HREC Support Documents - Explained

HREC Support Documents - overview

For research with Human Participants, researchers will need to prepare and submit some or all of the following document types depending on your study.

The list below shows the range of documents that can be included in the supporting documents template. Please also see the HREC Submissoins Checklist at the end of this page.

Mandatory Documents:

• Participant Information Leaflets:  you may need just one, or you might need one for each type of participant you are recruiting, such as one for parents/guardians and one for children/minors.
• Consent Forms: these should be provided to the participant separate from the Information Leaflet so that they can retain the details of the study.  For more information see the HREC Guideline on Informed Consent and for more general information on seeking consent in Ireland please see the (opens in a new window)HSE National Consent Policy.  Consent forms should include each component of the study that the participant is being asked to engagewith for the collection of their personal data, and these can include, but are not limited to, any or all of the following ways (see examples in the HREC Information Sheet & Consent Form Examples guide):
  • surveys/questionnaires
  • interviews
  • focus groups
  • photography
  • film/video
  • social media platforms
• Assent Forms: for children and minors so that they can decide whether they wish to participate or not despite any parental/guardian consent. These should be written in age-appropriate language.
• Letters of Endorsement/Permission: students should provide a letter of endorsement from their supervisor.  All researchers seeking to access participants should obtain permission from the relevant person/organisation to grant access.
• External REC Approval Letters: (mainly Low Risk Study stubmissions) in some instances ethics approval letters from a hospital REC, another university REC, HSE REC or other organisations that possess an REC, are required.
• Garda Vetting Certificates: for studies with children you will need to obtain a certificate. For further information see: Resources & Links

Study Related Documents:

• Questionnaires/Surveys/Interview Schedules: it is up to the researcher to ensure that they have permission to use a copyrighted questionnaire;
• Recruitment Advertisement Posters/Flyers/Text: these should show how you are recruiting your participants whether with a physical poster/notice, social media text, or online survey preamble.

Possible Additional Documents that may be requested, if applicable:

• Insurance: researchers must ensure that the appropriate insurance cover is in place for their study. This can be done via the use of the mandatory self-assessment checklist here.
• Human Research Risk Assessment: researchers conducting any face-to-face data collection, that is any research that requires researchers to be physically in the presence of research subjects regardless of whether physical contact takes place, are required to complete a risk assessment here.
  
• Data Protection Impact Assessments: when researchers collect, store or use/possess personal data from participants, they may be exposed to privacy risks. Please ensure that you understand how to protect your data - please see here.
• Tranlsations: For participants who have little or no English you should ensure that any documents you are presenting are translated into that participant's mother tongue.
• Interpreter/Translation Services: For some studies you may require the services of an interpreter/tranlsation service and you should prepare an agreement with regard to the collection and provision of the data including a signed agreement that the interpreter/translation service does not retain any of the data.
• Literacy: For participants who have reading impairment or literacy issues you should ensure that the documents are read to them by an independent third party and that these participants provide verbal consent.
• Data Sharing Agreements: researchers may be collaborating with other researchers either within the university or externally and will require a data sharing agreement to outline clearly who owns the data, who is responsible for archiving or destroying the data, and who has access to it or will have access to it after the the collection is completed.

To help you remember what you might need to include in your submission please see the HREC Submissions Checklist