Research EthicsResearch Ethics
Outline of Presentation
The need for a research ethics policy
Background to development of the policy
The role and purpose of Research Ethics Committees
The University Policy
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The need for a Research Ethics PolicyThe need for a Research Ethics Policy
and Proceduresand Procedures
Definitions of ethics usually include reference to
morals or the rules or standards governing the conduct
of a person or the members of a profession.
It can be argued however that ethics relate to a persons
own private considerations whereas morals relate to
Ethical Code DevelopmentEthical Code Development
1947 Nuremberg Code - first modern ethical code
1964 Declaration of Helsinki - modified several
1990 WHO International Guidelines on Ethics
1993 WHO International Ethical Guidelines for
Biomedical Research Involving Human Subjects.
Ethical Code DevelopmentEthical Code Development
Many learned bodies have published ethical
codes of practice, for example:
Medical Research Council
Economic and Social Research Committee
Central Office for Regional Ethics Committee (COREC - NHS based)
The Nuffield Foundation
British Society of Criminology
The British Sociological Society
Role of Research Ethics CommitteesRole 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.
As defined by the Central Office for Research Ethics Committees (COREC) -
Research Ethics Committees (REC)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, and
to provide reassurance to the public that this is
Objectives (cont….)Objectives (cont….)
In promoting these objectives a REC should remember that
research benefits society and they should take care not to
hinder it without good cause. Research Ethics Committees
also protect research workers from unjustified criticism.
(Taken from the Medical Research Council of South Africa -
www.mrc.ac.za/ethics/committees - accessed on 8 September 2003)
Purpose of a RECPurpose 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
University ResponsibilitiesUniversity Responsibilities
The University is responsible for:
developing, operating and reviewing policies and guidelines which
are consistent with recognised standards and best practice in the
providing appropriate guidance.
supporting researchers undertaking research, which is ethically
sound through implementation of guidance and appropriate
Establishing University and Faculty-based Research Ethics
Why do we need RECs?Why do we need RECs?
To ensure that all work involving human participants is
conducted in accordance with internationally accepted
ethical and professional standards.
Ethical ConductEthical Conduct
The ethical conduct of research is essential for those
working in all disciplines, but particularly for researchers
in medicine and life sciences.
An unethical approach can invalidate findings, lead to prosecution and damage the image of the research community within the public realm as a whole.
Taken from Higher Education and Research Opportunities (HERO)
Responsibilities of REC’sResponsibilities of REC’s
To consider the ethical implications of all experiments, investigations and
procedures involving human or animal subjects carried out in the University
and/or under the auspices of the University and in doing so ensure that:
The proposed study is scientifically valid and justifiable in terms of its possible benefits
compared with any risk of inconvenience or harm.
Adequate steps have been taken to anticipate and avoid physical or psychological harm for
That confidentiality of all personal and medical information is ensured and privacy
Consent is truly valid (informed) and given without any form of duress.
Informed ConsentInformed Consent
Adults are assumed to be competent unless demonstrated otherwise.
Potential subjects should be adequately informed of the aims,
methods, benefits, hazards and any discomfort.
Documentation given to potential subjects should be comprehensible.
Consent should normally be in writing and records kept.
Potential subjects are free to withdraw without implication.
All subjects should be volunteers, decisions not to participate should
not prejudice the subject in any way.
Informed Consent (cont..)Informed Consent (cont..)
If any potential participants are under the age of 18 or
are people over 18 (e.g adults with learning disabilities)
who are unable to reach informed decision about
participation, additional, separate consent forms are
needed from parents/guardians, alongside informed
agreement from the child, where applicable.
University of Sheffield Procedures for EthicalUniversity of Sheffield Procedures for Ethical
Ethical Clearance is required for all research involving
human subjects undertaken by staff, postgraduate
students (PGR and PGT) and final level undergraduate
students undertaking a research project as a final year
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