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 (

“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 educationaltests, anonymous surveys or interviews,public observations,research involvingpersons elected to or candidates for public officeandresearch which uses onlyexisting 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
  1. A child* sample (*anyone under 18 years old)

  1. A student sample

  1. 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)

  1. Deception

  1. A sensitive topic

  1. 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 Sub-Committee and the the document entitled Further Exploration of the Process of Seeking EthicsApproval for Researchbefore 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 EthicsApproval 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 Name:
2.2 Address for correspondence:
2.3 Telephone:
2.4 E-mail:

Research Supervisor

2.5 Name:
2.6 Departmental address:
2.7 Telephone:
2.8 E-mail:

Section 3: Details of Proposed Research

Provide a brief summary of the following information (max 200 words in any section).

Office Use only
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

Section 4: Criteria for Exemption

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 identifiableidentifiable

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

-any vulnerable groups?Yes No
(this includes UCD students unless the research is conducted by peers)
-Sensitive topics that may make participants feel
uncomfortable Yes No
(i.e. sexual behaviour, illegal activities, racial biases, etc.)
-use of drugs Yes No
-invasive procedures (e.g. blood sampling) Yes No
-physical stress/distress, discomfort Yes No
-psychological/mental stress/distress Yes No
-deception of/or withholding information from
subjects Yes No
-access to data by individuals or organizations
other than the investigatorsYes No
-conflict of interest issues Yes No
- or any other ethical dilemmasYes No
- Is there any blood sampling involved in the study? Yes No

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 HREC for all non-approved aspects of the study?

Yes No

* 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 allaspects 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 / /

Insurance
Please note that UCD’s existing insurance policy providing cover in relation to research work and placements, being undertaken by UCD staff and students, is currently limited to Public Liability only. Provisions of other types of insurance cover, as listed in the table below, are the sole responsibility of the researcher. The [UREC or TMREC office] will liaise with the Insurers and will advise you of any specific requirements, if necessary.
Please select the type of insurance required for this project and provide relevant details
Does this study require MEDICAL MALPRACTICE or CLINICAL IDEMNITY insurance cover? / Yes
No
Is relevant insurance cover in place? / Yes
No / If Yes, provide insurance holder’s name:
Is this study (NOT the applicant) covered by Clinical Indemnity Scheme (CIS)[1] / Yes
No
n/a / If Yes, provide healthcare provider’s name (hospital, clinic, GP practice etc.)
Is there any blood or tissue sampling involved in this study? / Yes
No / If Yes, (1) provide name and qualification of the person taking samples:
and (2) their professional indemnity insurance details:
Are there any other medical procedures involved in this study? / Yes
No / If Yes, name procedures involved:
Does this study involve travelling outside of Ireland? / Yes
No / If Yes, name country/countries where the researcher(s) will travel:

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[1]The Clinical Indemnity Scheme (CIS) is the main scheme under which theState Claims Agency(SCA) manages all clinicalnegligenceclaims taken against healthcare enterprises, hospitals and clinical, nursing and allied healthcare practitioners covered by the scheme. Under the CIS, the State assumes full responsibility for the indemnification and management of all clinical negligence claims.