A new perspective on research ethics.

• Author: Deschamps, Pierre

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 enterprise." (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. (8), (9)

   Current ethics review processes are seen by many as inefficient and inadequate. (10) Downie for example notes that these systems are less than comprehensive and, because of their non-comprehensiveness, represent a danger to the well-being of research participants and the ethical conduct of research." (11) McDonald, for his part, states that he is surprised and shocked by the fact that "the Canadian system for dealing with the ethics of human subjects research lacks learning systems." (12)

   It appears thus that there is a need to change our approach to ethics review as well as to the protection of research participants in relation to the research enterprise. This need was clearly acknowledged by the Institute of Medicine in its 2003 report entitled Responsible Research: A Systems Approach to Protecting Research Participants. (13) The Institute proposes, if a systems approach is to be adopted, that the focus from now on be not on research ethics boards but on research participant protection programs.

   According to the Institute, "appropriate protection that incorporates the necessary safeguards can most effectively be provided by a program of systematic and complementary functions within which discrete roles and respective accountability are clearly articulated." (14) For the Institute, "the critical factor in the effectiveness of any given system lies in how the discrete elements are brought together to achieve a common aim." (15)

   The systems approach developed by E. Deming appears to be an interesting starting point. Deming's system of profound knowledge (SoPK) provides a comprehensive framework for understanding how systems work and for improving the overall performance of systems His theoretical framework is based on four bodies of knowledge, more precisely of profound knowledge, that is knowledge of theory, of systems, of variation and of psychology. (16) These four bodies of knowledge are interrelated and intertwined and one must be able to combine these components and be able to master their inter-connectedness or interrelationship if one is to properly manage and optimize a system. (17)

   According to Horn, the "System of Profound Knowledge helps us to see how complex organisations work. When we understand this we can then figure out what we have to do to get long-term improvements in quality and efficiency. Ultimately, organisations led by people who are guided by the System of Profound Knowledge are likely to be much more efficient and successful than organisations which continue with the prevailing style of management." (18)

   A. Theoretical framework

   Firstly, in Deming's opinion, there can be no knowledge, no profound knowledge of a system without a theory. (19) The latter serves as a reference point if one is to assess whether or not the system is achieving its goal. In this context, there is a need to identify the system's aim, frontiers, constraints. For Deming, experience alone does not bring knowledge; it teaches you nothing. (20) For experience to be transformed into knowledge, there needs to exist a theory, concepts that will give meaning to personal experiences. This is not always the case.

   Indeed, when a system does not deliver the expected results or when something in the system breaks down, the normal reaction is to bring changes to the system, usually after an investigation of the circumstances which led to the bad outcome. For example, after the death of a research subject in the course of a clinical trial, investigators will look at an array of things that could have gone wrong. They will try to pinpoint the deficiencies that might have led to the bad outcome and make recommendations aimed at avoiding the repetition of past errors in the hope of improving the system as a whole.

   These recommendations, in a research context, can provide for the establishment of training programs for investigators and the allocation of more resources to the research ethics board among other things. They can also lead to the implementation of tighter controls over research activities without, unfortunately, any follow-up of the impact of these measures on the oversight system as a whole and the protection of human subjects or on the possible interference that these remedial means many have on the pursuit of research activities and the acquisition of new knowledge. (21)

   The lack of a theoretical framework to measure the adequateness of the recommendations made may hamper the ability of those implementing the recommendations to properly evaluate their real impact on the research enterprise.

   On another note, recent and upcoming changes to the current research environment do not appear to have led to an appraisal of what the changes will bring to the current oversight systems that exist in relation to research activities. For example, the arrival of...