[Paleopsych] J. Med. Ethics: John Harris: Scientific Research Is a Moral Duty

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John Harris: Scientific Research Is a Moral Duty


[First the summary from CHE, 5.4.4:

[A glance at the April issue of the Journal of Medical Ethics: Research 
participation as a moral duty Undertaking, supporting, and participating 
in scientific research, particularly biomedical research, is a moral duty, 
says John Harris, a professor of bioethics at the Institute of Medicine, 
Law, and Bioethics at the University of Manchester, in England.

["We all benefit from living in a society and, indeed, in a world in
which serious scientific research is carried out and which utilizes the
benefits of past research," he writes.

[Basic fairness dictates support of research, he says, as does the "duty
of beneficence, our basic moral obligation to help other people in
need."

[However, "research has almost universally been treated with suspicion
and even hostility by the vast majority of all those concerned with the
ethics and regulation of research," he writes.

[The prevailing assumption is that no one who is not directly benefited
by research should or would want to participate in it, he says. But Mr.
Harris argues that, instead, the assumption should be "that a person
would want to discharge his or her moral obligations."

[The article, "Scientific Research Is a Moral Duty," is online for
subscribers or for purchase at
http://jme.bmjjournals.com/cgi/content/extract/31/4/242

--Kellie Bartlett]
------------------------------

Scientific research is a moral duty
John Harris

Correspondence to:
John Harris
john.m.harris at manchester.ac.uk <mailto:john.m.harris at manchester.ac.uk>
   _____

Biomedical research is so important that there is a positive moral
obligation to pursue it and to participate in it
   _____

Keywords: scientific research; biomedical research; medical ethics

Science is under attack. In Europe, America, and Australasia in
particular, scientists are objects of suspicion and are on the
defensive. <http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN1>

"Frankenstein science" 5-
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R5>
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R8> is a phrase
never far from the lips of those who take exception to some aspect of
science or indeed some supposed abuse by scientists. We should not,
however, forget the powerful obligation there is to undertake, support,
and participate in scientific research, particularly biomedical
research, and the powerful moral imperative that underpins these
obligations. Now it is more imperative than ever to articulate and
explain these obligations and to do so is the subject and the object of
this paper.

Let me present the question in its starkest form: is there a moral
obligation to undertake, support and even to participate in serious
scientific research? If there is, does that obligation require not only
that beneficial research be undertaken but also that "we", as
individuals and "we" as societies be willing to support and even
participate in research where necessary?

Thus far the overwhelming answer given to this question has been "no",
and research has almost universally been treated with suspicion and even
hostility by the vast majority of all those concerned with the ethics
and regulation of research. The so called "precautionary approach"
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R9> sums up this
attitude, requiring dangers to be considered more likely and more
serious than benefits, and assuming that no sane person would or should
participate in research unless they had a pressing personal reason for
so doing, or unless they were motivated by a totally impersonal
altruism. International agreements and protocols-for example, the
Declaration of Helsinki 10
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R10> and the CIOMS
Guidelines 11
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R11>-have been
directed principally at protecting individuals from the dangers of
participation in research and ensuring that, where they participate,
their full informed consent is assured. The overwhelming presumption has
been and remains that participation in research is a supererogatory, and
probably a reckless, act not an obligation.

Suspicion of doctors and of medical research is well founded. In the
modern era it stems from the aftermath of the Nazi atrocities and from
the original Helsinki declaration prompted, although rather belatedly,
by the Nazi doctors' trial at Nuremberg. 12,
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R12> 13
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R13> More recently
it has been fuelled by further examples of extreme medical arrogance and
paternalism. The Tuskegee Study of Untreated Syphilis 14
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R14>-for example,
in which 412 poor African/American men were deliberately left untreated
from 1932-1972 so that the natural history of syphilis could be
determined. 15
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R15> Even when it
became known that penicillin was effective against syphilis they were
left untreated. More recently in the UK a major scandal caught the
public imagination and reflected serious medical malpractice, it
involved the unauthorised and deceitful post-mortem removal and
retention of organs and tissue from children. 16
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R16> (For a
commentary on some of the major issues concerning this case see my
paper, Law and regulation of retained organs: the ethical issues. 17
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R17>)

These and many other cases seem to provide ample justification for the
presumption of suspicion of, and even hostility to, medical research.
Vigilance against wrongdoing is, however, one thing; the inability to
identify wrongdoing with the result that the good is frustrated and harm
caused is quite another.

This paper challenges and seeks to reverse the presumption against
medical research.

When we ask whether there is a moral obligation to support and even to
participate in serious scientific research we need first to be clear
that we are talking of research directed toward preventing serious harm
or providing significant benefits to humankind. In all cases the degree
of harm or benefit must justify the degree of burden on research
subjects, individuals, or society. This balance will be explored below.
Of course the research must also be serious in the sense that the
project is well designed and with reasonable prospect of leading to
important knowledge that will benefit persons in the future. ii
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN2>

Two separate but complementary lines of argument underpin a powerful
obligation to pursue, support, and participate in scientific research.


DO NO HARM
The first is one of the most powerful obligations that we have, the
obligation not to harm others. Where our actions will, or may probably
prevent serious harm then if we can reasonably (given the balance of
risk and burden to ourselves and benefit to others) we clearly should
act because to fail to do so is to accept responsibility for the harm
that then occurs. (I set out arguments for and the basis of this duty in
Violence and Responsibility. 18
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R18>) This is the
strong side of a somewhat weaker, but still powerful duty of
beneficence, our basic moral obligation to help other people in need.
This is sometimes called "the rule of rescue". 19
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R19> Most, if not
all diseases create needs, in those who are affected, and in their
relatives, friends, and carers and indeed in society. Because medical
research is a necessary component of relieving that need in many
circumstances, furthering medical research becomes a moral obligation.
This obligation is not limited to actual physical participation in
research projects, but also involves supporting research in other ways,
for instance economically, at the personal, corporate, and societal
levels and indeed politically.


FAIRNESS
Second, the obligation also flows from an appeal to basic fairness. This
is sometimes expressed as an appeal to the unfairness of being a "free
rider". We all benefit from the existence of the social practice of
medical research. Many of us would not be here if infant mortality had
not been brought under control, or antibiotics had not been invented.
Most of us will continue to benefit from these and other medical
advances (and indeed other advances such as clean drinking water and
sanitation). Since we accept these benefits, we have an obligation in
justice to contribute to the social practice which produces them. We may
argue that since we could not opt out of advances that were made prior
to our becoming capable of autonomous decision making we are not obliged
to contribute. It may, however, still be unfair to accept their benefits
and implies also that we will forgo the fruits of any future advances.
20 <http://jme.bmjjournals.com/cgi/content/full/31/4/242#R20> Few,
however, are willing to do so, and even fewer are really willing to
forgo benefits that have been created through the sacrifices of others
when their own hour of need arises!

It should be clear how what I am claiming relates to the principle which
is sometimes called the "principle of fairness" developed by Herbert
Hart and later used by John Rawls. 21,
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R21> 22
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R22> That
principle may be interpreted as saying "those who have submitted
to...restrictions have a right to similar acquiescence on the part of
those who have benefited from their submission". 23
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R23> Here I am not
suggesting an enforceable obligation to participate based on fairness
although such an enforceable obligation would, as we shall see,
certainly in some circumstances be justified by the argument of this
paper. Nor am I proposing any right possessed by those who participate,
to similar acquiescence on the part of those who benefit. Being a free
rider is, however, unfair and people always have a moral reason not to
act unfairly. This moral reason is probably enough to justify an
enforceable obligation but we do not have to use compulsion as a
strategy of first resort. It is surely powerful enough, however, to
rebut some of the presumptions against an obligation to support and
participate in research.

There may be specific facts about me and my circumstances that absolve
me from the obligation to be a research subject in a given situation.
This could be the case if I have just participated in other burdensome
experiments and there are other potential research subjects who have not
done so, or if participation would create excessive burdens for me that
it would not create for other potential participants. This does not show
that the general obligation we have identified does not exist, just that
it, like most other or perhaps all moral obligations, can be overridden
by other moral considerations in specific circumstances. iii
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN3>


THE MORAL IMPERATIVE FOR RESEARCH
We all benefit from living in a society, and, indeed, in a world in
which serious scientific research is carried out and which utilises the
benefits of past research. It is both of benefit to patients and
research subjects and in their interests to be in a society which
pursues and actively accepts the benefits of research and where research
and its fruits are given a high priority. We all also benefit from the
knowledge that research is ongoing into diseases or conditions from
which we do not currently suffer but to which we may succumb. It makes
us feel more secure and gives us hope for the future, for ourselves and
our descendants, and for others for whom we care. If this is right, then
I have a strong general interest that there be research, and in all well
founded research; not excluding but not exclusively, research on me and
on my condition or on conditions which are likely to affect me and mine.
All such research is also of clear benefit to me. A narrow
interpretation of the requirement that research be of benefit to the
subject of the research is therefore perverse. 24
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R24>

Moreover, almost everyone now living, certainly everyone born in high
income industrialised societies, has benefited from the fruits of past
research. We all benefit-for example, either from having been vaccinated
against diseases such as polio, smallpox, and others or because others
have been vaccinated we benefit from the so called "herd" immunity; or
we benefit (as in the case of smallpox) from the fact that the disease
has actually been eradicated. To take another obvious example, almost at
random, we all benefit from the knowledge of connections between diet,
exercise, and heart disease. This knowledge enables us to adopt
preventive strategies and gives us ways of calculating our level of
personal risk.

In view of these considerations there is a clear moral obligation to
participate in medical research in certain specific circumstances. This
moral obligation is, as we have seen, straightforwardly derivable from
either of two of the most basic moral obligations we have as persons.

This entails that there are circumstances where an adult, competent
person ought to participate in research, even if participating is not in
his or her best interests narrowly defined. If I am asked to give a
blood sample for a worthwhile research project, or if I am asked if
tissue removed during an operation may be retained for research or
therapeutic use, I may have to think in the following way: in the case
of giving the blood sample I may say to myself: "I hate needles and the
sight of my own blood!". Equally with retained tissue or organs I may
feel that since I understand little of the future uses for my tissue it
would be safer to say "no".

In each case we will suppose that the disease being investigated is not
one that I or anyone I know is likely ever to get, so giving this blood
sample or allowing the use of excised tissue is not in my best interests
narrowly conceived. In this situation doing what is best, all things
considered, therefore seems to entail not doing what is best for myself,
not pursuing my own best interests. However, this is not really so. Some
of my main interests have not been identified and taken into account in
this hypothetical train of thought. One of these is my interest in
taking myself seriously as a reflective moral agent, and my interest in
being taken seriously by others. Identifying my moral obligations, and
acting on them is not contrary to my interests, but is an integral part
of what makes me a moral agent. iv
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN4>

More importantly, however, as we have seen, I do have a powerful
interest in living in a society and indeed in a world in which
scientific research is vigorously pursued and is given a high priority.


DO UNIVERSAL MORAL PRINCIPLES DENY THIS CLAIM?
A number of the most influential international protocols on science
research seem to contradict the claims so far made and we must now
examine these more closely. 25
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R25> One of the
most widely cited principles is contained in a crucial paragraph of the
World Medical Association's Declaration of Helsinki, adopted by the 52nd
General Assembly, in Edinburgh, Scotland, in October 2000.

 	In medical research on human subjects, considerations related to
the wellbeing of the human subject should take precedence over the
interests of science and society (WMA, 10
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R10> para 5).



This paragraph is widely cited in support of restrictions on scientific
research and is interpreted as requiring that all human subject research
is in the narrowly conceived interests of the research subjects
themselves. This article of faith has become almost unchallengeable.

We need first to examine more closely the idea of what is or is not in
someone's interests. (Here the argument echoes that of my paper, Ethical
genetic research.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R3>) In this paper
I shall neither follow nor consider what other commentators have made of
this idea but attempt a rigorous analysis of the meaning of the concepts
involved. We should note at the outset that what is or is not in a
particular individual's interests is an objective matter. While subjects
have a special role to play in determining this, we know that human
beings are apt to act against their own interests. Indeed the idea of
respect for persons which underpins this guideline has two clear and
sometimes incompatible elements, namely, concern for welfare and respect
for autonomy. Because people often have self harming preferences
(smoking, drug abuse, selfless altruism, etc) they are sometimes bad
judges of their interests.

The interests of the subject cannot be paramount nor can they
automatically take precedence over other interests of comparable moral
significance. Such a claim involves a straightforward mistake: being or
becoming a research subject is not the sort of thing that could
conceivably augment either someone's moral claims or, for that matter,
her rights. All people are morally important and, with respect to one
another, each has a claim to equal consideration. No one has a claim to
overriding consideration. To say that the interests of the subject must
take precedence over those of others, if it means anything, must be
understood as a way of reasserting that a researcher's narrowly
conceived professional interests must not have primacy over the human
rights of research subjects. (The researcher may also have specific
contractual duties to them.) As a general remark about the obligations
of the research community, the health care system, society or indeed of
the world community, it is not, however, sustainable.

This is not of course to say that human rights are vulnerable to the
interests of society whenever these can be demonstrated to be greater.
On the contrary, it is to say that the rights and interests of research
subjects are just the rights and interests of persons and must be
balanced against comparable rights and interests of other persons. In
the case of medical research the contrast is not between vulnerable
individuals on the one hand and an abstract entity such as "society" on
the other, but rather between two different groups of vulnerable
individuals. The rights and interests of research subjects are surely
not served by privileging them at the expense of the rights and
interests of those who will benefit from research. Both these groups are
potentially vulnerable, neither is obviously prima facie more vulnerable
or deserving of special protection.

It is important to emphasise that the point here is not that there is
some general incoherence in the idea of sometimes privileging the rights
and interests of particularly vulnerable groups in order to guarantee to
them the equal protection that they need and to which they are entitled.
Rather I am suggesting two things. The first is that all people have
equal rights and entitlement to equal consideration of interests. The
second is that any derogation from a principle as fundamental as that of
equality must be justified by especially powerful considerations.

Finally, although what is or is not in someone's interests is an
objective matter about which the subject her (or him) self may be
mistaken, it is usually the best policy to let people define and
determine "their own interests". While it is if course possible that
people will misunderstand their own interests and even act against them,
it is surely more likely that people will understand their own interests
best. It is also more respectful of research subjects for us to assume
that this is the case unless there are powerful reasons for not so
doing-for example, in cases of research on young children, mental
patients, and others whom it is reasonable to assume may not be
adequately competent.


IS THERE AN ENFORCEABLE OBLIGATION TO PARTICIPATE IN RESEARCH?
It is widely recognised that there is clearly sometimes an obligation to
make sacrifices for the community or an entitlement of the community to
go so far as to deny autonomy and even violate bodily integrity in the
public interest and this obligation is recognised in a number of ways.
26 <http://jme.bmjjournals.com/cgi/content/full/31/4/242#R26>

There are a perhaps surprisingly large number of cases where we accept
substantial degrees of compulsion or coercion in the interests of those
coerced and in the public interest. Numerous examples can be given:
limiting access to dangerous or addictive drugs or substances; control
of road traffic, including compulsory wearing of car seat belts;
vaccination as a requirement-for example, for school attendance or
travel; screening or diagnostic tests for pregnant mothers or for
newborns; genetic profiling for those suspected of crimes; quarantine
for some serious communicable diseases; compulsory military service;
detention under mental health acts; safety guidelines for certain
professional activities of HIV positive people, and compulsory
attendance for jury service at criminal trials. Some societies make
voting compulsory, taxation is omnipresent, universal education for
children, requiring as it does compulsory attendance in school, is
another obvious example. All these involve some denial of autonomy, some
imposition of public standards even where compliance is not based on the
competent consent of individuals. These are, however, clearly
exceptional cases where overriding moral considerations take precedence
over autonomy. Might medical research be another such case?


MANDATORY CONTRIBUTION TO PUBLIC GOODS
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN5>
The examples cited above demonstrate a wide range of what we might term
"mandatory contribution to public goods". I will take one of these as a
model for how we might think about participation in science research.
(For use of this principle in a different context see my paper, Organ
procurement-dead interests, living needs. 27
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R27> Taxation is
of course the clearest and commonest example.)

All British citizens between 18 and 70 vi
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN6> are liable
for jury service.

They may be called, and unless excused by the court, must serve. This
may involve a minimum of 10 days but sometimes months of daily
confinement in a jury box or room, whether they consent or not. However,
although all are liable for service only some are actually called. If
someone is called and fails to appear they may be fined. Most people
will never be called but some must be if the system of justice is not to
break down. Participation in, or facilitation of, this public good is
mandatory. There are many senses in which participation in vaccine or
drug trials involve features relevantly analogous to jury service. Both
involve inconvenience and the giving up of certain amounts of time. Both
are important public goods. It is this latter feature that is
particularly important. Although jury service (or compulsory attendance
as a witness) is an integral part of "due process", helping to safeguard
the liberty and rights of citizens, the same is also true of science
research. Disease and infirmity have profound effects on liberty and
while putting life threatening criminals out of circulation or
protecting the innocent from wrongful imprisonment is a minor
(numerically speaking) product of due process, life saving is a major
product of science research. If compulsion is justifiable in the case of
due process the same or indeed more powerful arguments would surely
justify it in the case of science research.

Of course "compulsion" covers a wide range of possible measures.
Compulsion may simply mean that something is legally required, without
there being any legal penalties for non-compliance. Such legal
requirement may of course also be supported by various penalties or
incentives, from public disapproval and criticism, fines or loss of tax
breaks on the one hand, to imprisonment or forcible attendance or
participation further along the spectrum. To say that it would be
legitimate to make science research compulsory is not to say that any
particular methods of compulsion are necessarily justified or
justifiable. While it seems clear that mandatory participation in
important public goods is not only justifiable but also widely accepted
as justifiable in most societies, as the examples above demonstrate, my
own view is that voluntary means are always best and that any form of
compulsion should be a last resort to be used only when consensual means
had failed or where the need for a particular research activity was
urgent and of overwhelming importance. If the arguments of this paper
are persuasive, compulsion should not be necessary and we may expect a
climate more receptive to both the needs and the benefits of science.
However, to point out that compulsion may be justifiable in some
circumstances in the case of science research establishes that a
fortiori less stringent means are justifiable in those circumstances.

I hope it is clear that I am not here advocating mandatory participation
in research, merely arguing that it is in principle justifiable, and may
in certain circumstances become justified in fact. There is a difference
between ethics and public policy. To say that something is ethical and
therefore justifiable is not the same as either saying it is justified
in any particular set of circumstances, nor is it to recommend it nor
yet to propose it as a policy for either immediate nor yet for eventual
implementation. I believe that consensual participation is always
preferable and that persuasion by a combination of evidence and rational
argument is always the most appropriate way of achieving social and
moral goals. This paper is an attempt to do precisely this. I
believe-for example, that conscription into the armed forces is
justifiable, but I am not recommending, still less advocating its
reintroduction into the UK at this time. The distinction between ethical
argument and policy proposal is crucial but is almost always ignored,
particularly by the press and news media that report on these matters.
In this paper I am intending to do ethics; this is not a policy proposal
although it contains one policy proposal, which we will come to in due
course.

If I am right in thinking that medical research is a public good, that
may in extremis justify compulsory participation, then a number of
things may be said to follow:

*	It should not simply be assumed that people would not wish to
act in the public interest, at least where the costs and risks involved
are minimal. In the absence of specific evidence to the contrary, if any
assumptions are made, they should be that people are public spirited and
would wish to participate. (I talk here of minimal risk in the sloppy
fashion usual in such contexts. "Risk" is, however, ambiguous between
"degree of danger" and "probability of occurrence of danger". Risk may
of course be minimal in either or both of these senses.)

*	It may be reasonable to presume that people would not consent
(unless misinformed or coerced) to do things contrary to their own and
to the public interest. The reverse is true when (as with vaccine
trials) participation is in both personal and public interest.

*	If it is right to claim that there is a general obligation to
act in the public interest, then there is less reason to challenge
consent and little reason to regard participation as actually or
potentially exploitative. We do not usually say: "are you quite sure you
want to" when people fulfil their moral and civic obligations. We do not
usually insist on informed consent in such cases, we are usually content
that they merely consent or simply acquiesce. When-for example, I am
called for jury service no one says: "only attend if you fully
understand the role of trial by jury, due process, etc in our
constitution and the civil liberties that fair trials guarantee".


If these suggestions are broadly acceptable and an obligation to
participate in research is established, this may well become one of the
ways in which research comes to be funded in the future.

We must weigh carefully and compassionately what it is reasonable to put
to potential participants in a trial for their free and unfettered
consideration. Provided, however, potential research subjects are given
full information, and are free to participate or not as they choose,
then the only remaining question is whether it is reasonable to permit
people freely to choose to participate, given the risks and the sorts of
likely gains. Is it reasonable to ask people to run whatever degree of
risk is involved, to put up with the inconvenience and intrusion of the
study, and so on in all the circumstances of the case? These
circumstances will include both the benefits to them personally of
participating in the study and the benefits that will flow from the
study to other persons, persons who are of course equally entitled to
our concern, respect, and protection. (If they are.) Putting the
question in this way makes it clear that the standards of care and
levels of protection to be accorded to research subjects who have full
information must be, to a certain extent, study relative.

It is crucial that the powerful moral reasons for conducting science
research are not drowned by the powerful reasons we have for protecting
research subjects. There is a balance to be struck here, but it is not a
balance that must always and inevitably be loaded in favour of the
protection of research subjects. They are entitled to our concern,
respect, and protection to be sure, but they are no more entitled to it
than are, say, the people whom-for example, HIV/AIDS or other major
diseases are threatening and killing on a daily basis. vii
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN7>

It is surely unethical to stand by and watch three million people die
this year of AIDS viii
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN8> alone and
avoid taking steps to prevent this level of loss, steps, which will not
put lives at risk and which are taken only with the fully informed
consent of those who participate.

Fully informed consent is the best guarantor of the interests of
research subjects. While not foolproof, residual dangers must be
balanced against the dangers of not conducting the trial or the
research, which include the massive loss of life that possibly
preventable diseases cause. These residual dangers include the
difficulties of constructing suitable consent protocols and supervising
their administration in rural and isolated communities and in
populations which may have low levels of formal education.

An interesting limiting case is that in which the risks to research
subjects are significant and the burdens onerous but where the benefits
to other people are equally significant and large. In such a case the
research is both urgent and moral but conscription would almost
certainly not be appropriate because of the unfairness of conscripting
any particular individual to bear such burdens in the public interest.
That is not of course to say that individuals should not be willing to
bear such burdens nor is it to say that it is not their moral duty so to
do. In fact the history of science research is full of examples of
people willing to bear significant risks in such circumstances, very
often these have been the researchers themselves. (For one prominent
example, that of Barry Marshall's work, in which he swallowed
Heliobacter pylori bacteria, thereby poisoning himself, to test a
bacterial explanation for peptic ulcers, see his website. 29
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R29>)


BENEFIT SHARING
I have so far said nothing about the public/private divide in research
funding and about the fact that much of the research we have referred to
has been carried out in the private sector for profit. This has
inevitably led both to a concentration on what the comedian Tom Lehrer
memorably called "diseases of the rich" and on diseases and conditions
where, for whatever reason, a maximum return on investment is to be
expected. In this paper there is room simply to note that the duty to
participate in research is not a duty to enable industry to profit from
moral commitment or basic decency, and that fairness and benefit sharing
as well as the widest and fairest possible availability of the products
of research is, as we have seen, an essential part of the moral force of
the arguments for the obligation to pursue research. Benefit sharing
must therefore be part of any mechanisms for implementing the arguments
of this paper.


A NEW PRINCIPLE OF RESEARCH ETHICS
A new principle of research ethics suggests itself as an appropriate
addition to the Declaration of Helsinki:

Biomedical research involving human subjects cannot legitimately be
neglected, and is therefore both permissible and mandatory, where the
importance of the objective is great and the risks to and the
possibility of exploitation of fully informed and consenting subjects is
small.



For an earlier version of this principle applied in the context of
genetics see my paper, Ethical genetic research on human subjects.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R3>

Thus while fully informed consent and the continuing provision to
research subjects of relevant information does not eliminate all
possibility of exploitation, 30
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R30> it does
reduce it to the point at which it could no longer be ethical to neglect
the claims and the interests of those who may benefit from the research.
It should be noted that it is fully informed consent, and the concern
and respect for the individual that it signals, which severs all
connection with the Nazi experiments and the concerns of Nuremberg, and
which rebuts spurious comparisons with the Tuskegee study. 30
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R30> It is this
recognition of the obligation to show equal concern and respect for all
persons, which is the defining characteristic of justice. 31
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R31> The
recognition that the obligation to do justice applies not only to
research subjects but also to those who will benefit from the research
must constitute an advance in thinking about international standards of
research ethics.


ON WHOM DOES THE OBLIGATION TO PARTICIPATE IN RESEARCH FALL?
The Declaration of Helsinki (paragraph 19) states:

Medical research is only justified if there is a reasonable likelihood
that the populations in which the research is carried out stand to
benefit from the results of the research (WMA, 10
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R10> para 19).




ME AND MY KIND
It is sometimes claimed that where consent is problematic or, as perhaps
with genetic research on archival material, where the sources of the
material are either dead or cannot be traced, that research may be
legitimate if it is for the benefit of the health needs of the subjects
or of people with similar or related disorders. See-for example, the
CIOMS guidelines (CIOMS, 11
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R11> guideline 6:
p 22). The suggestion that research which is not directly beneficial to
the patient be confined to research that will benefit the category of
patients to which the subject belongs seems not only untenable but also
offensive. What arguments sustain the idea that the most appropriate
reference group is that of fellow sufferers from a particular disease,
Alzheimer's-for example? Surely any moral obligation I have to accept
risk or harm for the benefit of others is not plausibly confined to
those others who are narrowly like me. This is surely close to claiming
that research should be confined to others who are "black like me" or
"English like me" or "God fearing like me"? The most appropriate
category is surely "a person like me". (I make a distinction between
humans and persons which is not particularly pertinent in this context
but which explains my choice of terminology. 32,
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R32> 33
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R33>)


CHILDREN AND THE INCOMPETENT
What, however, about children?
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R1> Do they have
an obligation to participate in research and if they have, is a parent
justified in taking it into account in making decisions for the child?

If children are moral agents, and most of them, except very young
infants are, then they have both obligations and rights; and it will be
difficult to find any obligations that are more basic than the
obligation to help others in need. There is therefore little doubt that
children share the obligation argued for in this paper, to participate
in medical research. A parent or guardian is accordingly obliged to take
this obligation into account when deciding on behalf of her child and is
justified in assuming that the person they are making decisions for is
or would wish to be, a moral person who wants to or is in any event
obliged to discharge his or her moral duties. If anything is presumed
about what children would have wished to do in such circumstances the
presumption should surely be that they would have wished to behave
decently and would not have wished to be free riders. If we simply
consult their best interests, (absent the possibility of a valid
consent) then again, as this paper has shown, participation in research
is, other things being equal, in their best interests. Because of the
primacy of autonomy in the structure of this argument we should,
however, be cautious about enrolling those who cannot consent in
research and should never force resisting incompetent individuals to
participate. It also follows from principles of justice and fairness
that those who are not competent to consent should not be exploited as
prime candidates for research. We should always therefore prefer
autonomous candidates and only use those who cannot consent when such
individuals are essential for the particular research contemplated and
where competent individuals cannot, because of the nature of the
research, be used-for example, because the research is into an illness
which only affects children or those with a particular condition which
affects competence. In those extreme cases in which we might contemplate
mandatory participation the same will hold. The incompetent should only
be used where competent individuals cannot be research subjects because
of the nature of the research itself.


INDUCEMENTS TO PARTICIPATE IN RESEARCH
Before concluding, a word needs to be said about inducements to
research. Most research ethics protocols and guidelines are antipathetic
to inducements. The CIOMS guidelines-for example, state that if
inducements to subjects are offered "[t]he payments should not be so
large, however, or the medical services so extensive as to induce
prospective subjects to consent to participate in the research against
their better judgment (undue inducement)" (CIOMS, 11
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R11> guideline 7).


However, the gloss the CIOMS document offers on this guideline is
perhaps confused. It states: "Someone without access to medical care may
or may not be unduly influenced to participate in research simply to
receive such care" (CIOMS, 11
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R11> pp 28ff). The
nub of the problem is the question what is it that makes inducement
undue? If inducement is undue when it undermines "better judgment", then
it cannot simply be the level of the inducement nor the fact that it is
the inducement that makes the difference between participation and
non-participation that undermines better judgment. If this were so, all
jobs with attractive remuneration packages would constitute "undue"
interference with the liberties of subjects and anyone who used their
better judgment to decide whether a total remuneration package plus job
was attractive would have been unduly influenced. ix
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN9>

Surely, it is only if things are very different that influence becomes
undue. If, for example, it were true that no sane person would
participate in the study and only incentives would induce them to
disregard "better judgment" or "rationality", or if the study were
somehow immoral, or participation was grossly undignified and so on,
would there be a legitimate presumption of undue influence.

Grant a number of assumptions: that research is well founded
scientifically; that it has important objectives which will advance
knowledge; that the subjects are at minimal risk, and that the
inconvenience and so on, of participation is not onerous. Then surely it
is not only in everyone's best interests that some people participate
but also in the interests of those who do. Better judgment surely will
not indicate that any particular person should not participate. Of
course someone consulting personal interest and convenience might not
participate "it's too much trouble, not worth the effort, rather
inconvenient" and so on. However, removing the force of these sorts of
objections with incentives is not undermining better judgment any more
than is making employment attractive. 34-
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R34> 36
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R36>

Of course inducements may be undue in a different sense. If, for
example, a research subject were a drug addict and she were to be
offered the drug of her choice to participate, or subjects were
blackmailed into participating in research, then in such cases we might
regard the inducements as undue. It is important, however, to note that
here the influence or inducement is undue, not because it is improper to
offer incentives to participate, nor because participation is against
the best interests of the subject, nor because the inducements are
coercive in the sense that they are irresistible, but rather because the
type of incentive offered is illegitimate or against the public interest
or immoral in itself.

If I offer you a million dollars to do something involving minimal risk
and inconvenience, something that is good in itself, is in your
interests, and will benefit mankind, my offer may be irresistible but it
will not be coercive. If, however, I threaten you with torture unless
you do the same thing, my act will be coercive even if you were going to
do it whether or not I threatened you. I should be punished for my
threat or blackmail or criminal offer of illegal substances, but surely
you should none the less do the deed and your freedom to do it should
not be curtailed because of my wrongdoing in attempting to force your
hand in a particular way. The wrong is not that I attempted to force
your hand but resides rather in the wrongness of the methods that I
chose. This is the distinction between undue inducement and inducements
which are undue. "Undue inducement" is the improper offering of
inducements, improper because no inducements should be offered. It is
this that it referred to in the various international protocols we have
been examining and which is almost always wrongly understood and
applied. "Inducements which are undue", refer to the nature of the
inducement, not to the fact of it being offered at all. This is an
important but much neglected distinction. Here it is the nature of the
inducement that is undue rather than the fact of inducements of some
sorts (even irresistible sorts) being offered.

We can see that offering incentives, perhaps in the form of direct
payment or tax concessions to people to participate in research, or-for
example, to make archive samples available for research would not be
unethical. We tend to forget that law and morality are methods of
encouraging and indeed enforcing morality. Approval and inducements are
others. All are acceptable if the conduct they promote is ethical and
worthwhile. Where science research is both of these, encouragement and,
as we have seen, enforcement are justifiable.


CONCLUSION
There is then a moral obligation to participate in medical research in
certain contexts.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#FN10>

This will obviously include minimally invasive and minimally risky
procedures such as participation in biobanks, provided safeguards
against wrongful use are in place. The argument concerning the
obligation to participate in research should be compelling for anyone
who believes there is a moral obligation to help others, and/or a moral
obligation to be just and do one's share. Little can be said to those
whose morality is so impoverished that they do not accept either of
these two obligations.

Furthermore we are justified in assuming that a person would want to
discharge his or her moral obligations in cases where we have no
knowledge about their actual preferences. This is a way of recognising
them as moral agents. To do otherwise would be to impute moral turpitude
as a default. Parents making decisions for their children are therefore
fully justified in assuming that their child will wish to do that which
is right, and not do that which is wrong.


ACKNOWLEDGEMENTS
The author acknowledges the stimulus and support of the European Project
(EU-RECA) sponsored by the European Commission, in the preparation of
this paper. (DG-Reseach as part of the Science and Society research
programme-6th framework.)


FOOTNOTES
i In this paper I use arguments developed for a paper I wrote with my
colleague Søren Holm. See our paper, Should we presume moral turpitude
in our children?
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R1>; my chapter,
Research on human subjects, exploitation and global principles of
ethics, <http://jme.bmjjournals.com/cgi/content/full/31/4/242#R2> and my
paper, Ethical genetic research.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R3> Recently these
themes have been taken up by Martyn Evans. See his paper, Should
patients be allowed to veto their participation in clinical research.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R4>
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN1>

ii Here the argument is restricted to research projects that are not
merely aimed at producing knowledge. Unless an increase in knowledge is
a good in itself (a question I will not discuss here) some realistic
hope of concrete benefits to persons in the future is necessary for the
validity of our arguments.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN2>

iii It is perhaps also worth pointing out that there is a separate
question about whether this moral obligation should be enforced on those
who do not discharge it voluntarily. This is not a question I will
discuss here.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN3>

iv I owe this formulation of the interest I have in being a moral agent
to Søren Holm.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN4>

v I use this term in a non-technical sense.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN5>

vi Those over 65 may be excused if they wish.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN6>

vii Of course the historical explanation of the Declaration of Helsinki
and its concerns lies in the Nuremberg trials and the legacy of Nazi
atrocities. We are, however, I believe, in real danger of allowing fear
of repeating one set of atrocities to lead us into committing other new
atrocities.  <http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN7>

viii Figures are for 2003, with an estimated five million people newly
acquiring HIV in that same year. 28
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R28>
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN8>

ix The CIOMS gloss on their own guidelines creates a kind of Catch 22
which is surely unreasonable and unwarranted. Wherever the best proven
diagnostic and therapeutic methods are guaranteed by a study in a
context or for a population who would not normally expect to receive
them, this guideline would be broken. The CIOMS guideline four therefore
surely contradicts and violates not only the Declaration of Helsinki but
also its own later guideline 14.
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN9>

x This obligation has been partly endorsed by the Hugo Ethics Committee
in its Statement on Human Genetic databases. 37
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R37> However, like
so many statements by august ethics committees the Hugo statement
contains not a single argument to sustain its proposals or conclusions.
This paper and those referred to in references 1, 2, 3, and 4 above
provide the missing arguments. For a critique of the operation of
national and international ethics committees see the introduction to my
book, Bioethics. 38
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#R38>
<http://jme.bmjjournals.com/cgi/content/full/31/4/242#RFN10>


REFERENCES



1.	Harris J , Holm S. Should we presume moral turpitude in our
children? Small children and consent to medical research. Theor Med
2003;24:121-9. [CrossRef]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=10.1023/A:102465
1013837&link_type=DOI>
2.	Harris J . Research on human subjects, exploitation and global
principles of ethics. In: Lewis ADE, Freeman M, eds. Current legal issue
3: law and medicine. Oxford: Oxford University Press, 2000:379-99.
3.	Harris J . Ethical genetic research. Jurimetrics 1999;40:77-93.
4.	Evans HM. Should patients be allowed to veto their participation
in clinical research? J Med Ethics 2004;30:198-203. [Abstract/Free Full
Text]
<http://jme.bmjjournals.com/cgi/ijlink?linkType=ABST&journalCode=medethi
cs&resid=30/2/198>
5.	Williams C , Kitzinger J, Henderson L. Envisaging the embryo in
stem cell research: rhetorical strategies and media reporting of the
ethical debates. Sociol Health Illn 2003;5:783-814.
6.
<http://www.causesthatmatter.com/AnimalProtection/AnimalProtecti6on.cfm?
ID=223&c=31&SubsiteID=13> (accessed 1 Apr 2004).
7.	<http://www.peta.org/mc/factsheet_display.asp?ID=82> (accessed 1
Apr 2004).
8.	<http://health.mappibiz.com/mpelembe/Frankenstein_Science.html>
(accessed 2 Apr 2004).
9.	Harris J , Holm S. Extended lifespan and the paradox of
precaution. J Med Philos 2002;27:355-68. [CrossRef]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=10.1076/jmep.27.
3.355.2983&link_type=DOI> [Medline]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=12187439&link_ty
pe=MED>
10.	World Medical Association. Declaration of Helsinki . Adopted by
the 52nd General Assembly, Edinburgh, Scotland Oct 2000: note of
clarification of para 29 added by the WMA General Assembly, Washington,
2002.
11.	Council for International Organisations of Medical Sciences,
(CIOMS). Guidelines. Geneva: CIOMS, 2002.
12.	Caplan AL. ed. When medicine went mad. Totowa: Humana Press,
1992.
13.	Glover J . Humanity: a moral history of the twentieth century.
London: Jonathan Cape, 1999, part 6.
14.	Angell M . The ethics of clinical research in the Third World. N
Engl J Med 1997;337:847. [Free Full Text]
<http://jme.bmjjournals.com/cgi/ijlink?linkType=FULL&journalCode=nejm&re
sid=337/12/847>
15.	Anon. Twenty years after: the legacy of the Tuskegee syphilis
study. Hastngs Cent Rep 1992;22:29-40.
16.	The Royal Liverpool Children's Inquiry Report . London: The
Stationery Office, London, 2001.
17.	Harris J . Law and regulation of retained organs: the ethical
issues. Legal Studies 2002;22:527-49.
18.	Harris J . Violence & responsibility. London: Routledge & Kegan
Paul, 1980.
19.	Barry B . Justice as impartiality. Oxford: Clarendon Press,
1995:228.
20.	Jonas H . Philosophical reflections on experimenting with human
subjects. In: Freund PA, ed. Experimentation with human subjects.
London: Allen and Unwin, 1972.
21.	Hart HLA. Are there any natural rights? Oxford Review No 4.
1967;Feb.
22.	Rawls J . A theory of justice. Cambridge: Harvard University
Press, 1972.
23.	Nozick R . Anarchy, state and Utopia. Oxford: Basil Blackwell,
1974:90.
24.	Harris J . The ethics of clinical research with cognitively
impaired subjects. Ital J Neurol Sci 1997;18:9-15. [Medline]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=9115037&link_typ
e=MED>
25.	Harris J , Holm S. Why should doctors take risks? Professional
responsibility and the assumption of risk. J R Soc Med 1997;90:625-9.
[Medline]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=9496276&link_typ
e=MED>
26.	Harris J . Ethical issues in geriatric medicine. In: Tallis RC,
Fillett HM, eds. Textbook of geriatric medicine and gerontology [6th
ed]. London: Churchill Livingstone, 2002.
27.	Harris J . Organ procurement-dead interests, living needs. J Med
Ethics 2003;29:130-5. [Free Full Text]
<http://jme.bmjjournals.com/cgi/ijlink?linkType=FULL&journalCode=medethi
cs&resid=29/3/130>
28.	Joint United Nations Programme on HIV/AI.
<http://www.cdc.gov/hiv/stats.htm> (accessed 3 Apr 2004).
29.	Marshall B . http://www.vianet.net.au/~bjmrshll/
<http://www.vianet.net.au/%7Ebjmrshll/> (accessed 3 Apr 2004).
30.	Marshall B . <http://www.faseb.org/opa/pylori/pylori.html>
(accessed 3 Apr 2004).
31.	Dworkin R . Taking rights seriously. London: Duckworth, 1977.
32.	Harris J . The value of life. London: Routledge and Kegan Paul,
1985, ch 1.
33.	Harris J . The concept of the person and the value of life.
Kennedy Inst Ethics J 1999;9:293-308. [Medline]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=11657913&link_ty
pe=MED>
34.	Wilkinson M , Moore A. Inducement in research. Bioethics
1997;11.
35.	McNeill P . Paying people to participate in research: why not?
Bioethics 1997;11:390-7. [CrossRef]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=10.1111/1467-851
9.00079&link_type=DOI> [Medline]
<http://jme.bmjjournals.com/cgi/external_ref?access_num=11655118&link_ty
pe=MED>
36.	Harris J . Wonderwoman and Superman: the ethics of human
biotechnology. Oxford: Oxford University Press, 1992, ch 6.
37.	Hugo Ethics Committee. Statement on human genetic databases.
<http://www.gene.ucl.ac.uk/hugo/HEC_Dec02.html> (accessed 3 Apr 2004).
38.	Harris J . ed. Bioethics: Oxford readings in philosophy series.
Oxford: Oxford University Press, 2001:1-25.