| Book
4: Foreword to the fourth edition |
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In his foreword
to the third edition of these Guidelines, Professor Solly Benatar
eloquently wrote of the 'resurgence of interest in the moral
aspects of medical practice' including research. In the intervening
years, that interest has increased at an exponential rate. Investigators,
participants and sponsors have become more aware of rights and
responsibilities.
This increase
in ethics information has made the task of the Editorial Committee
a difficult one. We decided to keep the basic framework of the
third edition, but to split the original single volume into
five. Our reasoning is that this will facilitate future updating
and reprinting and will enable people with specific interests
to find the book that suits them best. We tackled much of the
task ourselves, but approached experts in specific fields to
produce specialised sections. To these colleagues we are indebted,
and they are acknowledged in the front of each book.
As with
anything written by different teams, there are differences in
style for which we ask our readers' indulgence. Fortunately
the differences have been eased by the editorial skills of Mr
Brian Johnson-Barker. For consistency throughout the books,
the 'research subject' has been replaced with 'research participant'
to emphasise the team approach, 'researcher' is now 'investigator'
and 'doctor' is now 'clinician'. This last term acknowledges
that clinicians other than doctors do medical research.
The large
section on clinical trials that appeared in the third edition
has been removed. In its place there is reference to South African
and international Good Clinical Practice Guidelines. We saw
no need to reinvent the wheel and thereby waste scarce resources.
Of course
these Guidelines are among many produced round the world. While
all share principles, inevitably there are differences. Such
differences have been starkly indicated by the passionate response
to the 2000 revision of the Declaration of Helsinki (Appendix
VI, in Book 1: General Principles) which has been welcomed
by some and rejected by others. Our Guidelines have a developing-country
perspective, an African outlook, we believe. Our approach has
been strongly influenced by the South African Constitution,
which was adopted in 1996 and entrenches in the Bill of Rights
the principle of informed consent of participants in medical
and scientific experimentation. Given the vulnerable populations
in our country, the Editorial Committee's decision has been
to emphasise the principle of autonomy - particularly from the
perspective of 'non-exploitation' of research participants.
The theme of 'informed consent' recurs throughout. This is a
complex matter and recommended reading includes the excellent
compendium of views produced by the British Medical Journal
(Doyal L, Tobias JT, Editors. Informed consent in medical
research. London: BMJ Books, 2001: 1- 334).
There are
two final points. First, there is considerably more 'legalese'
in this edition. This is deliberate and has arisen from the
many queries directed to members of the Ethics Committee. Second,
we accept that there will be colleagues who disagree with some
things we have written; some may have additional points and
some may spot errors. Please send comments to the MRC (see the
HealthInfo website mentioned on page v) so that whoever
writes future editions may consider them.
The Editorial
Committee
There
are five books in the series Guidelines on Ethics for Medical
Research.
Book
1
Guidelines
on Ethics for Medical Research: General Principles.
Book
2
Guidelines
on Ethics for Medical Research: Reproductive Biology and Genetic
Research.
Book
3
Guidelines
on Ethics for Medical Research: Use of Animals in Research.
Book
4
Guidelines
on Ethics for Medical Research: Use of Biohazards and Radiation.
Book
5
Guidelines
on Ethics for Medical Research: HIV Vaccine Trials
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