Research 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

The need for a Research Ethics Policy and 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 social matters.

Ethical Code Development

1947 Nuremberg Code - first modern ethical code 1964 Declaration of Helsinki - modified several times 1990 WHO International Guidelines on Ethics and Epidemiology 1993 WHO International Ethical Guidelines for Biomedical Research Involving Human Subjects.

Ethical 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) Wellcome Trust The Nuffield Foundation British Society of Criminology The British Sociological Society

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.

As defined by the Central Office for Research Ethics Committees (COREC) - www.corec.ac.uk

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 being done.

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 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.

University Responsibilities
The University is responsible for: developing, operating and reviewing policies and guidelines which are consistent with recognised standards and best practice in the disciplines providing appropriate guidance. supporting researchers undertaking research, which is ethically sound through implementation of guidance and appropriate supervision. Establishing University and Faculty-based Research Ethics Committees.

Why do we need RECs?

To Protect To ensure that all work involving human participants is conducted in accordance with internationally accepted ethical and professional standards.

Ethical 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 RECs
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 research participants. That confidentiality of all personal and medical information is ensured and privacy maintained. Consent is truly valid (informed) and given without any form of duress.

Informed 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..)

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 Ethical Clearance

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 dissertation.