Application for Ethical Clearance for a Research Project
Involving Human Participants
ITT Dublin RE_2 Form
To be completed by staff proposing to submit an application to conduct research involving
human participants and human biological samples. The signed original and an electronic
copy of the completed form should be returned to the Secretary of the Research Ethics
Board.
Research must not commence until written approval has been received from the Research
Ethics Committee.
Guidelines to applicants submitting applications for ethical clearance are given in the SOP
entitled “Procedures for Submitting an Application for Ethics Clearance for Research
Projects”.
Please check that all supplementary information is attached to your application (in
both hard and soft copy).
ATTACHED
NOT
APPLICABLE
Information on existing protocols/best practice to be
followed in the proposed research
Ethical Approval from Other Committees Form
Bibliography/Reference Section
Participant recruitment advertisement
Informed Consent form(s)
Case report forms/diary cards/questionnaires to be
draft
final
used
Interview Schedule
draft
final
Hazard Assessment Form
Use of Drug/Medical Device Additional Information
Form
Use of Ionising Radiation Additional Information
Form
Use of GMO Form
Curriculum Vitae of principal researchers(s) and
collaborators indicating expertise in the research
area proposed
________________________________________________________________________
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SECTION 1:
1.1
APPLICANT DETAILS
General Information
PROJECT TITLE
THIS PROJECT IS:
(tick as
apply)
many
Staff Research Project
as
Student Research Project
Contract Research Project
Staff Research Project leading
to academic award in another
HEI
Clinical Trial
Funded Research
Masters
Consultancy Project
Taught postgraduate
PhD
Other
- Please Describe:
Project Start
Date:
1.2
Undergraduate
Project End
Date:
Investigator Contact Details
PRINCIPAL INVESTIGATOR(S):
TITLE
SURNAME
FIRST NAME
POSITION &
ROLE IN
RESEARCH
PHONE
FAX
EMAIL
FAX
EMAIL
OTHER INVESTIGATORS:
Including Collaborators and Off-Campus Supervisors
TITLE
SURNAME
FIRST NAME
POSITION &
ROLE IN
RESEARCH
PHONE
DEPARTMENT
SCHOOL
RESEARCH CENTRE
WILL THE RESEARCH BE UNDERTAKEN ON-SITE AT THE INSTITUTE OF
TECHNOLOGY TALLAGHT?
(If NO, give details of off-campus location.)
YES
NO
IS THIS PROTOCOL BEING SUBMITTED TO ANOTHER ETHICS COMMITTEE, OR
HAS IT BEEN PREVIOUSLY SUBMITTED TO AN ETHICS COMMITTEE?)
(If YES, please complete the Ethical Approval from Other
YES
NO
Committees Form and provide letter of approval, detail on
decision received etc.)
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SECTION 2:
DETAILS OF RESEARCH STUDY
In this section you are required to provide a brief outline of the project, aims, methods,
duration, funding, profile of participants and proposed interaction with them. This
description must be in everyday language that is free from jargon. Additional pages may be
added where necessary.
2.1
PROJECT OUTLINE - LAY DESCRIPTION
Provide a brief outline of the project, including what participants will be required to do. This description must be
in everyday language which is free from jargon. Please explain any technical terms or discipline-specific
phrases. (No more than 300 words).
2.2
AIMS OF AND JUSTIFICATION FOR THE RESEARCH
State the aims and significance of the project (approx. 400 words). Where relevant, state the specific hypothesis
to be tested. Also please provide a brief description of current research, a justification as to why this research
should proceed and an explanation of any expected benefits to the community. NB – all references cited
should be listed in an attached bibliography/reference section.
2.3
PROPOSED METHOD
Provide an outline of the proposed method, including details of data collection techniques, tasks participants will
be asked to do, the estimated time commitment involved, and how data will be analysed. If the project includes
any procedure which is beyond already established and accepted techniques please include a description of it.
(No more than 400 words.)
2.4
PARTICIPANT/SAMPLE PROFILE
Provide number, age range and source of participants. Please provide a justification of your proposed sample
size. Please provide a justification for selecting a specific gender. Please state how, how you are going to
comply with the relevant statutory and/or regulatory guidelines.
2.5
PLEASE EXPLAIN WHEN, HOW, WHERE, AND TO WHOM RESULTS WILL BE
DISSEMINATED, INCLUDING WHETHER PARTICIPANTS WILL BE PROVIDED
WITH ANY INFORMATION AS TO THE FINDINGS OR OUTCOMES OF THE
PROJECT?
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2.6
OTHER APPROVALS REQUIRED Has permission to gain access to another
location, organisation etc. been obtained?
YES
NO
NOT APPLICABLE
(If YES, please specify from whom and attach a copy of approval letter. If NO, please
explain when this will be obtained.)
2.7
HAS A SIMILAR PROPOSAL BEEN PREVIOUSLY APPROVED BY THE
RESEARCH ETHICS BOARD?
YES
NO
(If YES, please state both the REC Application Number and Project Title)
SECTION 3:
PARTICIPANT SELECTION
What are the primary location(s) for data collection? (e.g. classroom, participant’s home,
Hospital/clinic, laboratory, place of convenience for participant):
Please specify the types of subjects involved in this study and indicate the number of
each type:
Type of Subject:
Number Type of Samples:
 healthy subjects
– specify:
 in-patients
a)
 clinic attendees
b)
 minors
c)
Number
PROCEED NOW TO SECTION 3.2 IF NOT USING HUMAN SAMPLES
3.1 TO BE COMPLETED WHERE THE RESEARCH INVOLVES HUMAN SAMPLES/IMAGES
Sample description:
Rationale for using this sample type:
Are there potential risks with using this sample type, for the investigators, samples, the research
environment? Delete YES/NO as appropriate.
If YES, you must complete Section 6 of this form
Specify the number of samples of this type to be used in this project:
Please provide information on the proposed methods/protocols to be followed and what
experiments are to be conducted using these samples:
4
[can use extra sheet]
Provide information on what is to happen to the samples following their use and how they
will be treated/stored:
PROCEED NOW TO SECTION 6 IF NOT USING HUMAN SUBJECTS
3.2 TO BE COMPLETED WHERE THE RESEARCH INVOLVES HUMAN SUBJECTS
With regard to subjects to be involved in the research:
 How will subjects be recruited for the study? (use an additional sheet if needed)
 Is written consent to be obtained? If YES, you must also complete Section
4
Yes
No
 Are subjects under the age of 18 to be included? If YES, you must also Yes
complete Section 5
No
 Will any payments be made to subjects? If YES give details:
Yes
No

Is any proportion of this payment being paid by a commercially sponsored
organisation and if so by whom?
Yes
No

Are there potential risks within the project, if any, for the investigator,
subjects, samples, the environment and/or participants? If YES, you must
complete Section 6
Yes
No
 If controls are to be included please state how they are to be selected:
NB. Names of Student Subjects receiving payment in commercially sponsored research must be notified to
the Research Ethics Committee (attach list)
Specify the number of subjects to be used in this project, the selection criteria and the
exclusion criteria to be used:
Number:
List your exclusion/inclusion criteria for participant selection:
5
Inclusion criteria:
Exclusion criteria:
Specify whether any of the following procedures are involved: (Delete
necessary)
yes or no as
a) Any invasive procedures
Yes
No
b) Physical contact
Yes
No
c) Any procedure that may cause mental distress
Yes
No
Is a product such as pharmaceutical or devices to be administered to the participant?
DELETE YES/NO as appropriate
Where you have answered YES – Please provide a summary of all toxicological and
pharmacological data available on the product and clinical experience with the product to
date:
[can use an extra sheet]
Information on the sampling procedures involved in your study:
 Are samples to be taken? If YES, indicate:
Yes
No
Yes
No
a) Types of sample to be taken:
b) Frequency of samples:
c) Amount of sample:
d) Is this part of the person’s normal treatment?
If Radiological Investigations indicate the number and frequency of exposures and total
calculated dosage:
6
 Number of exposures:
 Frequency:
 Total dosage:
Identify the procedures which may cause physical or mental discomfort or distress and
the degree of discomfort or distress likely to be endured by the subjects:
a)
b)
c)
SECTION 4:
PARTICIPANT CONSENT I
Informed consent is required for all human subject participants in the proposed
research.
4.1
Will informed consent be obtained from the research participants?
YES
NO
If yes, please give details of who will take consent and how it will be done.
(Please attach a copy of letter, consent form (if required) and information leaflet.
See guidelines on how to prepare these documents in the Appendix 2 associated
with the Institute Ethics Procedures and adapt examples accordingly to suit your
study and participants)
4.2
What is the time interval between giving information and seeking consent?
(It is recommended that a period of seven days be provided for reflection. If it is proposed to be
less than this, please justify).
4.3
Will the participants be from any of the following groups? (Put an x in the
appropriate box)
7
YES
NO
Children under 18 years of age
Adults with learning disabilities, if YES, please specify
Adults with communication difficulties
Adults who are unconscious or very ill
Adults who have a terminal illness
Adults with mental illness
Adults suffering from dementia
Prisoners
Young Offenders in custodial care
Those who could have been considered to have a particularly
dependent relationship with the investigator, e.g. those in care
homes, students
People engaged in illegal activities (e.g. drug taking; illegal internet
behaviour etc.). If YES please specify group:
Other groups who may be considered vulnerable
(Please specify below)
4.4
If participants are to be recruited from any of the potentially vulnerable groups
listed above, please give details of:
(a) the extra steps taken to ensure that participants from any of these vulnerable
groups are as fully informed as possible about the nature of their involvement:
(b) who will give consent:
(c) how consent will be obtained (e.g. will it be verbal, written or visually indicated?):
(d) When consent will be obtained:
(e) The arrangements that have been made to inform those responsible for the care
of the research participants of their own involvement in research:
Questions 4.5 and 4.6 to be completed for research involving human participants in
biological or clinical trial studies
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4.5
Will participants include women of childbearing potential?
YES
4.6
NO
If No, please explain Why
Note: This information is required regardless of whether there are
potential implications for the well-being of participants or not
If women of childbearing potential are to be involved, does the study design
and the participant information sheet address the 9 essential points listed
below?
YES
NO
N/A
Have you included a copy of the participant information leaflet and
consent form to be given to each participant?
Does the nature of the study justify involving women of childbearing
potential?
Has toxicological and pharmacological testing in animals or
humans, performed to date, failed to produce any evidence that the
study drug may be teratogenic?
Is there a clear warning in the patient information sheet that the
effects of the study drug on a fetus are unknown but that they may
be damaging?
Is a pregnancy test to be performed immediately before the study
begins?
Are the forms of contraception allowed (and those forms which are
unacceptable) specifically stated in the research protocol?
Is there a clear indication in the patient information sheet that
effective contraception must be practised during and for a time
(corresponding to drug elimination kinetics) after the trial?
Does the study exclude any participant whom the investigators feel
is unlikely or unable to follow contraceptive advice?
Is there a statement that if the patient becomes pregnant, or thinks
she may be pregnant, that she should contact the study doctor
immediately?
If No, please explain why
Note: This information is required regardless of whether there are potential implications for the wellbeing of participants or not
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SECTION 5:
PARTICIPANT CONSENT II
(Additional information for “less powerful” subjects or those under the age of 18
years)
1. In what way, if any, does the proposed study benefit the individual subject? [Please type here]
2. Has parent/guardian consent to be obtained?
Yes
3. If YES, what form of consent was/will be obtained?
Tick as needed
Please attach a copy of the relevant forms to be used
Verbal:
No
Written:
Witnessed:
Other:
4. Will the child's or young person's assent be sought?
Yes
No
5. Are the risks of the investigation judged to be minimal or nil?
Yes
No
SECTION 6:
6.1
POTENTIAL RISKS & RISK MANAGEMENT
ARE THE RISKS TO SUBJECTS AND/OR RESEARCHERS ASSOCIATED WITH YOUR PROJECT
GREATER THAN THOSE ENCOUNTERED IN EVERYDAY LIFE?
YES
6.2
NO
DOES THE RESEARCH INVOLVE?
YES
NO
use of a questionnaire? (if YES please attach copy)
interviews (if YES please attach interview questions)
observation of participants without their knowledge
participant observation
audio- or video-taping interviewees or events
access to personal and/or confidential data (including student, patient or client data) without
the participant’s specific consent
administration of any stimuli, tasks, investigations or procedures which may be experienced
by participants as physically or mentally painful, stressful or unpleasant during or after the
research process
performance of any acts which might diminish the self-esteem of participants or cause them
to experience embarrassment, regret or depression
investigation of participants or direct contact with anyone involved in illegal activities
procedures that involve deception of participants
administration of any substance or agent to participant (if YES, please attach a Hazard
Assessment Form [ITT Dublin RE_5 Form] and a Use of Drug/Medical Device Form
[ITT Dublin RE_6])
the use of a medical device on or in a human participant (if YES, please attach a Use of
Drug/Medical Device Additional Information Form [ITT Dublin RE_6])
the use of genetically modified organisms (if YES, please attach a Use of GMO Form [ITT
Dublin RE_7])
the use of ionising radiation on a human participant (if YES, please attach a Use of Ionising
Radiation Additional Information Form [ITT Dublin RE_8])
use of non-treatment placebo control conditions
collection of body tissues or fluid samples
collection and/or testing of DNA samples
participation in a clinical trial
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6.3
POTENTIAL RISKS TO PARTICIPANTS AND RISK MANAGEMENT
PROCEDURES
Identify, as far as possible, all potential risks to participants (physical, psychological, social,
legal or economic etc.), associated with the proposed research. Please explain what risk
management procedures will be put in place.
6.4
ARE THERE LIKELY TO BE ANY BENEFITS (DIRECT OR INDIRECT) TO
PARTICIPANTS FROM THIS RESEARCH?
YES
6.5
NO
(If YES, provide details.)
ARE THERE ANY SPECIFIC RISKS TO RESEARCHERS? (e.g. risk of infection or
where research is undertaken at an off-campus location)
YES
6.6
NO
(If YES, please describe.)
ADVERSE/UNEXPECTED OUTCOMES
Please describe what measures you have, or will put in place, in the event that there are any
unexpected outcomes or adverse effects to participants arising from involvement in the
project.
6.7
MONITORING
Please explain how you propose to monitor the conduct of the project (especially where
several people are involved in recruiting or interviewing, and administering procedures) to
ensure that it conforms with the procedures set out in this application. In the case of student
projects please give details of how the supervisor(s) will monitor the conduct of the project.
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6.8
SUPPORT FOR PARTICIPANTS
Depending on risks to participants you may need to consider having additional support for participants during
and/or after the study. Consider whether your project would require additional support, e.g., external counseling
available to participants. Please advise what support will be available.
SECTION 7:
FUNDING & PAYMENT OF PARTICIPANTS
7.1
OUTLINE SOURCES OF FUNDING FOR THE STUDY IF APPLICABLE AND
HOW YOU WILL MANAGE ANY POSSIBLE CONFLICT BETWEEN THOSE
FUNDING THE STUDY AND THE AIMS AND RESULTS OF THE STUDY IF
APPLICABLE?
7.2
DO YOU PROPOSE TO PROVIDE INCENTIVES AND/OR EXPENSES TO
PARTICIPANTS?
YES
NO
If you have answered YES, please provide details on proposed incentives
7.3
WILL A PAYMENT BE MADE TO RESEARCH PARTICIPANTS?
YES
7.4
NONE OTHER THAN MINIMAL
EXPENSES TO COVER TRAVEL COSTS
ETC
NO
If you answered YES to question 7.3, please specify for what purpose the
payment will be made and the amount per participant:
12
SECTION 8:
8.1
CONFIDENTIALITY/ANONYMITY
WILL THE IDENTITY OF THE PARTICIPANTS BE PROTECTED?
YES
NO
(If NO, please explain)
If you have answered YES to question 8.1, then please answer questions 8.2 to 8.8:
8.2
What steps will you take to protect the confidentiality of the following, during
and after the study?
Participant identities:
Data collected and patient/client records:
Hardcopy records:
8.3
Is there any potential confidentiality issue through identification of the study
location?
8.4
If your data is to be held on computer, how will it be protected?
8.5
What other person(s) other than the researcher/team as listed will have
access to the data collected and what steps will be done to protect
confidentiality?
8.6
The Institute Data Protection Policy recommends secure retention of data for
5 years. If there is any reason to apply for variation from these guidelines,
please give details and justify:
13
8.7
If identifiable data or material will be retained after the study is completed, is it
stated on an informed consent form that this will be done and that material
will not be used in future unrelated studies without further specific permission
being obtained?
YES
8.8
NO
IF NO, PLEASE EXPLAIN WHY
If the study involves audio taping interviews, you must allow the participant
access to the transcript, if they so wish. This must be included in an Informed
Consent Form and Information Leaflet (if these forms are being used). Will the
participant be given access to a transcript of the audio tape interview?
YES
NO
SECTION 9:
N/A
IF NO, PLEASE EXPLAIN WHY
DATA/SAMPLE
DISPOSAL
STORAGE,
SECURITY
&
For the purpose of this section, “Data” includes that in a raw or processed state (e.g. interview
audiotape, transcript or analysis). “Samples” include body fluids or tissue samples.
9.1
HOW WILL THE DATA/SAMPLES BE STORED? (The REC recommends that all
data be stored on campus)
Stored at ITT Dubiln
Stored at another site
(Please explain where and for what purpose)
9.2
WHO WILL HAVE ACCESS TO DATA/SAMPLES?
Access by named researchers only
Access by people other than named researcher(s)
(Please explain who and for what purpose)
Other
(Please explain who and for what purpose)
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9.3
IF DATA/SAMPLES ARE TO BE DISPOSED OF, PLEASE EXPLAIN HOW,
WHEN AND BY WHOM THIS WILL BE DONE?
SECTION 10:
QUALIFICATIONS, EXPERIENCE & SKILLS OF
PROPOSED RESEARCHERS
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. No more than 200 words.
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SECTION 11: DECLARATION BY INVESTIGATORS & APPROVAL
SIGNATURES
PRINCIPAL INVESTIGATOR DECLARATION
The information contained herein is, to the best of my knowledge and belief, accurate. I have read
and agree to comply with the Institute’s Code of Conduct for Researchers and Process and
Procedures for Seeking Ethics Clearance for Research Projects. I have attempted to identify all
risks related to the proposed research that may arise in conducting this research and acknowledge
my obligations to and the rights of the participants. I am not aware of any other ethical issue not
addressed within this form.
I and my co-investigators 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.
I/We agree to abide by the decision of the Research Ethics Committee.
Name of Principal Investigator(s):
BLOCK CAPITALS
__________________________
__________________________
Signature(s):
Principal Investigator(s):
__________________________
__________________________
Date:
__________________________
HEAD OF SCHOOL/DEPARTMENT APPROVAL
The Head of School/Department must countersign and date the application below:
I approve this study to be carried out under the auspices of my School/Department:
Name of Head of School/Department: __________________________
BLOCK CAPITALS
Signature:
__________________________
Date:
__________________________
WHERE THE APPLICANT IS REGISTERED FOR AN ACADEMIC AWARD AT
ANOTHER HIGHER EDUCATION INSTITUTION THE SIGNATURE OF APPROVAL OF
THE OFF-CAMPUS SUPERVISOR SHOULD BE OBTAINED:
I approve this study to be carried out:
Supervisor Name:
BLOCK CAPITALS
__________________________
Signature:
__________________________
Date:
__________________________
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