Terms of Reference

Undergraduate and Taught Masters Research Ethics Committee - 
School of Medicine (UTMREC-SM)
 
Background
 
The UCD School of Medicine Undergraduate and Taught Masters Research Ethics Committee (UTMREC-SM) is constituted as a committee of the UCD School of Medicine and as a sub-committee of the UCD Human Research Ethics Committee - Sciences (UCD-HREC-LS). The Committee will review applications for ethical approval, or exemption from full ethical review, for research conducted by registered undergraduate and graduate taught students on behalf of UCD-HREC-LS. The Committee is established to ensure that all research carried out as part of undergraduate and graduate taught programmes in the UCD School of Medicine is undertaken in accordance with ethical principles and best practice standards for integrity in research. The Committee will act to ensure that all research is subjected to critical scrutiny by experienced researchers before such research commences.  It is important to note that ethical approval will not be granted retrospectively.
 
 
Terms of Reference
 
  • All human research conducted by staff or students in the School of Medicine and not associated with a Taught Masters or Undergraduate programme remains subject to ethical review and approval from HREC-LS, or may be granted an exemption from full ethical review by the HREC-LS.
  • The UTMREC-SM will use the standard REC Operating Procedures that set out best practice for all UCD Research Ethics Committees.
  • UTMREC-SM may refer any application to the main HREC-LS.
  • Administrative support to the UTMREC will process all submissions for both full ethical review and exemption/low risk for insurance.  
 
The UTMREC-SM will:
  • Review applications for ethical approval or exemption from full review from all current or future Taught Masters and Undergraduate programmes offered by the School of Medicine.  The UTMREC-SM will not review applications from any other programmes.
  • Give directions to applicants and their academic supervisors (if necessary) in relation to the applications received and, if deemed appropriate, will refer the applicant to the UCD-HREC-LS or to another committee for review. 
  • Through the Chair, submit a list of the names, student numbers, project titles and final outcomes of the ethical review process to the UCD Office of Research Ethics. 
  • Maintain records of meetings and submit an annual report to the Head of School, Associate Dean for Research and Innovation, Associate Dean for Graduate Taught Studies, and Chair of the UCD-HREC-LS. 
  • Conduct its business having due regard to the need for the timely processing of applications, to satisfy the academic requirements of the relevant programmes.
 
Committee Membership 
 
To establish a core membership, the UTMREC-SM will require two academic representatives from each of the undergraduate programmes in the School which have core research modules (who will each require an alternate). In addition, two representatives of the School of Medicine Student Summer Research Awards (SSRA) and two representatives (and alternates) from the graduate taught programmes.  Other members will be co-opted as necessary. For example, any researcher is a de facto member of the SM-REC and is, at a minimum, required to review applications based on a 1:1 ratio, i.e. if submitting one application, they must review at least one other.
 
Therefore, at a minimum, the Committee shall comprise the following 12 core members:
  • Two academic staff representing each of: BSc Biomedical Health and Life Sciences, BSc Physiology, and BSc Radiography programmes (six individuals)
  • Two academic staff to represent graduate taught programmes.
  • Two academic staff to represent the SSRA.
  • One nominee of the Chair of the UCD-HREC-LS.
  • One administrator at the grade of SEA, who will act as the Committee Secretary.
  • Other academic members will be co-opted as necessary.
 
The Head of School will approve membership and will appoint the Chair of the Committee. Two Deputy Chairs will be appointed, from the core membership, by the Committee.
 
Quorum
 
Either the Chair, or a Deputy Chair, must be present for all meetings. A quorum of seven is required.
 
Frequency of meetings
 
Meetings will take place at least once per trimester and will be scheduled in keeping with the timelines required to support the successful delivery of the programmes. 
 
Review and Approval Process 
 
  • Ordinarily project supervisors will be required to submit an electronic application form and supporting documents to the UTMREC-SM prior to the trimester in which the research is to be conducted.  While application form submission will be the supervisors responsibility it is expected that students will be involved in preparing the application.
  • Supervisors are responsible for ensuring that projects are in line with the UCD ethical guidelines and that applications and supporting documents are submitted for ethical approval/exemption from full review. 
  • Approval/exemption from full review application forms have been developed in recognition of the terms of reference of the UTMREC-SM.  
  • Applications for exemption from full review will be reviewed by the Chair.  Exemptions will be agreed by the Chair (in simple cases) or referred to the Committee for comment prior to responding to the applicant.  If the Chair or Committee do not agree that an exemption is appropriate the applicant will be advised to submit an application for full review.
  • All full applications will be reviewed by UTMREC-SM.  
  • The Committee will routinely meet once per academic trimester to review applications relating to projects that will be carried out in the following trimester. Under exceptional circumstances the committee will review applications electronically outside of this schedule.
  • As with submissions to the HRECs, the UTMREC-SM will examine applications to ensure that the researcher has addressed issues, such as the risks and benefits which participants may be exposed to or experience, and the informed consent process.
  • Feedback will normally be provided within a two-week period following the meeting of the UTMREC-SM committee.  The following outcomes will be available to the UTMREC-SM (as per HREC documentation):
    • Approval (approved, as is, with no conditions attached)
    • Approval Subject to clarifications (approved, subject to implementation of recommended changes)
    • Re-tabled (requires that the applicant address questions posed by the UTMREC-SM and communicate the changes to the UTMREC-SM)
    • Rejected (written reasons for the decision will be provided to the applicant and resubmission will be possible).
    • Judged as exempt from full ethical review and processed accordingly
  • Constructive comments and suggestions identified during the review process will be conveyed to the applicant.
  • It is the responsibility of the applicant, to ensure that any changes requested by the UTMREC-SM are met.
  • Any changes to the original research design must be approved by the UTMREC-SM.
  • Changes to the project made after initial approval will only be granted on foot of submission of an Amendments and Extensions Request Form approved by the UTMREC-SM Chair.
  • Following receipt of feedback from UTMREC-SM applicants will submit a signed copy of the application form, along with a letter from their supervisor confirming all requested changes have been made (where applicable).
  • All documentation to be archived by School of Medicine administrative staff.
  • An approval email will be sent to the applicant with a Research Ethics Reference Number (RERN) consisting of the name of the UTMREC (e.g., UTMREC-SM), the year approval was granted (e.g., 21), the Programme level (UG/PG – Undergraduate or Postgraduate) and the surname of the applicants (e.g.Smith). This number will be used in all communication regarding the research.
  • A list of applications recommended by UTMREC-SM will be sent to HREC-LS for approval.
 
Reporting responsibilities
 
In addition to reporting to the Head of School the UTMREC will:
  • Report directly to HREC-LS.
  • Have at least one member who is also a member of HREC-LS.
  • Provide full details of all applications submitted, and decisions reached, to HREC-LS.
  • Provide a report to each meeting of HREC-LS.
  • Adapt the current and latest version of the HREC Application form and the HREC Exemption from Full Review/Low Risk Form.