Creating comprehensive ethics

Efforts to improve research ethics may not succeed in the absence of ethics in clinical care. This is especially true in developing countries, where it is difficult to access routine health care. The gap between ethics in research and in clinical care may result in the poor implementation of ethical guidelines in clinical research. This could upset the efforts of international and national agencies to regulate clinical research in developing counties, and it is reflected in the difficulties often encountered by ethics committees to review research proposals in developing countries (1, 2).

Research has become an attractive proposition in developing countries, both for local investigators and global funding agencies. This has brought about some efforts to improve the review of research ethics using international guidelines. One reason for these growing efforts is that the data generated by multinationals has to be submitted to the Food and Drugs Administration in the United States or other regulatory agencies responsible for granting permission to market drugs. These regulatory agencies in the developed world must adhere to the International Conference on Harmonisation Good Clinical Practice standards, which involves an initial approval by an ethics committee. But such committees in developing countries have to function in difficult circumstances and multiple forces often make their independence questionable (3).

Researchers also find it difficult to resolve the conflicts arising out of ethical requirements in clinical research and the demands of routine health care. The same clinical investigators provide clinical care and recruit patients in clinical trials. They often find it difficult to balance the two roles. Research can be strengthened by creating greater awareness amongst researchers about the ethical principles applicable to clinical as well as research settings. It is necessary to develop clinical ethics simultaneously with research ethics if we want to put in place appropriate ethics reviews of research proposals.