Research Ethics

Participant Consent Form

Participant Information Sheet

Supervisor Declaration Form

Following review in accordance with the ATU Research Ethics Standard Operating Procedure (Version 1.2), the University Research Ethics Committee (UREC) issues the following decision:

Approved – The application has met all ethical, legal, and institutional requirements. The research may proceed as described.

Contingent Approval – The research may proceed only when the following minor issues have been addressed to the satisfaction of the Research Ethics Office (REO):

Deferred – A decision cannot yet be made. The applicant must provide the following further information or clarification:

Resubmission Required – The application in its current form cannot be approved. A substantially revised application must be submitted, addressing the following issues:

Rejected – The application is considered ethically unacceptable and cannot be approved. The project cannot proceed.

Please email: brian.doherty@atu.ie ATU Research Ethics Officer or urec@atu.ie

Step 1: Preparation of Application

Before submission, the researcher is responsible for preparing a complete application for ethical review. This includes drafting the online Research Ethics Application Form and attaching the relevant supporting documentation.

Supporting Documentation

• Participant Information Sheet (PIS): Provides potential participants with a clear explanation of the study’s purpose, procedures, risks, benefits, and data management practices, enabling them to make an informed decision.
• Informed Consent Form: Records the voluntary agreement of participants, confirming that they understand the nature of the study, associated risks, and their right to withdraw at any time without penalty.
• Supervisor Declaration Form (If Applicable): Confirms that the supervisor has reviewed the proposal, verified its compliance with ethical and legal standards, and accepts responsibility for ongoing oversight.
• Garda Vetting Form (if applicable): Required for research involving children, vulnerable persons, or sensitive environments, ensuring appropriate background checks in compliance with Irish law.
• Export Control Certificate (mandatory): Verifies compliance with Irish and international export control regulations, ensuring that sensitive data, technology, or know-how are not transferred in breach of obligations.
• Data Protection Impact Assessment (DPIA) (if applicable): Required where research involves high-risk data processing, such as special category health data, large-scale personal data collection, or emerging technologies.
• Interview Schedule for Interviews/Focus Groups: A list of key questions or topics used to guide interviews or focus groups.
• Questionnaire/Surveys: Should accompany a research ethics application to show exactly what information will be collected from participants and to ensure the questions are ethical, clear, and appropriate.
• Letter(s) of permission from external organisation(s) granting access to their business, school, charity, database: Letters of permission from external organisations should accompany a research ethics application to confirm that the researcher has formal approval to access the organisation, its data, or participants for the study.
• Any other relevant supporting documents specifically required for your study.

Supervisors must review applications before submission, ensuring completeness, accuracy, and compliance with ATU policy.

Step 2: Submission

The researcher submits the completed application through the designated Microsoft Forms portal, ATU Research Ethics Application form

• Upon submission, the researcher receives an automated confirmation email, including a timestamp, as official evidence that the application has been lodged.
• The supervisor, where applicable, is notified of the submission to confirm their oversight role.

Step 3: Initial Screening

Within two working days of submission, the Research Ethics Office (REO) conducts an initial screening of the application.

• Applications are reviewed for completeness, clarity, and compliance with ATU’s Research Ethics Policy and associated procedures.
• If required information is missing, unclear, or incomplete, the REO returns the application to the researcher with clear written guidance on the amendments needed.
• Applications may only proceed to the next stage once the required corrections have been made and resubmitted.

Step 4: Risk Assessment

Following initial screening, the REO assesses the application to determine whether the project presents a low or high level of ethical risk.

• Risk triggers include involvement of vulnerable populations, use of identifiable or sensitive health data, invasive procedures, or other factors that may increase potential risk to participants.
• Outcome:
  • Low-risk applications proceed to expedited review by two academic reviewers.
  • High-risk applications are referred to UREC for full committee consideration.

This classification ensures that the level of review is proportionate to the risks involved.

Step 5: ID Assignment and Secure Upload

To ensure traceability and transparency, the REO assigns each application a unique identifier (e.g., UREC-ATU-2025-001).

• All application materials are uploaded by the REO to a secure SharePoint location linked to the University’s Data Management System (DMS).
• This enables tracking of applications from submission through to decision, ensures the integrity of records, and provides an official record for audit and compliance purposes.

Step 6: Ethics Review

All applications, regardless of risk classification, are assigned to two independent academic reviewers.

• Reviewer Assignment: Where possible, applications are allocated to reviewers with expertise in the relevant discipline or methodology.
• Reviewer Anonymity: Reviewer identities remain confidential and are not disclosed to applicants, preserving impartiality.
• Collaboration: Reviewers may work collaboratively when considering an application, but each must submit an independent structured review form.
• Feedback: Reviewer feedback is submitted electronically to the REO, timestamped, and securely stored in the DMS.

This dual-reviewer system ensures fairness, academic rigour, and transparency.

Step 7: Decision Phase

The final decision on an application depends on its risk classification and is informed by reviewer feedback.

·         For low-risk applications, reviewers will collaborate to determine whether the application meets the review threshold. If the threshold is met, reviewers can jointly approve the application.

·         Decisions by reviewers are communicated to UREC for noting.

Low-Risk Pathway

• Based on reviewer feedback, and under delegated authority of UREC, the REO synthesises comments and issues a formal outcome letter to the researcher.
• Outcome letters confirm the ethical status of the application and are logged in the DMS as the official record.

High-Risk Pathway

The REO formally communicates UREC’s decision to the researcher in writing. This letter serves as the official confirmation and is archived in the DMS.

Applications classified as high-risk, along with reviewer feedback, are scheduled for consideration at the next UREC meeting.

The REO provides UREC with a summary of the application and highlights any key issues raised by reviewers.

UREC deliberates and issues one of five formal decisions:

Approve – application approved as submitted.

Contingent Approval– approval subject to specific modifications or clarifications.

Defer Approval – The committee cannot approve yet because more information or clarification is needed before a decision can be made.

Request Resubmit – The application has major issues and must be substantially revised and submitted again for full review.

Reject – application not approved on ethical grounds.

Step 8: Record Keeping and Archiving

Records Management

All applications, decisions, and correspondence are securely stored in a Teams-linked SharePoint folder.

The Faculty Research Ethics Committee (FREC) oversees the research ethics applications from undergraduate research and taught postgraduate research programs. 

The process is as follows:

1. Application Submission

• The researcher first contacts their Faculty Office or supervisor.
• A Self-Declaration Form is completed and submitted.

2. Faculty-Level Review

• FREC reviews the application.
• If approved, the applicant receives a formal letter of approval.
• If the project is considered high risk, it is escalated to the University Research Ethics Committee (UREC).

When Applications Are Escalated to UREC

Applications are typically referred to UREC if they involve:

High-Risk Participants

• Children or young people under 18
• Adults lacking the capacity to consent
• Prisoners, asylum seekers, or other vulnerable groups

High-Risk Methods

• Clinical interventions, drug trials, or invasive procedures
• Deception without adequate debriefing
• Research that could cause significant psychological distress, harm, or long-term impact

Legal or Ethical Issues

• Work involving the HSE, social services, or healthcare records
• Handling sensitive personal data (e.g., criminal records, immigration status)
• International fieldwork in politically unstable or unsafe regions

Potential Reputational Risk

• Research on highly controversial topics
• Projects likely to attract media or legal scrutiny

UREC High-Risk Pathway

Once escalated to UREC

1. Two reviewers are assigned to assess the application.
2. The application follows the High-Risk Pathway.
3. Reviewer feedback and the application are presented at the next UREC meeting.
   • All high-risk applications are considered directly by the committee.
4. The Research Ethics Officer issues a formal notification letter to the applicant.

Records Management

All applications, decisions, and correspondence are securely stored.

The image is a flowchart outlining the process for obtaining project authorization for certain animal research projects. It consists of a series of steps and decision points, presented in a logical sequence.

1. Start: The first step instructs the researcher to email awb@atu.ie to get guidance on the necessary approvals and relevant forms.
2. Prepare Submission: The researcher then prepares a submission to AREC (Animal Research Ethics Committee).
3. Initial Screening: A Compliance Officer conducts an initial screening. If the application is incomplete, it is returned for completion.
4. Review by AREC: Once complete, the application is reviewed by AREC. Feedback may be provided, and resubmission might be required.

At this point, the flowchart splits into two paths based on whether project authorization is required:

• If not required: The researcher should email awb@atu.ie again to prepare for project commencement.
• If required:
  • Submit a project authorization application to HPRA (Health Products Regulatory Authority), including a certificate of ethical approval.
  • Respond to feedback and clarification requests from HPRA.
  • Once approved, project authorisation is granted by HPRA, and the Compliance Officer is notified.
  • The researcher must then meet with the Animal Welfare Body to review the authorization before starting the research.