Transcript Ethics in socio-medical research

Ethics in medical research
Professor Ayo Ojuawo
Deparment of Paediatrics
University of Ilorin
[email protected]
Introduction
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Ethics in research is very critical and must be
addressed in proposals. Ethics is about what
is morally right and proper in research.
Ethics are vital because of past atrocities in
research work. Examples are the experiments
conducted by the Nazi doctors on Jews, the
Tuskegee experiments in the United States
etc.
While researchers in biological sciences and
medicine have always taken ethics seriously,
those in the social have not been inclined to
do so.
Every one is required to address ethics and
comply with, and do research in ethically
proper way today
What is Biomedical Ethics?
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Ethics is a philosophical consideration of
morals- right or wrong
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It is a process of thinking, of morals, of
behaviour and intentions
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Ethics evolves out of a collective
responsibility to humanity
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The term “bio-medical ethics” was coined in
the early 1970s to refer to the application of
moral reasoning to vexing questions at the
frontiers of biology and medicine
What constitutes a
Research?
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Sometimes it can be difficult to distinguish
research from program evaluation, health
care or public health interventions
If the goal is “generalizeable knowledge,”
then the activity is research
If the goal is generate knowledge relevant
only to a particular individual or program,
then it is not
Cont’d
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All healthy research must be
scientifically sound to be ethical
The scientific merit of any research
must be matched with the ethical
process
Unsound research on human
subjects may expose research
subjects to risks or inconvenience.
The Evolution of Research Ethics
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Ethical review and bio-medical ethics evolved
in response to a history of medical abuses
 Medical abuses by Nazi doctors
(Nuremburg Trial and code of 1947)
 Publication of article on medical abuses in
the New England Journal of Medicine
 Public revelation of the Tuskegee syphilis
study in 1974
The Evolution of Research
Guidelines
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The various abuses of the dignity and rights of human beings led
to the set-up of different commissions to set international
standards in Research involving human beings
The Nuremberg Code – outlines permissible medical experimentation on
human beings. The first provision of the code requires that “the
voluntary informed consent of the human subject is absolutely essential.”
The Code also requires that:
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the risks to patients be minimized
research be conducted by qualified investigators using
appropriate designs
participants always be free to withdraw from participation at
any time; and
Any research pursued, have a favorable risk/benefit ratio
The World Medical Association created the Declaration of Helsinki, to
guide physicians who become involved in medical research.
Ethical Principles
Three Basic Ethical Principles
 AUTONOMY -Respect for persons,
community etc
 BENEFICENCE / MALFICENCE –
ensuring that no harm is done
 JUSTICE- Distributive justice,
equality of individuals and that the
benefits and risks should be
distributed fairly
Respect for Persons / Community
Informed consent of
individuals
Respect for
participating will be
persons/communit obtained – orally,
y
through tapes, or in
written form
(international funding
bodies require
WRITTEN CONSENT
which is a challenge
for Nigerian
researchers)
 Provision of consent
form
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Cont’d
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Respect for
persons/community
etc
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Description of entry
into homes of
respondents and how
informed consent will
be obtained
Same with entry into
community
Same as the handling
of under-aged in
studies and how
informed consent will
be obtained
Sharing of outcomes
with targeted
individuals etc.
CONFIDENTIALITY
Beneficence
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Dimension of
beneficence
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DO NO HARM
Describing how harm
to respondents or
targeted community
will be avoided at all
cost
Ensuring full
disclosure of the
nature of the
research with
particular reference
to harm/ risks and
benefits
Distributive justice
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Dimensions of
distributive justice
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Giving every person
or community equal
chance of
participating in the
work.
Distributing benefits
fairly
Describing how the
conditions of the
individuals and
community will be
ameliorated in the
course and after the
research
UITH ETHICAL REVIEW COMMITTEE
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UITH ERC is well established and
functional since 1991, current
Provost was the 1st Chairman, yours
truly, Current Chairman
Thirteen member committee
including Laymen and Lawyers
Registered with NHREC and has
Federal Wide Assurance FWA
certification
Meet bi-monthly
UITH ERC ctd
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Reviews proposals from Lecturers,
Consultants, Residents,
Postgraduate students,
Undergraduate students etc
Review process – submit 5 copies,
takes about 2 weeks for review,
Researcher meets with the
committee to discuss the proposal,
corrections are pointed out to
researcher, final paper is reviewed
and approval given.
UITH ERC ctd
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The committee MONITORS the
project
Areas of concentration:
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Relevant Literature review: citing
relevant lite
Aims and objectives
METHODOLOGY
Study population
 Sampling technique
 Sample size
 Inclusion and Exclusion criteria
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Description of procedures
 Data Analysis
 INFORMED & UNDERSTOOD CONSENT
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Information sheet / Consent form
Information provided in different languages
States the procedure, risk, benefit,
confidentiality of information, voluntary
withdrawal without penalty
Consent form must be signed / thumb print
***Consent by proxy (minors, incompetent
etc)
Concluding Notes
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Please note that your proposal will be
reviewed by your institution’s review
board and the NATIONALHEALTH
RESEARCH ETHICS COMMITTEE
which is based in the Federal Ministry
of Health if project involves 3
collaborating centres or more, is a
national and/or funded by
international agencies
Download the document on NHREC
from the Internet. It describes process
etc for review
Check details for the international
funding agencies from their web site.
Con’td
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Ethics are not just about the review
of your proposal but transcend the
entire work. Funding can be
terminated if the funding bodies
finds ethics are being breached in
the course of research
Adherence to extant research code
and ensuring integrity in research
work (e.g., selection of
sample/respondents, reporting and
analysis of data)
THANK YOU