Research Ethics

Research Ethical Approval Committee (REAC)

• Introduction
• Good Research Practice
• Guidance on Procedures
• Decision Procedure
• Membership and administrative support
• Dates of Meetings
• Reseach Ethical Approval Application Form (MS Word)

Introduction

The over-arching ethical principles for research carried out in the name of Trinity College are:

• Respect for the individual subject or population
• Beneficience and the absence of maleficence (research should have the maximum benefit with minimal harm
• Justice (all research subjects should be treated fairly and equally).

Good Research Practice

All individuals involved in research have a role to play in facilitating and making sure that research is conducted ethically. The ethical conduct of research is a shared responsibility. Primary responsibility for the ethical conduct of research studies and for continued review during the lifetime of a project rests with the Principal Investigator (s) or Student Supervisor. Ethical duties and legal obligations may intersect but are not necessarily the same.

Ethical approval is required before any studies involving human subjects can commence. This requirement applies to studies to be undertaken by staff, postgraduate and undergraduate students. Studies which do not involve human subjects may be given a notification of exemption once the initial application is reviewed. Fieldwork cannot commence until such approval has been gained.

In the case of collaborative projects involving researchers from outside the School, ethical approval obtained from an external research ethics body may suffice – evidence of same must be submitted to the committee prior to the commencement of the study (see procedures below). In the absence of such external approval, approval must be obtained as per this document. Additional ethical approvals may be required if the project involves or is funded by an external body.

Please ensure that your study conforms to acceptable standards of anonymity preservation and data retention as directed by PI/Supervisor and outlined in the College code of practice. A study which requires either digital or photographic recordings or participants must include in the research ethics approval application a justification and documentation of the methods by which the statutory provisions and research practice guidelines will be met.

Informed consent is a critical component of ethical research practice. This applies both to agencies and individual research subjects and requires the provision of detailed information sheets, adequate time to consider participation, and signed consent forms. In the case of repeat interviewing or data collection, consents need to be renewed at each stage. ‘TCD stipulates that the autonomy of the potential research participant should be respected by providing, in clear and accessible format, the maximum information on the implications of participation of a project and allowing independent and informed decision-making on whether or not to participate. This information should include written details of risks and benefits in participating...in all cases, participants should be made aware of their right to withdraw from the research without penalty at any time, including the withdrawal of their data after participation. All participants should also be formally notified that they are also free to access their own data at any time under the Freedom of Information Act’. (TCD College Policy, 2009).

Sensitive topics and vulnerable populations warrant particular attention. Sensitive topics include those which might be considered personally intrusive. This includes such topics as illegal activities, sexual behaviours or experiences of abuse. The justification standard for studies involving such topics is higher, and the applicant must demonstrate that the potential and actual benefits of conducting such a study outweigh the possible harm to participants. It is also important that potential participants are fully appraised of the possible implications of sharing information, including the risk that formal notifications of suspected abuse or criminal acts may be necessary.

‘Where research involves those with literacy difficulties, children or other potentially vulnerable groups of participants, rigorous adherence to the appropriate professional codes of ethical practice is required and particular attention must be paid to issue such as access, informed consent by both participants and carers...and the duty of care and conduct adopted in College shall conform to that detailed in the guidelines published by the TCD Children’s Research Centre... Additional formal authorization for the research or clearance of research staff by An Garda Siochana may be required in certain cases.’ (TCD College Policy, 2009).

Your commitment as a researcher or student carrying out research under the auspices of Trinity College Dublin is to comply with the policies as set out in the College Research Policy (link) and additional compliance with the policies of the relevant body of the organization wherein any external research is conducted. This is your responsibility.

Link to 'Data Protection Guidelines on Research in the Health Sector' (2007).

Guidance on Procedure

To apply for ethical approval from the REAC, completed application forms together with supporting documentation should be submitted in hardcopy to the School Administrator and an electronic copy e-mailed to the School Administrator. The ethical approval form must be submitted no later than 14 days prior to a meeting of the REAC. Timetabled meetings take place from September to June each academic year. The only applications which can be considered outside this structure are those which are externally-funded staff applications involving a tight time-frame.

All applications must be reviewed and signed by the Supervisor or Principal Investigator. Forms which are not signed or presented to an acceptable standard (eg: incomplete; excessive typographical or grammatical errors) will be returned and may therefore incur delays for the researcher/student involved.

Please note that in signing the approval form as applicant, you are giving an undertaking that you have reviewed the provisions of the Data Protection Act, College Policy on Good Research Practice (2009) and any other legislation relevant to your particular study.

The Committee will normally provide a response within two weeks of the date of a meeting. One record of each application and decision will be kept by the School Administrator. All other copies of applications are destroyed once decisions are made.  An annual report of the work of the REAC will be provided to the School.

When approval has been obtained from an external research ethics committee a copy of the external ethical approval must be submitted to the School Administrator, prior to commencement of study, for review and noting by the REAC. Should the School Research Ethical Approval Committee fail to grant approval then the research cannot proceed. The Committee in some instances may require further information or advice before reaching a final decision.

Before seeking ethical approval researchers should:

During the research project researchers should:

Decision Procedure

Decisions are made by majority vote with the Chair having the casting vote. Members of the REAC will withdraw from the meeting when their applications are discussed and will not take part in any decision on the application. In the case of postgraduate courses, applications are collated and reviewed by the Course Director in consultation with the Chair of the Committee or delegate in relation to those for whom exemptions are sought and those needing full consideration. Decisions following meetings will be returned to individual students and their supervisors.

 
Membership and administrative support

The Committee will consist of members of the academic staff, the Director of Research, the Committee Secretary, a student representative and one lay member who is not an employee of the College.

Dates of Meetings

The REAC will meet on the following dates in 2012/13: