Research Ethics

Canterbury Christ Church University have clearly defined Ethics Policies governing research which can be downloaded here:

https://www.canterbury.ac.uk/research-and-consultancy/documents/ethics-policy.pdf

ETHICS POLICY FOR RESEARCH INVOLVING HUMAN PARTICIPANTS

 

1 INTRODUCTION

2 ETHICAL AND LEGAL ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS

3 RESEARCH REQUIRING ETHICAL REVIEW

3.1 Self-Assessment Checklist

3.2 Criteria for Applying to the Faculty Research Ethics Committee (FREC)

3.3 Criteria for Applying an NHS Research Ethics Committee

3.4 Criteria for Applying to a Social Care Ethics Committee

4 THE FACULTY RESEARCH ETHICS COMMITTEES (FREC)

4.1 The role of the Faculty Research Ethics Committees

4.2 Membership of the Committees

4.3 Operation of the Committees

5 SCRUTINY

6 REFERENCES

 

1. INTRODUCTION

To meaningfully apply the ethical principles described in An Introduction to Ethics Issues and Principles in Research Involving Human Participants (CCCU, 2006) in research, they must be integrated in such a way as to ensure that they relate specifically to individual researchprojects and are not applied in a formulaic fashion. This necessitates careful thought and insight combined with sensitivity to the context of the specific research so as to identify its unique contribution and to protect the rights of research participants. Where an exception to a particular principle is claimed the onus lies with the individual researcher to demonstrate that this is justified.

Difficulties can arise in applying ethical principles to specific research proposals not least because there are a variety of philosophical approaches to ethical problems; debate between the varying schools of thought can help to inform ethical decisions and ensure an evolving context for ethical approaches. Effective guiding principles also depend on procedures and policies for their implementation. Typically, the review is undertaken in local research institutions by independent, multidisciplinary research ethics committees that apply substantive and procedural norms. This Policy is consistent with that model.

The following sections outline the standards to be adopted when seeking Ethical Review within the University; the procedures to be followed are outlined in the University’s Ethical Procedures for the Conduct of Research involving Human Participants (CCCU, 2006).

 

2. ETHICAL AND LEGAL ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS
 
While ethical approval considers a wide range of important issues that must be addressed - see An Introduction to Ethics Issues and Principles in Research Involving Human Participants, (CCCU, 2006) - some of these also carry with them important legal liabilities and hence, specific legal requirements. These are detailed in the following sections:
 
2.1 The work may carry risk of social, psychological, physical or professional harm to the participant for which the researcher may be liable. Such risks may arise in both individual and collaborative projects involving any of the following:
 
• Surveys, interviews, experimental designs that may be seen to place the participant, the researcher or the University at risk from: criminal or civil liability, damage to his or her financial standing and/or employability, or emotional distress.
• Participants under the age of 16 years or who are members of any vulnerable group (see An Introduction to Ethics Issues and Principles in Researce Involving Human Participants, CCCU, 2006).
• Treatments, therapeutic techniques or other interventions.
• The administration or use of any substance or agent.
• The collection of any body fluids or tissue samples.
• Any invasive procedure involving penetration of the subject's skin or body orifices with any substance or device.
• Causes any physical or emotional pain or involves high intensities of auditory, visual, electrical or other stimuli.
• Which requires confining the participant or requiring them to undergo long periods of sensory deprivation, sleeplessness or other forms of stress.
• In which there is any risk of social, psychological, physical or professional harm arising out of any of the above.
 
 
2.2 The work may breach legislation, confidentiality and trust. Some research requires access to or collection of existing data or records of personal information held by a third party (public/private body, organisation, agency or individual). There is a legal requirement that ethical approval is obtained when:
 
The information required is not publicly available.
The data has been recorded in such a way that individuals can be identified directly or through identifiers which are directly linked to the subject.
• The third party cannot confirm that they have obtained prior consent from the data subject. In such situations the consent of the subject is required before data can be disclosed.

 
2.3 The work may necessitate secondary use of existing human specimens. Some studies require access to human specimens held by other authorities (e.g. pathology laboratories, clinicians). Ethical approval is required where:
 
The material has been provided by the participants for purposes other than those for which it is now to be used.
The samples would not normally be provided to the researcher for the purposes of research without the consent of those concerned or clearance by the organisation/individual in possession of that material.


2.4 The work may require that the usual form of written consent from participants is bypassed. This is an uncommon situation but one which may occasionally arise. In such circumstances full details of the proposed research - and an explanation as to why normal consent procedures cannot be adopted - must be submitted to the appropriate committee for ethics approval.
 

3. RESEARCH REQUIRING ETHICAL REVIEW

For the purposes of this policy, research is defined as work which involves a systematic investigation to establish understanding, facts, principles or generalisable knowledge. The policy covers any research involving human participants, however tangentially. Ethical practice in the management of research requires that a body, independent of the research team, examines the research design and system for protecting participant's interests so as to judge their ethical acceptability and their accountability. All research work involving human participants must, therefore, undergo ethical review. This will be conducted by multidisciplinary and independent reviewers including, where appropriate or relevant, consumers. The review committee, whether internal or external, is intended to help to ensure that ethical principles are applied to any research involving human participants.

The Faculty Research Ethics Committees (defined and explained later in Section 4) therefore have both educational and review roles thus serving as consultative bodies and contributing to education in research ethics. They are also responsible for independent, multidisciplinary review of the ethics of research to determine whether the research should be permitted to start or to continue. This Policy defines the steps required to determine whether individual projects need an ethical review before that project starts, and sets out the criteria for approaching the appropriate reviewing body.

(To continue reading this document, please download using the link above)

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