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Guidelines for Ethical Approval of Research

Guidelines for Ethical Approval of Research Involving Human Participants

Introduction
Protection of Participants and their Rights
Informed Consent
Recruitment and Payment of Participants
Ethics Standards of External Bodies

Introduction

The objectives of the Ethics Committee are to maintain ethical standards of practice in research, to protect the dignity, rights and welfare of research participants, both subjects and staff, and to provide reassurance to the public that this is being done. In achieving these objectives, the members of the Ethics Committee should remember that research benefits society and that they should take care not to hinder it without good cause. The Ethics Committee also protects researchers from unjustified criticism.
All research involving human participants, whether undertaken by the University's staff or students, must undergo an ethics review and ethical approval must be obtained before it commences. ‘Human participants’ are defined as including living human beings, human beings who have recently died (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids, and personal data and records¹ (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements).
It is the responsibility of the person proposing to carry out a research project to obtain the approval of the Ethics Committee. If a project is to be undertaken outside the University where a local ethics committee exists (eg within an NHS organisation), the University’s Committee need not necessarily be involved. However, approval of the local committee must be sought and obtained before research commences and the Research Governance and Planning Manager must be provided with all documentation relating to the approval.
In designing a research project involving human participants, investigators must be able to demonstrate a clear intention to benefit society and the research should be based on sound principles.
Investigators must ensure that there is no undeclared conflict of interest (which may be personal, academic or commercial) in their proposed work and that the relation between the sources of funding and researchers’ control over results is made clear, specifically in relation to the ownership, publication and subsequent use of research data.

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Protection of Participants and their Rights

All participants have the right not to participate in any investigation and this right must be respected. There should be no coercion of research subjects to participate in the research. Students and others in a dependent relationship with investigators must be assured that any decision not to participate will not prejudice their academic or other progress in any way.
Each participant must have the right to withdraw easily from the project whenever and for whatever reason without explanation or penalty.
All participants and research assistants have the right to expect protection from physical, psychological, social, legal and economic harm at all times during the investigation. Participants and researcher staff must be fully informed in advance of and protected against any hazardous, stressful or uncomfortable contexts and procedures. In addition, researchers should attempt to avoid harm not only to an immediate population of subjects but also to their wider family, kin and community.
Participants and researchers must be fully informed in advance of and protected against any hazardous, stressful or uncomfortable contexts and procedures. Should any adverse reaction / event occur, the researcher must report this immediately in writing to the Ethics Committee. The report should describe fully the adverse reaction / event, the action taken and the date, time and place of the event.
All participants have the right to expect that the information supplied by them will be treated as confidential and will be protected as such.
All participants have the right to expect that their identity will be protected.
Researchers should be aware of requirements with respect to personal data laid down in the Data Protection Act 1998. An information sheet, “Data Protection and Research Activity”, has been prepared by the University Records Manager which provides useful guidance and is available at http://www.essex.ac.uk/records_management/policies/data_protection_and_research.aspx.
Staff and students working with blood or blood products should advise the University Biological Safety Officer. In addition, they should be aware of the possible hazards, in particular blood borne viruses, and if in doubt should contact the University Occupational Health Adviser. The taking of blood samples is restricted to a person who has appropriate training.
Participants should be advised how, when and in what form it is planned to disseminate the findings of the research.

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Informed Consent

Prospective participants should be provided with as much information as possible about the research to enable them to make an informed decision about their possible involvement. If consent is not to be secured a statement justifying this must be provided. The primary objective is to conduct research openly and transparently without deception.
It should be remembered that research staff are also participants and need to be made fully aware of the proposed research and its potential risks to them.
Informed consent must be given on a consent form. It is also good practice to provide participants with a separate participant information sheet in advance.
Consent forms must be signed by participants before the start of any project indicating that they are giving their informed consent to participate in the project. If the participant is not capable of giving informed consent on their own behalf or is below the age of consent, then consent must be obtained from a carer, parent or guardian. Two points to note:
- The ability to consent depends upon having sufficient understanding and intelligence to make that decision; it does not depend on a fixed age limit. However, even when a child under 16 years of age is judged able to consent, approval from a carer, parent or guardian must be sought, and it may also be useful to consider seeking it for older children.
- In the case of incompetent adults, the law in the United Kingdom does not recognise proxy consent by a relative. However, the views of a relative and / or a carer should be sought. In addition, the assent of the incompetent person him/herself should be sought.
Consent should also be obtained for the sharing of research data as appropriate and for the publication of findings. Many funding bodies require that data obtained from a funded project is made available for research undertaken by others at a later date. Participants should be advised how the data that they provide will be stored, used and accessed including details of how confidentiality will be maintained. Consent for this needs to be obtained from participants before the start of the original project.
Participants should be provided with a copy of their signed consent form.

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Recruitment of and Payments to Participants

Advertisements or other recruiting materials seeking human participants for a research project require ethical approval.
Participants must be clearly advised, in advance, of any arrangements to reimburse them for expenses incurred or for loss of earnings.
Incentives, additional payments and rewards paid to participants require approval by the Ethics Committee.

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Ethics Standards of External Bodies

In addition to University guidelines, researchers should be aware of ethics codes of the relevant professional or regulatory bodies related to their research. Such codes should be followed.
The following documents and websites may be useful:

British Psychological Society: Code of Conduct and Ethical Guidelines;
British Sociological Association: “Statement of Ethical Practice for the British Sociological Association”;
Department of Health: "Research Governance Framework for Health and Social Care. Second Edition";
Economic and Social Research Council: “Framework for Research Ethics (FRE)”;
Government Office for Science: “Rigour, Respect Responsibility: A Universal Ethical Code for Scientists”;
Human Tissue Act;
Medical Research Council: Ethics and Research Guidance;
NERC: Ethics Policy;
NHS National Research Ethics Service
RESPECT project funded by the EC’s IST programme to draw up professional and ethical guidelines for the conduct of socio-economic research;
RESPECT Code of Practice for Socio-Economic Research;
Royal College of Physicians of London : “Guidelines on the Practice of Ethics Committees in Medical Research involving Human Subjects” (Fourth edition) published in September 2007 and “Ethics in practice – Background and recommendations for enhanced support: A report of the Working Party on Clinical Ethics”;
Social Research Association: “Ethical Guidelines”.

If research is to be conducted in an institutional setting other than the University, eg NHS organisations, schools, prisons, etc, researchers must follow any ethics standards, procedures and regulatory guidelines of that institution. This will include obtaining approval from the local ethics committee, if required, and may necessitate obtaining a Criminal Records Bureau (CRB) check.

¹Research involving personal data and records which have been made available to the public will not require ethical approval.

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