What is the South African Medical Research Council's ethics
MRC recognises injustices in our past and subscribes to the
values enshrined in the Constitution of the Republic of South
Africa Act, No 108 of 1996: human dignity, the achievement of
equality and the advancement of human rights and freedoms.
policy of the MRC is clear. All research sponsored by the Council
must be of the highest ethics standard. No research will be
sponsored without ethics clearance from a Research Ethics Committee
recognised by the Council and operating in accordance with MRC
1.2 For whom are these Guidelines intended?
MRC Guidelines are concerned with research on human participants
and animals. The Guidelines consider all forms of research on
individual persons, whether they be volunteers or patients,
and include the study of treatment which might benefit the individual
patient (therapeutic research) and the acquisition of knowledge
that may be of no immediate benefit to the healthy volunteer
(non-therapeutic research). These Guidelines apply also to non-clinical
research on humans. Guidelines on ethics in the use of animals
in research are dealt with in Book 3 of the current MRC Guidelines
in the chapters of this Book 1 of the series Guidelines
on Ethics for Medical Research is extensively based
on three previous editions and on international documents1-9
(see also Appendices V - VII) but is adapted for South African
conditions and law.
1.3 Ethics principles
The MRC promotes the four principles of biomedical ethics:
(respect for the person - a notion of human dignity)
(benefit to the research participant)
(absence of harm to the research participant)
(notably distributive justice - equal distribution of risks
and benefits between communities)
considerable debate about whether one or more of these principles
require or deserve preference when ethical problems are considered.
For example, the trend in most Western countries seems to emphasise
autonomy over beneficence. This counters the alleged danger
of paternalism in the practice of medicine, and emphasises the
importance of the consent and freedom of patients in making
decisions about their own health and well-being. Such views
are questioned in the context of many developing countries,
where solidarity within communities is valued together with
respect for individual choices, and where there is increasing
concern about conflict between personal autonomy and public
safety in the face of, for example, infectious diseases such
as tuberculosis and, particularly today, the HIV/AIDS pandemic.
Concern for distributive justice in developing countries also
enjoys a higher priority than in some wealthy Western nations.
is convinced of the importance of adherence to the four classical
principles of biomedical ethics, and of the importance of human
rights and individual dignity, but it takes no prejudicial position
in debates on the ranking of these principles. The MRC also
does not commit to any one approach to moral reasoning or to
any one strategy for the resolution of complex ethical dilemmas.
It seems clear that, in most disputes in biomedical ethics,
some balance between the four principles should be pursued.
In maintaining commitment to the classical principles, the complexities
of each case must be understood and taken into account in any
effort to make justified moral judgements. Of more importance
than the consistent adherence to a specific approach or strategy
for the resolution of moral dilemmas, is the willingness and
ability to justify whatever position is taken, through sound
of ethics standards requires a critical evaluation of the relative
merits of each of the four principles of ethics to produce a
harmony appropriate to a particular research project.
What is research?
What constitutes research on humans?
an activity is undertaken with the sole intention of benefiting
an individual patient, and where there is a reasonable chance
of success, that activity may be considered to be part of clinical
practice. The progressive modification of methods of investigation
and treatment, in the light of a clinician's experience, is
a normal feature of clinical practice and should not be considered
is a systematic investigation, including research development,
testing and evaluation designed to develop or contribute to
generalisable knowledge. Any such investigation raises ethical
issues. The issues themselves may be small, but because studies
may involve subordination of at least the immediate interest
of the individual participant to the objective of the advancement
of knowledge, they must be subject to ethics review.
220.127.116.11 Therapeutic research
aim of therapeutic research is to benefit the individual research
participant or patient by treating or curing their condition.
18.104.22.168 Non-therapeutic research
aim of non-therapeutic research is to benefit people other than
the research participant. The participant or healthy volunteer
may unexpectedly become a direct or indirect beneficiary of
non-therapeutic research. The acquisition of knowledge may be
of no immediate benefit to the participant or healthy volunteer.
22.214.171.124 Intervention research
is always invasive and interferes with the research participant's
mental or physical integrity by, for example, the removal of
bodily material, the introduction of (contrast) fluids into
the body or the use of a procedure or method that has not been
adequately tested. It always involves risks, the magnitude of
which may be unpredictable.
126.96.36.199 Observation research may be:
involving no risk and no interference with the mental or physical
integrity of the human being; for example, the unlinked and
anonymous gathering of information about the person by means
of a questionnaire or from clinical records, the unlinked
and anonymous examination of a specimen taken from a patient
for a clinically indicated intervention; measuring; observing.
of mental or physical integrity, but involving no risks or
only negligible risks which are known from routine medical
experience; for example, the taking of one blood sample, the
collection or urine or of slightly more bodily material than
is strictly necessary for a normal, medically indicated intervention.
Clinical practice and research
distinction between clinical practice and research is often
less clear than is suggested above, because both may be practised
simultaneously on the same person. Any activity aimed at obtaining
knowledge affecting a person in any way, and which is additional
to ordinary clinical practice, is to be regarded as research
(see also 7). A useful rule of thumb8 is that if this new knowledge
is generalised or transferred to others, or presented at a scientific
meeting, or submitted for publication or for a higher qualification,
it is research. Clinical audits through examination of patient
records; observation of activities of individuals; health systems
research to improve efficiency, cost-effectiveness and equity
in health care, all are recognised as valid research.
188.8.131.52 Non-clinical research
This type of research includes studies of anatomy, physiology
and laboratory investigations not involving patients.
special circumstances of an individual patient's illness
lead a clinician to step outside what is accepted as normal
clinical practice. Innovative treatment does not necessarily
innovative treatment, the sole motive for the action is
to choose the best possible course for the individual patient,
even though it may be unconventional. The responsibility
for using innovative treatment is that of the clinician,
who remains subject to the usual constraints that direct
ordinary clinical practice.
a clinician contemplates a marked divergence from normal
clinical practice in an individual case, with the prime
purpose of acquiring information for application to future
patients, the activity becomes research and must be subject
to all the considerations of proper informed consent and
scrutiny by Research Ethics Committees described here. A
useful rule of thumb is to consider the 'intent' of the
clinician - if the intent is to apply information to others,
or to present it at a scientific meeting, or submit it for
publication or for a higher qualification - in other words,
to contribute to generalisable knowledge - this is research.
a major innovation is called into regular use and the procedure
is not yet incorporated into clinical practice generally,
the innovation should become the subject of formal research
without delay, so that its true worth may be established.
research focuses on concise concepts as well as on variables,
and collects information under controlled conditions. It
uses structured and established procedures to collect information,
and uses objectivity in the analysis of information. Quantitative
research analyses numerical information using statistical
procedures, it involves logistic and deductive reasoning,
and the investigator does not interact with the event being
research attempts to understand phenomena in entirety. It
comprises research to understand social and cultural problems,
and focuses on interactive processes to collect subjective
information that is not structured numerically, but intuitively.
Qualitative research attempts to understand human experience.
It analyses thematic and narrative information. The investigator
interacts with people in a sustained manner.