| 3.
What is meant by research ethics? |
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3.1
General philosophical concerns and human or anthropological
perspectives on ethics in medical research
3.1.1
Medical ethics
Ethics is the science of criteria, norms and values
for human action and conduct. It is engaged in reflection and
analysis of morals concerning whether an act is good or bad
and how it influences our basic quest for meaning, our search
for humanity and our attempt to create a humane society. Its
intention is to safeguard human dignity and to promote justice,
equality, truth and trust. In a nutshell, ethics is critical
reflection on morality.
Medical
ethics is not only about the moral behaviour of clinicians,
but about ethics and health care. It can be described as the
reflection on moral actions within the framework of health care.
Its objective is to promote health, to care, to heal, to alleviate
pain and to prevent suffering.
Ethics
for health research is the enterprise that determines norms
and values to guide the systematic reflection and scientific
evaluation or assessment of clinical knowledge and any form
of experimentation or survey, with the prime objective of promoting
health care. Its sole intent is to benefit patients, to alleviate
pain and to prevent suffering.
3.1.2
Basic assumption and point of view
The
basic ethical assumption in health research is the autonomy
of the individual within the broader context of human relations.
The social and cultural environment should be taken into consideration
in all circumstances. People should be treated as human beings
in the context of their social, political, economic and religious
environments. Assessment of both patients and healthy volunteers
in research programmes should be made within the context of
the family and cultural system. Research programmes should treat
people as part of a community while simultaneously respecting
their individual autonomy. This is of paramount importance for
health research in an African context.
3.1.3
Basic ethics codes of behaviour
The
following should apply to any research programme:
- The
participant as a person
Respect for the autonomy of the participant, whether patient
or volunteer, demands that the participant must be treated
as a unique human person within the context of his or her
community system. Freedom of choice must be safeguarded.
-
Human rights
Respect for the basic rights of the individual as a human
being as well as the rights of groups and communities.
-
The ethic of justice, fairness and objectivity
Research should always respect the dignity of people involved
and should never expose them to intentions and motives not
directly attached to the research project, its methodology
and objectives.
-
Competence
Researchers must be professionally and personally qualified.
In all circumstances they must be accountable and act in a
responsible manner. Professional standards should be upheld
in accordance with academic training.
-
Integrity
Integrity should be promoted by being honest and fair. Researchers
must be honest about their own limitations, competence, belief
systems, values and needs.
-
Sensitivity
Sensitivity in research implies balancing scientific interest
(the research) with general values and norms affecting the
human dignity of the people involved.
-
Confidentiality
Confidentiality must be respected under all circumstances.
Documentation should be safeguarded and viewed as strictly
private in terms of the limits set by the research project.
-
Demarcation of roles
There should be mutual understanding of the roles and interests
of investigators and participants in research.
-
Communication
Clear and understandable verbal communication is required,
with factual data. Emotional and cultural values should be
considered.
-
Possible dangers to be taken into consideration
- The
danger of objectification and fragmentation
Special care must be taken not to treat a participant
as a mere object. Research objectives are subordinate
to the following principle: to treat human beings with
respect.
- The
danger of direct or indirect coercion
Direct or indirect coercion of people in the name of research
must be avoided under all circumstances. Coercion may
include the exploitation of vulnerable people; taking
undue advantage of a participant, volunteer or any other
person; or the misuse of the authority and influence of
the research.
4. The medical justification for research
4.1
Healthy volunteers
Research
on healthy volunteers is required to gain knowledge in two main
fields, outlined below.
4.1.1
Human biology and psychology
Further
knowledge of human biology and psychology is important in its
own right and also because it increases understanding of disease.
Research may be by observation or experiment.
4.1.2
Medicines, cosmetics, medical devices and other agents
| 4.1.2.1 |
New
medicines intended for human use need to be tested in humans
to discover whether they are effective and safe, and to
determine appropriate dosages. The response to drugs in
humans may be different from that in laboratory animals.
|
| 4.1.2.2 |
It
may be argued that it is more ethical to test medicines
on patients who might benefit, rather than on healthy volunteers,
but there are advantages in doing initial studies on healthy
volunteers. In healthy persons there is less physiological
variation and their responses are likely to be more uniform.
Healthy persons are often better able to collaborate in
more complex experiments, and the ethical dilemmas of treatment
with an inadequate dose, or of withholding potentially effective
treatment, do not arise. |
| 4.1.2.3 |
Where
harmful effects of a medicine may be expected at therapeutic
dose levels, it is unethical to use healthy volunteers.
With certain drugs, such as those for cancer or leukaemia,
it is necessary to undertake initial studies on patients
who might benefit. |
| 4.1.2.4 |
Cosmetics
and other substances, such as domestic washing powders used
on or by humans, may need to be tested on healthy volunteers.
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4.2 Patients
(See also 6.1)
Much important health research is carried out in non-clinical
laboratories and some research into novel treatments requires
prior testing in animals, but the ultimate test of the effectiveness,
safety and relevance of clinical procedures, investigations
and treatments is whether they can be shown to be of benefit
in patients. The aim of research on patients is to benefit the
individual and/or society. Research on patients falls into five
main
categories:
4.2.1
Causes of disease
The
individual patient usually does not benefit from the results
of such research. The character of the research may vary greatly,
from non-intrusive epidemiological studies to surgical removal
of tissue for examination. In the latter case, patients are
necessarily intimately involved and there is a clear need to
protect them from unwillingly or unwittingly being subjected
to discomfort or hazard. Epidemiological studies usually involve
no risk of bodily discomfort or harm, but issues of privacy
and confidentiality may arise and special safeguards may be
necessary.
4.2.2 Improvement of the diagnosis or assessment of disease
The
bulk of research intended to improve the diagnosis or assessment
of disease inevitably involves the personal participation of
patients and takes a variety of forms. Patients do not usually
benefit directly and, if they do, this may be no more than a
fortunate by-product of the research.
4.2.3 Improvement of the treatment of disease
Before
new medicines are given to patients, they are commonly tested
in animals and, usually, also in healthy volunteers. However,
to determine their value and safety they must eventually be
studied in patients who need them. It is normally necessary
to compare the outcome in a large number of patients, some of
whom receive the new treatment and some of whom receive standard
treatment (control patients). Some trials may also require the
use of inert or placebo preparations for comparison.
4.3.4 Health care in communities
Patients
have an essential role to play in studies designed to assess
the effectiveness of health care, even when novel treatments
are not involved.
4.2.3 Basic human biology
Much
research into the functioning of the human body and mind involves
healthy volunteers and is based on the study of the whole individual,
or of tissues or body fluids. Sometimes the study of patients
who have a particular abnormality, or who are undergoing a diagnostic
or therapeutic procedure, may be the only means of obtaining
new information about human biology. Benefits that result from
the new information may be obvious in terms of their potential
application to the development of new diagnostic tests or treatments.
Sometimes, however, the information may be considered worth
seeking as an addition to overall understanding with only an
uncertain, remote or indirect chance of benefit to patient care.
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