Dublin City University Research Ethics Committee

Dublin City University – Research Ethics Committee

/ Dublin City University
RESEARCH ETHICS COMMITTEE
APPLICATION FOR APPROVAL OF A PROJECT INVOLVING ANIMALS, WHERE THE PROJECT DOESNOT REQUIRE A PROJECT AUTHORISATION FROM THE HEALTH PRODUCTS REGULATORY AUTHORITY(HPRA)
Application No. (office use only)DCUREC/2015/
Period of Approval (office use only)...... /...... /...... to...... /...... /....

This application form is to be used by researchers seeking ethical approval for individual projects and studies involving the use of animals, where the proposed project or study does NOT require a Project Authorisation from the Health Products Regulatory Authority (HPRA) (formerly known as the Irish Medicines Board (IMB)) under the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2014. . If you are unsure about whether or not the work that you propose to do requires an authorisation from the HPRA, please contactthe Chairman of theBio Resource Advisory Group (BRAG)(Damian O’Donohue) for advice (Telephone (01) 700 5313).

Before your application will be considered by the DCU Research Ethics Committee (REC), you must submit an electronic copyof your draft application (this form) to the Chairman of the Bio Resource Advisory Group (BRAG) (Damian O’Donohue), with an electronic copy to the.

Note:If your research requires approval from the Biosafety Committee, this approval should be in place prior to REC submission.

Once you have obtained the necessary approval or reccomendationfrom the BRAG, asigned electronic copy of your completed application must be submitted by E-mail to the BRAG, by whom it will be forwarded to the DCU Research Ethics Committee.

The electronic copy should consist ofone file only, which incorporates all supplementary documentation.
The completed application must be proofread and spell-checked before submission to the REC. All sections of the application form should be completed.
Applications must be completed on the appropriate form. No handwritten application will be accepted.
Applications thatdo not adhere to these requirements will not be accepted for review and will be returned directly to the applicant.

NB - Research must not commence until written approval has been received from the DCU Research Ethics Committee.

PROJECT TITLE

PRINCIPAL INVESTIGATOR(S)

Please check that all supplementary information is attached to your application

ATTACHED / NOT APPLICABLE
Confirmation of Biosafety Committee approval
Evidence of external approvals related to the research
Bibliography
Other (e.g. EPA application)

Guidelines to Applicants

1.1 PRINCIPAL INVESTIGATOR(S): Supervisors and co-supervisors of student projects are Principal Investigators. PhD and Doctoral students should be listed as Other Investigators.

1.2 WILL THE RESEARCH BE UNDERTAKEN ON-SITE AT DUBLIN CITY UNIVERSITY: Projects involving the use of pathogens or GM animals, microbes or cells will need to obtain approval from the Biosafety Committee. Approval from the REC is conditional on receipt of a letter of approval from the Biosafety Committee.

2.0 project outline: Provide a brief outline of the project, aims, methods, duration, funding, subjects and proposed interaction with them. This description must be in everyday language that is free from jargon. Please explain any technical terms or discipline-specific phrases.

3.0 Justification for the use of animals: This application form should only be used where it is NOT the intention to conduct a “procedure” (as defined in the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (SI 543 of 2012)) so, in general, this application form will be used in cases where it is intended to kill animals so that their tissues or organs can be used for scientific or educational purposes in vitro. Nevertheless, the DCU Research Ethics Committee (REC) must be satisfied that the use of animals is justified, based on the scientific or educational value of the work. Overall, answers provided in this section should provide REC members, particularly external lay and welfare members, with a clear idea of why the experiments are necessary. The REC requires that the applicant(s) state briefly what is known and not known about the issue under investigation, what further knowledge can be obtained from the proposed research, and why it is considered essential now to use animals. All information provided in this section must be in language that can be understood by an interested, intelligent person without a scientific background. Do not use scientific jargon and avoid using abbreviations. Where additional information is being provided, this should usually be limited to approximately 100 words. Where a longer reply is required, or when tables are being used, the information should be provided as an appendix

3.2 ARE ALTERNATIVES THAT REPLACE OR REDUCE THE USE OF ANIMALS BEING UTILIZED IN THIS PROJECT?: The aim of the DCU REC is to ensure the ethical use and the humane care of animals used for scientific purposes. To this end, there is a need in scientific and teaching activities to consider methods that replace and reduce the use of animals, even in projects that do not involve conducting procedures on animals.

3.3 JUSTIFY THE NUMBER OF ANIMALS REQUESTED IN TERMS OF STATISTICAL CONSIDERATIONS AND/OR OTHER CONSIDERATIONS IN THE EXPERIMENTAL DESIGN: In accordance with the aim of the DCU REC, there is a need in scientific and teaching activities to consider the reduction in the number of animals used. Note that in some cases however, it may be better to use more animals in order to maximise the effectiveness of the project.

3.5 JUSTIFY YOUR CHOICE OF ANIMAL (SPECIES/STRAIN): Please provide references to justify your choice. NB – all references cited should be listed in an attached bibliography.

3.6DOES THE PROJECT INVOLVE THE USE OR PRODUCTION OF GENETICALLY MODIFIED ANIMALS, E.G. TRANSGENIC, KNOCKOUT?:In accordance withthe aim of the DCU REC,, there is a need in scientific and teaching activities to consider the refinement of techniques used to reduce the impact on animals (Note that the use of such animals is also governed by the GMO (Contained Use) Regulations, 2001, S.I. No. 73 of 2001). Note also that the breeding or production of genetically modified animals whose health, welfare, breeding or life span may be adversely affected by the modification (i.e. that have a “harmful phenotype” requires a project authorisation from the HPRA. This application form should not be used for REC approval of such projects.

3.11 WHERE WILL ANIMALS BE HOUSED, AND WHAT TYPE OF HOUSING WILL BE USED?:Include details of methods used to ensure that housing meets the specific requirements of the animals being held. Describe any special housing requirements. In cases where the animals will be housed in the Bio Resource Unit at DCU, it will be sufficient to state that fact, without specifying the details of housing and husbandry.

4.0PROJECT DESCRIPTION: This section should explain the scientific rationale of the project and provide a description of the experimental design. It is not necessary to include excessive detail about procedures not involving the use of live animals.

5.2 PERSON(S) KILLING ANIMALS: Although a project authorisation is not required for the killing of animals solely for the use of their organs or tissues, the person(s) killing the animals must hold an appropriate Individual Authorisation (a “killing authorisation”) issued by the HPRA or the Irish Medicines Board (IMB)

6.0 INVESTIGATOR QUALIFICATIONS, EXPERIENCE AND SKILLS: List the academic qualifications and outline the experience and skills relevant to this project that the researchers and any supporting staff have in carrying out the research and in dealing with any emergencies, unexpected outcomes, or contingencies that may arise. If animals are to be killed for use in the project, identify the person(s) who has/have the appropriate “killing authorisation” from the HPRA, if relevant.

For further information please consult the DCU REC website:

Please note:

Any amendments to the original approved proposal must receive REC approval before implementation.
As a condition of approval investigators are required to document and report immediately to the Secretary of the Research Ethics Committee any adverse event, any issues which might negatively impact on the conduct of the research and/or any complaint from a participant relating to their participation in the study.
All REC applications will be securely stored in a locked filing cabinet in the Office of the Vice-President for Research.

When review of your application by the BRAG has been completed, please submitasigned electronic copy of your completed to the Chairman of the BRAG (Damian O’Donohue), who will then forward it, together with a Report and Recommendation from the BRAG, to the Secretary to the Research Ethics Committee (). Hard copy is not required.

1.ADMINISTRATIVE DETAILS

PROJECT TITLE:
THEPRIMARY PURPOSE OF THIS PROJECT IS: / Research Project / Funded Consultancy
(Tick only one) / Practical Class / Prelude to Clinical Trial
Student Research Project
(please indicate level) / Other - Please Describe:
Undergraduate
Masters
PhD
Project Start Date: / Project End date:

1.1INVESTIGATOR CONTACT DETAILS(see Guidelines)

PRINCIPAL INVESTIGATOR(S):

TITLE / SURNAME / FIRST NAME / PHONE / FAX / EMAIL

OTHER INVESTIGATORS:

TITLE / SURNAME / FIRST NAME / PHONE / FAX / EMAIL
FACULTY/DEPARTMENT/SCHOOL/ CENTRE:

1.2WILL THE RESEARCH BE UNDERTAKEN ON-SITE AT DUBLIN CITY UNIVERSITY?

YES / NO / (If NO, give details of off-campus location.)

IF YOU ANSWERED YES, PLEASE ANSWER THE FOLLOWING:

DOES YOUR PROJECT INVOLVE THE USE OF PATHOGENS OR GM ANIMALS, MICROBES OR CELLS?

YES / NO

HAVE YOU RECEIVED APPROVAL FOR YOUR PROJECT FROM THE DCU BIOSAFETY COMMITTEE?

YES / NO / Please note that approval from the BSC must be obtained before you submit your application to the REC. You should attach confirmation of BSC approval to your application.

1.3IS THIS PROTOCOL BEING SUBMITTED TO ANOTHER ETHICS COMMITTEE, OR HAS IT BEEN PREVIOUSLY SUBMITTED TO AN ETHICS COMMITTEE?)

YES / NO / (If YES, please provide details and append copies of approval(s) received etc.)

1.4DETAILS OF ANIMALS TO BE USED

SPECIES(AND COMMON NAME) / STRAIN /

AGE

/ TOTAL NUMBER PER PROJECT / SOURCE

1.5DOES THE PROPOSED RESEARCH REFER TO CONTINUING WORK?

YES / NO / (If YES, please provide details of previous work and indicate the additional benefit expected to emerge from the continuing work)

1.6PLEASE CATEGORISE THE OBJECTIVE OF THE WORK:

Research
Teaching
Diagnostic/Forensic
Drug Testing/Manufacture
Other (please specify)

DECLARATION BY INVESTIGATORS

The information contained herein is, to the best of my knowledge and belief, accurate. I have read the University’s current research ethics guidelines, and accept responsibility for the conduct of the procedures set out in the attached application in accordance with the guidelines, the University’s policy on Conflict of Interest and any other condition laid down by the Dublin City University Research Ethics Committee or its Sub-Committees. I have attempted to identify all risks related to the research that may arise in conducting this research and acknowledge my obligations and the rights of the subjects.

Any affiliation or financial interest for researcher(s) in this research or its outcomes or any other circumstances which might represent a perceived, potential or actual conflict of interest has been declared in accordance with Dublin City University policy on Conflicts of Interest.

I and my co-investigators or supporting staff have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise.

Signature(s):

Last updated: 27th August 2015Page 1

Dublin City University – Research Ethics Committee

Signature of principal investigator(s):

Last updated: 27th August 2015Page 1

Dublin City University – Research Ethics Committee

Type name:
Date

NB – if you are a first-time applicant, your supervisor(s) must also sign off this application:

Last updated: 27th August 2015Page 1

Dublin City University – Research Ethics Committee

Signature of supervisor(s):

Last updated: 27th August 2015Page 1

Dublin City University – Research Ethics Committee

Type name:
Date

Last updated: 27th August 2015Page 1

Dublin City University – Research Ethics Committee

2.PROJECT OUTLINE (No more than 300 words – see Guidelines)

3.JUSTIFICATION FOR THE USE OF ANIMALS (see Guidelines)

3.1HAS ANY OF THE ANIMALS BEEN THE SUBJECT OF A PREVIOUS SCIENTIFIC OR TEACHING ACTIVITY?

YES / NO / If YES, provide DCU REC Register Number/s of the other project/s, DoHC Licence / IMB / HPRA Project Authorisation number(s) if applicable, and details of what was done to them previously, and justify their use in this project.

3.2ARE ALTERNATIVES THAT REPLACE OR REDUCE THE USE OF ANIMALS BEING UTILIZED IN THIS PROJECT? (see Guidelines)

YES / NO / If YES, please describe what alternatives are being used.
If NO, please describe what alternatives were considered and explain
why they are unsuitable for this project.

3.3JUSTIFY THE NUMBER OF ANIMALS REQUESTED IN TERMS OF STATISTICAL CONSIDERATIONS AND/OR OTHER CONSIDERATIONS IN THE EXPERIMENTAL DESIGN. (Where appropriate, present the numbers in table form based on treatment group, as an appendix. See Guidelines).

3.4TOREDUCE ANIMAL USE, COULD TISSUES OR ORGANS FROM THE ANIMALS IN THIS PROJECT ALSO BE USED IN OTHER PROJECTS?

YES / NO / If NO, briefly describe why.

3.5JUSTIFY YOUR CHOICE OF ANIMAL (SPECIES/STRAIN)

3.6DOES THE PROJECT INVOLVE THE USE OR PRODUCTION OF GENETICALLY MODIFIED ANIMALS, E.G. TRANSGENIC, KNOCKOUT? (see Guidelines)

YES / NO / If YES, briefly describe the function/s of the gene/s that have been/will be modified and why their modification is relevant to the project.

IF YOU ANSWERED YES TO 3.6, PLEASE ANSWER QUESTIONS 3.7 TO 3.9:

3.7DESCRIBE HOW AND WHEN TISSUE USED FOR GENOTYPING THE ANIMALS WILL BE COLLECTED.

3.8FROM WHERE WILL THE ANIMALS BE OBTAINED?

3.9IS EPA REGISTRATION REQUIRED?

YES / NO / UNKNOWN / If YES, provide evidence of same.
If UNKNOWN, provide a brief explanation

3.10WILL ANIMALS NEED TO BE TRANSPORTED FROM THE SOURCE LOCATION TO THE LOCATION WHERE THEY WILL BE HELD FOR THIS PROJECT?

YES / NO / If YES, provide details of transportation and acclimatisation procedures.

3.11WHERE WILL ANIMALS BE HOUSED BEFORE BEING KILLED, AND WHAT TYPE OF HOUSING WILL BE USED? (see Guidelines)

4.PROJECT DESCRIPTION (See Guidelines)

4.1DESCRIBE THE OVERALL PURPOSE OF THE PROJECT (Not more than 500 words)

4.2DESCRIBE THE CURRENT STATE OF SCIENTIFIC KNOWLEDGE FOR THE WORK TO BE PERFORMED IN THE PROJECT (Not more than 500 words)

4.3HOW DO THE OBJECTIVES OF THIS PROJECT DIFFER FROM THE FINDINGS OF PREVIOUS STUDIES IN THIS AREA? (Not more than 500 words)

4.4DETAIL THE EXPECTED SCIENTIFIC BENEFIT OF THE PROJECT(Not more than 500 words)

4.5PROVIDE A BRIEF DESCRIPTION OF THE EXPERIMENTAL DESIGN(Not more than 500 words)

5.KILLING AND DISPOSAL (No more than 200 words. If a longer reply is required, or if a Standard Operating Procedure is being provided, then the information should be provided as an appendix)

5.1WILL ANIMALS BE KILLED IN ACCORDANCE WITH ANNEX IV OF DIRECTIVE 2010/63/EU?

YES / NO / (If NO, please provide an explanation)

5.2CONFIRM THAT THEPERSON(S) KILLING THE ANIMALSCURRENTLY HOLD (OR WILL HOLD) AN APPROPRIATE INDIVIDUAL AUTHORISATION (A “KILLING AUTHORISATION”) FROM THE HPRA / IMB

YES / NO

5.3WHAT WILL BE THE METHOD OF DISPOSAL OF DEAD ANIMALS AND TISSUES AND ORGANS FROM ANIMALS?

6.INVESTIGATOR QUALIFICATIONS, EXPERIENCE AND SKILLS (Approx. 200 words – see Guidelines)

7.FUNDING

7.1HOW IS THIS WORK BEING FUNDED?

7.2PROJECT GRANT NUMBER (If relevant and/or known)

7.3DOES THE PROJECT REQUIRE APPROVAL BEFORE CONSIDERATION FOR FUNDING BY A GRANTING BODY?

YES / NO

7.4DOES ANY OF THE RESEARCHERS, SUPERVISORS OR FUNDERS OF THIS PROJECT HAVE A PERSONAL, FINANCIAL OR COMMERCIAL INTEREST IN ITS OUTCOME THAT MIGHT COMPROMISE THE INDEPENDENCE AND INTEGRITY OF THE RESEARCH, OR BIAS THE CONDUCT OR RESULTS OF THE RESEARCH, OR UNDULY DELAY OR OTHERWISE AFFECT THEIR PUBLICATION?

YES / NO / (If Yes, please specify how this conflict of interest will be addressed.)

8.DECLARATIONS

I CONFIRM THAT THE REQUIRED ANIMALS CAN BE OBTAINED FROM AND/OR HOUSED IN THE BIORESOURCE UNIT:

BRU MANAGER’S NAME:
BRU MANAGER’S SIGNATURE:
DATE:

I CONFIRM THAT THE BIO RESOURCE ADVISORY GROUP HAS REVIEWED THIS PROPOSAL:

CHAIRPERSON’S NAME:
CHAIRPERSON’S SIGNATURE:
DATE:

Last updated: 27th August 2015Page 1