HUMAN AND ANIMAL EXPERIMENTATION

Conceptual Issues

human experimentation: experimentation using human being as research subjects
therapy: activities -- including treatment, diagnosis and even some preventative measures (e.g. vaccination) -- whose primary purpose is

to relieve suffering,
restore or maintain health,
or prolong life

research or experimentation: activities whose primary purpose is to develop or contribute to generalizable knowledge
therapeutic research

aims to develop or contribute to generalizable knowledge
while at the same time providing treatment benefits to the patient-subjects
example: first human patients to undergo some new procedure, e.g., coronary bypass surgery

nontherapeutic research

has the sole purpose of developing or contributing to generalizable knowledge
not intended to result in therapeutic benefits for subjects

therapeutic vs. nontherapeutic research

not always the brightest line between them

often "therapeutic" research requires patients to undergo procedures -- e.g., catheterization & blood drawings -- for no therapeutic purpose
often nontherapeutic research provides indirect benefits -- e.g., closer medical care -- for the subjects

nevertheless widely thought to be a useful rough & ready distinctions

many codes of research ethics -- e.g., the Declaration of Helsinki (in our text) invoke it
like another rough & ready but elusive distinction: acts v. omissions

general consensus: in therapeutic research a slightly higher degree of risk to subjects is ethically permissible

The Justifiability of Experiments Using Human Subjects

To the extent that human experimentation exposes subjects to risks -- as it generally does -- it requires justification
Utilitarian Justification

Two ways in which research is beneficial

Human research enhances the discovery of new therapeutic and diagnostic techniques, e.g.,

polio vaccine
transplants
coronary bypass surgery

Controlled experiments are necessary for sound medical practice

to weed out treatments that have no therapeutic benefits (e.g., bloodletting)
even harmful treatments

Where these outweigh the risks of harmful consequences to subjects the research will be justified:

human experimentation is not only morally permissible
but morally required or obligatory

Justice-based Justification

We are the beneficiaries of advances due to past medical research.
Therefore, we have a moral duty to reciprocate by serving as subjects ourselves
Rejoinder:

Medical progress is an optional goal, not an imperative.
Therefore, no obligation to participate in research can be derived from this goal.

The Informed-Consent Requirement

Discussion of human experimentation focuses on the question of under what conditions it is ethically permissible

Different codes of ethics identifying these conditions have been formalized, the most important being

The Nuremberg Code and
The Declaration of Helsinki

These codes focus on consent

voluntary informed consent of subjects or
proxy consent where appropriate

Justification of the informed-consent requirement

Deontological justification: appeal to principle of respect for autonomy or respect for persons

We are required to protect and promote the autonomy of human beings.
Experimenting on subjects without their informed-consent is a violation of their autonomy.
So, we ought not to experiment on subjects without their informed-consent.

Serves as a deontological check on any attempt to justify the use human subjects solely on utilitarian grounds

even if the social benefits are very great
subject-consent must be obtained

Special causes for concern

historical causes: egregious failures of some past research to comply with the informed-consent requirement

Nazi experiments on nonconsenting adults spawned the Nuremberg Code
U.S.A.

Cold War radiation exposure experiments
The infamous Tuskeegee syphilis experiments: longitudinal study

of syphilis infected black males
who were not informed of the availability of an effective treatment (penicillin)
after this was discovered.

cultural causes

racism

apparent in both the Tuskeegee
also the Nazi case: Jews & Gypsies were among the unfortunate subjects

war and the surrounding atmosphere

makes lives seem expendable

like Rick told Elsa in Casablanca: "the problems of two little people don't mean a hill of beans"
so too in wartime the informed-consent of a few experimental subjects might seem not to mean a hill a beans

just plain sadism & cruelty: the Japanese -- sex change -- experiment on my friends uncle

Proxy Consent for Research Subjects Incapable of Informed-Consent

Research involving children

insofar as children are incapable of fully comprehending the situation they cannot give informed consent
therapeutic research: usually agreed that proxies, such as parents, can consent on the child's behalf
nontherapeutic research on children: controversial whether this is ever permissible

In favor of nontherapeutic research using children

point in favor: such research benefits children as a group

the correct dosages and degrees of treatments for children can't simply be extrapolated cases of adults
there are diseases that are unique to children, e.g. infantile autism

Richard A. McCormick

parents can give a valid proxy consent to nontherapeutic pediatric research when

the risks are minimal
the potential benefits to children as a group are great

natural law theoretic justification

humans are by nature social animals
as such have obligations to society, even as children

to undertake to benefit society
when it involves minimal risk to themselves

Against nontherapeutic research using children (Ramsey)

All human experimentation must be a joint venture, freely undertaken by two autonomous persons.
Therefore, proxy consent is not valid for nontherapeutic purposes.

Research on incompetent adults, e.g. Alzheimer's patients (Brown)

such may be permissible given proxy consent
if the research would benefit Alzheimer's patients as a group

Experimental Design and Randomized Clinical Trials

The randomized clinical trial (RCT) is considered the "gold standard" of clinical research
RCT

comparison of two or more treatment arms
scientifically controlled with random assignment of subjects
to study the efficacy of new therapies

Dilemma for researchers presented by RCT

typically at the beginning or at some point during the study, researchers have an opinion about which course of treatment

will be more effective
or already appears to be proving more effective

the dilemma this poses: to see the study through or to act in what they believe to be the subjects best medical interest

to share their opinion & perhaps even to switch the alternative therapy or control group over to the "best bet" therapy
to complete the experiment to conclusively determine if their best bet really is correct

Appeal to equipoise (Benjamin Freedman) softens this dilemma

equipoise exists when within the medical community there is genuine uncertainty about the relative merits of the treatments being compared
regardless of their own opinion, researchers are warranted in conducting and continuing RCT where such equipoise exists.

Semi-Randomized Trials (Veatch)

subjects -- especially those who are socially disadvantaged
should have the option

of submitting to randomization
or of receiving the therapy of their choice, typically

the standard
the experimental

by doing this

justice will be served
and science will not be seriously compromised (at worst, we might need larger sample sizes)

randomization already compromised by permission of dropouts

at any point someone on the experimental arm may choose to drop out
and receive the standard therapy

Animal Experimentation

The importance of the research
The moral status of animals

Singer

the interests of animals should be given equal consideration to those of humans
the vast bulk of animal experimentation

causes great harm to animals
while rarely achieving important goals

the use of animals in research is justified only when the use of a human with similar mental capacities would also be justified

Sommers

animals' interests deserve serious consideration

their interests in avoiding suffering in particular

but human lives have greater value than animal lives
therefore the use of animals is justified in some instances when the use of humans with similar mental capacities wouldn't be

Issues involving therapeutic uses of animals, e.g., in transplanting animal organs into humans (Nelson)