Ethical Guidelines for

Biomedical Research and Scientific

Medical Writing
Djamhoer Martaadisoebrata
Bioetics & Humanities V (Session V VI)

Unit Bioethics and Humanism,
School of Medicine, University of Padjadjaran
INTRODUCTION
Bioethics and Humanism in Medical Education
1. Philosophy of science
2. Social & cultural science (health anthropology)
3. Health behavior
4. Ethics in medical profession
4.1 History of medicine
4.2 Legal aspects in medicine
4.3 Ethical guidelines in medical profession
4.4 Ethical guidelines in biomedical research
and scientific medical writing
Why do we need biomedical research ?

Many aspects of disease are still unknown
or controversial, such as :
Epidemiology
Etiology
Risk factors
Pathogenesis
Diagnosis
Etcetera
Why is ethical issues important in
biomedical research ?

Without ethical consideration, subjects
might be exposed to :
@ Violation of human right
@ Unnecessary risks, (death or disability)
@ Inconveniencies
Examples : Jews prisoner of war
Pellagra study, etc.
Development of ethical issues in biomedical
research

Vow of Hindoes Doctors (1500 AD)
Do not inflict damage to the patients
Hippocrates (400 AD)
Per primum non nocere
Neuremberg Code (1955)
Declaration of Helsinki (1964 1996)
CIOMS (1982)
Ethical Commission on Biomedical
Research, Indonesia (1982), Bandung (1993)
Guidelines for Biomedical Research
# Declaration of Helsinki (Revised 1996)

1. Basic principles
1.1 Must conform to general accepted
scientific principles and animal
experimentation
1.2 Research protocol reviewed and
approved by Independent Ethical
Committee
1.3 Must only be performed by qualified
and competent scientists (clinicians)
1.4 The important of the objective must be in
proportion to the inherent risks
1.5 Should be preceded by careful assessment
of predictable risks, and the interest of
subject must prevail over the interest of
science and society
1.6 The integrity of subject must be
respected
1.7 Physicians must take into account all
predictable risks, and cease the study
when it occurs.
Continued
1.8 Results must be published accurately
1.9 A complete and clear information should be
provided to the subject before asking for
Informed Consent (IC) and that they are
free to withdraw at any time they wish
1.10 IC should not be obtained by caring
clinician
1.11 In case of legal incompetence, IC should
be obtained from legal guardian
1.12 Ethical consideration should be included in
the protocol
Continued
2. Medical research combined with
professional care (clinical research)

2.1 Physician are allowed to apply new method
in D/ or Th/, if it is beneficial to the
patient
2.2 Benefits, hazards and discomfort should
be compared with the best current
method
2.3 Subject must be provided with the best
method of D/ and TH/
2.4 The refusal of subject should not interfere
with physician-patient relationship
2.5 In certain cases IC might not be essential,
yet this exception should be stated in the
protocol
2.6 Biomedical research may be combined with
professional care if it is beneficial to the
patient
Continued
3. Non-therapeutic biomedical research
involving human subject (non-clinical
biomedical research)

3.1 In purely scientific research, physician must
protect the life and health of the subject
3.2 Subjects should be volunteers either
healthy persons or patients for which the
study is not related to their disease
3.3 The investigator should discontinue the
study, if in his/her judgment it may be
harmful
3.4 The well being of subject is more important
then science and society
# International Ethical Guidelines for
Biomedical Research Involving Human
Subjects

Introduction
Adopted in 1982 as a result of collaboration
between WHO and CIOMS, because new
advances in science and biotechnology has
raised ethical questions not foreseen when
Declaration of Helsinki was formulated.
Example : AIDS study
Two points merits special attention :

The basic ethical principles are :
respect for persons, beneficence and
justice
Scientifically unsound research protocol
on human subject is ipso facto unethical
# Guidelines for Good Clinical Practice
in Indonesia

Issued by the Dept of Health in 2000,
completely adopted from ICH-GCP, with
supplement related to Indonesia
Clinical Trial
Technical term for studies on drugs or
devises using human subjects
Can only be used after complete animal
experiment
Consists of 4 Phases :
Phase I

# Conducted in hospital under strict
supervision.
# Small number of healthy volunteers
# Objective : to study the kinetic and
dynamic of the drug
# Ethically speaking it belongs to non-
therapeutic research
Phase II

@ Subjects : small number of patients,
carefully selected

@ Objective: to study the effectiveness
of the drugs
Phase III

Subjects : bigger number of patients
with rather loose selection
Rare side effect may be encountered
With satisfactory result, it will be
ready for marketing.
Phase IV (Post Marketing Study)
Still has to be done due to some weakness
in the preceding phases, such as :

number of subjects is limited and selected
clinical situation is different than
population
long term side effects are still to be
discovered
relationship between the use of drug and
the population factors must be investigated
Weakness of Phase IV

Number of subjects are too big
Supervision are rather loose
Discovery of side effects might be too
late.
Remember the case Thalidomide-Phocomelia
Special requirements for Phase IV

Study design should be meticulously prepared
Team consists of clinician, epidemiologist and
statistician
Separate ethical clearance must be obtained
Special precaution should be exercised to
protect subjects
Evaluation should be done periodically.
Informed Consent (IC)

Consent given by competent individual
after having received satisfactory
information

Investigator Subjects
Information

Consent
Essential information

The expected duration of participation
The aims and method of research
The expected benefits
The foreseeable risks and discomfort
Essential information (Continued)
Alternative procedure or course of
treatment advantageous to the subjects
The extent of confidentiality
The extent of investigators responsibility
Possibility of compensation for subjects
family or dependants
The right to refuse or withdraw at any
time they wish
Special subjects

Children

Children is indispensable for research into
diseases of childhood to which children
are particularly susceptible
Should not be involved in research that
might equally well be carried out with
adults
The purpose is to obtain knowledge relevant
to the health need of children
The parent or legal guardian has given
proxy consent
The consent of each children has been
obtained to the extent of the childs
capability
Continued
Pregnant or nursing women

In no circumstances be subjects to
non-clinical research, except in
special cases, such as AIDSstudy
Can only be used in Clinical Trial, if
non-pregnant or nursing women are
not suitable for the study
Persons with mental or behavioral
disorders

Should not be used in research that might
equally be carried out in normal persons
Objective : to obtain relevant knowledge
IC has been obtained to the extent that
subjects capability
In case of incompetence, IC obtained from
legal guardian
Persons with vulnerable social status

Medical or nursing students
Hospital, laboratory and pharmaceutical
workers
Prisoners
Military forces
Their IC might be biased

Developing communities
Most subjects are layman
IC obtained from local leaders
Ethical aspects in Scientific Medical
Writing (SMW)

Every study must be completed with
SMW
It is ethically unacceptable not to
publish its results
Scientific writers must be honest with
noble intention
No law against dishonest writer, only
ethical sanction can be applied
Standard structure of scientific writing

Title
Name of author(s)
Summary Introduction
Materials and methods
Results
Discussion and conclusion
Acknowledgement
References
General ethical issues

One article, one publication
Publishing one article in two different
journals, not permissible
Permission must be obtained from the
related journal, if another publication is
wanted
For congresss articles, permission must be
obtained from committee
It is unethical to make small series of
articles from one whole article
Other investigators contributing some data,
should be in included in preparation of
paper
Permission should asked before using other
peoples data
Continued
Special issues
#Related to each element of standard
structure

Title
Must be precise, logic and accurate
Bombastic title should be avoided
Must not be part of propaganda or promotion
No personal interest
Must have some bearing to the studys issues
Name of author(s)

Author(s) : only persons actively involved
Author(s) must be aware of their
involvement, and will be held responsible
for the content and form of article
Sequence of author(s)s name must be
related to their role
Candidate researcher could act as main
author, with his senior as co-author