Ethics: and Dental Research
Ethics: and Dental Research
Abstract. Dentistry is a Hippocratic profession and is One of my most vivid cinematic memories is the sequence in
therefore committed to ongoing research into the causes "Star Trek IV" where one of the crew suffers a head injury
and treatments of disease. This research embodies ethical during a visit to 20th Century Los Angeles to save a whale. The
standards which place a high value on a respect for persons. crew member is rushed to a hospital emergency room to have
Those standards emphasize that we obtain informed his extradural hematoma removed so that he will not die. But
consent from individuals selected to participate in research. Kirk and McCoy have to rescue him from the "barbarous" 20th
The relevant information required for informed consent Century neurosurgeons who are about to slice into his head
varies from situation to situation but should take into with a scalpel and then bore a hole into his skull with a drill
account the need for participants to make a reasoned (perhaps even a brace and bit). They manage to save him, of
decision about their involvement. Where community course, and then, with a few quick twiddles on his little box of
research is involved, there should be consultation with tricks, McCoy restores the patient to perfect health. The
appropriate representatives. In all contemporary medical salience of this sequence in my mind is closely related to the
research, there is an inherent conflict between the ethical ethics of health care research, in that, viewed from the
requirement that we share information which will help perspective of Kirk and McCoy, what was about to happen was
those who are suffering and the need to preserve rights to barbaric. For me, a 20th Century neurosurgeon, it was state-of-
competitively sensitive information related to product the-art and a clear reminder that the techniques we now
development and academic funding. These various command are provisional and sure to be superseded by what
pressures on research emphasize the need for an active and lies around the corner in medical science. This raises in an acute
lively appreciation of ethical issues in contemporary way the ethical issues associated with research and the
biomedical sciences. constraints that must be brought to bear on an activity which is
clearly part of our professional responsibility in delivering
Key words. Ethics, Dental Research, AIDS. effective care to patients (those who suffer).
Dentistry, like medicine, is a Hippocratic profession. It
has developed and now uses a set of techniques that have
evolved rapidly and discernibly within the lifetime of us
all. Hippocrates incorporated into his school at Cos three
ingredients which have survived into contemporary health
care practice (Lloyd, 1978):
First, there was a skill or art which was learned by
apprenticeship in dealing with actual cases.
Second, there was a search for the natural explanations
Based on a symposium entitled "Ethics in Dental Research", of disease and an attempt to build up a body of scientific
presented July 1, 1992, during the 70th General Session of the IADR knowledge which could be used to inform one's skill.
in Glasgow, Scotland, sponsored by the IADR and The Ethics Third, there was an ethos of caring and respect for
Committee, and supported by Unilever human beings.
1766
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j Dent Res 7301) 1994 Ethics and Dental Research 1767
The first two elements made the Hippocratic approach in the household of your patient do, however, show that
to medicine a suitable foundation for a tradition of health respect for patients was an important part of the tradition.
care apt to continue into a scientific age. The combination of In learning the skills of medicine, the Hippocratic
skilled care of individual cases with reflection upon that practitioner would necessarily acquire both knowledge of
experience in the company of those who have greater diseases informed by carefully documented scientific
knowledge and expertise has remained the foundation of research and also sensitive knowledge about his patients'
good clinical training to the present day. Hippocrates lives. In handling each of these, his ethical standards are, of
advocated systematic observation and intervention in cases course, crucially important.
as the basis of medical knowledge. The gaining of medical The value commitments of the Hippocratic tradition can,
knowledge was based on "industrious toil and the passage of however, create conflicts in practice-for instance, between
time" (Lloyd, 1978). We ought never to forget that the desire for standardized and comprehensive knowledge
practitioners, however well-versed in theory, are first and and the need to respect persons as individuals. Despite these
foremost committed to improving the quality of care which conflicts, such commitments remain an inescapable part of
can be given to suffering individuals. It is therefore the proper function of a health care profession. Therefore,
appropriate that medical knowledge should be based on we must find ethical resolutions to the various conflicts that
systematic observation and the care of patients. But the can arise if we are to practice properly as Hippocratic
Hippocratic orientation did not rest solely on the professionals.
accumulation of case-based skill; it also encouraged and
attempted to achieve explanations for the disease The imperative to research
phenomena it treated.
The causes of illness and the patterns of manifestation to The most important commitment for the purposes of health
be expected from those causes can be determined only care research is the imperative to do research. In
within a framework that goes beyond the immediate Hippocrates' day, there were very few effective remedies,
presenting problems and takes seriously the functioning of and most of those were based in empirical folk methods.
the whole human organism. Thus, a responsible health care There was, however, a growing body of knowledge about
profession conducts both clinical research, on patients, and human function, much of it, to our ears, as quaint as the
basic research into biological and human function. Some of mythology of the age. Despite its inadequacies, the
this is done in laboratories and some with healthy human Hippocratic corpus represents an attempt to find out, to
volunteers. I will confine myself to clinical research and study nature and learn. This is obviously in direct ancestral
that involving human subjects rather than digress into lineage to contemporary scientific and technological
animal ethics (itself a contentious issue). research, and it has the same aim: to build a knowledge base
The third element of the Hippocratic approach is the one which enables effective therapy to occur. The
most often remembered because it has survived in the overwhelming impression created by reading the history of
Hippocratic Oath. It guards medical practice against the medicine is that there is a close link between a passionate
unscrupulous use of that specialized and privileged care about what happens to human beings and a scientific
knowledge which has been obtained in an attempt to offer concern to improve what we are doing when we practice
real benefits to suffering people. The Hippocratic school health care. For this reason, health care research is not an
was so concerned that the art they practiced should be optional extra on the professional agenda; it is closely tied to
surrounded by the ethical commitments which they the fundamental nature of a Hippocratic enterprise. The day
considered important that their oath included the words; we cease to do research is the day we cease to care about the
suffering caused by the inadequacies of our current
I will impart a knowledge of the Art to my own methods; it is the day we allow the brace and bit to reign
sons and those of my teachers and to the supreme over Dr. McCoy's magic box.
disciples bound by a stipulation and oath The Hippocratic corpus also, as I have noted, involves a
according to the law of medicine but to no respect for patients as persons. Those who suffer do not, on
other. (Gillett, 1989) account of their suffering, cease to be people with an active
interest in what is happening to them and with an active
The implication of this underlying ethical commitment is contribution to make to any decisions made about them
that any Hippocratic professional must primarily share a (Gillett, 1989). Increasingly, we realize the importance of
caring ethos and that only on that basis was he fit to learn this in clinical practice, but it is also an important part of
the specialized skills of clinical care. The Hippocratic stress research. What is more, respecting patients as persons
on caring and benefit is often misinterpreted as expressing a sometimes means that we ought to include them in research
relative neglect, in health care practice, of the respect for the where that is possible and appropriate. There is something
patient as a person. Those elements of the oath concerning right about giving the patient an opportunity to be part of
confidentiality and the proper way to honor your position ongoing research into the problem which has caused his
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1768 Gillett J Dent Res 73(11)1994
suffering. This is attested to by the willingness of many risk is justified in view of the possible benefits of the
patients to take part in research. Patients with serious research. We could be very laissezfaire about this and let
problems will often say, "Look, if there is anything that you patients decide for themselves about their levels of risk-
can do in my case that might help someone else, please do taking. This would imply that we would tell patients about
it." The dangers of accepting such a carte blanche the risks and potential benefits of the research and leave
authorization are, however, obvious, and we have them to make up their own minds no matter what was
surrounded research participation with a number of ethical involved in the contemplated study. However, patients are
safeguards for subjects. As we discuss these, the various very acquiescent and, in most countries, tend to agree to
issues for clinical researchers to consider will be clarified, whatever a health professional suggests. This means that we
but we ought not lose sight of the fact that participation in should exercise some supervision over the risks to which
research, on the proper terms, enhances the role of the people are allowed to expose themselves. This is what we do
patient as a partner in the health care enterprise that is in legislation concerning safety standards for drivers, and so
directed at his problem. it is entirely consistent that we should also do so in clinical
research where subjects may have less of a grasp of what is
Risk and consent at stake for them in a risk-benefit situation.
The unfamiliarity (to a lay person) of the knowledge
Before we launch into specific situations, we ought to make involved in assessing clinical research means that we
certain broad distinctions. The first is between therapeutic and should also ask how much information is enough to ensure
non-therapeutic research. Therapeutic research has a chance of that a person is informed about the research into which
benefiting the subject participating, and non-therapeutic he/she is entering. Again, it is impossible to make a blanket
research does not. There is also a distinction between patients statement; too much information is confusing and obscures
and healthy volunteers. Some of the ethical issues surrounding the real issues, but any selection of information may omit
research will have different implications depending on the way something that the person in question would find important
in which the research fits onto this grid of distinctions. For in deciding whether or not to participate in the research.
example, the patient contemplating participation in a Thus, we need commonly agreed upon ethical standards
therapeutic research trial has a different standing vis-d-vis risks within any profession conducting research, and these
of participation from the healthy volunteer, who, by definition, should probably be informed by opinion from the lay
is participating in non-therapeutic research. The patient community in which the research is to be conducted. The
involved in therapeutic research has access to something which best way to ensure that such standards are being met is to
may benefit him or her and can therefore make a rational have research proposals discussed by a mix of lay and
decision to obtain that chance even where there is a risk professional people before subjects are recruited. This
involved, whereas a candidate for non-therapeutic research is facilitates a free discussion of the risks and benefits and a
differently placed. careful assessment of the adequacy of the information
We will find that in all research there is a potential presented to participants.
conflict (least in the case of therapeutic research) between The way in which these safeguards are put in place
the rights of individuals and the good of society (Capron, varies from situation to situation and country to country. In
1983). Things are done to people with uncertain effect so most developed countries, there exists some kind of ethical
that we can all benefit from what is learned. The review process. In the United States, most institutions have
consideration of any research project requires a weighing Institutional Review Boards, and in Britain there are Ethics
and balancing of individual and societal interests in a way Committees attached to most large hospitals, but areas such
that any piece of legislation does. No one consideration can as dental research can often be neglected and lack an
be allowed to have a trumping role, particularly where that obvious source for ethical appraisal. In some cases, the
is a value exported from a certain cultural setting (such as profession will itself have a review process, but this is not
the inviolable right to personal liberty). always the case and can be compromised by a perceived
The ethical requirements in relation to health care weakness. The worry is that the profession has certain
research are designed to avoid foreseeable harm to research internal standards which are not answerable to the lay
participants and to obtain freely given informed consent to public on whom the research is done. It is conceivable that
participation. They are, as we have noted, based on the standards which are either too liberal or too restrictive
Hippocratic principle of respect for persons. To translate could emerge and develop in a profession in a way that the
these into practice (e.g., for partially blinded or randomized lay public would not endorse. For the most part, the
trials), a profession must settle on standards of acceptable perceived danger is that ethics committees would favor too
risk or proven safety and standards for reasonable sharing strongly "the value of research" (Veatch, 1975). This clearly
of information. Both types of standards are available within happened in the case of the New Zealand Cervical Cancer
biomedical ethics, but neither is a matter for watertight, trial, which became subject to review by a Royal
legalistic definition. It is, for instance, difficult to say when a Commission which found against the researchers involved
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j Dent Res 7301) 1994 Ethics and Dental Research 1769
(Cartwright, 1988). For this reason, most countries recognize proposed research and his or her part in it prior to
the need for lay or non-professional members on research enrollment in the trial. This information should include
ethics committees. The lay participation needs, however, to reference to any relevant risks or benefits of participation, a
be more than a 'token' representation, because lay people disclaimer to the effect that the person's treatment will not
may be intimidated by professionals in such a setting be prejudiced by non-participation, and an assurance that
(McNeill, 1993). Whatever the arrangements in a given adequate provisions have been made for compensation in
setting, some process providing ethical review which has a the event of trial-related harm befalling the patient. It is also
role in evaluation and regulation of research with human becoming customary, in most developed countries, to
subjects ought to be in place for dental research and should inform the participants, at least in broad outline, of the
be informed by certain key considerations. results of the research to which they have contributed. This
has the benefit of keeping the public informed about
Ethical standards for research research and recognizing the vital role played by those good
enough to take part.
The ethical standards governing clinical research must The major question that is always asked in connection
include some assessment of the risks and benefits of that with informed consent to participation is the extent to
research. Some projects require only that one monitor which patients should be informed about risks. In general,
existing practice and report on the results in a controlled the requirements are greater in research than in clinical
and scientific manner. Such observational research involves treatment, and they include what would be of material
no harm to individuals, apart, perhaps, from the possible relevance to a reasonable person. Material relevance is
threat to privacy resulting from the need to review case defined in terms of the knowledge that a reasonable person
records. Arguably it is part of any good clinical care that would take into account in making the decision in question
such 'audit' be ongoing, and yet some would argue that it is a (Skegg, 1988). This is likely to include all major risks, even
use of clinical information for purposes beyond those stated where those are relatively unexpected, and any frequently
when the information was obtained. But as long as encountered minor problems about which a patient may
procedures to safeguard confidentiality are properly worry or feel aggrieved at not having been told.
incorporated into the research methodology, such research The need for the non-treatment group to receive the best
can be done without individual consent from participants, conventional care can all too easily be overlooked in
who have everything to gain and nothing to lose from assessing research. Some researchers even regard it as
audit- or review-type research being conducted by the interfering with the purity of their results. But we ought to
professionals they consult. In many cases, ensuring the remember that any person presenting him or herself for
anonymity of the data and the use of statistical methods to health care expects that a reasonable standard of care will
report it together offer sufficient protection for the personal be given and that it is part of our duty as clinicians and
interests involved. researchers to be able to inform people that they will not be
The case is quite different with interventional research, prejudiced in their care by non-participation. It is obvious
where a treatment is changed or instituted in a way that, it is that the denial of best standard care for the non-treatment
hoped, might carry advantages for those who are treated. In group violates this expectation and its correlated duty.
this case, there are direct risks not only to the privacy but
also to the well-being of participants, and therefore the Special scenarios
relevant standards must be somewhat stricter.
First, there must be good reason to believe that the If these requirements are met, then interventional research,
experimental treatment is at least as good as if not better even where it uses a randomized double-blind
than the conventional best treatment. The standards to methodology, should strike no particular ethical problems.
ensure this for drugs and other substances to be used in Double-blind interventional research is often thought to
human health care are well-documented internationally. (It create insuperable problems for informed consent, but in
is often not quite as clear what controls should exist for fact, these are more apparent than real. It is true that the
therapeutic procedures that are being researched, but there patient does not know what treatment he or she is receiving.
are no good ethical reasons for any distinction.) It is also true that the fact that the participant is ignorant of
Second, the non-treatment group must be assured that the exact nature of the treatment is part of the research
they will receive the best conventional care. This ensures design. However, the ignorance and information balance is
that patients randomized to a control group are not not as unethical as it might seem. The participant knows
disadvantaged by entry into the trial (it has the added effect that he or she is receiving treatment for a certain purpose,
of ensuring that the new treatment is compared with best and he/she should in general know what type of treatment
existing methods and precludes claims of superiority based that is and what effects it might be expected to have. He/she
on spurious and indirect evidence). knows that he/she will be receiving treatment that is at
Third, the research subject must be fully informed of the least as good as if not better than current methods of dealing
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1770 Gillett J Dent Res 73(11)1994
with his/her problem. He/she will have been told of any that no deception is ever justified. This, arguably, has the
known risks of the treatment and that it is to some extent effect of excluding any studies in which the subjects'
experimental and will therefore have been fairly warned in behavior is almost certain to be influenced by full
case he/she is in the experimental group. Above and beyond knowledge of the research aims. There are some situations
these general facts and the specific details about what is in which the public interest would urge that accurate
being done, there seems little that a reasonable person information must be gained about behavior-for instance, in
would want to know. Indeed, in many cases the level of assessing the prevalence of overtreatment among dental
information and supervision of the participant's response professionals. In such a case, there again needs to be
will be greater than in ordinary clinical treatment. balancing among the conflicting ethical principles rather
Therefore, in all material respects, there should be nothing than a uniform deference to one principle that is accorded
denied to a participant in double-blind research that is pre-eminent status.
available to an ordinary patient except the knowledge of Research with healthy volunteers raises other issues.
which particular treatment is being used at a given point in Some research, particularly involving new substances and
time. As I have shown, this should not be materially the response of the normal human being to those, requires
relevant to the individual if the other information relating that we intervene in people who have no current medical
to the trial is adequately conveyed. need. Here we should recall that present medical needs are
Where participants cannot give consent-say, in a trial of not the only medical needs and that future requirements for
some early intervention in facial trauma, or where children treatment stand to be affected by what we currently learn.
are involved-there clearly needs to be f urther In this sense, although research on healthy volunteers is
consideration of information and consent. In general, a trial non-therapeutic, it has potential therapeutic relevance even
conducted in such circumstances ought to be one that is to the healthy people on whom it is conducted. What we
impossible to do under other conditions. The patient- cannot do is to allow this projected and somewhat indirect
centered concern should then be that it is a type of future need to prejudice the interests of the present subject.
intervention or measure to which a patient might We must therefore be quite sensitive to the risks involved in
reasonably consent if, were it not impossible, he or she the research and to the degree to which the subjects are
could do so. If, for instance, it were suspected that early participating on the basis of adequate information and lack
rather than delayed fixation of facial fractures might reduce of coercion. Coercion can be a significant factor when there
complications, then it would be reasonable for a patient to are relatively substantial sums of money involved in
have the chance of the early intervention. If it were vulnerable populations, such as students or those who are
impossible to obtain adequately informed consent for poor.
participation in this trial, then there is still a case for
offering it to the patient, provided only that there is some Community-based research
mechanism for assessing the patient's probable wishes and
balancing the desire of the researcher to do the research. In Above and beyond these fundamental considerations to do
cases like this, the researchers should try to make sure that a with individuals, we must consider the difficult moral
substitute decision-maker is available and contacted about weightings that need to be applied to community-based and
each participant. Such a person is usually a close relative or epidemiological research, where that precludes individual
friend who can reasonably be expected to have the patient's informed consent. Often, there are reasons why it would be
best interests at heart. Of course, there are situations where impractical to obtain individual informed consent to
such a person cannot be found. If this is the case, then there observational research or even interventional research
should be procedures in place whereby researchers can which involves, say, the dental health of a particular target
obtain ethical advice, including adequate lay input, about group. The CIOMS (Council of International Organizations
the trial and the individual's participation in it (Campbell et for Medical Sciences) has noted this possibility and issued
al., 1992). An opinion about the trial in general should be guidelines and discussion documents which emphasize the
obtained before it is started, and, where this is done, the necessity of obtaining suitable consent for community-
individual situation is often covered by the advice given. based studies (CIOMS, 1991). Their guidelines state:
However, in certain institutions there are also provisions for
ethical advice in emergency settings, and this can be helpful When it is not possible to request informed
if a difficult situation arises. consent from every individual to be studied,
Some research involves more than impracticality in the agreement of a representative of a
information-giving to the participant and requires active community or group may be sought but the
deception. This is most likely to occur in behavioral representative should be chosen according to
research and can be approved only when there is no other the nature, traditions and political philosophy
way to gather valid data and when adequate provisions for of the community or group.
debriefing of subjects are put in place. Some would argue
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J Dent Res 7301) 1994 Ethics and Dental Research 1771
A discussant of these guidelines comments: many of the initial fears by researchers and others that, for
instance, it would prove cumbersome and capricious have
It is extremely important that the subjects for not been realized.
such community research are fully informed of A further point that needs to be considered in relation to
the objectives of the research directly and community-based research is the right of individuals to
through responsible men and women of their exclude themselves from such research. This may, in fact, be
own class and living with them...This has to be impossible, as in the case of experiments involving general
done well in advance of the commencement of sanitation or manipulation of the water supply. It may also
the research and has to be frequently reinforced reflect a Western bias in which the interests of an
in the course of the research operations. Any individual are often perceived to trump those of that
misgivings or misunderstandings with regard individual's community. This, in many settings, is seen to be
to the proposed research must be cleared immoral, and so it will always be an issue as to whether the
through patient explanation and assurances, in right of individual dissent is a permissible provision, given
terms which the community can understand the ethos and values of the community involved and the
and appreciate (Gopalan, 1982). nature of the project being undertaken.
patient, professional, and scientist. This partnership fosters allegations concerning the treatment of cervical cancer at
a mutual enterprise directed toward the health and well- National Women's Hospital and related matters. Auckland,
being of those who suffer-patients. Health care research is NZ: Government Printing Office.
an integral part of this enterprise and therefore highly to be CIOMS (1991). International guidelines for ethical review of
prized by any caring society. It is, in our day, increasingly epidemiological studies. Geneva: CIOMS.
subject to pressures from within and without, but where it is Gillett G (1989). Reasonable care. Bristol: Bristol Press.
conducted with due regard for the persons who participate Gopalan C (1982). Ethical aspects in community-based research
and the ends that need to be served, it is an asset that with particular emphasis on nutrition research. In: Human
represents over two thousand years of concerted experimentation and medical ethics. Bankowski Z, Howard-
humanitarian effort. Jones N, editors. Geneva: CIOMS, pp. 124-139.
Lloyd GER, editor (1978). Hippocratic writings. Harmondsworth:
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