Applying for Ethical Approval
CORE ETHICAL PRINCIPLES FOR SOCIAL RESEARCH
All studies must adhere to the following key ethical principles:
1. Informed voluntary consent
Informed voluntary consent means that all participants who take part in your research do so freely and have a clear idea of what it is they are agreeing to. Informed consent applies both to agencies and individual research participants and requires the provision of detailed information sheets, adequate time to consider participation, and signed consent forms.
Information sheets and consent forms are a crucial tool in ensuring that the principle of informed voluntary consent is observed and you should devote time and attention to their development. The information sheet should provide all information necessary for informed consent and in a format accessible to the relevant population.
Information sheets and consent forms will need to be tailored to your individual project but you can use the following templates as a starting point:
- Template for participant information sheet (PDF, 149 KB)
- Template for participant consent form (PDF, 426 KB)
- Template for gate keeper / agency information sheet and consent form (PDF, 434 KB)
Note that in the case of repeat interviewing or data collection, consent need to be renewed at each stage.
The time the person is given to consider participation will vary between studies depending on the nature of the topic, what participation involves, the capacity of the participant and so on. While it might be acceptable to gain quick consent for a short questionnaire participation in a lengthy series of biographical interviews would require a much longer period of consideration. What is appropriate needs to be thought through for each study. Typically a qualitative interview on a non-sensitive topic with a person who is not from non-vulnerable population would involve a period of consideration somewhere between 24 hours and one week depending on the population and topic.
Researchers should be aware that information to which they have access in a professional capacity (e.g. as a nurse or social worker) cannot be used for research purposes without the consent of the individuals involved.
2. Confidentiality and anonymity
Under normal circumstances you will guarantee confidentiality to all participants in your research. This means that you will do everything you can to protect their privacy and ensure that it will not be possible for third parties to trace any information they provide to you back to them (without their permission). This guarantee of confidentially and anonymity also extends to people whom the participant may talk about in interview.
Prior to the interview you should discuss the limits of confidentiality with the participant i.e. the circumstances under which you may have to reveal what the participant tells you without their permission. This might occur if the researcher has a strong belief that there is a serious risk of harm or danger to either the participant or another individual (e.g. physical, emotional or sexual abuse, concerns for child protection, rape, self-harm, suicidal intent or criminal activity) or if a serious crime has been committed.
Researchers should also clearly explain to participants that non-anonymised data in the form of signed consent forms and audio recordings are collected and retained as part of the research process. A study which requires either digital or photographic recordings of 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. In exceptional circumstances the nature of your research may mean that it is not possible to guarantee confidentiality to your participants (e.g. very rare and high profile events, interviews with public figures). In such circumstances it is very important that participants are made aware of this prior to the interview and that information sheets and consent forms are adjusted accordingly.
3. Data retention, protection and destruction
In all cases involving human subjects, consent must be obtained from all participants in the study for the specific data retention / storage / destruction policy involved in that specific study.
For taught postgraduate students, data must be destroyed two years after the completion of the relevant course, unless student and supervisor have arranged jointly to retain it for publication purposes. All raw data must be kept until exam boards confirm a student’s results for a dissertation. Anonymised interview transcripts are to be retained for two years from the date of the exam board. If you require an extension to retain data beyond two years then you must seek the approval of the Research Ethics Committee.
For research postgraduate students and staff research projects, research students and staff will normally plan to keep their data for longer periods, in consultation with their supervisors/PIs or research teams. The principle must be adhered to that this is done with clear and informed consent from all participants in the study. This requires an explicit data retention / storage / destruction policy to be developed for each individual Research Ethics Committee application and to be included in all participant and agency information sheets and consent forms. They will also need to inform participants of their rights to access their personal data at any time (under Freedom of Information legislation).
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 (PDF, 248 KB) and additional compliance with the policies of the relevant body of the organization wherein any external research is conducted. This is your responsibility.
For further information on data protection see 'Data Protection Guidelines on Research in the Health Sector' (2007) (PDF, 291 KB).
4. Limitation of risk
Although some level of discomfort, stress or embarrassment and risk of harm to both participants and researchers may be unavoidable, the researcher is expected to show that they have done everything possible to minimise such risk and discomfort. The researcher must also ensure that participants have been made fully aware of any potential risks or discomforts in advance so that they can make properly informed consent.
Researchers are also obliged to limit the risk of physical and psychological harm to themselves as much as possible – in the research context taking risks is not a personal decision. This includes taking proper precautions for their physical safety. Although it is not part of the ethical approval process for research with non-vulnerable populations and non-sensitive topics, researchers should be aware that research is by its nature intrusive and may uncover distressing material in completely unexpected ways. For their own benefit and the benefit of their participants it is recommended that all researchers familiarize themselves with distress protocols typically used in researching sensitive topics. See for example:
Draucker C B, Martsolf D S and Poole C (2009) Developing Distress Protocols for research on Sensitive Topics. Archives of Psychiatric Nursing 23 (5) pp. 343-350.
McCosker,H Barnard, A Gerber, R (2001). Undertaking Sensitive Research: Issues and Strategies for Meeting the Safety Needs of All. Forum: Qualitative Social Research, 2(1).
THE APPLICATION PROCESS
Before applying for ethical approval researchers should:
- Identify all actual and potential ethical issues that might arise
- Reflect on how these will be addressed
- Formulate procedures to deal with all such issues to the approval of their supervisor / PI
The ethical approval application form is available here.
All applications must be reviewed and signed by Supervisor or Principal Investigator. Forms which are not signed or presented to an acceptable standard (e.g. incomplete; excessive typographical or grammatical errors) will be returned and may therefore incur delays. Please note that in signing the application form, you are giving an undertaking that you have reviewed and incorporated the provisions of Data Protection legislation, College Policy on Good Research Practice (2009) and any other legislation relevant to your particular study.
The completed application form together with supporting documentation should be submitted as a single document. One hard-copy must be submitted to the post box of Ms Noreen O'Sullivan (Arts 3063, 3rd Floor, Arts Building) and one electronic copy sent to email@example.com.
Upcoming submission deadlines and meeting dates:
|Submission Deadline||Date of REC meeting|
|Thursday 22nd September-16||Thursday 06th October-16|
|Thursday 06th October-16||Thursday 20th October-16|
|Thursday 27th October-16||Thursday 10th November-16|
|Thursday 24th November-16||Thursday 08th December-16|
|Thursday 12th January-17||Thursday 26th January-17|
|Thursday 06th April-17||Thursday 20th April-17|
|Thursday 04th May-17||Thursday 18th May-17|
|Thursday 25th May-17||Thursday 08th June-17|
The only applications which can be considered outside of regularly scheduled meetings are PHD or externally-funded staff applications which involve a tight time-frame. PHD students and staff members wishing to make such applications must append to their application a full explanation of why they could not apply within the framework of the regular eight meetings a year.
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. All other copies of applications are destroyed once decisions are made. Decisions following meetings will be returned to individual students and their supervisors.
DURING AND AFTER YOUR RESEARCH PROJECT
During the research project researchers should:
- Implement the ethical procedures outlined in their approved ethical application
- Obtain continuous feedback from participants about ethical issues
- Periodically review the ethical strategy in the light of feedback received
- Seek approval from the Research Ethics Committee for any significant changes in methodology or scope which have ethical implications
When your project is complete you must submit the ‘End of project / Annual Review’ form electronically to the Research Ethic Committee administrator.
If your study takes longer than one year to complete you should submit the ‘End of project / Annual Review’ form electronically to the Research Ethic Committee administrator annually.