Human Subjects Ethical Approval Exemption from Review Form

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Reference No: HREC-
April 2011 Version
This number is assigned when your application is accepted
Quote on all documentation
Human Subjects Exemption from Full Ethical Review Form
PLEASE DO NOT SUBMIT this form as a PDF DOC – PLEASE USE WORD
DO NOT SUBMIT Multiple Exemption Forms in the one email - One form per email only.
Part A: General Information
* please provide an answer or your submission will be returned
1. Project Details
a) Project Title*:
b) Projected start date*:
c) Is this a campus wide survey?*
Yes
No
If yes, please read the University Student Survey Board Policy and complete a University Student Survey
Board Form (USSB): http://www.ucd.ie/researchethics/ethical_review.html
d) Are you accessing UCD Students campus wide?*
Yes
No
If yes, please read the REC Access to UCD Policy and complete a Request to Access UCD Students Form:
http://www.ucd.ie/researchethics/ucd_researchers_accessing_ucd_students.html
e) Projected duration of study*:
f) Proposed duration of the data collection*:
NOTE: In no case will approval be given if recruitment and/or data collection has already begun
2. Applicant details
a) Name of Applicant*:
(please tick appropriate box by double clicking and then checking): *
Student
Staff
b) UCD School / Department / Institute*:
c) UCD Contact details ONLY (please do not provide hotmail or other eternal email addresses) *
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
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behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
April 2011 Version
Reference No: HRECThis number is assigned when your application is accepted
Quote on all documentation
UCD Telephone:
UCD E-mail*:
d) Name of Supervisor (to be completed by students only) *
UCD Telephone:
UCD E-mail*:
e) UCD Investigator(s) and Affiliations (name all investigators on project)
f) External Investigator(s) and Affiliations (if applicable)
g) Funding Source and Amount (if applicable)
h) Have you obtained UCD Insurance/Indemnity? *
Yes
No
(As a member of UCD you are obliged to seek approval from the UCD Safety Officer (safety@ucd.ie) to
ascertain whether you are insured to carry out your research)
1) is there any blood sampling involved in this study?
Yes
2) are there are other medical procedures involved in this study?
Yes
No
No
If you answer yes to either of these please contact the UCD Safety Office
Please note: if insurance is required you will need to provide this as a supporting document – insurance
can be obtained after you submit this form to the Office of Research Ethics. Please quote your reference
number to the Safety Office and ensure that you quote your reference when submitting proof of your
insurance.
i) Research Keywords (up to four):
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
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behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
April 2011 Version
Reference No: HRECThis number is assigned when your application is accepted
Quote on all documentation
Part B: Research Design & Methodology
3. Research Proposal
Using the following headings provide a brief description of your research
a) Aims and objectives of the study (in brief lay language – no more than 300 words) *
b) Research design (in brief lay language – no more than 300 words) *
c) Who are the participants or informants? (size and composition) *
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
3
behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
April 2011 Version
Reference No: HRECThis number is assigned when your application is accepted
Quote on all documentation
d) Methods of data collection (please tick appropriate box by double clicking and then checking) *
1. standard educational practices
Yes
No
2. standard educational tests
Yes
No
3. standard personality tests
Yes
No
4. standard psychological tests
Yes
No
5. interviews or focus groups
Yes
No
6. public observations
Yes
No
Yes
N
8. research which uses only existing data
Yes
No
9. surveys and/or questionnaires
Yes
No
10. audio/video recordings
Yes
No
7. research involving persons elected to or
candidates for public office
Other: (please specify)
e) Will the collected data be anonymised or identifiable? *
(please tick the relevant box and provide detail)
anonymised
identifiable
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
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behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
Reference No: HREC-
April 2011 Version
This number is assigned when your application is accepted
Quote on all documentation
Part C: Basis for Exemption
4. Research Participants: Risk, Harm, Selection and Consent
a) Is this research likely to involve any foreseeable risk to participants, above the level
experienced in everyday life? *
Yes
No
b) Does this research involve the following: *
[you are advised to read the HREC Guideline Documents – see HREC Policies &
Guidelines http://www.ucd.ie/researchethics/hrec_policies_and_guidelines.html ]
(please tick appropriate box by double clicking and then checking)
1. any vulnerable groups? (this includes UCD students)
Yes
No
(i.e. sexual behaviour, illegal activities, racial biases, etc.)
Yes
No
3. use of drugs
Yes
No
4. invasive procedures (e.g. blood sampling)
Yes
No
5. physical stress/distress, discomfort
Yes
No
6. psychological/mental stress/distress
Yes
No
7. deception of/or withholding information from subjects
Yes
No
Yes
No
9. conflict of interest issues
Yes
No
10. or any other ethical dilemmas
Yes
No
11. Is there any blood sampling involved in the study?
Yes
No
2. Sensitive topics that may make participants feel uncomfortable
8. access to data by individuals or organizations other than the
investigators
(if yes the safety office needs to be informed)
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
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behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
Reference No: HREC-
April 2011 Version
This number is assigned when your application is accepted
Quote on all documentation
5. Has this proposal received Ethical Approval from another body?
(e.g. Hospital REC or data collected by another organisation for a specific purpose)
Yes
No
(if your answer is no please proceed to Section 8)
6* Ethical Approval from body other than UCD for this study or parts of this study
(if applicable)
a) Name of the organisation that has approved the study?
b) Approval No: _______________
c) Approval Date: ______________
(please provide a copy of the approval)
d) Provide a brief account of aspects of study not covered by approval.
e) Can you confirm that only those aspects of the study over which the approving body
has jurisdiction and has approved are subject to this application for grant of approval?
Yes
No
f) Can you confirm that you will seek full ethical approval from UCD HREC for all nonapproved aspects of the study?
Yes
No
* Note: a grant of approval with exemption from review will only be granted by UCD HREC for
those aspects of the study that have been approved and are under the jurisdiction of the
approving body
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
6
behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
April 2011 Version
Reference No: HRECThis number is assigned when your application is accepted
Quote on all documentation
7. Approval from an approved body (if applicable)
a) Have all aspects of the protocol received ethical approval from an approved body
Yes
No
b) Does the approving body have jurisdiction over all aspects of the study?
Yes
No
8. If you are using existing data, please explain why this is exempt from full ethical
review
(eg. Data collected by another organisation for a specific purpose) *
9. Have you read the following?:*
a) the current Guidelines and Policies for Ethical Approval of Research Involving
Human Subjects issued by the Human Research Ethics Committee? Please see the
research ethics website:
http://www.ucd.ie/researchethics/hrec_policies_and_guidelines.html
(please tick)
Yes
No
b) The UCD Data Protection Policy?
www.ucd.ie/dataprotection/policy
(please tick)
Yes
No
c) The Data Protection Guidelines on Research in the Health Sector
http://www.dataprotection.ie/documents/guidance/health_research.pdf
(please tick)
Yes
No
Please note: It is not sufficient to read a paper copy which may be out of date. The latest versions of
the guidelines and policies are posted on the UCD website. Your application may not be considered if
you have not read the latest versions.
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
7
behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
April 2011 Version
Reference No: HRECThis number is assigned when your application is accepted
Quote on all documentation
Part D: Declaration
I, the undersigned researcher, have read the UCD Guidelines and Policy for Ethical Approval of
Research Involving Human Subjects and Further Exploration of the Process of Seeking Ethical
Approval for Research and agree to abide by them in conducting this research. I confirm that,
based on my understanding of these guidelines and policy documents, I consider that this
research protocol meets the requirements for exemption from review.
I confirm that the information provided on this form is correct and accurate.
We the undersigned researchers acknowledge or agree with the University:
(a) It is our sole responsibility and obligation to comply with all domestic Irish and
European legislation and to obtain such statutory consents as may be necessary;
(b) Not to commence any research until any such consents have been obtained;
(c) To furnish to the proper officer of UCD a true copy of any consent obtained;
(d) That neither the University, the Committee, nor individual members of the Committee
accept any legal obligation (to us or to any third party) in relation to the processing of
this application or to any advice offered in respect of it nor for the subsequent
supervision of the research;
(e) That the research will be conducted in accordance with any approval for an
exemption from full review granted by the Committee and in conformity with the
documentation submitted with this application and with licence granted under any
legislation;
(f) That the undersigned researcher(s) have read the most recent UCD Research Ethics
Committee Guidelines and Policy for Ethical Approval of Research involving Humans –
which are available on the UCD website (www.ucd.ie/researchethics) and agree to
abide by them in conducting this research;
(g) Confirm that the information provided on this form is correct and accurate;
(h) In conducting research a researcher has both ethical duties and legal obligations.
Compliance with one set of responsibilities does not guarantee compliance with the other what is legally permissible may not be ethical and vice versa. It is for the researcher to inform
himself and herself as to what ethical duties and legal obligations apply to his or her
research and to comply with these duties and obligations;
(i) It is not acceptable for an applicant to treat the grant of ethical approval as absolving them
from the responsibility of informing themselves of their legal responsibilities in relation to
data protection and of complying with these;
(j) It must be understood that any ethical approval granted is premised on the assumption that
the research will be carried out within the limits of the law;
(k) Ethical approval does not constitute any sort of advice or representation to the applicant
that compliance with the requirements, as laid down by the UCD Human Research Ethics
Committee, will be sufficient to comply with the applicable law in the area.
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
8
behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
Reference No: HREC-
April 2011 Version
This number is assigned when your application is accepted
Quote on all documentation
I apply for Approval for Exemption from review of the research protocol summarised above,
on the basis that: (indicate category) *
a) All aspects of the protocol have received ethical approval from an approved body
(e.g. Hospital REC)
b) These aspects of a larger research protocol have received ethical approval from an approved
body
(e.g. Hospital REC).
c) The research protocol meets the criteria for exemption from review as detailed in Section 3 of
Further Exploration of the Process of Seeking Ethical Approval for Research
Signature of Principal Investigator: _______________________________
Date:
/
/
Endorsement of Supervisor / Head of School *
I have read the above application, and am satisfied that the study appears to meet all
requirements for a Grant of Ethical Approval with Exemption from Review from UCD
HREC.
Signature of Supervisor / Head of School: __________________________
Date:
/
/
CHECKLIST:

DO NOT SUBMIT THIS FORM AS A PDF DOC – PLEASE USE WORD. All submissions of
the HREC Exemption form in a PDF doc cannot be processed and therefore will not
receive a research ethics reference number.

DO NOT SUBMIT Multiple Exemption Forms in the one email - multiple submissions
will not be processed and will be returned. One form per email only.

DO NOT SUBMIT an older version of this form. Submissions on the wrong form will
be returned without being processed.

NOTE: You may be required to submit a Request to Access UCD Student Form.

NOTE: You may be required to submit a USSB form in order to conduct a survey.
Note: Your Supervisor/Head of School must forward this completed form to the Office of Research Ethics on your
9
behalf, endorsing your application for exemption from review by email only (research.ethics@ucd.ie). The signed hard
copy is retained by your School.
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