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The Ethics Process Explained

The Ethics Process Explained:

Require ethical approval:

  • Student projects at undergraduate and postgraduate level
  • Staff projects
  • Questionnaires
  • Findings that will be reported or published externally

Do not require ethical approval:

  • Audits or course evaluations of teaching programmes

· I’d like to do some research. What do I start?

Check the meeting dates and deadlines on this website. The best advice we can give you is to get as much help as early as possible from the REC and with experts in your research area with your submission. Also, try to enlist the help of a statistician when designing your research study.

All the forms you need MUST be downloaded from this site.

There’s also a helpful CHECKLIST at the end to ensure you are submitting everything you need.

Begin to complete and compile the relevant forms: there are 4 main forms you need for an ethics application:

  1. A Research Ethics Committee Standard Application (RECSAF) Form
  2. A Participant Information Leaflet and Informed Consent Form (PIL/ICF)
  3. A Data Protection Impact Assessment (DPIA) Form
  4. A Local Checklist and Signatory Page

Research Ethics Committee Standard Application Form (RECSAF).

A guide to filling in this document can be found here: https://www.beaconhospital.ie/wp-content/uploads/2014/12/Guidance-Manual-for-application-5.6.pdf

Please fill in ALL sections.

· A PIL: Participant Information Leaflet and Informed Consent Form: (PIL)

All research requires the explicit consent of the research subject. (S.I. 314 of 2018)

If your research involves adult patients over 16 years of age:
They need to be given a Participant Information Leaflet and sign a Consent Form.

If your research involves patients under 16 years of age:

You will need a Participant Information Leaflet and an Assent Form, (written in a language children and young people can understand). You will also need an Information Leaflet for Parents/Guardians and a Consent Form to consent their ward/child to be involved in research. When the participant becomes of legal age, they will then need to be re-consented using the consent form to continue participation in the study.

If your research involves participants that are unable to give consent:

You will need to obtain an exemption from the Consent Declaration Committee (CDC) for your study. The process will involve applying to the REC for approval and then to the CDC. Once approved by the Consent Declaration Committee, you must submit their approval to the REC to receive full approval before commencing your research.

The Consent Form needs to be read, understood, initialled and signed by the participants in the presence of the researcher and a witness.

· A Data Protection Impact Assessment or DPIA:

There is a legislative requirement to ensure researchers respect the confidentiality of their participants’ data. You MUST complete and submit a DPIA which the REC will ensure is reviewed and signed off by the Beacon Hospitals Data Protection Officer (DPO).

The key stages of completing the DPIA are:

Identify the need for the DPIA – determine the inherent risks associated with data processing for your project.

Describe the information flow – be able to describe how the information within the processing operation is collected, stored, used and deleted.

Identify privacy and related risks – catalogue the range of threats and their related vulnerabilities to the rights and freedoms of individuals whose data you collect and/or process.

Identify and evaluate solutions – for each identified risk make a decision whether to accept or reject the risk and why; including how to take steps to reduce the impact or likelihood of any threats.

Sign off and record the DPIA outcomes – record the outcomes of the DPIA in a report that is signed off by the Data Protection Officer for your organization. Where a high risk has been identified, the organisation must submit the DPIA to the regulatory authority for consultation.

Integrate the DPIA outcomes into the project plan – you will need to continually refer to the DPIA in order to ensure that it is being followed and that its responses to the risks have been implemented effectively.

· A Local Checklist and Signatory Page (download here)

Please ensure you have all of these forms completed before submitting and also check the accompanying documents you need – see checklist

Please ensure ALL investigators sign this signatory form

Please ensure all these forms are version controlled and dated in the footer of the documents

If you can check all the items on the checklist here you can submit your application to: ethics@beaconhospital.ie

Download Checklist Here

Your application will be reviewed and within 10 working days of the ethics meeting you will be sent a letter outlining the committee’s comments in relation to your application.

You will need to respond to these comments and make any changes or amendments requested.

There are 3 types of letters from the REC:

Full Approval
The REC is satisfied with your application and documentation you have supplied. You can now commence your study.

Conditional Approval
You cannot commence your study until any issues/queries the REC have outlined are responded to and re-reviewed by the REC. Once you have satisfied all queries satisfactorily you will receive full approval and can commence with your study.

Withheld Approval
Your study does not meet the required ethical standards and therefore you cannot proceed with the study.

Enjoy your research!

Make a note of the Full approval date and within 12 months please submit an Annual Progress Report found here

Please send a Final Report to the REC found here

Please outline ALL Research Outputs and Activities you have undertaken while completing the study