Procedure for Ethical Review of Minimal Risk Form

Procedure for Ethical Review of Minimal Risk Form

3. 
   The Chairs (or nominees) of the IPC and IREC will review the proposal, and decide to refer it to either the IPC if no further ethical consideration is required or the IREC for further ethical consideration is required.
   

3. 
   Where a proposal is referred to the IREC, the proposer(s) will complete and submit an IREC Application Form (See Appendix 4) to the Chair of the IREC by a specified date.
   

2. Procedure for Ethical Review by the Institute Research Ethics Committee

1. 
   The IREC will consider the Research Ethics Committee Application Form in respect of a research proposal referred to the Committee by the Chairs of the Institute Postgraduate Committee (IPC) and Institute Research Ethics Committee (IREC).
   

2. 
   The Committee will consider if the nature of the research activity described in the proposal complies with the Institute Ethics Policy Statement. Where the research activity complies with Institute Policy, the proposal will be subjected to detailed review. Where the research activity does not comply with Institute Policy, approval will be refused, and the IREC will inform the proposer of this decision, and the reason(s) for the decision, of the IREC to refuse a proposal.
   

3. 
   The detailed review of a research proposal will determine if the measures specified in the proposal adequately address issues of ethical concern. The Committee shall approve proposals on the basis that ethical considerations of the proposals have been adequately addressed. The IREC will inform the proposer of their decision to approve or refuse a proposal, and the reason(s) for the decision of the IREC to refuse a proposal.
   

4. 
   Where IREC decide that additional safeguards are required, approval may be granted subject to conditions.
   

5. 
   Approved Postgraduate Research Degree Proposals will be forwarded to the IPC. Unsuccessful proposals will be returned to the proposer.
   

6. 
   The decisions of IREC in respect of postgraduate research degree proposals will be communicated to the Chair of the IPC.
   

7. 
   There shall be no facility to appeal decisions of the joint meeting of the Chairs of the IPC and IREC or of the Institute Research Ethics Committee.
   

6. Procedures for Ethical Review of Proposals for Research Activity, not leading to an Award on the National Framework of Qualifications.

1. Definitions

Research Activity not leading to an award on the NFQ is research conducted by individual or a team of Institute staff members, and collaborative partners, which has been commissioned or sanctioned by the Institute of Technology Tralee, and / or funded by local, regional, national or international agencies.

2. Procedure for Ethical Review of Minimal Risk Form

1. 
   The proposer of research activity not leading to an award on the NFQ, will prepare the proposal in consultation with the relevant manager and / or approver of resources where relevant, and will complete the Minimum Risk Form.
   

2. 
   A completed proposal for which resources have been approved by the relevant manager will be referred by the proposer to the Chair of the IREC.
   

3. 
   A completed proposal not requiring approval by a line manager will be submitted directly to the Chair of the IREC.
   

4. 
   The Chairs (or nominees) of the IPC and IREC will review the proposal and decide to refer it to the Development Office if no further ethical consideration is required or the IREC for further ethical consideration is required.
   

4. 
   Where a proposal is referred to the IREC, the proposer(s) will complete and submit an IREC Application Form (Appendix 3) to the Chair of the IREC by a specified date.
   

2. Procedure for Ethical Review by the Institute Research Ethics Committee

1. 
   The IREC will consider IREC Application Forms in respect of a research proposal referred to the Committee by the Chairs of the Institute Postgraduate Committee (IPC) and Institute Research Ethics Committee (IREC).
   

2. 
   The Committee will consider if the nature of the research activity described in the proposal complies with the Institute Ethics Policy Statement. Where the research activity complies with the Policy Statement, the proposal will be subjected to detailed review. Where the research activity does not comply with the Policy Statement, approval will be refused, and the IREC will inform the proposer of this decision, and the reason(s) for the decision by IREC to refuse a proposal.
   

3. 
   The detailed review of a research proposal will determine if the measures specified in the proposal adequately address issues of ethical concern. The Committee shall approve proposals on the basis that ethical considerations of the proposals have been adequately addressed. The IREC will inform the proposer of their decision to approve or refuse a research proposal, and the reason(s) for the decision of the IREC to refuse a proposal.
   

4. 
   Where IREC decide that additional safeguards are required, approval may be granted subject to conditions.
   

5. 
   Type B research proposals which have received ethical approval by the IREC will be also be forwarded to the Research Office.
   

6. 
   There shall be no facility to appeal decisions of the joint meeting of the Chairs of the IPC and IREC or of the Institute Research Ethics Committee.
   

Ethics in respect of Postgraduate Research Degree Programmes and approved Other Research Activity conducted in the Institute of Technology Tralee, to include:

1. 
   Postgraduate Research Degree Programmes,
   
2. 
   Other Research Activity conducted by individual and teams of staff that has been commissioned or sponsored by the Institute of Technology Tralee,
   
3. 
   Other Research Activity sanctioned by the Institute and funded by national or international agencies
   
4. 
   Research by external agencies involving staff and students of the Institute.
   

The membership of the Institute Research Ethics Committee shall be comprised as follows:

• 
  Chairperson, appointed by the Institute Executive
  
• 
  Head of Development
  
• 
  Up to 6 persons appointed by the Academic Council to ensure appropriate representation of the individual areas of research
  
• 
  Person with knowledge and experience of working in another ethics committee, appointed by the Academic Council
  
• 
  Person with knowledge of and current experience in the professional care, counselling or treatment of people (e.g. medical practitioner, clinical psychologist, social worker, nurse), appointed by the Academic Council
  
• 
  Person with a qualification in law, appointed by the Academic Council
  
• 
  Person with experience in pastoral care and training in theology, ethics or morality, appointed by the academic council
  
• 
  Two persons, appointed by the Academic Council, neither of whom shall be the holder of a teaching, research or administrative post in the Institute or in any college.
  

The total membership of the IREC is 14 and the Quorum of the Institute Research Ethics Committee shall be 7.

The Institute Research Ethics Committee will report to the Research and Development Subcommittee of the Academic Council. It will also advise the Institute Postgraduate Committee of its decisions in respect of ethical appropriateness of Postgraduate Research Degree Programmes and the Development Office in respect of Other Research Activity.

The IREC will meet at least once each Semester. Meetings will be scheduled to facilitate timely decisions with regard to the ethical appropriateness of Postgraduate Research Degree Programme and Other Research Activity proposals.

1. 
   Establish, implement, and keep under review codes of practice, procedures, and guidelines for the ethical review of research projects which are undertaken by members of staff and/or student members of the Institute;
   

2. 
   Ensure that ethical principles are clearly laid down and are disseminated to staff and student members in support of good ethical practice;
   

3. 
   Consider applications for approval referred to the committee by the Chairs of the IPC and IREC, and make a decision in relation to those applications. Report the decisions in relation to applications to the Registrar or Head of Development as appropriate;
   

4. 
   Consider and advise on training arrangements to be put in place for those involved in considering applications under this machinery and, as and when appropriate, for those undertaking research;
   

5. 
   Consider any relevant issues, including reports, concerning the ethics of research referred to the committee by any other institution or external body.
   

The committee shall make an annual report to the Chairperson of the Research and Development Subcommittee, who shall present the report to the Academic Council.

1. 
   The Call Documentation should be read prior to completing this application form.
   

2. 
   Completed applications must not exceed 9 pages in length (excluding this coversheet and appendices). Applications over 9 pages in length will be returned to the applicant and will be deemed ineligible for consideration.
   

3. 
   Appendices may include additional support from potential collaborative partners (if applicable).
   

4. 
   Pro-forma supervisor profile sheets to extend to a maximum of 5 pages.
   

5. 
   Please ensure that you complete all sections of this form (using typescript Ariel font pitch size 10).
   

6. 
   One electronic copy of this application form must be submitted in Word format to aine.brosnan@ittralee.ie in the Research Office by XXXXX.
   

Title of Research Proposal:

Principle Project Supervisor:
Department:
Research Group/Centre:

Project Co-Supervisor:
Department:
Research Group/Centre:

Mentor Supervisor (if applicable):
Department:
Research Group/Centre:

1. 
   Abstract
   

Please bear in mind that this could be read by non- specialists, as well as peers, and should be written in order to communicate with them effectively. Max 300 words

2.	Description of Topic

To include, for example aims, objectives and central research questions. Max 500 words

3.	Methodology

To include for example, investigative and analytical methods and theoretical frameworks Max 500 words

4.	Research Schedule
To include for example a timeline for the completion of tasks/phases of the project and efficient management and performance of the research. Max 500 words

Suggest how the project will make a new contribution to knowledge. Do not provide bibliographical lists or footnotes here. Max 500 words

6.	Description of any specialist knowledge/data required to undertake the project
For example, language competence, technical skills, use of specialist software etc. Describe plans for acquiring this knowledge/data if it is not already in place. Describe how data for this project will be assessed. Max 500 words

7.	Description of dissemination plans and potential impact
Max 500 words

8.	Please outline your reasons for choosing your specific theme, including how your research proposal is aligned with the Institutes research strategy and national research priorities.
Max 500 words

9.	Career Training and Development Plan
Provide a description of how this research will further a student’s acquisition of new specialist knowledge and skills, and generic knowledge and skills e.g. where appropriate include a reference to the Description of Specialist Knowledge in Section 6 above Max 1000 words

10.	Ethical Statement
I am familiar with the Institute’s procedures with regards to research ethics and integrity. Yes  No  Are there ethical considerations to be addressed within the research proposal outlined in this submission? Yes  No  I have given full consideration to the ethical issues that may arise in the course of this research. Please expand below or indicate N/A if there are no ethical issues associated with the proposed research. I am aware that the proposed research must undergo a formal research ethics review prior to the commencement of the research aligned with the Institutes QA procedures for a research proposal to be approved as a research degree programme. _____________________________ Signature of Principal Supervisor Research ethics issues identified and proposed ethics management plan:
11.	Sex/Gender Dimension
Does your proposed research programme involve any of the following: 1. Humans as the research focus 2. Animals as the research focus 3. Human samples and/or data 4. Humans involved as consumers, users, patients, or in trials 5. Research on animals, animal samples and/or data 6. Research outputs with implications for end users or consumers Yes  No 
If not, please explain why there is no potential sex-gender dimension to be considered in your proposed research. If your research does involve one of these components, indicate how potential sex-gender issues will be handled. Max 500 words
12.	Financial Justification
Please provide the total cost for the full duration of the scholarship. The exact amount of eligible direct research expenses to be allocated is subject to sufficient justification being made. An itemised breakdown of costs and the associated justification is required e.g. list separately the cost and justification for individual pieces of computer equipment and software. Small consumables can be grouped as one item e.g. general lab or stationery supplies. Essential direct research expenses: Total cost requested for Funding Term: Justification. Please provide itemised breakdown of costs and reason needed: Essential research supplies such as small consumables: Software and hardware critical for the proposed research: Conference travel and participation: Generic and/or specialist disciplinary skills training: Publishing and write-up costs: Other costs: Total: