Need to strengthen ethics committees
Ethics committees overseeing clinical trials in poor countries need reforming to protect participants, argue J. Karbwang and F. Crawley.
Independent ethics committees are crucial for the protection of participants in drug and vaccine trials in tropical countries, but they often suffer from conflicts of interest and lack of training. Improving committees and designing better informed consent procedures would strengthen confidence in the application of research ethics in resource-poor settings.
The challenge is to implement standard ethical considerations in environments that have high disease and death rates alongside an extremely weak social and healthcare infrastructure.
Some of the ethical requirements for research in economically advanced countries, particularly the criteria for informed consent, may not work in countries with a different cultural and social background.
For example, in some areas a wife is expected to seek permission from her husband before participating in research. In rural locations, community consent is often needed as well as individual consent.
The detailed information required in the informed consent form is controversial, as it could prevent potential participants from making a decision in their own best interest.
In addition, definitions of ethics, or the criteria for making ethical decisions, in the developed world can differ from those used in parts of Africa, Asia or Latin America.
But the force of local custom and law, as well as local practice and beliefs, cannot justify neglecting certain fundamental ethical requirements in research, including the right to self-determination.
Differences in doctor–patient relationships need to be taken into account. Patients in developing countries may see consenting to participate in a clinical trial as important for establishing a legal relationship with a doctor. Most patients believe that whatever a trusted doctor does will benefit them, so they readily give their consent. They may see refusing to participate in a study as a potential threat to the patient–doctor relationship and possibly to future treatment as well.
Most patients will not fully understand or be acquainted with all the facts of a particular study.
There is little evidence that informed consent, as currently practised, provides sufficient protection against the potential exploitation of research participants.
Careful scrutiny of proposed research by independent ethics committees (IECs), coupled with culturally sensitive and locally appropriate informed-consent procedures, seems to provide the highest protection.
So it is necessary to strengthen the ethical review process in developing countries where disease is endemic.
The IEC should be responsible for examining the experimental design, the scientific and healthcare procedures to be employed, the expertise of the investigators, and other ethical considerations that support and even go beyond the informed consent processes.
The IEC should also advise on how informed consent is to be obtained, the degree and breadth of the explanation given to the patient, and the manner in which subjects are invited to participate.
Effective IECs can build a bridge between international ethical standards and local practices and expectations in health research.
In resource-poor settings, IECs may not be able to achieve full independence because their members are largely drawn from the institutions in which the committees are established. Conflicts of interest may not be recognised. For example, members might feel compelled to review positively research from their own institution or research likely to bring in significant funding.
Sometimes, negotiating international standards and local laws and regulations can be easier than the prospect of facing a colleague or superior to whom your committee has provided a negative opinion.
Ethics committee members require training in general ethical principles, in the structure of good clinical practice, and in new developments in biomedical research that are associated with ethical issues.
In our experience, few members of ethics committees have read or adequately considered the international and national guidelines under which they are supposed to operate.
The training should also emphasise the need for standardised practices and independent decision-making.
No longer acceptable
It is becoming evident that IECs need to increase their capability in regions targeted by international health research and development efforts. It is no longer acceptable to overlook deficiencies in ethical review and rely on informed consent practices developed by researchers in very different cultures thousands of kilometres away.
There is rarely an existing procedure in place to monitor the informed consent process, and researchers should be aware that something more than a simple signature at the end of a long and complicated form is required. Forceful and reliable ethical review procedures must underpin the ongoing development of improved informed consent practices in developing countries.
Juntra Karbwang is clinical coordinator at the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, the World Health Organization; Francis P. Crawley is executive director of the Good Clinical Practice Alliance – Europe. The authors founded the Strategic Initiative for Developing Capacity in Ethical Review.