, both across RECs and between RECs and other bodies, like regulatory authorities.
Models for research ethics training
Organizers of ethics training programs from Nigeria, China, the Czech Republic, and Costa Rica presented and assessed training projects from their countries. Two sub-sessions developed further lessons from ethics training practice: the first a market-place in which about twenty teachers demonstrated their pedagogical practice, and the second presentations from student participants in ethics training programs.
Mental health research
The Forum’s special emphasis was on the ethics of mental health research. Rodrigo Salinas (Chilean Ministry of Health) gave a plenary address on problems with research trials sponsored by pharmaceutical companies. He argued that a combination of publication bias and carefully constructed studies allows researchers studying psycho-active drugs to get the answers they want. For example, studies of drugs sometimes bias results through the careful selection of exclusion criteria for research participants. These exclusions tend not to be mentioned when the drugs are marketed. Salinas also highlighted the trend towards “disease mongering,” whereby conditions once considered normal are turned into psychiatric illnesses. For instance, he cited research which suggested that a million Australians suffered from a novel ailment called “social disorder.” Salinas argued that more critical examination of the social value of psychiatric research is needed. This, he said, is a job for RECs.
Discussants struggled with the definition of mental illness and were concerned with the criteria used to diagnose mental disorders, particularly where they lacked biomedical markers. They also voiced concern about the lack of expertise in mental health among REC members. They suggested that specialized RECs could take on mental health protocols, or that REC members could receive subject-specific training. Similarly, mental health researchers might benefit from more ethics training. Though it was acknowledged that many people with mental disorders retain the capacity to consent, a number of questions emerged about research on people whose capacity was diminished because of their illness. Discussants emphasized the need for research into mental disorders and the value of still including people in research where they are likely to benefit from it. This is particularly important where the available mental health care resources are very limited, which is frequently the case in the developing world.
The meeting provided a unique opportunity for participants who might not otherwise have communicated to share information, expertise, and best practices on the development of research ethics infrastructure. It showed that there are common challenges across the world in optimising the ethical oversight of research, including specialized areas, like mental health research. It also highlighted some solutions, such as acquiring and disseminating data on regional research ethics capacity, creating systems for communicating information on research ethics, and providing resources and making institutional changes to minimise conflicts of interest and allow RECs to operate independently.
The next GFBR is scheduled for December 2008 in Auckland, New Zealand. It will focus on ethical issues related to research on indigenous and vulnerable populations.
Full information on the Eighth Global Forum on Bioethics in Research, including the keynote presentations, is available online.