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Annex IV/D
ETHICAL
ON RESEARCH
GUIDELINES
INVOLVING
HUMAN
SUBJECTS
Introduction
Principles
The need for human research
Definitions
Fundamental principles
Assessment of risk and benefit
Consent
Confidentiality
Implementation
Areas of responsibility
The Research Ethics Committee
responsibility
and objectives
composition
operations
assessing research
continuing
Other
proposals
review
accessibility
issues
Reference Materials
Acknowledgements
Appendices
I
Example of Consent Form
II
Members
Aug 97
of the Working
Group on Human Research
ETHICAL
GUIDELINES
ON RESEARCH
INVOLVING
HUMAN
SUBJECTS
INTRODUCTION
1.1
Although
adhere
it
is now generally
to codes
establish
more
accepted
accepted
such as those
detailed
that
research
of
the
Helsinki
guidelines
to
help
on human subjects
Declaration,
there
investigators
should
is a need to
conform
to
generally
principles.
1.2
Currently, individual medical institutions in Singapore have ad hoc ethics committees
to review the ethical acceptability of research proposals involving human subjects.
In the absence of general guidelines with broad community support, differences of
opinion between the investigators and ethics committees are often difficult to
resolve. The lack of clear guidelines may either hinder useful research or result in
inadequate protection of potential experimental subjects.
1.3
The objective of these guidelines is not to tell those responsible for making ethical
decisions what course of action they should take. Rather, the purpose is to provide
a broad framework of ethical principles which local ethics committees should take
into consideration in their deliberations and to suggest procedures which these
committees should follow in the decision-making process. The ultimate goal is to
encourage awareness among research workers of the ethical values which are
acceptable to the community, bearing in mind that ethical principles may change with
time and with changes in public perception.
PRINCIPLES
2.1
The need for human research
It
is clear
that
research
The discovery
example.
Animal or other
human studies.
continuing
2.2
on human subjects
advances.
has resulted
in significant
of the smallpox vaccine by Edward Jenner
models of biomedical
The careful
study
research
of human disease
medical
in 1796 is a good
cannot
entirely
is a necessary
replace
part
of the
as studies
which
process of improving diagnosis and treatment.
Definitions
2.2.1
Research.
generate
Human
individual's
well-being.
generation
patient
result
this
research
can
data about human subjects
The
mayor
manner.
directly,
records,
for
directly.
does not alter
human research
subjects
purpose
or the testing
may not benefit
the activity
broadly
includes
not related
of
research
The fact
that
surveys
patient's
is the
The individual
some benefit
as "research".
not only studies
to the
activity
of a hypothesis.
its status
but also epidemio logical
purposes
defined
which go beyond what is needed for the
primary
of new information
from
be
which
in
involve human
and reviews
immediate
may
Defined
of patient
health
care