Procedures for Exemption from Full Review
Undergraduate & Taught Masters Research Ethics Committees
A number of Undergraduate Research Ethics Committees (URECs) and Taught Masters
Research Ethics Committee (TMREC) are currently operating within the framework of the
HREC-HS and the HREC-LS. However these committees have not been able to accept
applications for Exemption from Full Review. The UCD Research Ethics Committee has
approved the extension of the exemption process to the UREC and TMREC structures using
the existing criteria for exemption.
The current documentation on seeking ethics approval states the following criteria for
application for exemption (http://www.ucd.ie/researchethics/exemption_from_review.html):
“A research protocol is exempt from the need for full review by UCD HREC if all
aspects of the research protocol have been reviewed and approved by a recognised
REC. Where a study has been approved elsewhere, UCD HREC approval, with
exemption from ethical review, will only be granted for those aspects of the study
over which the REC granting the approval has full jurisdiction. If the reviewing
REC(s) does not, or do not, have full jurisdiction over all aspects of the research,
approval must be obtained from the relevant REC(s) for all other aspects of the
protocol. This includes, but is not limited to, full review by UCD HREC for
recruitment of UCD students.
There are six other categories of research in which a full review is generally not
required by the HREC … :standard educational practices, standard educational
tests, anonymous surveys or interviews, public observations, research involving
persons elected to or candidates for public office and research which uses only
existing data which is publicly available.
However, not all research in these categories is exempt from review; please refer
to the relevant section below for further details. In general, a study that involves
vulnerable groups, sensitive topics, or would expose participants to risk or harm to
a degree that is greater than they would normally be exposed to is not exempt.”
The form below has been approved for use by URECs and TMRECs for the purpose of
applications for exemption from full review. As with existing applications to these
subcommittees, applications for exemption should be submitted to and considered by the
local committee but noted by the HREC-HS and HREC LS (and the REC) as part of the
regular report of the URECs and TMRECs.
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UCD Undergraduate/Taught Masters Research Ethics Committees
Exemption from Ethical Review Form
Section 1: Overview
1.1
Title of Proposed Research:
1.2
Does the proposed research involve any of the following? (Place X in relevant box.)
For office use only
i. A child* sample (*anyone under 18 years old)
ii. A student sample
iii. A potentially vulnerable sample (people with a language
difficulty, intellectual/mental impairment, elderly, people who are
incarcerated or in an unequal relationship with the researcher)
iv. Deception
v. A sensitive topic
vi. A potentially invasive form of data collection
Please note: All applicants MUST review the UCD Summary Guidelines and Policy for Ethical
Approval of Research Involving Human Subjects issued by the Human Research Ethics SubCommittee and the the document entitled Further Exploration of the Process of Seeking Ethics
Approval for Research before submitting an application for exemption from full review.
Please confirm the following:
[ ] I have read the UCD Summary Guidelines and Policy for Ethical Approval of Research Involving
Human Subjects
[ ] I have read the document entitled Further Exploration of the Process of Seeking Ethics
Approval for Research
Please indicate any other ethical guidelines or codes of ethics you have consulted in preparing your
application.
Section 2: Applicant Details
2.1
2.2
2.3
2.4
Name:
Address for correspondence:
Telephone:
E-mail:
Research Supervisor
2.5
Name:
2.6
Departmental address:
2.7
Telephone:
2.8
E-mail:
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Section 3: Details of Proposed Research
Provide a brief summary of the following information (max 200 words in any section).
3.1 Proposed starting date
3.2 Aims of the study
3.3 Scientific background (e.g. summary of key article)
3.4 Research design
3.5 Methods of data collection
3.6 Nature of any proposed pilot study
3.7 Size of the study population
3.8 How sample size determined
3.9 Methods of analysis to be used
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Section 4: Criteria for Exmption
a) Is this research likely to involve any foreseeable risk to participants, above the level
experienced in everyday life?
Yes
No
b) Methods of data collection (please tick appropriate box by double clicking and then checking)
a) standard educational practices
Yes
No
b) standard educational tests
Yes
No
c) standard personality tests
Yes
No
d) standard psychological tests
Yes
No
e) interviews or focus groups
Yes
No
f) public observations
Yes
No
g) research involving persons elected to or
candidates for public office
Yes
No
h) research which uses only existing data
Yes
No
i) surveys and/or questionnaires
Yes
No
j) audio/video recordings
Yes
No
Other: (please specify)
c) Will the collected data be …? please tick the relevant box and provide detail)
( anonymised
potentially identifiable
identifiable
d) 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)
e) 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
-any vulnerable groups?
Yes
No
(this includes UCD students unless the research is conducted by peers)
-Sensitive topics that may make participants feel
uncomfortable
(i.e. sexual behaviour, illegal activities, racial biases, etc.)
-use of drugs
-invasive procedures (e.g. blood sampling)
-physical stress/distress, discomfort
-psychological/mental stress/distress
-deception of/or withholding information from
subjects
-access to data by individuals or organizations
other than the investigators
-conflict of interest issues
- or any other ethical dilemmas
- Is there any blood sampling involved in the study?
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
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f) Has this proposal received Ethical Approval from another body (e.g. Hospital REC) (e.g data
collected by another organisation for a specific purpose)
Yes
No (if your answer is no please proceed to Section 5)
If you are requesting an exemption on the basis of criterion f - Ethical Approval from another
body – please complete the following.
a) Name of the organisation that has approved the study?
b) Approval No: _______________
c) Approval Date: ______________
(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
approved aspects of the study?
Yes
No
HREC
for
all
non-
* Note: a grant of approval with exemption from review will only be granted by the relevant local UCD ethics
subcommittee for those aspects of the study that have been approved and are under the jurisdiction of the approving
body
g) Have all aspects of the protocol received ethical approval from an approved body
Yes
No
h) Does the approving body have jurisdiction over all aspects of the study?
Yes
No
Section 5: Declaration
We, the undersigned have read UCD Guidelines and Policy for Ethical Approval of Research
Involving Human Subjects issued by the Human Research Ethics Sub-Committee, and agree to
abide by them in conducting this research. We confirm that the information provided on this form is
correct and accurate.
Signature of Applicant ________________________________
Date
Signature of Supervisor _______________________________
Date
/
/
/
/
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