Low Risk Study Submissions
Low-Risk Study Submissions
- Low-Risk Review applications should be submitted via email to firstname.lastname@example.org - there is no deadline but allow time for the process - it can take two weeks to process and respond.
- Support Documents: you must include information sheets and sperate consent forms using the the HR2 Support Template and follow the HREC Guideslines here. REC approvals from external organistaions/hospitals and Garda Vetting Certificates can be provided as a separate pdf.
- Secondary Data: low-risk submissions should provide permissions for access to the data and provide support documents using the HR2 Support Template for relevant supporting materials specifically for this type of study.
How to Submit:
- For staff: submit the correct version of the form and support template (described above)by email email@example.com
- For students: supervisors submits the correct version of the form and support template (as above) by email firstname.lastname@example.org on behalf of the student by way of endorsement, and includes the . Please include for all supports except REC approvals from external organistaions/hospitals, which can be provided as a separate pdf.
Please note that this is a two-tiered process but all submissions are reviewed either by the Office of Research Ethics (ORE) or the HREC Chairs. The following is a guide and the types of studies include, but are not limited to the categories listed for each tier below:
- Tier 1: review by ORE - studies that have obtained REC approval elsewhere, or with public office/professionals and other non-vulnerable individuals or groups, non-sensitive topics, anonymous data collection (not health data), some online surveys and some secondary data studies.
- Tier 2: review by HREC chairs - studies that involved UCD students (including anonymous surveys, online surveys) , studies overseas (including EU), health data, some online surveys with adults (depending on the nature of the study) and some secondary data studies. HREC Chairs are themselves active researchers and academics who have many demands on their time. They endeavour to provide a quick turn-around, but it cannot be guaranteed. Please take this into account and allow for potentially 1-2 weeks for a Chair's review
In order to determine whether your study is low-risk or not you should consult your supervisor / Head of School in the first instance.
Taught Masters/MSc/Undergraduate students should read further information here.
What are the criteria for a Low-Risk Study Review?
- reviewed and approved by a recognised REC (such as a hospital ethics committee or another appropriate body or local authority that has appropriate jurisdiction over all aspects of the study*
- standard educational practices
- standard educational tests
- anonymous surveys or interviews that do not involve the collection of identifiable data or health data
- public observations
- research involving persons elected to, or candidates for, public office, persons speaking in their professional capacity
- research which uses only existing data which is publicly available.
*Approval for a study by an external REC does not cover access to UCD Students.
How to determine if your study is low risk:
Whether a study requires a full review or a low risk review will be determined by the nature of the study, who the participants are, what kind of data you are collecting and what you are going to do with that data. To help you decide, the following questions may help. Does your research involve:
- Any vulnerable groups? (this includes UCD Students but there are exceptions such as some anonymous surveys)
- Sensitive topics that may make participants feel uncomfortable i.e. sexual behaviour, illegal activities, racial biases, etc?
- Use of drugs?
- Invasive procedures (e.g. blood sampling)?
- Physical stress/distress, discomfort?
- Psychological/mental stress/distress?
- Deception of/or withholding information from subjects?
- Access to data by individuals or organizations other than the investigators?
- Conflict of interest issues?
- Ethical dilemmas?
If you have answered NO to these questions and your study meets the low-risk study criteria above, please complete the latest version of the form above. The ORE will determine whether your submission is for a Tier 1 or Tier 2 review.
If you have answered YES to any of the questions above, then please discuss with your supervisor, if applicable. If you need further clarification please contact email@example.com and mark your email 'low risk query'.
NOTE: The Office of Research Ethics is not responsible for keeping your records for you. All approvals for Low-Risk Study submission and the data management details for that study should be noted by your school for their records. This is especially important if the research data is being archived.