|
A peer-reviewed
electronic journal published by the Institute
for Ethics and ISSN
1541-0099 18(1)
– May 2008 |
Ethical Issues in Enhancement Research
Fred Gifford
Department of Philosophy
Michigan State University
Journal of Evolution and Technology -
Vol. 18 Issue 1 – May 2008 – pgs 42-49
http://jetpress.org/v18/gifford.htm
Abstract
This paper is a preliminary exploration
concerning how the ethics of research on human subjects may differ when we move
from the well-discussed context of research on therapies to the less-discussed
context of research on enhancements. A
number of differences are described. There are some features that make such
research more morally problematic in certain ways, but some of the features may
actually ameliorate some of the moral tensions that exist in human subjects
research. It is hoped that this analysis will aid and encourage discussion of
the topic that could help guide those who intend to carry out such this
research.
Introduction
In the not-too-distant
future, we will surely find ourselves with a variety of enhancement
technologies available, ones provided through genetic alteration, pharmacology
and implants of various kinds. Much has been written concerning whether or not
this is to be welcomed, and about the potential social problems and ethical
issues raised by making these things available. But less noted has been the
need to have reliable evidence of the safety and efficacy of these
interventions, which will have to be obtained through testing on human
subjects.
The ethics of human
experimentation concerning the safety and efficacy of therapeutic interventions
have been discussed extensively. In the United States, for example, we have
federal legislation and regulations on human subjects research and a system of
institutional review boards to safeguard the rights and welfare of human
subjects of medical research, and the extensive discussion has created a
certain degree of consensus. But enhancement technologies differ somewhat, in
their nature and purpose, from clinical therapies. Thus it is worth
considering, as we begin to carry out such research, how and to what extent
significant aspects of the ethical issues concerning their investigation may be
importantly different.
In this short paper, I can
only sketch some general aspects of this topic. I will describe a few central
aspects of the ethical issues concerning research on therapies, and a few core
features of enhancement interventions, and then examine briefly some of the
implications of this for the ethics of enhancement research involving human
subjects. I hope thereby to encourage
discussion of the topic that could help guide those who intend to carry out
such this research.
Necessarily,
this analysis proceeds at a rather general level. The broad features discussed
do not apply fully to all cases of enhancement technologies. And I will leave
out important but narrowly applicable issues, such as the problems of consent
of those from future generations that arise in the case of germ-line genetic
enhancements. The idea is to examine more general issues about the ethics of
human subjects research on enhancement technologies
per se.
Ethics of human subjects
research (for therapy)
The central ethical issues
concerning human subjects research on therapies are generated as
follows. We want to gain maximally useful and reliable scientific results
concerning the safety and efficacy of therapeutic interventions for the benefit
of future patients. But at the same time, of course, we want to promote and
protect the interests and rights of the present subjects of research.
To clarify the
ethical tension, it is useful to note two aspects of a research trial being
“experimental.” It’s experimental in the sense that the new intervention is new
and untested, so there is (on average) greater uncertainty. But, secondly – and more
significantly for our purposes – it’s experimental in the sense of being designed to
generate new knowledge, so the protocol requires that one’s “treatment”
deviates from what would be given were the sole goal the maximization of
subject welfare. For instance, “treatment” (including placebo) is determined by
random selection, not by clinical judgment. “Double-blinding,” set dosages, and
restrictions on concurrent medications limit the physician’s ability to use
specific knowledge in one’s interest.
Extra test procedures are undergone. Finally, this continues to the
point of statistical significance.
Research on
enhancements, analogously, will not just involve uncertainty about safety and
efficacy, but, more specifically, will require protocols with double-blind,
placebo-controlled experiments carried out to the point of statistical significance.
Thus, for enhancement
research as well as research on therapies, there is, on average, a kind of
“cost” (even if this is really “suboptimal treatment”) to being in a trial
(Gifford 1986). In part due to this cost, and to a consequent potential for
exploitation, several broad criteria have been identified to evaluate the
ethical acceptability of a trial and thereby safeguard against such
exploitation. Amongst these are social value, favorable risk-benefit ratio,
informed consent, and justice in subject selection.1
Consider first the “social
value” of a trial. Human subjects should not be exposed to potential harm
unless there is a good expectation of clinical, scientific or social benefit.
Otherwise there is a risk of exploitation, not to mention of the unwise or
unfair use of scarce resources.
This social value
is also one element of the second requirement – that there be a “favorable
risk-benefit ratio.” Risks should be minimized, potential benefits should be
enhanced, and risks to subjects should be proportionate to benefits to subject
and society.
Third, each research subject
must give voluntary, informed consent. Barriers to such consent must be
identified and addressed.
Fourth, even if each of
informed consent, social value, and a favorable risk/benefit ratio obtain,
there are also issues concerning justice in subject selection. Those who bear
the burdens of research should be able to have the benefits. Researchers
shouldn’t target the vulnerable for risky research or favor the advantaged for
beneficial research.
Having identified these as
the central ethical criteria, our question here is: How might these issues
change as we move to the context of testing the safety and efficacy of
enhancement regimens?
Scope of “Enhancement
technologies”
Of course, we must say
something about what this class of enhancement technologies is that we are
concerned to evaluate here. On the face of it, enhancements alter the features
of individuals in a way that doesn’t (just) restore health, but that goes
beyond the standard of health; on one view of the definition of health, that
means doing more than just curing and responding to disease. Put otherwise,
enhancements raise individuals above the species-typical norm (as opposed to
only bringing them up to that norm).
As
a result, enhancement is sometimes said to go beyond what medicine can
(objectively) justify. It’s less
objectively important; indeed it is optional, in a way that addressing illness
is not. Relatedly, value judgments are
required to determine what direction counts as enhancement. Nor, unlike the
case of therapy, is there an objective answer concerning what natural stopping
point there might be to the enhancement. In addition, it’s said that it goes
beyond human nature.
The attempt to make such
generalizations raises various important issues: First, the kinds of things
that fall under the category “enhancement technologies” are quite varied:
genetic enhancement of physical and mental abilities; increasing the human life
span; inserting chips into one’s brain; drugs to enhance physical and mental
performance or one’s personality characteristics. These might not all fit the
above characterizations. Relatedly, there is controversy over whether a line
can meaningfully and usefully be drawn between therapy and enhancement.
These
are important issues, but I will not pursue this further here. I don’t take my
project here to be to draw sharp lines, or to capture the essence of
enhancement technologies. More specifically, I do not claim that the analysis
provided here applies across the board to all instances of enhancement
research, or certainly that the issues would be serious in every case; there is
much variation and also many countervailing factors. Still, the intent here is
to identify issues that are not just incidental, but that arise often and
because of enhancement in the above senses. Thus these are things that those
embarking on such research need specifically to keep in mind as research trials
are planned and executed.
So what are some of the
features of research on enhancements which may potentially alter the ethics of
research? I will outline a number of them, using the taxonomy described above:
social value, risk-benefit ratio, informed consent, and subject selection.
(1)
Social Value
Let us first consider social
value. What features are there that affect the extent to which enhancement
research is objectively important and socially valuable?
One position would be to
claim that these enhancements, by being outside of the natural or the bounds of
human nature, are in fact inherently a bad idea. But such appeals are
notoriously vague and there is reason to be skeptical about them. I will leave
this aside here.
Instead, I propose to focus
on the fact that enhancements, by not being about bringing one up to the level
of health, but going beyond that, will typically be optional. This may suggest
their being not as objectively important to the individual as life or health.
But there is another implication of their being optional and not a matter of
addressing ill-health: it also means that insurance is less likely to cover
them, and this has several implications. The knowledge resulting from such
investigation doesn’t do as much good, for it doesn’t help as many people. It
also can give unfair advantage to those already advantaged, thus exacerbating
the gap between haves and have-nots.
Leaving aside the insurance coverage question and returning to the lack
of grounding in a standard of health, other points are often made: given the
competitive advantage and no obvious stopping point, going down this road could
give rise to a spiraling arms-race, as people strive to get ahead with respect
to increasingly demanding norms.
Some have appealed to such
considerations to argue that we simply should not pursue these things; their
conclusion concerning research would simply be that we should not do it. What I
want to focus on here is the more modest claim that this affects the assessment
of the social value of the research, one of the components in evaluating
particular trials. This then impacts, for instance, the degree of risk that
could acceptably be imposed.
Of course, while much more
modest than the claim that these factors argue against allowing the provision
of these enhancements, this is still a controversial line of thought, and a
number of potential objections come to mind.
One might object that if an
enhancement is genuinely not so important, then it is not such an injustice
that those with less resources will not have access to it. Note that one
important response to this is that, actually, these are just the things (many
of them) that can provide great social and economic advantages to individuals,
even if they don’t technically count as “medical” needs that are thus deemed to
warrant insurance coverage.
It might also be objected
that these problems are not unique to enhancement. After all, if a given
therapeutic regimen has substantial cost but is covered by most insurance
plans, then a crucial inequality occurs between those with and without
(adequate) insurance. One might be tempted to respond that the fault here lies
with the lack of universal access to health care, and not with medical research
into therapies. But of course, then one might make a similar appeal in the case
of enhancements: that research on enhancements shouldn’t be hindered because
the insurance system fails to cover these truly important enhancement
interventions.
In any case, if one really
ensures that these enhancements are available for all and not just the rich,
then this indeed would address the problem here. (One question that arises is
whether it is enough to charge that the blame lies elsewhere in this manner, or
whether one must in fact pledge to change the insurance system as a condition
of being able to do the research.)
A different line of thought
would be to argue directly that in the long run these enhancements will indeed
actually be deeply socially important for the future of humanity, due to the
great, almost unlimited potential benefit that these things could bring. (All
this raises some questions about how and to what extent such an assessment
ought to take into account inequality, and to what extent need we focus our
attention on the near future and to what extent on the distant future.)
I cannot begin to resolve
all the questions, empirical and normative, that can be seen to arise. What’s true is that such features concerning
inequality won’t apply equally across the board of enhancements. And many cases
will be complex: drugs for enhanced attention might, due to expense and thus
differential availability, exacerbate inequality, but also serve as an
important public good in their use by physicians, pilots and air-traffic
controllers.
Still, as a trend, I think
that this feature, of diminished
social value due to lack of access and inequality, is to be taken
seriously as a central issue for those embarking on enhancement research. We
should explore its consequences further for the ethics of human subject
research in this area, and researchers have a responsibility to look out for
and assess such factors.
(2) Costs and Benefits of
Being a Subject
The second locus of
assessment involves consideration of the costs and benefits for the individual
subject in such a trial, and the comparison of this with the social value of
the research.
The benefits being optional
is again relevant. One implication of this is that these benefits are not so
objectively important for the individual, especially when compared to any
countervailing medical risks. Thus this fact will lower the benefit and hence
the benefit/risk ratio. But note at the same time that another implication of
its being optional (and viewing the optional as less valuable) is that being in
the placebo group and forgoing the benefit is not such a high cost. This would
tend to diminish the moral difficulties with clinical trials of enhancement
interventions.
This illustrates that we
cannot provide here some overall judgment about research on enhancement
technologies being more (or less) morally problematic; rather, we can only
identify factors that have to be attended to because they tend to alter the
structure of the risk/benefit assessment.
For a more specific example
bearing on enhancements and the risk-benefit ratio, consider research on therapies
where it appears that participation is not in the medical best interest of the
patient, and we wonder whether the subject is being rational in entering the
trial. It is sometimes said that part of why entering a given trial may not be
such a bad choice (despite its downsides) is that participants get special
medical attention from expert clinicians – or even that they get access to
doctors, which they might not have gotten it otherwise. But in the enhancement
case, this won’t be a factor, so there will be an important difference.
Again, like other
differences between the therapy and enhancement contexts, this cuts both ways:
On the one hand, there isn’t the added benefit that makes being in the trial
more valuable to the subjects (thus making the enhancement research case more
problematic). But on the other, there isn’t the worry of subjects being
vulnerable to coercion or manipulation by this sort of “perk” (thus reducing
the moral worries about the trials).
(3) Informed Consent
The next locus of assessment
is the requirement of voluntary informed consent of all participants. Much has been said about the details of what
is required, and what dilemmas exist concerning what counts as competent or
informed, etc. How might the move from therapy to enhancement affect these
matters?
There are many questions one
could explore here: Is the information
more complicated (or less so)? More (or less) liable to misunderstanding? Is
the population different with respect to their ability to understand, or with
respect to their motives or vulnerabilities? To explore this systematically, it
would be important to consider (and obtain empirical information concerning)
who the subjects of such experiments will in fact be and what characteristics
they will have. This is a large task and must be left for another occasion.
But I do want to focus our
attention on one especially important topic. One of the most serious
difficulties concerning the ethics of clinical research, and which ties
specifically to the adequacy of consent, concerns the “therapeutic
misconception” – the mistaken belief that the research protocol is designed
to advance the patient’s interests. Research shows that subjects tend not to
understand, or take seriously, how research is different from therapy
(Appelbaum, et al. 1987). They don’t
understand concepts like placebo, randomization, or double-blinding. Despite
being told otherwise, they very often believe their treatments are chosen
specifically on the basis of what is medically best for them. It is clear that
we must work much harder to make informed consent effective, and also that
informed consent cannot stand on its own as a sufficient justification of
trials.
Now surely, it will be said,
research on enhancement technologies will raise considerably less moral
difficulties in this crucial respect. Those entering enhancement trials will
surely know that the goal is enhancement, not therapy. So, potentially, here is
a way in which enhancement trials could be substantially less morally worrisome
than trials of therapies.
I think there is something
to this, but I also think that simply to accept it at face value would
constitute an understandable but profound mistake. The contrast between therapy
and enhancement is a different contrast from that between research and therapy;
indeed, the latter should really be termed “research vs. practice,” where practice can be either
therapy or enhancement. The “therapeutic misconception” involves confusing
therapy in the sense of “we are doing this for you (the patient or subject)”
(that is, practice) with research in the sense of “we are doing this for the
greater good (or future patients).” This confusion is caused, amongst other
things, by the subjects’ intense need to believe they are being helped.
But subjects of
enhancement research could also be confused (or in denial) about the likelihood
that the intervention given to them (in the study) will help them, and whether
they are being given that which is thought most likely to help them.
The outcome of
experimental enhancement intervention, if “successful,” could well be a benefit
for the research subject (and these benefits might well be hoped for, longed
for or even desperately and perhaps irrationally sought after). People can
certainly want desperately to gain what they take to be a bit of social and
economic advantage. And yet, because of risks due to increased uncertainty and
(more importantly) failure of benefit due to the requirement of study design,
the potential subjects can well – in exactly the same way as with clinical
research – think that they are expected to receive benefit when they are not
(or, overestimate the degree of expected benefit). So the therapeutic
misconception problem, as a profound challenge to the adequacy of informed
consent, cannot be ruled out in this way.
On the other hand, it does
seem that this would not tend to be the rather extreme kind of situation
sometimes faced in the “therapeutic” context. It won’t come at the end of a
long line of attempts at experimental treatments, where a patient has run out
of alternatives and may be facing death.
The subject is less likely to think specifically that their doctor has
chosen this for them (despite explanations of randomization, etc.). For one thing, their personal physician is
less likely even to be involved.
Still, the degree to which a
strong desire to have these enhancements could come to be a source of
irrationality, hindering informed judgment, is an empirical question, one
related to the psychology of individuals and the social forces that make such
enhancements attractive. The issue is worthy of further investigation.
(4) Fair Selection of
Subjects
Fair selection of subjects
requires, amongst other things, that those populations who bear the burdens of
research should have the potential to share in the benefits. I will consider
here just a couple of issues.
The first relates to the
point discussed earlier: some populations will be unlikely to benefit from
research on interventions not covered by insurance, and this, along with
exacerbation of inequality, would negatively affect the “social benefit”
component of whether a trial is ethical (and hence the benefit/risk ratio).
But here the point is
different – that it lessens the moral legitimacy of enrolling particular subjects
in the trials, because some groups that bear trial burdens will not share the
benefits. The point is often made in terms of the especially egregious practice of singling out such groups –
which is not going on here –
but it has moral force more generally. Indeed, at least in some
circumstances, it seems plausible that those who will volunteer for such trials
will often be just those who will not be able to afford getting the “treatment”
“on their own”, once it is deemed safe and effective and put on the market.
Participation in research would be their only shot at getting whatever benefits
might come from this.
Again, there is a variety of
responses to this. We could exclude such individuals from such trials, but this
would be difficult and perhaps not desirable. We might take all this to be a
reason not to pursue such trials because they cannot be carried out fairly. Or
we might infer instead that this generates a special obligation to ensure that
all benefit from the knowledge, by making access not dependent on insurance.
Here is a second, more
profound issue. It is partly about whether it is fair to involve certain
subjects in a trial. But it crosses categories and involves as well whether
subjects will have adequate knowledge for informed consent, or, if they do,
will in fact volunteer. The issue involves taking seriously a particular
motivation for subject participation (altruism) and the way different goals can
be intertwined in research.
A central part of the reason
people volunteer to be subjects in human experimentation is altruism. They may want to give back to the medical
enterprise which has benefited them in the past; they may have taken on the
general goal of finding a cure for a given disease. But surely such prospective
volunteers will normally assume that the benefit potentially produced by their
participation would be to the therapeutic enterprise, not to the enhancement
enterprise, so if in fact it instead went to the enhancement enterprise
(indeed, if that was a significant part of the motivation of the research),
this would not respect those subjects but instead exploit them. On the one
hand, this argues against the moral fairness and thus legitimacy of enrolling
such patients. But note that it also
has implications for the practical matters of future trust, cooperation and
recruitment.
Of course, a subject might
potentially be altruistic in this broader way – for instance, having the goal
of “giving back” to society as a whole, not just to the therapeutic
enterprise. This fact reminds us that we need to have a better
understanding of what the reasons are for agreeing to be part of human
research, and whether this might be different in the case of enhancement
research. (And this again calls for
some empirical research.) But I do take the narrower sort of altruism to be
more likely – that a subject would be less likely to go along in the hope of
contributing to enhancement capabilities rather than therapeutic capabilities –
and so this poses the above problem for enhancement research.
This is an especially thorny
issue because research will often serve a dual purpose – partly for knowledge
about therapy and partly for knowledge about enhancements – and it will be
difficult or perhaps impossible to tease apart the actual benefits, let alone
the intended benefits and motivations for the research (and, relatedly, the
potential subjects’ perceptions of all this). This will be more so in the case
of more basic research that will have widely applicable results, but it might
be hard ever to separate it out completely. And of course the more enhancement
treatments “take off” and become especially prominent and profitable, the more
it could come to take up (and be perceived as taking up) a significant portion
of the driving force of research.
Again, part of the response
could be to ensure that various classes of society do indeed benefit from the
technologies generated. But note that the issue here is partly a matter of
whether benefits go to the wealthy or to all, but also partly a matter of
identification with the therapeutic enterprise or the enhancement enterprise.
Hence the problem is not completely resolved even by ensuring that the
resultant interventions will be made available to all.
Conclusion
Much of the ethics of enhancement
research on human subjects will be the same as that concerning therapy
research on human subjects. But I have identified various relevant differences
within each of the categories of social value, risk/benefit ratio, informed
consent, and subject selection. The basic claim is that those pursuing and
evaluating this research must take note of these differences, and not just
proceed on the assumption that we have already addressed these questions with
our experience with research on therapies (or, worse, that such issues don’t
even arise because this is not clinical research).
The assessment here doesn’t
all go in one direction; it is not that overall there are moral reasons making
research on enhancement more morally difficult. Rather, some of the features
make such research more morally problematic in certain ways (and hence these
things might be used in arguments against pursuing enhancement). But some of
the features may actually ameliorate some of the moral tensions that exist in
human subjects research.
Relatedly, these are not the
kind of considerations that apply across the board. Much depends on the
particular features of a given case. For example, I have focused on aspects
arising from inequality. But if one can identify enhancements that really will
be affordable and helpful to all, then for those cases, these concerns don’t
apply. Still, something’s being an
enhancement technology should heighten our awareness of the possibilities of
this concern.
Again, we are
reminded throughout this discussion that, in order to adequately address the
set of ethical issues concerning this research, we really need more empirical
information about a number of matters (how the subjects of such experiments
might be different, why subjects in fact decide to participate, the likelihood
of actually making various enhancements widely available after testing, etc.).
So there is also more of this sort of research to be done before we can be
confident of our judgments here.
References
Appelbaum, P., L. Roth, C.
Lidz. 1987. False Hopes and Best Data: Consent to Research and the Therapeutic
Misconception. Hastings Center Report 17: 20-24.
Emanuel, E., D. Wendler, and
C. Grady. 2000. What Makes Clinical Research Ethical? Journal of the
American Medical Association 283: 2701-2711.
Gifford, F. 1986. The
Conflict Between Randomized Clinical Trials and the Therapeutic Obligation. Journal
of Medicine and Philosophy 11: 347-366.
Notes
1. These four are amongst a group of seven
kinds of considerations determining the ethical acceptability of research on
medical therapies identified by Emanuel, et. al. (2000), who also include
scientific validity, independent review, and respect for enrolled subjects.