Historical Overview

There have been a number of examples of ethically questionable research. In some rare cases, significant violations resulted in criminal sanctions. These latter cases aside, many of the former unethical situations were rooted in the ‘dual-role’ of doctors who were also researchers.

In addition, it is generally accepted that participation in research may expose individuals to harm that they would not otherwise experience. This is one of the reasons why research involving humans requires review and approval by an independent REC according to accepted standards. This review serves to assess the ethical acceptability of research studies and helps researchers improve the quality of their projects.

The doctor’s role [that can be extended to other healthcare providers] in the doctor-patient relationship is different from the researcher’s role in the researcher-participant relationship, even if the doctor and the researcher are the same person. The doctor’s primary responsibility is the health and well-being of the patient, whereas the researcher’s primary responsibility is the generation of knowledge, which may or may not contribute to the research participant’s health and well-being. Thus, there is a potential for conflict between the two roles. When this occurs, the doctor role must take precedence over the researcher.

Medical research is a well-funded enterprise, and study centres are sometimes offered considerable rewards for participating. These can include cash payments per research participant enrolled, equipment such as computers to transmit the research data, invitations to conferences to discuss the research findings, and co-authorship of publications on the results of the research.

This dual-role is relevant to all healthcare providers who have a relationship of trust with patients and who also conduct research. The potential conflicts between the two roles are minimised by the development and implementation of appropriate legislation and guidelines.

In the context of international collaborative research, there are often inequalities in resources between developed countries, which often sponsor research, and developing countries that host the research. This raises important ethical concerns, including the potential for exploitation. Given the need for research in developing countries, awareness of the risk of exploitation reinforces the need for robust evaluation of research by RECs.