Quality Assurance Manual

Part A – Application Form

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Part A – Application Form

Proposer Name(s)
Investigator/Researcher Name (if known)

Project Type
Research Degree Programme	YES NO
Other (Specify)	YES NO

Responsibility School/Department Research/Group/Other

Supervisor Name(s)

(All Undergraduate and Research Degree Programmes will require Supervision)

Project Title:
Two page summary of Protocol attached		YES NO

Proposed Duration (in Months)
Start Date:		End Date:

* Does not apply to Ethics Screening of projects on Taught Programmes

Aims of Project (Broad Statement of c.100 words )

Plain English Summary of Project (100 words or less)

Checklists
The following checklists are designed to alert you to the major types of ethical issues that may arise with your research:
Checklist A – Research Involving Human Participants or Impacting on Individuals or

General Public
Checklist B – Research Involving Impacts on Animals;
Checklist C – Research Involving Impacts on the Environment;
Checklist D – Research Involving Business Impacts on Society
You must Complete Checklist A in full and other Checklists as appropriate
Note 1

Research that raises concerns that are over and above what is determined to be Minimal Risk will need Full Ethical Approval before it can proceed. The tables below illustrates the approach required for ethical evaluation of projects that are NOT approved at the level of Minimal Risk Review.

Note 2

Project Supervisor(s) have the primary responsibility to ensure that students/ researchers do not take on research that could expose them and participants to significant risk.

Type of Research	Competent Body for Full Ethical Approval beyond Minimal Risk
Checklist A – Research involving Human Participants or Impacts on Individuals or General Public	Institute Research Ethic Committee (IREC)
Checklist B – Research Involving Animals	External Animal Ethics Review Committee*
Checklist C – Research Involving Impacts on the Environment	External Environmental Ethics Review Committee *
Checklist D – Research Involving Business Impacts on Society	Institute Research Ethic Committee (IREC)

*The Institute does not have such a committee and such research will require referral to a competent external body if approval is not provided at the level of Minimal Risk. It is the responsibility of the Proposer/Researcher to arrange such referral.

Checklist A - Research involving Human Participants or Impacting on Individuals or General Public
Research involving Human Participants or impacting on Individuals or General Public as follows:

Engagement with or Observation of Human Participants directly;
Using Information on Human Participants collected directly or from another source or as part of another process

Does your research involve:	(please tick)	If YES please comment and elaborate in next section of form as required
Processes that potentially exclude and/or disadvantage a person or group, such as the collection of information which may expose the person/group to discrimination or misrepresentation?	YES N/A
Research activity undertaken outside of the jurisdiction of the Irish State	YES N/A
Participants who are minors (under 18 years) other than in the observation of normal school based activity?	YES N/A
Participants who are in a dependent situation, such as children, students, service-users or residents of an institution	YES N/A
Participants who may be unable to give or are incapable of giving informed consent?	YES N/A
Any measures which impede a fully informed consent process?	YES N/A
Payments or inducements, other than reasonable recompense, to participants for their participation?	YES N/A
Deception of the participants including concealment and covert observation?	YES N/A
Subjection to physical pain, beyond mild discomfort?	YES N/A
Any novel procedure in the therapy or management of participants in a clinical setting?	YES N/A
The administration of any form of drug, medicine or placebo?	YES N/A
Potential inducement of psychological stress or anxiety beyond the risks encountered in normal life?	YES N/A
Any physically invasive procedure such as body fluid/tissues collection (eg blood, urine, semen), exercise regimens or physical examination which is not part of clinical management?	YES N/A
Obtaining and storage of blood, body fluid or tissue samples from the participants	YES N/A
The collection and/or storage and/or disclosure of personal information?	YES N/A
Acquisition of personal information on individuals through any form of database, online forum or social media?	YES N/A
Any sharing of confidential information with third parties	YES N/A
Any lack of clarity regarding confidentiality and/or anonymity?	YES N/A
Use of questionnaires or interviews which may be linked either directly (eg. through recording of names) or indirectly (eg through a cross-linked code) to the individual/ participant/researcher at any stage of the research?	YES N/A
The disclosure of personal information about participants or others with associated professional or legal responsibilities (ref. Mandatory Disclosure Regulations)?	YES N/A
The disclosure of information which could place the participants at risk of criminal prosecution or civil liability or be damaging to their financial standing, employability, professional or personal relationships?	YES N/A
Not specifying safeguards in regard to data acquisition and retention?	YES N/A
Risk to the researcher beyond minimal risk (greater than that experienced in everyday life)	YES N/A
More than minimal risk to any research participants (greater than would be experience in everyday life.)?	YES N/A
Any plan/intention to use the data from this study in further studies and if so have the participants been appropriately informed?	YES N/A
Garda clearance?	YES N/A
The permission of a ‘gatekeeper’?	YES N/A
Any requirement for Ethical Approval of the proposed research from another body involved in any way with the research project.	YES N/A
Any methodology that is novel, unconventional or unproven	YES N/A
The use of physical agents or processes that the Institute is licensed to use and for which there are Standard Operating Procedures in place	YES N/A
The use of chemical agents or processes that the Institute is licensed to use and for which there are Standard Operating Procedures in place	YES N/A
The use of biological materials or processes that the Institute is licensed to use and for which the Institute has Standard Operating Procedures in place	YES N/A
The use of agents or processes requiring any special license or permission from an external agency and which the Institute does not currently hold a licensed/permit or for which Standard Operating Procedures are not in place	YES N/A
Any other ethical issue of the study which has not been addressed in this Checklist?	YES N/A

Provide Clarifications on points to which a YES answer was provided and comment above not sufficient
Number	Clarification

Participant Recruitment Procedures are in accordance with the principles of the Declaration of Helsinki (World Medical Association, 2008) - and its amendments

YES N/A

Provide details relating to Participant Data including Sources, Collection Methods, Storage & Retention

(Refer to Data Protection Act (Government of Ireland, 1988)):

Access approved or Letter of Support from organisation from which participants are to be recruited:

Checklist B – Research Involving Impacts on Animals

Does your research involve:	(please tick)	If YES please comment and elaborate in next section of form as required
Animals in wildlife setting	YES N/A
Use of any methods requiring approval from National Parks and Wildlife Service or similar authority for approval under Irish or European law	YES N/A
Animals in an agricultural setting	YES N/A
Use of methods outside of normal animal husbandry requiring specialist/professional expertise	YES N/A
Animals in a laboratory or experimental setting	YES N/A
Animal experimentation under the definition of the Amendment of Cruelty to Animals Act 2002 and involving permissions and licensing issued by competent authorities	YES N/A
Methodologies that are novel, unconventional or unproven	YES N/A

Provide clarifications on points to which a YES answer was provided and comment above not sufficient
Number	Clarification

Checklist C – Research Involving Impact on the Environment

Does your research involve:	(please tick)	If YES please comment and elaborate in next section of form as required
Impact (Add to, Subtract from or Change) the Physical/Natural Environment	YES N/A
Permissions/Licenses from National Agencies or Authorities in respect of the Physical/Natural Environment	YES N/A
Impact on the Built Environment (Private or Public)	YES N/A
Permissions/Licenses from Private or Public bodies in respect of the Built Environment	YES N/A
Methodologies that are novel, unconventional or unproven	YES N/A

Provide clarifications on points to which a YES answer was provided and comment above not sufficient
Number	Clarification

Checklist D – Research Involving Business Impacts on Society

Does your research involve:	(please tick)	If YES please comment and elaborate in next section of form as required
Work on an Individual’s or Organisation’s Planning, Management or Operations in a Business environment that are not under the control of the Institute	YES N/A
Any aspect of an Individual’s or Organisation’s Business Practices that does not comply with Irish and EU law	YES N/A
Business Research Methodologies that are not fully in accordance with recognised ethically approved standards nationally or internationally	YES N/A
Methodologies that are novel, unconventional or unproven	YES N/A

Provide clarifications on points to which a YES answer was provided and comment above not sufficient
Number	Clarification

Any other Comments or Observations that may be of assistance in the ethical evaluation of this research proposal

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