A New Perspective on Research Ethics

Introduction In 2011, research is not, as it used to be, the work of a single individual, working in his laboratory, trying to discover something that has yet to be discovered. (1) As stated by Grady, advances in knowledge, technology and resources have changed the face of research and have transformed the research (2) Research, today, is mostly done in settings where researchers work in teams that compete against each other. (3) Researchers get their funding from public agencies as well as from private sponsors which have, often times, a vested interest in the research being conducted by these teams. (4) All of the above players are part of what is now called the research enterprise. Recently with the advent of participatory research, consumers have become part of this research enterprise. (5) The research enterprise comprises many segments. It can be seen as a chain of activities that are intertwined. Research often times starts with an idea or even a hunch. The researcher then formalizes his idea or hunch in a research protocol that usually sets out his objectives, his methodology, the different procedures to be followed, the expected results, and the risks and inconveniences to which research participants will be exposed. Given the ethical rules that exist, the researcher will have to lay down in a properly written consent form the information that needs to be brought to the attention of a research participant so that the latter can freely provide informed consent to the research that is being proposed. Then, the research proposal as well as the consent form are submitted to a research ethics board for its review and approval as prescribed by many regulatory instruments such as the TCPS2 (2010) and the Declaration of Helsinki. At the implementation stage of the research protocol, the research activities are often monitored by different bodies to ensure that the protocol is properly implemented, and that the ethical and legal rules that apply are followed. For example, sponsors will audit studies to determine if the studies are in compliance with the protocol and will identify possible protocol violations. Ethics review is an integral part of the research enterprise where people come together and work together in order to achieve a common goal; that is, to improve the knowledge that will provide a better understanding of certain realities of life including how people behave, why they behave in certain ways, why people are sick and what can be done in order to improve their health or cure their disease. (6) Unfortunately at the present time, the ethics review process is sometime seen as an obstacle or a hurdle that researchers need to overcome in order to do their research the way they wish. The research ethics board is seen by many as a necessary evil operating in a vacuum, as a nitpicking entity that can harm research, and as inefficient and ineffective in protecting the welfare and the rights of research participants. (7) This paper sheds new light on the research enterprise in general, and on research ethics in particular. First, it looks at the importance of adopting a systems approach in a research setting where all the players are called upon to work in harmony so as to achieve the desired result, namely-the development of new knowledge through the ethical conduct of all those involved in the research enterprise. Second, the paper focuses on what needs to be done in order to measure the quality of what is now being done with respect to the ethics review process and the overall oversight system related to the protection of research participants. As such, it lays the groundwork for future investigations into the assessment of quality with respect to the ethics review processes and oversight systems in the field of research. 1. Systems Approach In many venues, research ethics is seen as a means of regulating research, of dictating how research activities involving humans should be conducted, and as a means of protecting research participants against the 'evils of research', including for example self-interest and profit-making motives, as well as conflicts of interest -- all of which have contributed to the abuse and deaths of research participants. …

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