Research Ethics Procedure

1.    Introduction

This procedure sets out the steps to be followed for the ethical review and approval of research conducted by staff and students of National College of Ireland (NCI). It should be read in conjunction with the Research Ethics Policy, which establishes the principles, definitions, risk categories, and governance structures referred to throughout this procedure.

This procedure applies to all researchers conducting projects that involve direct and/or indirect (e.g. online data collection) interaction with human participants, and/or the use of identifiable personal data.

Two forms support this procedure: the Ethics Screening Form (used to apply for exemption from ethical review or for expedited review) and the Human Participants Research Ethics Application Form (used for full ethical review).

2.    Determining Whether Ethical Approval is Required

Researchers must first determine whether ethical approval is required before recruitment and data collection. It is expected that the researcher will seek ethical approval from a recognised ethics committee in the following circumstances:

• Research involves direct interaction with human participants for data collection using methods such as interviews, questionnaires, focus groups, behavioural experiments etc.
• Research collects data from human participants with indirect interaction e.g. using online data collection methods, surveys, observation etc.
• Research involves access to or utilisation of identifiable personal data.

Where the researcher is the Principal Investigator and NCI is the host institution, it is generally expected that the researcher will seek ethical approval from the NCI Ethics Committee and/or notify the NCI Ethics Committee that approval has been obtained from another institution.

Researchers are expected to consult their own disciplinary ethical guidelines and practices to determine whether ethical approval is required. If researchers have any doubts about whether ethics approval is required, they should contact the NCI Ethics Committee prior to participant recruitment, data collection and/or analysis.

3.    Exemptions and Expedited Review

In certain limited cases, a research project may be exempt from ethical review, or eligible for an expedited review process (minimal risk projects).

3.1.                     Exemptions from ethical review

Projects may be exempt from ethical review in the following circumstances:

• Project involves secondary analysis of fully anonymised, publicly available datasets or other publicly available data sources only (e.g. published financial reports, annual statements, legal rulings, case studies based solely on public sources).
• Project involves systematic review/meta-analysis and/or other purely conceptual or theoretical work without any primary data collection.
• Project involves quality assurance, service evaluation, or audit and is not intended to produce generalisable research findings and/or outcomes for publication.
• Ethical approval has already been provided by another recognised ethics committee. Examples of recognised ethics committees include ethics committees from other third level institutions or other statutory services (e.g. Health Service Executive). Note that you may be required to get approval from more than one ethics committee.

Staff conducting research should consult the criteria above to determine if their research is exempt from review. Staff conducting projects that are exempt based on prior ethical approval from another committee should submit a copy of the relevant ethical approval letter to the Ethics Committee. Students whose research meets the criteria for exemption from review should document this using the Ethics Screening Form and submit it to their supervisor for confirmation.

3.2.                     Expedited review

Filter Committees for student research may choose to implement an expedited review process where appropriate. Student projects posing minimal risk (Category A, as defined in the Research Ethics Policy) may be eligible for expedited review in the following circumstances:

• Participants are adults (aged 18+), and the project does not recruit participants who belong to any vulnerable groups.
• Data collection relates to non-sensitive topics, and/or no sensitive personal data is collected.
• Research does not involve risk of psychological or mental distress, physical stress or discomfort, or any other risk to participants.
• Data is collected anonymously or promptly anonymised after collection.
• The study does not involve any deception.
• There is no power imbalance between the researcher and research participants.
• There are no conflicts of interest.
• There is no reputational risk to individuals or organisations.

Examples of typical minimal risk projects, meeting the criteria above, include:

• Anonymous online surveys on non-sensitive topics
• Interviews about professional practices (non-sensitive)
• Consumer preference studies without any deception
• Employee engagement surveys (non-sensitive, voluntary)

Applications for expedited review are made using the Ethics Screening Form. The Filter Committee will exercise discretion as to whether expedited reviews can be conducted; this will depend on discipline-specific and relevant professional body requirements for review of student research projects. Filter Committees may include research supervisors, and in these cases expedited reviews may be conducted at supervisor level. Expedited reviews at supervisor level are deemed particularly suitable to facilitate required turnaround times for a large volume of student applications, with minimal associated risk.

4.    Ethics Review Process and Outcomes

4.1.                     Levels of review

Research proposals are reviewed at the level of oversight proportionate to their ethical risk, through the scalable governance framework set out in the Research Ethics Policy. Review operates across three levels: supervisor screening of student projects, Filter Committee review, and Ethics Committee review.

4.1.1.     Supervisor screening

Research supervisors provide the initial review of student research proposals to determine whether a project may be exempt from ethical review, suitable for expedited review, or required to undergo full ethical review. Supervisors are responsible for ensuring that students complete the appropriate ethics screening documentation. Students must liaise with their supervisors to ensure that research proposals are sufficiently developed prior to submission for formal ethics review.

4.2.                     Filter Committee review and outcomes

Student research projects that involve minimal ethical risk are reviewed by the relevant Filter Committee. Filter Committees assess whether proposed research involves adult participants only, addresses non-sensitive topics, presents minimal risk to participants, and complies with the ethical principles outlined in the Research Ethics Policy.

Students whose projects are not eligible for an exemption or expedited review must complete the Human Participants Research Ethics Application Form and submit it to the relevant Filter Committee for review. For research that falls under Research Category A (low ethical risk), a favourable outcome at the Filter Committee will typically be sufficient to secure ethical approval, subject to any required amendments. The Filter Committee retains the right to escalate Category A proposals for full committee review where it deems this appropriate. Where a project presents elevated ethical risk (Category B) or requires further scrutiny, it is escalated to the Ethics Committee for full review before approval may be granted.

The outcomes that may arise from Filter Committee review are:

• Research Category A: Approved by Filter Committee (no amendments)
• Research Category A: Approved by Filter Committee pending minor amendments (to be accepted by research supervisor)
• Research Category A: Approved by Filter Committee pending major amendments (to be accepted by Filter Chair and research supervisor)
• Research Category A requiring further review OR Research Category B: Escalated for review by Ethics Committee
• Research proposal rejected: resubmission required

Following consideration of student research projects submitted for ethical review, each Filter Committee will submit an outcome report to the Ethics Committee summarising the applications considered and the decisions made.

4.3.                     Ethics Committee review and outcomes

The Ethics Committee conducts full ethical review of research projects that involve higher levels of ethical complexity or risk. This includes:

• research conducted by staff,
• student research escalated from Filter Committees,
• research involving vulnerable populations,
• research involving sensitive personal data,
• research that may involve significant ethical considerations.

Applications by staff, and applications for student projects escalated for full review, will be reviewed by the Ethics Committee at the next scheduled meeting. In exceptional circumstances, where timelines require review outside of the schedule of meetings, applications may be reviewed by two members of the committee via Chair's action. The Human Participants Research Ethics Application Form should be submitted to the Committee for review by the required deadline (deadlines are published on the NCI website).

The outcomes that may arise from Ethics Committee review are:

• Research proposal approved (no recommendations)
• Research proposal approved pending minor revisions (to be submitted and accepted by the Chair)
• Research proposal approved pending major revisions (to be resubmitted and approved by the Ethics Committee)
• Research proposal rejected (resubmission necessary)

The relevant committee will provide written confirmation of ethical review outcomes to the researchers. Researchers must not commence participant recruitment and/or data collection until the required ethical approval is in place.

Note that the implementation of an expedited review process for student projects is at the discretion of the relevant Filter Committee, depending on subject-specific and/or professional body requirements. Filter Committees may request that all students submit a full ethics application for Filter review if deemed appropriate.

Figure 1: Ethics Review Process for Student Applications

Figure 2:  Ethics Review Process for Staff Applications

5.    Amendments to Approved Research

Ethical approval applies only to the research activities described in the approved application (see Scope of Ethical Approval in the Research Ethics Policy). Any substantive changes to the research design, participant recruitment, research procedures, or data collection methods must be submitted to the Ethics Committee for review and approval prior to implementation. Researchers must not implement such changes until approval for the amendment has been granted.

6.    Appeals

Appeals against the Committee's decision may be made within ten working days. In this case, the Ethics Committee Chair (or the Chair's nominee) will convene an Appeals Committee comprising three faculty members who did not review the original application, to consider the appeal. The Appeals Committee will review the original application along with any additional information submitted by the applicant.

7.    Escalation of Potential Research Misconduct

Where concerns arise during the ethics review process or during the conduct of an approved research project that may indicate potential research misconduct, the matter will be referred in accordance with the National College of Ireland Research Misconduct Procedures and the Research Integrity Policy.

Concerns may arise from:

• review of an ethics application
• monitoring of an approved research project
• reports from research participants
• concerns raised by supervisors, researchers, or members of the Ethics Committee

Examples of issues that may require escalation include, but are not limited to:

• conducting research involving human participants without prior ethical approval
• failure to obtain informed consent
• breaches of confidentiality or data protection requirements
• fabrication, falsification, or misrepresentation of research data
• failure to comply with approved research procedures.

Where such concerns arise, the Chair of the Ethics Committee will determine whether the issue relates to an ethics compliance matter or whether it may constitute potential research misconduct. Where potential research misconduct is suspected, the matter will be formally referred to the Research Integrity Officer for consideration under the Research Misconduct Procedures, which are linked with and supported by wider institutional policies related to staff and student conduct, and HR policies for cases involving staff.

The Ethics Committee may suspend or withdraw ethical approval where necessary to protect research participants or maintain research integrity while the matter is considered under the institutional procedures.

8.    Researcher Responsibilities

Researchers are responsible for ensuring that their research is conducted in accordance with the conditions of ethical approval granted by the College. Researchers must adhere to the approved research protocol, ensure that informed consent procedures are properly implemented, and maintain appropriate safeguards to protect the rights, dignity, and confidentiality of research participants throughout the research process. Any adverse events, unexpected risks, or ethical concerns arising during the conduct of the research must be reported promptly to the Ethics Committee. Researcher responsibilities include:

• Ensure that ethical approval has been granted prior to conducting any recruitment of participants or data collection.
• Notify the Ethics Committee of any material changes to their project, including change of participant inclusion or exclusion criteria, change in data collection strategies or techniques, or any other changes that change the level of risk to participants.
• Comply with relevant policies and procedures including but not limited to NCI's Research Integrity Policy, institutional and local data protection guidelines and best practices.
• Complete training provided by NCI, as and when required.

Version Control

• Research Ethics Procedure.pdf600 KB
• Ethics Screening Form (Student Projects).docx60 KB
• Ethics Application Form.docx70 KB