Research ethics
Session outline
• Define ethics
• Human subject research
• The need for a research ethics
• The role and purpose of Research Ethics
Committees
• What is informed consent ?
WHAT IS ETHICS ?
• The word is derived form the Greek
word “ethos” meaning;
“the set of moral principles”
What do we mean by ethics?
• Morality or ethics represents a code of conduct
that governs how people treat each other.
• In essence, it is concerned with the way people
act or behave.
• The term ‘ethics’ usually refers to the moral
principles, guiding conduct, which are held by a
group or even a profession”
(Wellington, 2000: 54)
WHAT IS: ETHICS ?
• Ethics
are
ways
of
understanding
and
examining the moral life, or of right and wrong
human conduct.
• Bioethics is a way of understanding and
examining the moral aspects of biomedical
research and practice
HUMAN SUBJECT RESEARCH
A research Involving living
individuals about whom the
researcher obtains:
Data through
intervention
or interaction
Identifiable
AND
OR Human Material
+/Private
Information
BALANCING TWO GOALS
Protection of
Subject Welfare/Rights
Advancement
of Science
Types of human participation in research
• As research subjects
(on whom experiments, including testing of new
drugs, are conducted)
• As persons whose body organs or tissues are
obtained and/or retained for research
– Eg, blood, saliva, urine, biopsy specimens
• As research participants from whom information is
obtained
– Eg, through observation, interviews, focus groups,
questionnaires, telephone surveys, psychological
or other types of testing
Types of human participation in research
• As people who might be identified in official
documents
– Eg, employment records, student records,
police records, court documents, medical
records.
• As people whose information (identified or deidentified) is part of an existing, unpublished
source
– Eg, a researcher wishing to use all, or part of,
an unpublished data-base obtained by
another researcher for a different research
project
The need for a research ethics
• Why do we need it?
– History tells us that if research is not
ethically approved, humans will attempt
devastating and immoral practices on the
vulnerable to determine outcomes
– Past unethical/moral dilemmas highlight
this
– All research must now go before an ethics
committee for approval
– Protect the vulnerable – human & animal
– Protection of human rights
Role of Research Ethics Committees
• Research Ethics Committees are the Committees which
are convened to provide independent advice to
participants, researchers, funders, sponsors, employers,
care organisations and professionals on the extent to
which proposals for research studies comply with
recognised ethical standards.
Research Ethics Committees (REC)
The main objectives of a REC are to:
• Maintain ethical standards of practice in research
• To protect subjects of research and research workers
from harm or exploitation
• To preserve the subjects rights
• To provide reassurance to the public that this is being
done.
Purpose of a REC
The purpose of a REC is to review a proposed study and
to ensure the dignity, rights, safety and well-being of all
actual or potential research participants is protected.
Ethical guidelines for conduct of research
• Nuremburg Code was developed in 1947 following the
mistreatment of human subjects by Nazis
• The Nuremberg Code (10 principles)
–
–
–
–
–
–
–
–
Voluntary informed consent
Likelihood of some good resulting
Based on prior research (animal models)
Avoidance of physical or psychological injury or harm
Benefits should outweigh risks
Proper experience of researcher
Right to withdraw consent
Research must stop if harm is resulting
(no specific mention of children, unconscious people, or
others who may not be competent to give consent)
What is informed consent ?
Respect for Persons
 voluntary decision taken by an individual to
participate in research based on understanding the
objectives, risks, benefits, and alternatives of the
research.
 the principal investigator has responsibility to obtain
voluntary informed consent (either verbal or
written) from all prospective participants or
 in the case of individuals who are not capable of
giving informed consent, the permission of their
legally authorized guardians (proxy consent).
What is informed consent ?
Respect for Persons
 voluntary decision taken by an individual to
participate in research based on understanding the
objectives, risks, benefits, and alternatives of the
research.
 the principal investigator has responsibility to obtain
voluntary informed consent (either verbal or
written) from all prospective participants or
 in the case of individuals who are not capable of
giving informed consent, the permission of their
legally authorized guardians (proxy consent).
Components of informed consent
 Information sheet
 seek consent only after the participant has received
and adequately understood all necessary information
and the consequences of participation as given in the
information sheet
 if written, the consent form has to be in all three
languages
 if written, consent should be obtained by signing on
a consent form
Informed consent contin..
Information sheet should contain









Self introduction – from where & who you are;
purpose of the research;
description of benefits from participating;
description of risks from participating;
details of time commitment required;
details of any remuneration;
plans to ensure the confidentiality of data;
details about the right to withdraw at any time for any reason;
information about how to communicate a decision to withdraw from the
study;
 name(s) of investigator(s) contact details.
The wording should suit the individual’s level of understanding