UNDERGRADUATE AND LEVEL 9 TAUGHT MASTERS PROGRAMMES RESEARCH INVOLVING HUMAN PARTICIPANTS
FORM REC 1/L6-8/9T
DECLARATION OF ETHICAL CONSIDERATION
FORM REC 1/L6-8/9T
DECLARATION OF ETHICAL CONSIDERATION
NOTE: This form, (together with sample participant information sheet and sample informed consent form in the case of research to which Section C of this form applies) must be submitted to the supervisor with research proposal prior to commencement of research project.
This form (and additional documentation where Section C applies) shall be retained by the supervisor.The documentation shall be retained to be available for inspection by the REC as required and shall subsequently be attached to the completed research project once submitted for assessment.
In the case of research to which Section C of this form applies, the signature of a second supervisor is required to independently confirm that all relevant ethical issues have been adequately considered and addressed.
Research projects submitted for assessment which have not followed this procedure, shall not be assessed.
Main Research Supervisor
TO BE COMPLETED PRIOR TO COMMENCEMENT OF RESEARCH
Does your proposed research project involve (circle as appropriate):
1. A requirement for participant information sheets and receipt of informed consent?
2. Management and retention of personal data of participants?
3. Vulnerable groups (e.g. children, prisoners, individuals who require assisted living or individuals for whom English is not the primary language)
4. Sensitive topics that may make subjects uncomfortable (e.g. sexual behaviour, illegal activities, racial bias or religious affiliation)
5. Use of Drugs
6. Invasive procedures (e.g. blood or tissue sampling)
7. Physical stress or discomfort
8. Psychological distress
9. Deception of, or withholding information from subjects
10. Access to data by individuals or organisations other than the researcher
11. Any conflict of interest relating to or arising from the research project
12. Any ethical dilemma relating to or arising from the research project.
If the answer to all of the above is NO, please sign this form and include it in your final project/thesis/dissertation
If the answer to any of the above questions is YES, please proceed to complete Section C
To be completed PRIOR TO COMMENCEMENT OF RESEARCH where you do not qualify for an exemption under section B.
Please declare that the following control measures will be implemented in the case of your research thesis/ project/ dissertation:
I have assessed, identified and can demonstrate within the attachments to this document the potential risks associated with my research.
I confirm that the dignity and respect for participants will be adhered to at all times.
I confirm that I will communicate effectively to all potential participants that their participation in the research is voluntary and that all participants have the right to withdraw at any time
I have carefully considered the potential physical, psychological and emotional impact of my research on participants and will put in place appropriate safeguards in place to protect, support and minimise risk to those participating in the project
Where risks to the well-being of participants becomes apparent during the course of my research, where such risks were not foreseen at planning stage and/ or commencement of my research, I will immediately put appropriate safeguards in place to minimise such risks.(Details/ Examples/ Evidence of such safeguards shall be set out in an appendix to my completed project/thesis/dissertation)
I will not offer incentives to my research participants.
My methods are respectful and designed to fully consider the needs and vulnerabilities of my participants.
Every effort will be made to obtain full, voluntary and informed consent from all participants (including where appropriate, parents/ guardians/ gatekeepers)
I will provide a detailed information sheet to all participants.The information provided makes each of the following explicitly clear:
· What exactly the research involves (i.e. purpose and methodology);
· What the participants will be expected to do during the research process
(including all known risks however slight associated with participation);
· The full set of inclusionary and exclusionary criteria for participation in the research
· What measures will be put in place to deal with any potential risks to participants;
· If the research involves the taking of samples (e.g. blood, tissue etc.), how those samples will be taken, how they will be stored and how and when they will be disposed of.
· The expected benefit/s of the research;
· For what purpose/ purposes the data provided by them will be used;
· That the data relating to each participant will be kept only for the purpose/ purposes specified (and that it may be included in future publications where that possibility is envisaged by the researcher);
· That data collected will be securely stored and electronic material will be password protected;
· Who will have access to the data and why;
· That all data relating to participants will be kept confidential and anonymity of participants will be preserved (apart from situations where limits of confidentiality and anonymity may apply);
· That any potential limits on confidentiality have been properly explained (for example in circumstances where information is provided by a participant which must be disclosed to the Gardai and/ or other relevant authorities or where material is subject to a court order/ judicial ruling);
· How long the data will be retained by researcher;
· How the data will be disposed of (so as to preserve confidentiality);
· Confirmation that an assessment of the data protection implications of the research has been carried out and an indication of the level of risk identified by such
· That participation is entirely voluntary and that participants have a right to a ‘cooling off period’ (where reasonably practicable) entitling them to a change of mind before commencing participation.
· That participants are otherwise free to withdraw from the research at any time.
· That feedback on research findings will be made available to participants and how this will be achieved.
· Whether the results of the research will be used or disclosed for commercial purposes
I confirm that the information sheet detailing all of the above will be provided to the participants, (including, where appropriate parents/ guardians/ gatekeepers), and that it is drafted, in terms of the language used, in a manner that is appropriate to the participants involved
I have included a copy of the Participant Information Sheet I will use at Appendix I of this form
I have also included a copy of the template Informed Consent Form to be signed by participants at Appendix II of this form.
I confirm that I have read the IT Carlow Policy on Ethics in Research and the IT Carlow Guidelines on Research involving Human Participants prior to completion of this form.
The Institute of Technology Carlow is committed to protecting the rights and privacy of individuals with respect to the processing of their personal data. A copy of the Institute’s Privacy notice is available on the Institute’s website (
). This website also contains further information relating to your rights regarding subject access requests, records retention and data protection in general. Any further queries in relation to the GDPR can be addressed to the Institute’s Data Protection Oversight Group (e-mail: firstname.lastname@example.org)
I hereby declare that the above measures have been taken by me in respect of my proposed research thesis/project/dissertation.
I understand that failure to comply with the above shall constitute a breach of the Institute’s policies and procedures regarding research conduct and ethics in research
Learner Signature: ___________________________________
Supervisor 1 Declaration:
I declare that I have discussed with the learner the ethical considerations surrounding his/her proposed research and the operation of the control measures indicated above.
Supervisor Name (Printed): __________________________________
Supervisor Signature: __________________________________
Supervisor 2 Declaration:
I declare that I have reviewed the documentation submitted and that all relevant ethical issues in the proposed research have been adequately considered and addressed.
Supervisor Name (Printed): _______________________________
Supervisor Signature: _______________________________
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