|PROCEEDINGS OF THE NCEHR RETREAT - MARCH 1998
he National Council on Ethics in Human Research organized a retreat in March of this year in order to educate members about some of the most important ethical issues that occur in research in the social sciences and humanities and some other areas at the intersection of the health and human sciences. The quality of the presentations made on this occasion was so good that we thought it important to share this information with our readers.
Chaired by Dr. Janet Storch,
Director, School of Nursing, University of Victoria
Dr. Henry Dinsdale, President of the NCEHR welcomed the participants to the Retreat and gave a brief introduction to the Retreat. He then introduced Dr. Paul Bernard who made the following presentation.
Dr. Paul Bernard
Professor of Sociology, Université de Montréal
Areas of interest: Research and teaching in the areas of work and social inequality, as well as in methodology and epistemology
A number of challenges and opportunities have arisen as a result of the recent adoption of the Tri-Council Policy Statement on Ethics. As a member of the Social Sciences and Humanities Research Council, I would like to discuss the roles that members of the research community will be called upon to play with respect to this Statement, and how the Statement will be implemented. Also, as a working social scientist, I would like to help those of you who may be less familiar with our disciplines to better understand our practices. I wish to address three major issues in my talk:
- What is the exact nature of ethical endeavour in science, and how is it embodied in the Statement that we have in front of us?
- What are the challenges in implementing the Statement, and what types of problems are we likely to confront in the ethical evaluation process?
- To what extent can the application of this Policy Statement help improve not only ethical standards, but also research itself?
The nature of the ethical endeavor in science
Science, as we all know, is a complex activity—not only because of its internal dynamics, where we face constantly receding but always present complexity and uncertainty, but also because it is practised in the context of a larger society, with political and economic forces at play. Curiosity itself may lead scientists into practices that raise ethical issues, but these stakes are even higher when the political and economic processes that shape scientific activity threaten to lead it in directions that might compromise ethical standards, as well as the very practice of science. For this reason, ethical guidelines have to be stated and implemented.
It would seem that one simple way to do this would be to adopt legislation. After all, we live in a society where rights and duties are firmly entrenched in law. This solution has been adopted by a number of other societies, but it has proven cumbersome— not only with respect to enforcement mechanisms, but also with respect to mechanisms that have to be used to adapt legislation to an ever-evolving scientific activity.
More generally, the relationship between science and the State, or for that matter between science and the economy, has always proven to be very delicate. All three of these systems have a logic of their own and their incompatibility may prove highly destructive, as the experience of other societies tends to show. For this reason, the three federal granting councils of Canada have followed another path. They have chosen to adopt a common policy statement that would allow the self-regulation of the scientific community with respect to ethical conduct, so that State intervention in the form of legislation would not be necessary. This should provide us with the flexibility required to constantly adapt our research to ethical standards, and to adapt our ethical standards to the changing practices of our scientific activity.
Yet, this raises a troubling issue: if we are to adopt a policy statement to avoid cumbersome legislation, then we could be tempted to consider this Statement as if it were a piece of internal legislation within the scientific community. Should we take such a stance? Should we lay the emphasis, in dealing with the statement, on the mechanisms for the enforcement of a very specific set of rules, much in the way that the courts would do it? I think not, because we would then have simply reproduced internally what could have been imposed from outside. On the contrary, we should promote an awareness of ethical standards in the scientific community; we should insist on inviting "the citizens of the republic of science" to rise to the occasion, and indeed to become active creators of ethical standards appropriate to the evolving situation of scientific practices.
In addition, we should encourage an active dialogue around these ethical standards, so that issues and their provisional resolutions are brought to the general attention, and become part of the ongoing activity of the scientific community. For this to take place, it is crucial that the policy statement and its implementation mechanism be at once highly principled and very practical. Indeed, experience shows that impractical procedures tend to not be implemented. But there is more to this than sheer impracticality. If we cannot devise practical implementation procedures, then the ongoing creation and discussion processes I am calling for will not take place. We have to find ways of discussing the ethical issues surrounding research practices in ways that do not restrict legitimate research practices; we might even consider how ethical reflection and dialogue can enhance research, a point I will turn to in the last section of this presentation.
Basically, we’re faced with a delicate balancing act between sensitizing activities and controlling activities. Education and dialogue are, of course, the solution of choice. If we could convince all researchers that it is important to apply ethical norms, and if we could inform them of the current wisdom about those ethical norms, control would become unnecessary. But of course, this is unlikely to happen, and enforcement remains necessary when sensitization fails.
Indeed the relationship between dialogue and control is quite complex. As I just mentioned, the former lessens the need for the latter. But on the other hand, control is, in essence, part of a sensitization strategy; when abuse happens, justice has to be done, and it must be seen to be done. Moreover, and even more importantly, control can interfere with dialogue, in the sense that the fear of sanctions can hinder the circulation of information, which obviously is integral to the dialogue on ethical issues.
I have no general solution to propose for this balancing act between sensitization and control, and indeed I suspect that there exists no general solution; answers have to be found as issues arise, and as communities and institutions evolve. I can, however, try to shed some more light on how such a balance can be achieved by outlining the different types of people and views that Research Ethics Boards are likely to be confronted with. I have developed a twelve-fold typology, which may not be exhaustive, but at least allows us to identify problems that may arise during the ethical review process. Some of these problems are of a specifically ethical nature; some have to do with the competence of the players involved; and some concern the politics of the players involved.
The first three types pertain to ethics as such. The first type is the most classic case of the cheaters, that is, researchers who knowingly violate ethical norms.
There may not be very many such cheaters, as most people tend to conceal, even from themselves, self-interested motivations in their various activities. In this case, control is mandated and sensitization efforts would probably be lost, at least on the offenders themselves.
The second type is the reluctant or minimalist researcher, who will abide by the rules in a legalistic sense, but will be far less than proactive in reflecting on subtle or emerging ethical issues. This researcher might also insist that others— and in particular the Research Ethics Board—do the same. The Policy Statement is seen as a code by the minimalists, and what is covered by that code should, in their view, be carefully demarcated.
The third type I call the vengeful. These are researchers involved in a conflict of interest during an ethical review. For example, they may accuse a colleague of not abiding by some of the principles in the Policy Statement, but only because they wish to curb or undermine that colleague’s research, and take revenge for some offence. I also call them Trojan Horses, because their co-operation with a Research Ethics Board may at first sight appear to be motivated by purely ethical considerations.
The next four types involve competence problems, either with respect to ethics or with respect to research itself. The fourth type, the unaware, covers researchers who do not take into account the Policy Statement in their research, or those who neglect some aspect of it. Sensitization efforts have failed to help these researchers, mainly because of their own negligence, or because educational efforts have been insufficient.
The fifth type, the unsophisticated, is an attenuated version of the fourth type. These researchers have had some basic exposure to ethical principles, but they have not adequately reflected on the various ethical issues arising out of their own work, or in the work that they have to review. Increased sensitization efforts are necessary for both the fourth and fifth types.
Our sixth type is the ignoramus. These are members of Research Ethics Boards, or even sometimes researchers themselves, who do not know enough about research itself and its complexities: they are unable to either identify ethical issues in a field, or to assess the risks involved, or to situate issues and risks in the context of scholarly standards.
The seventh type I call the uninformed, an attenuated, indeed more narrowly specific, version of the previous type. These are researchers or members of Research Ethics Boards who do not know enough about a specific research protocol or field to be able to identify the ethical issues involved, and to put them in the appropriate context. Again, an increase in sensitization efforts is the preferred course of corrective action for these two types, if people have the ability and the willingness to learn.
There are fives types of political positions impinging on ethical review issues. Type eight I call the obstructionist. These people either deny that ethics is an issue at all, at least in the social sciences and humanities, or they think that it should not be assessed in advance of the research process but only at the end, when research products are being evaluated.
Of course the problem here is that harm may have already been done.
The ninth type is the zealot. They are people who interpret the Policy Statement literally and apply its strictest provisions in an inappropriate context.
There are also privacy activists, who think research is a privilege, and who consequently fail to see it as a legitimate activity whose requirements have to be balanced against the needs for privacy.
The eleventh type I call uneasy allies. They are researchers and members of Research Ethics Boards who consider the Policy Statementinsufficiently sophisticated, and who will hold themselves, as well as others, to higher standards. Such people are concerned about promoting a greater awareness of ethics; they actively push us further in our reflections on research practices, which is good. Yet, they are uneasy allies because their thrust towards higher standards may make implementation efforts by Research Ethics Boards somewhat difficult and impractical—indeed, it may, under certain circumstances, jeopardize the whole enterprise by pointing to ever-present shortcomings. As we say in French, "Le mieux est l’ennemi du bien".
The last type I call political activists. These are people who pursue political causes, broadly speaking, and who approach research and ethical issues only in light of their impact on the designated cause. This may, of course, have beneficial effects for certain disadvantaged or marginalized groups, but it may also have adverse effects by displacing ethics as the centre of the ethical review process.
As I’ve mentioned above, these types may not be exhaustive and they certainly are not mutually exclusive. Yet to be aware of them may help the Research Ethics Boards, in our universities and institutions, to maintain the balance between necessary control and ongoing dialogue. Now that we have reviewed the challenges and problems of implementing the Tri-Council Policy Statement on Ethics, let us examine some of its unforeseen prospects.
Applying the Policy Statementwill obviously require fairly substantial, though largely invisible, resources. Above all, the review process will require a considerable commitment of time and energy from faculty members and researchers; this will mean less time for actual research. Consequently, if ethical reflections are to become part of the continual practice of researchers, we will have to consider not only ways of making ethical review practical, but also of making ethical thinking and review contribute to the enrichment of research as such.
I can think of two avenues that open up in this respect. In the first place, we should note that this is a Tri-Council Policy Statement. What this means is that there will have to be a greater joint involvement not only of the Councils themselves, but of practising researchers in universities from the fields of natural sciences and engineering, medical sciences, and social sciences and humanities; they should all co-operate in putting into practice what is mandated by the Policy Statement. In other words, the Statement and its implementation can move us further towards interdisciplinary dialogue and co-operation—which is increasingly considered by researchers and by users of research results as a superior method of doing science.
Specialization obviously entails large payoffs in the process of discovery, but ideas also have a disconcerting habit of coming to people from angles that they had not anticipated. Profound discoveries are often made in the process of trying to explain to a gifted neophyte or to a colleague who is not a specialist in our own discipline (or sub-discipline) what it is that we are doing and why we are doing it. Such dialogue can increase our awareness of why we do things a certain way, and they may also provide us with alternative ways in which we might go about looking for truth; in a word, they help us develop lateral thinking.
Thus, the practical effect of the Tri-Council Statement will be to bring together researchers belonging to different disciplines and different areas of knowledge. This is an opportunity to form links beyond the frontiers of disciplines, learn more about the practices of other scientists, and improve our own research practices.
In the second place, and probably even more importantly, the adoption of the Policy Statement will help us refine and redefine our conception of the research participant. Instead of considering this participant as a mere subject, we will have to increase our awareness of the effect of our research on this person, and on the person’s social environment. We will have to encourage participants and the groups to which they belong to tell us more about the effects of research on them, and to tell us more about the social environments in which our encounters with them occur. This will provide us with a more holistic view of the research participants, and it will give us a better understanding of all the dimensions of their lives. These dimensions interact in complex ways and heavily influence the research results in which we are ultimately interested.
To put it in different words, we will be moving towards a better balance between the externalist, often quantitative, approach to research, and a more experiential, qualitative one, concerned with the whole of the individual, in the sense that John Ralston Saul gives to the latter notion. The social sciences and humanities are gradually moving away from a "magic bullet" approach to policies and programs; they may help engineering, as well as the natural and medical sciences to move towards a broader vision of their technological and therapeutic accomplishments.
I hope I have made clear that ethical review should be a very dynamic process, which gets researchers involved in reflecting on the ethical underpinnings of their activity. Of course, there will be difficult debates, involving various types of people, concerning the issues that Research Ethics Boards are likely to meet as they attempt to strike a balance between dialogue and control. But if handled correctly, implementation efforts should lead to increased dialogue among the disciplines, and to a more active involvement of research participants; both of these trends should translate into improvements not only in ethics, but also in research itself.
Over time, the efforts of the Research Ethics Boards should be constantly fed back into an ongoing revision of the Policy Statement. If left to itself, this document will tend to petrify, if only because it is a compromise between major institutions, and it is not easily changed once adopted. Yet, change is of the essence in ethical reflection. This is true not only because our research practices evolve and require new solutions, but also because ethical reflection itself, even on old problems, continues to generate new questions and new answers. These should be recycled into an improved Policy Statement. Whether we will achieve this goal or not is contingent to a large extent on whether Research Ethics Boards take a pro-active stand on research ethics, and whether they can successfully involve a large part of the community in open dialogue on the ethical aspects of research.
Thank you very much.
|New Challenges to the Ethics Review Process: Disciplinary Perspectives
Chair: Dr. John Foerster,
Executive Committee NCEHR
Department of Medicine, University of Manitoba, Director of Research at St. Boniface Hospital Research Institute.
r. Foerster, whose clinical interests are in hæmatology and oncology, begins by welcoming everyone to the session on new challenges to the ethics review process. He draws attention to the wonderful introductory lecture to the weekend retreat delivered by Professor P. Bernard and points out that, of all the many positive challenges emerging from the new Tri-Council Policy Statement, the full integration of ethics into research appears to be imperative. What this means, in part, is that we must relinquish our view of ethics as yet another formality required to obtain subsidies.
The best code of ethics, when considered only as an accessory, may not prevent the most de-humanizing acts. A shocking example of this pernicious effect of a compartmentalized research process can be found in the Nazi experiments conducted by brilliant and sometimes renowned researchers who received their authority from a country (Germany) which was known at the time to have the best code of ethics in the world. These atrocities, which have gradually become public knowledge, might have been avoided if the code of ethics had been taught in German universities and integrated into the lives of physicians, academics and researchers.
Teaching the principles embodied in the Tri-Council Policy Statement and promoting the integration of ethics into research now represents the most important mandate of NCEHR. This tremendous endeavour will, however, entail more training of Council members, since it was felt that the Council as a whole had an incomplete knowledge base of the concerns and challenges faced by colleagues in the humanities and social sciences. This first session on the ethical challenges met by human research in psychology (Dr. Daphne Maurer, McMaster University), anthropology (Dr. Dorothy Counts, University of Waterloo) and history (Dr. Chris Armstrong, York University) can serve as a familiarization exercise.
Dr. Daphne Maurer
Professor of Psychology, McMaster University.
Area of interests: Developmental Psychology, especially the development of infants’ visual perception; author of: The World of the Newborn.
r. Maurer’s lecture is intended to draw attention to the ethical issues related to psychological research involving human subjects. She approaches her topic from her own research experience, i.e. from the point of view of a go-getter researcher with no particular training in research ethics. Her presentation focuses primarily on:
- the use of subject pools: a requirement to participate in research as part of a course
- the use of deception
1) Subject pools
It is common practice for researchers in psychology to recruit their experimental subjects from within the psychology student body. Any student who registers for a psychology class will likely be required to take on the role of a research subject as a way of earning credits or bonus marks. The rationale is that taking part in scientific research will provide the student with a better understanding of the research process and of the experimental results they learn about in the textbook and lectures.
Mandatory participation in research generates hundreds of hours of research participation and more representative samples than those that are obtained when research is restricted to volunteers. It also makes it possible for researchers – who are often PhD. candidates or undergraduate honour students – to get their work done within a short time. The economic factor appears obvious: researchers get maximum fringe benefits in exchange for minimum monetary investment. This leaves granting councils with more money to distribute to psychology researchers who do not deal with human subjects and who must buy the animals required for their experiments.
The benefit to the student is education about the topic of the study and about the research process. The University of Toronto’s requirements for Introductory Psychology are a good model of a structure designed to assure that students receive such a benefit. For example, researchers wishing to use the subject pool must sign a contract that they will abide by the rules outlined in a 13-page manual; their proposed study and consent form must be approved by the Research Ethics Board; they must prepare (and get approved) a study package for the subjects that includes information about the problem being studied, the experimental procedure, the hypotheses, the independent and dependent variables, implications for theory or practice, a reference to relevant pages in the textbook for the course, and a current reference in the literature; and they must have approved 6 test questions a subject should be able to answer after reading the study package. Students receive credit for participation only if they answer correctly whichever one of those questions they are given.
From the participants’ perspective, there are three concerns about required research participation: the availability of an attractive experiment to sign up for; meeting the inclusion criteria for participation in an individual experiment (e.g., right-handed females aged 18-22); and the coercive nature of the requirement. Psychology researchers tend to downplay the coercion factor, because the assignment is educational (like being required to read a textbook) and the student can choose among many experiments, all of minimal risk. Dr. Maurer notes that the freedom to choose among experiments is sometimes purely rhetorical, since the choice is typically based on skimpy information provided on announcement boards. Nevertheless, other than a few isolated complaints, there is no indication that students actually feel coerced into participation in these experiments. On the contrary, surveys show that students generally feel that they have acquired a better understanding of scientific research and are satisfied with the educational value of their participation. So, subject pools seem to be able to serve two interdependent clienteles well: researchers and students.
In order to ensure that the benefits work both ways, Dr. Maurer offers five suggestions:
- the subject pool procedure used in a particular psychology department should be thoroughly evaluated by an external party, i.e. an unbiased REB;
- the subject pool should be run by a faculty member [as opposed to a support staff member, as is sometimes the case];
- students should receive a debriefing form explaining the purpose of the experiment, and it should be approved in advance;
- any alternative to research participation should be equivalent in the effort required and educational value [e.g., U of T’s alternative that students may ask to participate "only as an observer" and be "walked through" the experiment without generating any data];
- data should be collected about the participants’ perception of the effort/benefit ratio.
The use of deception in psychological research grew out of efforts in the 1950s to establish a scientific basis for social psychology. The use of deception not only made possible the observation and measurement of behaviour in a controlled environment, it also effectively neutralized any attempt by the subjects to make what they conjectured was the "correct" response to the perceived stimuli. In order to obtain as natural a response as possible, the subjects were methodically misled as to the actual purpose of the experiment. Repeated empirical demonstrations that subjects’ change their behaviour to fit the experimenter’s hypothesis has led researchers in all branches of psychology to keep participants in the dark about the full purpose of a study – until after the data are collected.
The act of misleading is referred to as deception and has, according to Dr. Maurer, a two-fold meaning: omission and commission. Omission occurs when the researcher deliberately conceals information that is pertinent to the experiment from the subject. For example, the experimenter may conceal the hypothesis being tested, in order to avoid influencing the participant’s responses. This form of deception is considered rather benign. However, there are cases where the omission can be more serious. For example, a serious omission occurs when subjects are told that they are being given alcohol but are kept ignorant about the side effects and, moreover, about the true purpose of the experiment, which is to examine their reactions to these side effects. Commission occurs when the subject is deliberately deceived in order for the pre-selected variable to be properly isolated. For that purpose, the researcher may lie about the purpose of the experiment or may provide false feedback. Commission can be benign,e.g., asking the subject to classify objects, and then giving a surprise memory test in order to test the relationship between classification and later recall. But it often raises troubling ethical issues.
Take for example the social psychology landmark commonly referred to as the "Milgram experiment". This particularly deceptive experimental procedure was developed in the early 60’s as a means to study obedience to authority. The subjects, recruited by ads in the papers, were told that the experiment was designed to measure the impact of punishment on learning. Unknown to these subjects, the assignment of roles was predetermined, so that they always held the "teacher" position, while a confederate 47-year-old accountant always held the "student" position. The "teacher" was instructed to teach the student by applying gradually increasing "electric shocks" for each wrong answer provided. The subjects were told that the "shocks", although extremely painful, would cause no permanent tissue damage. The confederate had been coached to make errors and to react to the shocks according to a fixed script. The subjects were thus deceived about the following facts:
- the ‘victim’ was not actually getting shocked
- the ‘victim’ was actually a confederate
- the subjects could actually quit at any time [which they were led to believe was not the case, since the person in charge of the experiment kept insisting that the subject must continue]
Without a doubt, this type of methodology raises important ethical issues related to respect for persons and to their right to make voluntary choices when participating in experiments. When a choice is based on false pretences, it cannot be said to be voluntary. Another ethical issue is the breach of trust between the researcher and the subject. Many experiments in psychology today include some form of deception, but there is no consensus among psychologists about when it is justifiable and when it is unethical. However, most agree that it is justifiable only if:
- there are no other means of obtaining the desired information;
- the benefits of the research substantially outweigh the potential harm;
- the subjects are given the option to withdraw at any time during an experiment without penalty and are made aware of that option
- any physical or psychological harm is temporary;
- the subjects will be debriefed;
- the procedure to be used is open to public scrutiny;
- the researcher would not be embarrassed if the protocol were on the front page of the newspaper tomorrow.
The ethical issues surrounding experiments like Milgram’s are many-faceted, and do not lead to easy conclusions or generalizations. The principal argument put forth by those researchers who are comfortable with severe forms of deception like this is academic freedom. They argue that deception is a necessary component of psychology research and that as long as the risk of harm is kept to a minimum, there is no infringement of the person’s rights. Any interference with their research, however, would constitute a violation of their academic freedom, since they are being prevented from producing new knowledge.
As for psychologists who do not use deception in their own research, attitudes vary from respect for the professionalism of other areas to pure and simple condemnation. Dr. Maurer notes there is a concern for the effect of deception on the quality of the rapport between the scientific community and society as a whole. But what if simulation or role-playing were used instead of deception? Researchers who use deception argue that there will always be a difference between simulation and real life, and it is the latter that we aim to understand. Dr. Maurer notes that one viewpoint that would be worth listening to, but which is usually absent from the discussion, is that of the confederate. How does the confederate (often a student) feel about playing a scripted deceptive role? One of the articles distributed to our retreat participants described the unease of one confederate.
Another viewpoint absent from most debates is that of the participants who were deceived. The little information available is surprising. For example, in a follow-up study of Milgram’s experiment, the great majority of subjects said that they were glad to have participated in the experiment. (However, their answers might have been influenced by the five-page summary handed out to them prior to the questionnaire, which emphasized the important knowledge that was gained from the experimental results.)
A similar picture emerges from participants in a later version of Milgram’s experiment, in which subjects were given either alcohol or a placebo. The independent variable was the effect of alcohol on the willingness to give shock. The subjects were misled by being told that:
- the focus of the study was the effect of alcohol on pain perception rather than on obedience to authority;
- they were all receiving alcohol, when in fact some of them were given a placebo; and
- the presumed victim was actually receiving real electric shocks, when in fact he was not.
In a follow-up questionnaire returned by 57 participants:
- only 3 said that they were bothered by the deception and only 4 said they were bothered about having to give shocks;
- all 7 of these participants said they were only mildly bothered, and that the distress did not last very long (1 hour or less);
- 3 subjects said that they were bothered by boredom;
- 5 subjects said that they were bothered by having to drink alcohol (although 2 of these had received the placebo) and they remained uncomfortable far longer than those who were bothered by deception, the application of shock, or boredom (on average, 20 hours).
Reactions of people on the street (of Chicago) to deception are similarly benign. When presented with different accounts of Milgram’s experiment, answers to questions about whether a researcher should be allowed to conduct such an experiment, whether such experiments should be federally funded, and to what extent these experiments were valuable, etc. were related to the findings that were described (i.e., whether subjects gave high level of shocks or refused to do so) and not by whether or not the subjects had been deceived about the shocks.
The participants’ perspective about deception is probably influenced by the quality of the debriefing. A good debriefing has the following characteristics:
- it is performed face-to-face;
- it unfolds gradually, allowing enough time to fully explain the purpose of the experiment and what actually happened, and to allow the participant to assimilate the new version of events (dehoaxing);
- it explains why deception was necessary to fulfill the purpose of the study and seeks to restore the relationship of trust between the subject and the researcher;
- it tries to relieve any anxieties about what the subject did or was told (e.g., inflicting painful shocks on the confederate or being told that you have homosexual tendencies) (desensitizing); subjects may be told that their reaction was normal for this situation;
- it emphasizes why it is important not to tell future participants about the deception.
There is little research on the effectiveness of debriefing. One study compared the effect of debriefing on subjects asked to give the "learner" feedback in the form of noise (instead of shock) of any loudness (low stress group) or of increasing loudness, to the point that the confederate complained it was very painful (high stress group). After the subsequent debriefing, the high stress group resembled the low stress group in pulse rate, reported enjoyment of the experiment, and willingness to participate in similar experiments in the future. They exceeded the low stress group in reported arousal, and in thinking they had learned something important about themselves and psychology.
In conclusion, what is to be said about deception? First of all, Dr. Maurer asserts that her own research for this talk made it clear that it is a very complex subject. Deception has many dimensions and it can be used procedurally in many different ways. It cannot be condemned outright; neither can it be condoned. What clearly is needed is better education of psychologists and REBS about the forms that deception takes, their role in different types of research, and the ethical issues involved in each case. In Dr. Maurer’s view, neither the guidelines written by American Psychological Association (APA, distributed in resource kit) nor by the Canadian Psychological Association (CPA) provide adequate education about deception and proper debriefing. It will take a lot of work to create clear guidelines on the use of deception. Moreover, these ethical issues must be addressed during the training process of experimental psychologists.
. Does this type of research on deception require any particular specialization on the part of the psychologists? If so, what is the relationship between this interest in deception and the use of special techniques by intelligence services to obtain information?
We must be reminded that deception comes in many varieties. Probably 95% of psychologists who conduct research on human adults use deception/manipulation in the course of their studies — to discourage the participants from working to support the experimenter’s hypothesis. So, in its broadest meaning, deception is not peculiar to any particular specialization.
Before and during the Second World War, research on deception was conducted by the military, but it did not have a large influence on university research. But, Dr. Maurer does not think that research using deception has been driven by military or government needs.
How valid is the justification of deception as a way to obtain information? And how is it possible that subjects are not bothered by the fact that they have been deceived?
The justifications used by a modal psychologist are three-fold:
- it is the only way to obtain the information;
- there is no permanent harm resulting from deception;
- the validity of the results is compromised when the subject is made aware of the variable that is going to be measured.
Dr. Maurer reiterates that the participants’ perspective does not always correspond to predictions — they often have said that they do not mind having been deceived because it was necessary to answer an important question. However, it would be a mistake to generalize from participants’ statements about particular studies they were part of. It is likely that a participant’s perspective will depend on the quality of the debriefing and the specific type of deception.
Does section 2.4 of the Policy Statement on justifying REB’s use of partial disclosure or deception give enough room to really allow this type of research? How much more is there to be learned from this method?
This section is likely to evolve over time. A lot depends on the meaning we ascribe to deception and partial disclosure, and whether omission is included in the meaning of deception. Is there more to be learned? Yes, there is more to be learned from studies using deception. For example, it is very important to learn the conditions under which reports of early memories are credible, but it would alter the subjects’ behaviour to let them in on key details of the experiment, and would therefore compromise the scientific value of the study.
If the Milgram study were done today, would it be approved by most REBs?
Dr. Maurer has also wondered about that and felt unsure how to answer that question. She hopes that it would not be approved.
N.B.: Dr. Derevensky notes that when the Milgram study is taught at the University, the ethical issues are seldom discussed. People interested in the Milgram study usually focus on its results. If ethics is not practised and taught, and if the Milgram study were reduced to the factual data it yielded, the ethical issues would not be absorbed by students.
Dr. Maurer agrees that there is a need for better ethical education of experimental psychologists. For example, almost everything she knows about ethics she learned through osmosis from her supervisor.
Professor Dorothy Counts
Professor of Anthropology, University of Waterloo
Dr. Counts introduces her lecture by acknowledging the co-operation of fellow anthropologists, whom she asked for suggestions on specific ethical concerns she should address at this retreat. Her presentation attempts to summarize their feedback, but she also draws attention to some of her own concerns. It would be surprising not to find an ethical component in any undergraduate or graduate anthropology program. Ethics is intimately linked to anthropology research. Because of the way anthropologists do research, they are perhaps more concerned with teaching ethics to their students than other disciplines are. Dishonesty can always be unearthed, and when it is, not only is the researcher’s credibility on the line, so is the anthropology profession.
It is important to be aware of the fact that the ethical challenges anthropologists have to face depend on characteristics typical of anthropological research – two of which will be discussed here:
- Long-term based research
Participant-observation is a procedure whereby the anthropologists actually live with the people they are studying and participate fully in their daily life. Some anthropologists are even brought into the kinship system of the community in which they work. By being given a particular social standing in the community, they take on certain obligations toward their kinship group and they are also entitled to the rights of this group. In short, there is a reciprocal understanding between the researcher and the community with respect to rights and responsibilities. The researcher is, therefore, expected to give something back to the community in exchange for its participation in the study. An example of this is Dr. Stan Barry’s research (University of Guelph) conducted on a neo-Nazi group in southern Ontario. The group accepted his presence among them and allowed him to collect information, but their condition was that his research constitute an attempt at providing reasonable explanations for their socially unacceptable behaviour. In their view, knowledge is the first step toward dialogue. They believe that they are being ostracized simply because of society’s ignorance.
As for the long-term quality of anthropology research, Dr. Counts asserts that it is recent and common. When she started her fieldwork in 1966, few people had done long-term research. Among the colleagues she has known for a decade or so, most have made two or more extended field trips back to the communities they have studied. An anthropologist’s research implies a long-term relationship with a community of people. Like any healthy human relationship, it calls for respect and empathy.
Anthropologists have opened up numerous areas of research all over the world and the research setting is very naturalistic. In an earlier draft of the Policy Statement, we defined this naturalistic setting as: "[g]enerally not perceived as established for the sole and primary purpose of conducting research". The immediate consequence of this setting is an environment in which all participants share control, in contrast to its being controlled solely by the researcher. This in turn sets the scene for unexpected and unpredictable variables and events. Dr. Counts recalls travelling to different communities with the intent of building a repertoire of legends and folk tales. Because of an unforeseen situation that put the research team at risk, they instead conducted completely different research at the request of a community that was involved in domestic violence. This raised several questions: What were the researchers to do? Were they to miss out on this wonderful opportunity and go back home because their original ethics protocol was no longer relevant? Needless to say, a naturalistic setting and long-term research require a good deal of flexibility on the part of anthropologists who want to conduct research successfully.
What are the ethical principles anthropologists agree on? Two fundamental principles are:
- the research being conducted should not do any harm and, if possible, should have a positive impact;
- clandestine research should not be conducted.
While the principles in themselves appear very simple and straightforward, the problems start when interpretation comes into play. What does it mean "not to do harm"? Usually, an anthropologist will grant "no-harm" priority to individuals over groups. But as Cynthia Keppley Mahmoud’s article1 shows, the desire to fully understand a community sometimes implies witnessing acts of violence which should not be condoned. Still worse, even though anthropologists do not mean for harm to occur as a result of their research, it may take place unpredictably. A good example of this is the event that led to the first ethical statement by the American Anthropological Association. In the early 70’s, a group of anthropologists set out to do some research in Thailand. Permission was granted by government authorities to conduct such research, but only on the condition that a certain kind of apparently innocuous data be collected and deposited in their hands afterwards. Little did the anthropologists know that the data they had gathered would end up being used by the military –Thai and American – to bomb villages, poison water supplies, and execute leaders. Are there any ethical guidelines in existence that might prove to be helpful in this kind of situation? One of them is to take appropriate measures in order for the data not to end up in the wrong hands for the wrong reasons, even if this eventually means cancelling a particular research project.
What about the claim that research ought to have a positive impact? This is difficult to measure. It does not necessarily follow immediately after the research that good has been done, as it does not necessarily result in commensurable wealth. The repatriation of culture is one of these intangible goods. But then again, the situation can be very complex. It may be the case that a particular community, for reasons of honour and dignity, does not wish for the various data collected by anthropologists to be rendered public in their midst. The preservation of anonymity entails another kind of ethical problem and also has its adverse effects. Anonymity, in itself, does not constitute an absolute means of securing sensitive data. There are unimaginable ways to find out what one really wants to find out. When it comes to the principle of harm/good, anthropologists must make themselves aware of the many possibilities – however unlikely – of a terrible discrepancy between their initial intent and reality. Thus folklorist Bruce Jackson rightly warns: "think what use might be made of this material later, think how you would feel if your words were used that way, and then decide accordingly. If your material includes things that might harm people, then you should not be depositing it in an archive over which you have no control". The anthropologist’s ethical responsibilities stretch over time.
The principle of no-clandestine research states that everyone must know who the anthropologist is, why the research is being conducted and how it is going to be done. Here is an excerpt taken from the pledge made by the Society for Applied Anthropology:
[T]o the people we study we owe disclosure of our research goals, methods and sponsorship. The participation of people in our research activities shall only be on a voluntary and informed basis. We shall provide a means throughout our research activities and subsequent publications to maintain the confidentiality of those we study. The people we study must be made aware of the likely limits of confidentiality and they must not be promised a greater degree of confidentiality than can be realistically expected under current legal circumstances in our respective nations. We shall within the limits of our knowledge disclose any significant risk that may result from our activities to those we study.
Lack of disclosure never pays off and any serious breach of trust will most likely result in the impossibility of conducting the research any further, and in the researcher’s eviction from the community. A serious breach of trust may even put the researcher’s life at risk. But even without having to go this far, serious problems may arise out of the study of a community. Working on the Tri-Council Policy has made Dr. Counts aware that legitimacy is problematic. There is a need to clearly determine who has the right to speak in the name of a community and who has the proper authority to give permission for an anthropologist to study a particular community.
She cites the case of an anthropologist who agreed to help a community deal with political disputes involving the provincial authorities, specifically at the request of this community, and who travelled to Papua New Guinea with a tourist visa because her research application was denied by the provincial officials. Upon learning of her activities with the community, the authorities expelled her from the country, prohibited her from returning, and placed a moratorium on anthropological research for an indefinite period of time. This incident had a negative impact not only on her career, but also on other anthropologists who worked in Oceania. Finally, the authorities censured her. Of course it was a clear case of clandestine research. The government authorities had a right to know of her research activities. But it does not mean that they can rightly presume to speak for the local community with which the anthropologist wanted to work. Researchers are expected to respect the political rules of the host country, but what if the political is unethical?
What is to be deduced from all of these considerations? First, real life provides ample room for the two fundamental anthropological research principles: do not harm; do not conduct clandestine research. Second, anthropological research is definitely characterized by its nativistic setting and the resulting relationship between the researcher and the communities that are studied. Here are Dr. Count’s concluding recommendations:
- Anthropological research projects should be evaluated by peers. Even researchers in other disciplines who plan to do participant-observation type of ethnographic research should consider asking an anthropologist (officially or unofficially) to review their procedures with regard to ethical considerations
- Research projects should put forth concrete means of ensuring the no-harm clause and securing the benefit clause as well as the means of ensuring the no-clandestine principle
- Researchers should be required to demonstrate the existence of permission from relevant authorities to do research. In the absence of relevant authorities, researchers should demonstrate how they would let the communities in which they intend to work know about the work and how they can get feedback.
In your opinion, how necessary or useful is it to draft a common ethical policy for two disciplines that are as closely related as Psychology and Anthropology? If necessary, how can this policy deal with the fact that deception may be required in psychology while dishonesty is unethical in anthropology?
While the SSHRC guidelines for research with human subjects had worked well for anthropological research and were approved by the CAA, it is not clear that the Tri-Council Statement will suit the requirements of anthropological research – which is characterized by unique procedures. This may explain some of the tensions underlying the new Tri-Council Policy Statement. Psychology and anthropology are quite different disciplines; hence, their ethical problems are different. It is too simple to regard research ethics issues as overlapping between human and social sciences and bio-medical sciences. This is because the ethical issues vary even within the human and social sciences.
Is there a time limit on the control of the data by the group that is being studied? If so, at what point does the community lose control of the data?
There is an increasing attempt, as people become literate, to submit the content and conclusions of the research to the community for feedback. The ability to reach this level of co-operation varies with the level of access that the community has to the information, as well as with the ability of the researcher to translate the information into their native language.
Prof. Chris Armstrong,
Research in Business and Economic History (buying and selling securities)
Why do historical researchers routinely ignore ethical guidelines for the use of human subjects?
Professor Armstrong begins by citing some questions sampled from York University’s research policies. Some questions are focused on the profile of participants, i.e. age, gender, social status; others are oriented more toward methods, e.g., what the participants will be asked to do, location of study, stimuli, material. Researchers are expected to provide precise answers.
Human subjects represent a broad spectrum in terms of age, social status, etc. Prof. Armstrong once received a grant from SSHRC to investigate the history of the evolution of the securities market in Canada from the late nineteenth century to 1980. When he began his research, he found that a number of individuals who had been important in the securities market in Canada mainly in the period since the second world war – as stockbrokers, lawyers, civil servants, regulators, etc. – were still alive. He then contacted and interviewed some of these people. An 84-year-old man who had been a regulator and stockbroker was interviewed, and he provided a number of historical photos. In return for having agreed to be interviewed, the man was shown the chapters where he was mentioned in the book.
Prof. Armstrong mentions one of his doctoral candidates who is working on the impact of hydroelectric projects on the native Cree population in Northwestern Ontario. According to Prof. Armstrong, the doctoral candidate ran into trouble in his quest for support for his research when he responded to a questionnaire from the Faculty of Graduate Studies.
He neglected the section on human participants, so the Faculty of Graduate Studies returned the questionnaire with instructions to fill out the area he had missed. Prof. Armstrong then had to sign a declaration stating the following: "I and the other two members of the supervisory committee, in our opinion, believe that the research for the above-named dissertation as outlined in the proposal represents minimal risk to the research participants". Prof. Armstrong mentions another doctoral candidate who had been conducting research on the late nineteenth century and who then decided to write a historical study of the chain donut store.
When he changed his dissertation topic, he began to interview people at donut shops; however, he did not do anything about filing the human participants review questionnaire, even though he had been reminded several times.
Why do some historians routinely ignore ethical guidelines governing the use of human subjects? When historians deal with written, oral or pictorial evidence about historical figures, they view them differently from the way that the social-human scientists and the medical scientists view their experimental subjects. Historians do not use the term "subjects"; they refer to people whom they write about as "objects". The a priori understanding is that they are not "vulnerable". Interviewees always have the right to specify the information they are willing to share and that which they do not wish to be publicized. Under cross-examination by a well-informed historian, they can handle themselves. Of course, part of the game is to get the participants to admit things that they might not otherwise want to. But this can be done at minimal risk for participants.
Historians also hold a different point of view on privacy. The right to free access to information seems to infringe on the right to privacy. Under the Privacy Act researchers are not allowed to reveal certain private information without signing an agreement saying that they will use it only with personal identifiers removed. The problem is that privacy regulation mandates the obliteration of personal identifiers for certain kinds of information and even mandates the destruction of records. The result is that a very low percentage of information is left to consult. According to the Canadian National Archivist, Canada retains approximately 5% of records generated by the federal government. In Sweden, the percentage is much higher. Historians generally assume that the only way to get at the truth of events is through archives, documents, letters and interviews. From this point of view, privacy is perceived as an obstacle to truth. For example, Statistics Canada takes the view that the manuscript census returns – which represent a particularly valuable source of information about Canadians – should be closed for a period of 100 years and only opened after one’s death or, alternatively, they should be closed forever. This creates a real problem for historians of western Canada interested in the socio-economic analysis of the European immigrants who first arrived in western Canada only in 1911. What this means is that research into this population can begin only in 2011. But there are pressing considerations for unearthing this information sooner.
The copyright law is another obstacle for historians. It gives rise to privacy concerns, as well as the ethical use of information. Suppose a researcher is the recipient of a response-letter from an interviewee. It is not easy to determine precisely how much or how many of this person’s ideas the researcher is allowed to reproduce. While the academic community has neglected the relevance of these concerns, historians are rather rebellious about them and most feel that guidelines are not relevant to them. But it is not clear that we should leave oral history and the use of historical documents solely to the practitioner’s judgement.
To summarize: historians generally display a sceptical attitude about the notion that the kind of revelations that are made can be regarded as a serious invasion of personal privacy or that they pose a real risk to the well-being of the subjects involved. Thus, Prof. Armstrong makes the following suggestions:
- REBs should include people from a number of disciplines. If more people were involved, then REBs might be taken more seriously;
- General guidelines should be drawn to create consensus rather than detailed guidelines that try to account for every possible problem arising out of every discipline.
Does the broadening of guidelines imply that historical research should not be considered as research? If so, can historical research legitimately avoid REBs?
Historians are quite simple-minded about what constitutes research. In the past, research methods were relatively unproblematic, because historical research meant going to archives and reading documents. Technology has made issues much more complicated: tapes, sounds, and images are now part of what we take as historical evidence. A subjective approach may be preferable to an objective one. In other words, it is much easier to define what a researcher is than what research is. A researcher is someone who, on top of consulting historical evidence, is trying to come up with intellectually defensible generalizations about them.
Chair: Fernand Roberge,
Executive Committee, NCEHR
Professor Jeffrey Derevensky
McGill University, Department of Educational and Counselling Psychology
he first characteristic of educational research is that it is relatively new in Canada. This novelty is the product of a dramatic shift in our perception of the role of the university teaching profession. In the past, professors were master teachers, very practically-oriented people whose main concern was to teach how to teach. This pedagogical aspect is still very important, but university teachers are now more interested in research, processes and applications. Another characteristic is its low-cost factor. Most educational research being conducted today is not funded because it is mainly conducted in classrooms. This raises particular ethical issues. The concept of "client" is somewhat obscure from an educational perspective. Prof. Derevensky believes that more attention has to be paid to these issues, although he is certain that few of his colleagues value the ethical aspect of doing research. Another ethical issue arises when the findings of the researchers are inconsistent with the policies of the school boards. Should the results be made public? Most of Dr. Derevensky’s colleagues feel that they do not do any harm, that going through an REB is an annoyance, and that it is insulting to be questioned about their research. Many feel upset when an incomplete ethics form is returned to them by an REB. Typically, these forms are returned because the committee feels that the form does not convey sufficient detail to allow the parents to give informed consent. Most educational researchers do, however, have a commitment to the individuals being studied and to their needs. Even those who do basic research firmly believe this.
The premise underlying educational research is that research ought to be done for the pursuit of knowledge. This pursuit of knowledge can be done in terms of either basic knowledge or applied knowledge. In the educational sphere, this alternative is, however, controversial. Most school boards do not favour basic research. If they perceive that there are no applications directly ensuing from this basic research, they will not allow it on their administrative territory. The other problem is the balanced relationship between the money invested for research by school boards and the benefits of the research. Schools always ask how long this will take. Another premise is that informed consent is based upon an understanding of the issues involved and the potential risk. When children are asked to give their consent, we must ensure that they understand the implications, even if the parents are asked to sign the consent form. The rights of the individual to privacy, confidentiality and anonymity are assumed. Researchers also have an obligation to the population served. There are also particular constraints related to educational research. The first is the obligation to ask for parental consent when the research requires participants still in their childhood or adolescence. The researcher must ensure that the parents who agree to allow their child to participate in the research form a representative sample of all parents.
Another concern is the general scope of the findings. In the United States, educational research is exempt from ethical review if it is conducted in established or commonly accepted educational settings involving normal educational practices such as:
- research as regular and special educational instruction strategies;
- research on the effectiveness of, or comparison among, instructional techniques, curricula or classroom management techniques.
In these settings, there is no need for REBs or for parental consent. This raises the objectivity of such research. Do teacher researchers have the necessary objectivity to look at the results in an effective way? Do they not have vested interests? Many educational research studies have shown that when curricula innovation is done using volunteer teachers, the five or ten teachers selected from a school to evaluate the effectiveness of the curricula normally find positive results. When the study is duplicated across the board, the results are far less promising. Once the program is applied on a larger scale, other teachers are neither as keen nor have the same support systems, nor do they have the same instructional intervention. The ethical issue is that this setting opens the door to all kinds of over-generalizations based on a selective, unrepresentative sample of volunteers who participate in the study.
There are much less restrictive guidelines found in educational research than in other disciplines. While everyone agrees that there should be a letter of consent for children under 18, few pay attention to the intelligibility (what language should be used?) of this letter or its accuracy. It is unethical to authorize and conduct methodologically unsound research. Dr. Derevensky, therefore, suggests that in addition to ethical issues, scientific issues should be addressed. In order to do so, he recommends that parallel committees be set up in conjunction with REBs to evaluate the scientific merit of research projects.
There also remains the vast problem of anonymity, which, on the practical level, means adequately storing the audio/video information gathered during research and determining its ownership and usage. Is the data re-useable by further educational research? If so, must parental consent be obtained again? Usually government agencies provide the necessary research funds, but many researchers get their funding from outside agencies and gambling institutions (e.g., Loto Quebec, which is youth-oriented). In that case, who owns the data and who should be able to use it? Can the data be reported to the media? What control do researchers have over what is reported? What about sensitive issues and vulnerable groups?
Educational researchers, REBs and school boards are particularly sensitive to childrens’ safety. Some studies require strenuous physical activities on the part of children. How do we ensure that no harm is going to be done to them? If their participation results in absence from the classroom, what is to be done with the children who are not allowed by their parents to participate? If a regular classroom day were in store for them, would it not appear as though they were being punished?
All of these research ethics problems are endemic to the educational setting, and there are no clear and definitive answers. According to Dr. Derevensky, educational research also falls into a grey area from the point of view of science. He, therefore, strongly recommends that REBs be reinforced with a science component. As for school boards, they need to become more acquainted with research ethics guidelines and should be given assistance in generating guidelines for research. Finally, it is important to stress the need for researchers to engage in both basic and applied research in schools, because the former generates material for the latter.
A subject that often comes up in public health sciences is the problem of determining whether research interferes with the time specifically allocated to normal activities. Is this problem encountered in other disciplines? If so, is it necessary to obtain ethical clearance?
Indeed, this represents a contentious issue that has to be addressed by the school boards and by educational researchers. At McGill University, it is mandatory for graduate students to include the ethical clearance form –signed by the faculty REB – in their dissertation. This issue may not seem important for graduate students who may reply as follows: if the school boards are unconcerned about interference with normal activities, then they [the students] have no reason to be concerned. Obviously, there is a need to foster closer contacts with school boards.
How is it possible for an educational researcher, who is conducting research in a classroom, not to observe the children whose parents did not sign the consent form?
Observational research undoubtedly raises very complex questions to which there do not seem to be any definitive answers. This methodological issue is currently being discussed with various REB chairs. To date, there is no scientific review committee. Many researchers are convinced that their research will not cause any harm and, consequently, they feel that REBs constitute an annoyance. This is bound to worsen should the REBs begin to examine the scientific value of research. Another concern often expressed by researchers is the amount of time "wasted" on ethical and scientific clearance. It is both interesting and important to address these issues at the University level, but probably even more important at the school level – in order to provide these schools with the expertise necessary to deal with some of these ethical questions.
Children and parents are, and always have been, vulnerable in relation to educational research. Given that studies eventually translate into changes in educational programs, would you agree that children and parents have become increasingly vulnerable to various political agendas?
Yes, it is definitely the case. If a school board decides that pedagogy X is no longer desirable, parents and children alike have really no option but to settle for new pedagogy Y. But researchers may be vulnerable as well. It may be that their findings are inconsistent with the policies of the schools. Even if the researcher agrees not to publish any of the data, it is still available in libraries and, consequently, readily accessible for anyone to consult. Consultation may even lead to opportunities for publication. However this may put researchers in an awkward situation; that is, school boards may prevent researchers from entering schools.
What is the difference between funded and unfunded research?
The methodological design of funded research (whether it be MRC, NSERC or SSHRC) is always strictly evaluated. However, SSHRC, while ensuring that an ethics certificate has been issued by the University Research Ethics Committee (UREC) for a particular research project, does not verify the suitability of the consent form, nor does it ensure that the child can withdraw from the study at any time without retribution. SSHRC assumes simply that the REB is meticulous in evaluating the various aspects of the research project. But not all research is funded. Unfunded research typically does not have this review process in place.
Business and Management
Professors Terri Lituchy and James Jans,
Although Dr. Lituchy graduated from the University of Arizona Business School, her academic activities are very closely related to social research. The purpose of her presentation is to describe the ethical issues that ensue from various kinds of business and management research.
Commerce research is normally concerned with stock markets, the effects of economic changes on the value of RRSPs, and various investment oppor- tunities. It is concerned also with risk-taking in relationship to decision-making and its impact on manager’s remuneration. As for marketing research it is focussed on sales, advertising, and consumer behaviour. Management research deals with organizational behaviour and human resource management – two areas closely related to psychology. For example, research projects will address questions like motivation, stress, shift work, as well as psychological issues at the individual and group levels – all within an organizational setting. Sometimes, management research wears a sociological hat and addresses issues like strategic-level planning, privatization, and small-business planning. Management Information Systems is concerned with questions, that may, as well, have some applications to computer science, i.e., Internet, intranet, competing software packages. These tools aid managers in decision-making. In Production and Operations Management (POM), interests are akin to engineering interests. POM is concerned with designing jobs, and exploring ways of designing furniture used in offices. Human research participants are involved neither in finance nor in accounting research. However, some of the research projects have included interviews, surveys and experimental components. But there is a lot of human research in Marketing Management. Business often overlaps with other areas, i.e. social sciences, engineering, medical science and security (RCMP). Research projects usually require that human subjects participate in surveys, questionnaires or interviews. Management frequently has recourse to simulations and role-playing to find out just how user-friendly certain products are.
According to Dr. Lituchy, people in business schools do not seem to be too concerned with ethical issues. They assume that their research will cause no harm, coercion or deception. For example, she knows of someone from a university finance department who claims never to have had a problem with the ethics committee. Yet, this person had being going into classrooms to ask students to participate in a study. Clearly, this constitutes coercion. One of the statements from this researcher’s consent letter leaves little doubt as to the presence of coercion:
[t]he research will not be conducted as part of the course, although a small amount of class time (10-15 minutes) may be used to solicit student volunteers.
Spending 10 to 15 minutes for the sole purpose of asking people to participate in a study seems excessive. Researchers have also been interviewing senior managers from different government levels without obtaining a written consent from them, simply because they do not feel it is necessary under the circumstances. But research ethics committees clearly believe that it is necessary.
Business and management faculty members generally have a problem dealing with ethics committees. They feel that members of ethics committee who are not part of business schools do not understand the special conditions of business research. One may argue that this is not true only of business schools; other faculties have voiced similar complaints. One particular ethical issue in business research is the definition we attribute to "end of study". When the consent form states that participants can withdraw from the study at any time, does it mean that they can reclaim their survey answer sheet even after they have sent it? Or does it mean that they can withdraw any time before the survey is completed? It seems reasonable to claim that if the data can be readily retrieved – i.e. if the surveys have not yet been coded and computerized – then a participant uncomfortable with the survey should be allowed to withdraw from the study. But this kind of practical reasoning does not take into consideration the promises made by the surveyor in the consent letter. If anonymity is guaranteed to the participants, then the questionnaires cannot under any circumstances be returned to them, since the absence of identification tags on the questionnaires prevents the surveyor from determining the identity of the participant. (One may note, however, that since the sender’s fax number always appears on the fax sheets, the sender’s anonymity is seriously compromised). The principle behind this reasoning is that participation ends when what is required of the participants has been completed. Once the questionnaires have been filled out and returned, the subjects’ participation in the study is officially ended. The research, however, is not completed until the research is published.
Another interesting problem is how strongly it should be stressed that the participant may withdraw at any time during the study. Psychology, exercise science and education researchers argue that it should be strongly stressed. Business people, however, think that the right to withdraw is quite obvious and need not be stated. In their view, they are dealing with adults (most of them CEOs) old enough to decide whether or not to fill out a questionnaire and whether or not to send it in the mail. Why should it be specified that they are allowed to ignore the questionnaire and throw it in the garbage if they so wish? But SSHRC has always emphasized that written consent which unequivocally allows withdrawal is preferable, and that oral consent should be obtained only in extraordinary circumstances. These extraordinary circumstances, which may be uncommon in most disciplines, seem to be very common in business research. For example, a business researcher found it difficult to obtain signatures from business owners representing minority groups. They would agree to be interviewed and even taped, but they would refuse to sign their name even when reassured that it would be kept confidential. Given the fact that they are very protective of their anonymity, it seems that if their right to withdraw were too strongly emphasized, then they would simply refuse to participate. Some researchers accept minimum requirements put forth by ethics codes, i.e., the right of participants to withdraw should be simply stated.
One last problem is whether or not the cover letter should mention anything about the source of funding for the study. Knowing that a study is funded, people may feel somewhat pressured to take part in the study.
Overall, people in the business schools feel that the nature of their research is not properly understood by REBs. This makes them feel unduly persecuted. It appears that ethics committees are perceived strictly in terms of their thoroughness, and rarely in terms of their wisdom – which is to contribute to the quality of the research. Can we solve these communication problems? These problems cannot be explained simply by the plurality of academic backgrounds; rather, the overriding factor is that business researchers seem to have a reductive understanding of the term "scientific research". Therefore, business researchers do not consider their activities as having anything to do with ethical guidelines applying to scientific research on human beings. This is why it is vital to introduce the new Tri-Council Policy Statement into business and administration research. With this common policy, nobody will be able to opt out of ethical obligations simply because they feel "it does not really apply to them".
Is there any attempt to educate graduate business students about the ethical aspects of research relevant to their field?
It has become a part of the teaching in almost all programs, so that undergraduate and graduate students are exposed to the need to incorporate ethics into research. In business schools at the undergraduate level, there are specific courses in ethics that are mandatory. In addition to these specific courses, ethics is integrated into management, marketing, finance, and accounting. Research ethics, however, is not part of the curriculum at the graduate level; but students learn to fill out research protocol forms in order to obtain an ethical clearance certificate.
Spokespersons from the various working groups shared the results of their deliberations in response to the following issue:
How should we reach out to the various communities for education purposes?
|Group One: Janet Storch, spokesperson
||NCEHR’s mandate in its educational role has to be clearly established:
||This mandate has to be understood and agreed to by scientific communities;
||NCEHR’s legitimacy and capabilities have to be recognized by scientific communities.
||NCEHR’s key role should be to market the Tri-Council Policy Statement;
||In co-operation with disciplinary boards and professional bodies, NCEHR should develop and disseminate more educational material regarding ethics and research ethics education;
||NCEHR should establish connections with, and educate, REBs across Canada.
|Group Two: Joseph Kaufert, spokesperson
||It should be communicated to research communities that rather than being "carved in stone", the Tri-Council Policy Statement is an evolving document that does not replace discipline-specific guidelines. The Council must recognize that more specific codes dealing with methodological and ethical issues unique to some disciplines will continue to be needed.
It must also be recognized that stakeholder communities, such as First Nations, have developed and will apply their own codes and guidelines. These documents may provide the frameworks for decision-making. Collectivities, including First Nations will increasingly be the "gatekeepers"in the conduct of research.
||Our journal Communiqué and our web site should continue to be our communication tools; but other means such as sponsorship of initiatives to work with stakeholder communities in interpreting the Guidelines are important. Regional workshops may be one mechanism for communicating information about the Guidelines.
||In order to give the site visits an educational value, an appendix with supporting materials should be added to the Tri-Council Policy. A database could be used to provide a sense of process that would allow researchers to understand the evolution of the document.
|Group Three: Kathy Glass, spokesperson
||In order to promote acceptance of the Tri-Council Policy Statement, the three research councils should send letters to all university presidents and vice-presidents of research, as well as to other concerned communities, supporting the Policy Statement;
||In order to accomplish our mandate, a registry should be developed which would provide detailed information about the communities that NCEHR will serve;
||NCEHR should provide assistance to REBs that are experiencing difficulties in solving a particular problem. Also, they should set up a communication network to allow people to share their experiences and discuss solutions to problems and conflicts.
|Group Four: Carole Guzman, spokesperson
|NCEHR should be a link between the research Councils and the Learned Societies, or between the Councils and the universities.
|Group Five: Daphne Maurer, spokesperson
||Given the fact that NCEHR is involved in the implementation of the Tri-Council Policy Statement, there should be some kind of co-operative approach involving the granting Councils and NCEHR.
||NCEHR should have higher visibility.
||It must be determined whether NCEHR is going to assume a leadership role or a counselling role.
||The ethical issues raised by research with human subjects should be brought to the attention of not only university officials and REBs, but of researchers themselves through their professions, Learned Societies, CAUT etc.
||In order to remedy NCEHR’s credibility issue and the "you don’t understand us" reaction from some researchers, it is recommended that leaders from the affected disciplines be asked to contribute to the design of the educational package.
Implementing and Monitoring the Ethics Review Process: Issues and Challenges
Chair: Carole Guzman,
Chair, Communications and Education Committee, NCEHR
he main purpose of the retreat was to get the participants to develop ways of implementing the Tri-Council Policy Statement. Dr. Bernard set forth a number of challenges, but also opened an exciting window of opportunity for us, which has made us aware of the uniqueness of Canada’s initiative in building an interdisciplinary policy. This pioneer work may eventually enable Canada to assume a leadership role in research ethics. We heard various concerns particular to the social sciences. During the break-out sessions we were given opportunities to share our views on the educational role of NCEHR, and what strategies should be used in promoting the Tri-Council Policy Statement. The time has now come to think about how the Policy Statement should be implemented and monitored.
Who reviews the reviewers? Issues in implementing
Dr. Gordon Crelinsten,
Chair, Evaluation Committee, NCEHR
A few years ago in Montreal, a research subject died while undergoing a low-risk, non-therapeutic intervention that had no potential benefits to him. The project and the information disclosed in the informed consent process were reviewed and accepted by a research ethics board in a Montreal academic teaching hospital. When this case was subjected to the scrutiny of the law, a court found the REB negligent in accepting the protocol as presented. Although extremely rare death was known to occur with the proposed intervention, disclosure of this risk was not part of the informed consent process. The court felt that a reasonable person being asked to participate in non-therapeutic research with no personal potential benefit should be made aware of all serious material risks, no matter how remote or how rare, in order that true informed choice could occur.
Research involving human subjects is a special privilege granted by society and carries with it an awesome responsibility to ensure the safety and well-being of the research subject. The importance of such research is rooted in the recognized need to advance knowledge. The REBs are charged with the duty of objectively evaluating research protocols with respect to recognized research ethics guidelines, principles and criteria. Research is not without risk, not only to the health and safety of the individual, but also to the protection of confidential information, and to the beliefs, customs and social structures of collectivities. It may also present a risk to the personal and professional integrity of the investigators and to the social good in general. Because of the complexity, importance and responsibility of the task, it is appropriate to ask: who reviews the reviewers? We should be able to address this issue better once we answer the following questions:
- Why is the question important?
- What does a recent snapshot of Canadian research ethics review show us?
- What models exist that allow us to establish conformity of review or rules for review?
- Where do we go from here?
Why is the question important? The research enterprise in Canada is a growing concern. The quest for new knowledge, the development of skilled and inquisitive research minds, the need for the development of new techniques, new technologies and new pharmaceuticals have spawned research efforts at academic and commercial sites across this country. Each protocol requires review, and the increasing demands on time and personnel are immense. Not only is there a cost to ethics review, there is also an expertise demanded which cannot be assumed to be intrinsic to the person, but rather requires knowledge, skill and training. Research ethics boards are composed of individuals who are required to interpret the ethical, to an extent scientific, appropriateness of research. Society places an emphasis on accountability of human interaction. It seems just, therefore, that the effectiveness, efficiency and conformity of individual Research Ethics Boards be open to scrutiny.
Here is a snapshot of the functioning of research ethics boards in 16 Canadian faculties of medicine, based on a three-year study conducted by NCBHR’s Working Group on Evaluation. In most institutions, there were multiple REBs. In one institution, more than 30 were identified. In general, communication among REBs was poor; in some, it was nonexistent. The sharing of experience can be important in the field of ethics because, frequently problems identified by one REB have been solved or at least faced by another. The mechanisms for recording REB activity, for appeal of REB decisions, for reviewing multi-centre trials and for the evaluation of the merits of competing protocols varied widely within and across institutions. The composition of REB membership and the availability of education protocols for investigators and REB members also varied widely. Most importantly, the interpretation of certain aspects of research guidelines was highly varied. Active monitoring of on-going research was glaringly absent.
Are there any models that may allow us to establish conformity of review or rules for review? One example is a document entitled Reflections on Monitoring Ethics Review of Research with Human Subjects in Canada, produced by Louis-Nicolas Fortin and Thérèse Leroux at the request of NCBHR. An informal site visit can help detect strengths and weaknesses in a system, but it still is a weak review. On the contrary, the Canadian Council of Animal Care has established an assessment program based upon the mechanism of predetermined mandatory site visits within a formal framework of review. The advantage of this system is that it allows the development of strict and consistent criteria that can be tested and assessed for compliance. A system could be devised similar to that used to accredit health institutions. Such a system provides established evaluation procedures, whereby an institution is granted a certificate attesting that it meets predetermined criteria or standards. This accreditation system also needs to be recognized by scientific communities.
The US model is prescriptive: it enforces respect for rules and regulations and thus grants investigative powers and functions as well as the ability to impose strong and binding sanctions. The future and what it holds for society demand a renewed recognition of the place of ethics and ethics review in all disciplines conducting scientific inquiries involving human subjects. This recognition would call for a system of ethics review that is helpful, resourceful, efficient and effective, based on consistent knowledge and values, and is accountable and open to review and audit.
How can this be achieved? Research ethics boards must realize that governments, granting agencies and the public are increasing their demands for accountability in all aspects of social behaviour. This includes research. There is a need for performance measurement, outcome analysis and the creation of standards. The first level of review resides within the individual REB itself. The REB needs to have accurate, relevant, and clearly defined data, which represent its activities and can be used to measure and evaluate its performance. This can be accomplished only with the establishment of performance indicators that would serve as a guide to monitor, evaluate and improve the quality of ethics review. As an example, the ability to recognize adverse effects of research promptly and the ability to introduce corrective measures may be evaluated. If individual REBs are truly committed to the task of ensuring the safety and well-being of the research subject as well as the promotion of good science, then structured standards may be helpful to ensure that these goals are being met. A standard is a statement of good practice that allows for compliance evaluation. It represents requirements that must be met and it aims at the realization of values. Here are some examples of standards developed by clinical ethics boards in hospitals that could very well be applied to any REB:
- The functions of a hospital ethics program (REB) are clearly defined by a mission statement and/or written policies.
- The REB’s structure and operating rules as defined by the mission statement and specific policies ensure fairness and accountability to those who use the services of REBs.
- An REB evaluates and reviews its services. Every ethics committee member within an appropriate time frame, e.g., one year, completes the education necessary to function as a knowledgeable and effective member of the committee. Each member participates in a program of continuing education to maintain current knowledge and skills.
- REB members are taught by designated teachers who must have the appropriate knowledge and/or training in the area in which they teach. These teachers must also demonstrate their ability to teach in these areas.
The time for a laissez-faire approach to ethics committees is long past. Some form of regulatory supervision is to be expected because the activities of ethics committees are increasingly brought to bear directly on peoples’ rights. This regulatory supervision enables REBs to continue in the kind of decision-making that values and protects human dignity and freedom. The Tri-Council Policy Statement can be regarded as a series of peer-created standards, which may serve as an excellent framework for the consistent evaluation of REB performance. It could also be used by local REBs to adjust and create their own standards against which they could be evaluated. The advantages of using a national policy cannot be ignored:
- It is economical and saves energy.
- It provides access to standards that have been successful in the past.
The disadvantage of using a national policy is that it may, at times, lack relevance to local circumstances, which may cause this policy to lose credibility and commitment. Therefore, the REB has to be creative and set standards that are grounded in socio-cultural values.
The most successful approach to setting standards normally involves a careful and considered combination of theoretical and practical experience. Published guidelines provide a theoretical foundation, and practical experience can be gained by working in REB environments.
The question "Who reviews the reviewers?" is important for REBs. REB members are involved in a serious business that demands excellence and accountability. REBs should be self-critical and accepting of peer scrutiny.
How can one prevent the quantitative bent from taking over?
The standard is not necessarily quantitative. For example, the institution’s ability to have a built-in conversation and the level of dedication and commitment on the part of REB members can only be measured qualitatively. How are we to do this? Perhaps we could rely on a structural standard as opposed to a function or outcome standard? A formally standardized group of lay people and experts who are interested in dealing with these issues and who are always available may be able to implement these qualitative measurements. The Tri-Council Policy Statement (and other guidelines or practical experience) could well serve as a resource to establish these measurements.
Since ‘experimentation’ does not necessarily mean research involving human beings, would the first question posed by Dr. Crelinsten not be better stated in the following way?: Is the formal review of the ethics of human experimentation important enough in itself to demand a standardized approach? And would the question not assume that that importance demands a standardized approach?
Human experimentation is an approach that originated from the biomedical model and could very easily have been stated as research involving human subjects. The terms are probably inter- changeable, but the real issue here seems to be whether or not a standardized approach constitutes an appropriate tool. The challenge taken by the Tri-Council consists in establishing a common ground for meaningful dialogue among people from various disciplines. Perhaps the expression "transparent and publicly accountable" could be used instead of "standardized"?
Given that the implementation of the Tri-Council Policy Statement is going to be an evolutionary process and that there is probably going to be continuing debate about some issues, does the standardization of the ethical review process represent a big enough objective for the immediate future?
It is important to have a standardized process. Structural standards should be indicated first, because they are probably the easiest to implement. These standards can be universally applied to all disciplines. Other standards may also arise during the evolutionary process of review. The idea is that ethics should not be seen as a burden, but as an integral part of doing good science.
New challenges to the ethics review process: perspective from the University administration
Vice-Provost Faculty of Medicine, University of Western Ontario
External codes are necessary. Neither the individual nor the small group is enough to provide universal ethical standards. The process of laying down acceptable ethical standards requires a larger community. This has been captured very well in the Tri-Council Policy Statement. We must also bear in mind that we live in a changing world. What was acceptable yesterday is not necessarily acceptable today. The kind of human experimentation that took place in a Montréal psychiatric institute or the problem of omission in the treatment of syphilis in Afro-Americans would simply not be permitted today. Yet there were people who went along with this not so long ago. But times have changed, and we must acknowledge the need for appropriate ethical standards. These standards are also relative to political settings. We now know that a large number of physicians joined the Nazi party and that quite a few were involved in obscene research that was considered acceptable, according to Nazi ethics. Although the title may indicate a typical administrative point of view on the part of universities vis-à vis the Tri-Council Policy Statement, Dr. Brooke notes that his comments are based on his experience with a specific Health Sciences REB at The University of Western Ontario. These comments are also tied to the following questions prepared and sent by Dr. Carpentier:
1What are the resource implications for universities, especially in terms of personnel time and money, and how will they be met?
1 They will be very demanding. Approximately 500-600 ethical protocols are assessed each year. This process of assessment is very time-consuming for REB members. Recruiting and retaining REB personnel is already difficult. Since there will be extra tasks for them to undertake, it will make it even more difficult to recruit and retain people. There will also be additional support staff required, and more hours spent by researchers on some of the requirements; consequently, more money will have to be spent. The universities are under great financial stress, so costs incurred as a result of the implementation of the new Policy Statement will have to come from sources like granting agencies.
2 Is the Tri-Council Policy Statement going to change the role of REBs and the way they are perceived in the institution? Will they, for example, gain credibility and respect?
2 It does not appear that REBs will receive more respect. On the contrary, researchers will tend to show some hostility toward REBs. Therefore, REBs, which have until now enjoyed a good rapport with researchers, may lose this rapport.
3 What support should be given to a decision made by an REB? For example, what if an REB decides to reject a research proposal – especially one that is submitted by a well known, well funded researcher? What position is the university likely to take regarding procedures for appealing REB decisions?
3 Speaking from his particular point of view, Dr. Brooke claims that REBs have not been subjected to reprisals from universities for finding proposals to be inconsistent with ethical guidelines. Solutions were generally found after discussion and negotiations. Therefore, no appeal board has yet been necessary. But an appeal structure could be set up in the event that a solution is not found. If a well-known researcher were to have a proposal rejected, this researcher might feel that their position in the university was threatened. The university would likely want to protect its faculty if it felt that a researcher was being treated unjustly by the REB. One problem that might ensue from having independent REBs is the erosion of the university’s authority. It is quite important that the university retain ultimate authority, because the REB chair may not have the maturity to deal with the problem and may have to appeal to outside resources.
4 Will there be a chilling effect resulting from the introduction of the New Policy Statement? Will it be perceived as interfering with freedom of research? How will the universities react?
4 Yes, there will be a chilling effect. According to Dr. Brooke, universities will tend to side with their researchers. So far there has not been a great deal of support for the document. Hopefully, this will change.
5 Do you think that the introduction of the new Policy Statement is likely to encourage researchers to avoid research ethics interference? Do you think that it will encourage them to cheat in order to misrepresent what they are setting out to do, so that they do not have to submit to REB scrutiny?
5 Thus far, the REB at the University of Western Ontario has been perceived by researchers as helpful rather than hindering. Researchers have even sent letters saying that criticism and comments made by the REB have helped their research protocol. The Policy Statement will, however, increase the sense of burden already felt by researchers.
6 What can universities do to create the right atmosphere for researchers to allow them to adapt to the new environment? How should universities act in order to educate their different research communities as to the requirements of ethics research?
6 Ethics boards should be holding seminars. If seminars are already being held, their numbers should be increased. Chairs of ethics boards should give lectures to the university community and to the general public. As work on ethics boards is very demanding and time-consuming, it should be formally recognized in consideration for promotions and in the granting of tenure. Chairs and deans should insist that REBs approve all research involving ethical issues. This should start at the departmental level.
As for the Policy Statement, it is unfortunate that its earlier drafts antagonized and even offended some researchers in the university community. Although more recent versions have largely mitigated this situation, the climate created by the early versions will make it more difficult to implement a decent document. There was an air of secrecy, of not sharing things earlier on. In short, communication did not take place.
The Policy Statement is too long and its length may irritate or even antagonize people. Each of the three Research Councils should bring out a summarized working document and insist that it be made mandatory reading. The 10 Commandments barely fill one page and have served the ethical behaviour of a large portion of the civilized world for several thousand years.
Perhaps the document is trying to address too many issues at once 2. People usually like to do things gradually. A gradual introduction of these changes might be better. The insistence on a Tri-Council Policy Statement complicates matters. Whole sections of the document pertain to just one Council. Their inclusion lengthens the document. A unified code cannot satisfactorily address three dramatically different research domains. There is no need for a single policy statement. It is just as easy for the Councils to monitor compliance with policies as it is to monitor a code. Making the change from Code to Policy Statement goes a long way to placate those who have opposed the document. Regardless of criticism that has been made in the past, universities will accept the revised Policy Statement as long as it is kept short, simple and less demanding on their already scarce financial resources.
Dr. Last reinforced strongly what Dr. Brooke said. He noted that one of the most important lessons that he has learned as an editor of medical journals and books is that brevity, clarity and readability are the watchwords. The Policy Statement is far too long. It contains several chapters that are totally irrelevant to researchers outside of the biomedical field, and may even be irrelevant to many within the field. These chapters should be placed in an appendix where they would be targeted to the appropriate constituency of researchers.
Dr. Henry Dinsdale,
All of the speakers and guests must be wholeheartedly thanked on behalf of NCEHR. The retreat exceeded our expectations and provided an opportunity for the exchange of attitudes and opinions that we all hoped would transpire today. NCEHR will publish a document based on the papers that were presented and the many useful and judicious comments that were made. The following points are intended to summarize the retreat.
Paul Bernard began by emphasizing the need to broaden the involvement of REBs in the ethics review process and the need to raise consciousness about ethics. The point that he made initially, and which has been repeated, is that ethics should really be part of the fabric of research. He noted that the issue of vulnerability often differed between disciplines. He also felt that getting people involved through REBs was very important, and that people should get credit for the time spent on their REBs.
Daphne Maurer focused on the primacy of the individual, and identified some issues raised by student participation. She stressed the importance of being able to communicate our experience of working in an environment where student participation is sought. She cited the University of Toronto walk-through model as a good example of ethical student recruitment. Secondly, she focused on the issue of deception. There are different elements in the definition of deception. An adequate debriefing should address all these elements.
Dorothy Counts’ presentation was of great interest to those of us who have little involvement with anthropological research. The notion of participant observation, in which the researcher becomes a part of the community, is obviously part of the fabric of anthropology. Naturalistic research, which implies working in a setting not designed for research, is little known to the biomedical investigator. Her plea for flexibility raised a few eyebrows. The reasons she gave for changing an REB-approved research protocol, due to an unpredictable turn of events, are quite understandable. Nevertheless, she insisted that ethics be considered an intrinsic part of the curriculum in anthropology. This kind of problem and the problem of clandestine research is obviously a trans-disciplinary matter that merits further discussion and debate within an REB setting.
Chris Armstrong’s unique example of a stockbroker as a human subject was quite interesting. The discussion of the ethical use of information and the ethical implications of certain copyright laws was helpful in developing an awareness and sensitivity to what constitutes a research subject. Good historical research gets past the façade of political actors, who obviously delight in wearing masks. Given this particular setting, how should historians conduct interviews consistent with ethical guidelines? The notions of damage and discomfort definitely assume a different meaning in these circumstances. Freedom of information is linked to privacy laws. This raises important implications.
We learned from Jeff Derevensky that research is a relatively recent development in the field of education. We also learned from him that many of his colleagues simply assume that their research complies with the principle of non-maleficence, so they do not see the need for ethical reviews. Dealing with school boards may give rise to political problems that compromise the publication of findings. This recent development in the field of education constitutes a special issue for REBs. There are additional problems: can teachers be objective researchers? What about the use of archival video tapes? All of these are important issues.
But educational research is not alone in ignoring ethical issues. According to Terry Lituchi and James Jans, ethics is of little concern for business and management researchers. Moreover, they feel that REBs do not understand their research. This raises the problem of the credibility of REBs. There is a lot of work that needs to be done in developing such credibility. This is a challenge for REBs. It was interesting to see that the buck stopped [the signing of consent forms] at the door of CEOs, which again raises some interesting paradigms for debate.
The feedback from our groups this afternoon showed that the implementation of the Policy Statement will have to take place at a number of different levels. In order to accomplish this, a number of different groups will have to get involved:
- Professional associations
- Research Councils in partnership with universities
In spite of the reservations that we have heard, NCEHR is not responsible by itself for promoting the Tri-Council Policy Statement. REBs, professional associations, and Research Councils in partnership with universities must be involved in this promotion. Education is an integral aspect of promotion. In that respect, the primary responsibility of NCEHR is to create a variety of educational tools. Thus, NCEHR will:
- set up a web site as a resource base;
- establish an FAQ page (frequently asked questions and answers)on its web site;
- create a forum for discussion targeted at REBs;
- make site visits;
- publish documents.
With his example of the death of a research subject, Gordon Crelinsten reminded us of the vital need for biomedical responsibilities. At the same time, he cautioned against trivializing the ethical implications of research in other types of human research. His important evaluation of the REB review process carried out by NCBHR, has had an enormous impact on research on human beings in this country. We do not believe that anything quite like that has taken place in any other country. Our site visits were carried out smoothly. We requested permission to visit several universities, and eventually all of these universities received us. As our requests were successful, we intend to proceed by contacting other universities in the same respectful fashion.
Dr.Crelinsten’s recommendation that regulatory supervision of hospital REBs be implemented – given the tremendous impact of medical research on human beings – represents an important step toward integrating ethics into human research in this country.
The importance of reviewing the reviewer was well stated. It was important to determine more precisely what is meant by standards. Standards refer simply to common principles. A standardized process is the formal application of these common principles. However, this should not be understood as a rigid process. This flexible structure does allow many applications of these common principles. Thus, the special needs of all disciplines are respected.
Dr. Crelinsten’s comparison of ethical research with the status of statistics in research a few years ago was quite helpful. In those years, we learned how to make use of a statistician. Now it is part of the fabric of research, and we expect that the introduction of ethics in research will follow suit.
Ralph Brooke reviewed some of the practical ramifications of this Policy Statement, and he noted that it is important that we deal with them as we promulgate this Statement across the country. He also wisely cautioned us to keep the process simple. This should help us to resolve a number of problems.
In closing, I would like to thank everyone who participated in this retreat. The presentations undoubtedly will be helpful to NCEHR and its committee members as we plan our future activities. We are now aware of a range of problems, which we intend to address in our work plan. For example, we need to carefully consider how we will conduct our site visits. In a political setting, we must be prepared for the unexpected. This will be an interesting year for us.
I wish to congratulate the staff at NCEHR, Richard Carpentier, Marvel Sampson and Bernadette Misigaro, for their resourcefulness. Without their assistance, this retreat would not have been possible. I would also like to extend my thanks to Abbyann Lynch for mentioning the Millcroft Inn as a site for the retreat. It has been a wonderful venue.