form here - RCSI Bahrain

Royal College of Surgeons in Ireland
Medical University of Bahrain
RESEARCH ETHICS COMMITTEE
APPLICATION FORM
For Applicant to Complete
Applicant's Name:
Short Title of Project:
Number:
For Ethics Committee
Outcome:
Date received
Approved:
Use only
Not approved:
Revision
req'd
Applicant informed (Date):
INSTRUCTIONS:
Do you have permission to do this research if work is to be carried out in another
institution / body? Evidence of permission will be required with this application.

Completed application form. Please fill in all appropriate boxes – an incomplete
application may delay the application process

Select Yes/No options as appropriate.

Refer to the accompanying Guidance Notes

Complete the Checklist below

Ensure that all supporting documents are attached securely to the 1 copy of the
application form and secured together with a staple. Documents requiring only 1
copy such as CV etc may be left loose.

Applications which are not collated in sets will be returned to the author.

Send application: Abeer Abdel Aal, RCSI-MUB, PO Box 15503, Adliya, Bahrain
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Please indicate if the following have been enclosed by selecting Yes/No/Not applicable
options below. Please forward copies of the form and relevant enclosures required as
outlined below.
YES
CHECKLIST
NO
N/A
4 copies of application form (double-sided if possible)
1 electronic copy sent to [email protected]
1 copy of protocol (no more than 4 A4 : pages double-sided
if possible)
1 copy of Supervisors Report form
1 participant consent form(s)
1 participant information sheet(s)
1 GP/consultant information sheet(s)
1 Questionnaire (s)
Finalized (please indicate)
1 copy of lead applicant’s CV on 1 side A4
Copy of manufacturer’s indemnity (1 copy only)
Annex A** (one copy only) -If the study involves the use
of a new medicinal product or medical device, or the use
of an existing product outside the terms of its product
license.
Annex B*** (one copy only) - If the study includes the
use of ionizing or non-ionizing radiation, radioactive
substances or X rays.
Annex C† - For research in general practice.
Please send completed application to:
Ms Abeer Abdel Aal,
P.O. Box 15503,
Adliya,
Bahrain
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Section 1 – Details of Applicant(s)
1: Title
Short Title of Project:
Full Title of Project:
2: Contact Details of Applicant (All correspondence will be sent to this address
unless indicated otherwise.)
Surname:
Forename:
Title (Prof, Dr., Mr. Ms):
Present Appt of Applicant:
Qualifications:
Address:
Tel:
Fax:
Email:
3: Other Workers/Departments involved (Name, Department, and
Appointment):
1.
2.
4: Signature of Relevant Personnel
Applicant
I undertake to carry out the work outlined here in accordance with the principles of the
Declaration of Helsinki (Current Guidelines) and RCSI Guidelines on Good Research Practice
- (copies available on website or from the REC secretary) and its amendments. The details
contained in this document are, to the best of my knowledge, correct. I confirm that any
training necessary for the execution of this project will be undertaken by current and by future
researchers on the project.
Date:
Signature:
Print Name:
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Supervisor with overall responsibility for the project

I am fully aware of the details of this project and agreeable for it to continue as
outlined in this application.

I can confirm that the necessary facilities and resources are available to the
researcher.
Date:
Signature:
Print Name:
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Section 2– Details of Project
This section must be completed. A copy of the protocol should be enclosed with the
application form but it is not sufficient to complete questions by referring to the protocol.
Please summarize in the space provided.
5: Aims and Objectives of the Project:
What is the intention of the project?
Study endpoints:
Summary of practical benefits/improvement in patient care which are envisaged
6: Scientific Background to Study
7: Brief Outline of Project:
What do you intend to do?
.
8: Study Design (e.g., cohort, case control)
9(a): How was the size of the study determined?
9(b): Is there formal statistical input into the overall study design?
Yes
No
9(c): What method of Analysis will be used?
10(a): Does the study fall into any of the following categories?
Pilot
Yes
No
Multi-centre study
Yes
No
If Multi Centre Study:
Undergraduate Student Project
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Name of Centre(s)
Yes
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If student project
Name of Course:
Name of Institution:
10(b): Which Ethics Committees have been approached, and what is the
outcome to date?
Name of Ethics Committee:
Outcome:
10(c): Who will have overall responsibility for the study?
10(d): Who has control of the data generated?
11: Where will the study take place and in what setting? (e.g.,
Bahrain/General Practice/Home)
12: Has funding been obtained, or is it being sought by the investigator
in respect of this study?
Funding applied for:
Yes
No
Funding secured:
Yes
No
Does the investigator(s) have any direct
personal involvement (e.g. financial, shareholding, etc.) in the sponsoring organization?
Yes
No

If Yes, please give details:
13. Schedule
Proposed Starting Date:
Proposed Duration:
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Section 3– Recruitment of Participants and Control Groups
14(a): How will the participants in the study be selected, approached,
and recruited?
14(b): What inclusion and exclusion criteria will be used?
15: How many participants will be recruited and of what age?
16: How will the control group (is used) be selected, approached, and
recruited?
16(b): Control Group: What inclusion and exclusion criteria will be
used?
17: How many controls will be recruited and of what age?
18: Are the participants included in this study involved in any other
research investigation at the present time?
Yes
No
Not Known
If yes, please provide details:
19: Will participants receive any payment or other incentive to
participate?
Yes
No
If Yes:

Please give details of incentive per participant:
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
Please indicate the source of the incentive:
In cases where the research involves an intervention that may interact with concurrent
medical treatment, applicants should undertake to explain to participants that the researcher
will contact their doctor to ask about any medical treatment.
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Section 4– Consent
20: Is written consent to be obtained?
Yes
No
If yes, please attach a copy of the Consent Form to be used

Guidance on Consent is provided in Appendices 2-4 in The Guidance Notes
If No, please justify:As part of the introduction about the Phone Survey I advise that all
information is confidential and if they are happy to give verbal consent for the survey that we
can proceed. Copy of introduction attached.
21: Does the study include participants for whom English is not a first
language?
Children under 18
Yes
No
Not Known
People with learning difficulties
Yes
No
Not Known
Other vulnerable groups
Yes
No
Not Known
(e.g. psychological disorders,
dementia)
If you have answered “Yes” to any of these questions, please complete the questions below
- Otherwise proceed to Question 23.
1. What special arrangements have been made to deal with the issues of consent and
assent, e.g. is parental or guardian agreement to be obtained, and if so what form?
2. In what way, if any can the proposed study be expected to benefit the individual who
participates?
(Please answer Question 22 only where invasive or other interventions are planned
which could be a risk to the pregnancy)
22: Are women of childbearing age included?
Yes
No
Not Known
If YES, Does the protocol/patient information sheet address the 8 points in the committee’s
check list for studies involving women of childbearing potential
1. Scientific justification,
2. Negative teratogenic studies,
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3. Warning participant that fetus may be damaged,
4. Initial negative pregnancy test,
5. Forms of contraception defined,
6. Duration of use to exceed drug metabolism,
7. Exclude those unlikely to follow contraceptive advice,
8. Notify investigator if pregnancy suspected?
If NO, Please explain:
23: Will the participant be given a written information sheet or letter?
Yes
No

If “Yes”, please attach copy to this application form

If “No”, please justify:
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Section 5 – Details of Interventions
24:
Does the study involve the use of a new medicinal product or
medical device or the use of an existing product outside the terms
of its product license?
Yes

No
If yes, please complete this page and then Annex A. Question 25.
25: Will any ionizing or non-ionizing radiation, or radioactive
substances or X-rays be administered to a participant?
Yes
No

Please ensure information in Q14 includes exclusion criteria with regard to ionizing
radiation if appropriate.

If yes, please complete this page and then Annex A. Question 26.
26: What investigations and/or interventions will participants and/or
controls have over and above routine care?
(Please complete the table below by selecting YES/NO options as appropriate. If YES, details
should be available in protocol.) Please see guidance notes*
Investigation:
Self completion questionnaires
Yes
No
Interviews/interview administered questionnaires
Yes
No
Video/audio tape recording
Yes
No
Physical examination
Yes
No
Internal physical examination
Yes
No
Venepuncture*
Yes
No
Arterial puncture*
Yes
No
Biopsy material*
Yes
No
Other tissue/body sample*
Yes
No
Imaging investigations (not radiation)
Yes
No
Other investigations not part of normal care
Yes
No
Additional outpatients attendances
Yes
No
Longer inpatient stays
Yes
No
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Local anesthesia
Yes
No
General anesthesia
Yes
No
Other
Yes
No
Details:
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Section 6 – Risks and Ethical Problems
27:
Are there any ethical problems or considerations that the
investigators consider to be important or difficult with the
proposed study?
Yes

No
If yes, please give details:
27 (a): What ethical problems, if any?
Yes

No
If yes, please give details:
27(b): Will treatments provided during the study be available if needed at
the end of the study?
Yes
No
Not Applicable
Not known
27(c): If not is this made clear in the patient information sheet?
Yes

28:
No
If "no", please give reasons:
Are there any potential hazards to participants or patients?
Yes

29:
If Yes, please give details, and give the likelihood and details of precautions taken to
minimize them, and arrangements to deal with adverse events, including reporting to
the relevant authorities:
Is this study likely to cause discomfort or distress to
participants/patients?
Yes

No

No
If Yes; estimate the degree and likelihood of discomfort or distress entailed and the
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precautions to be taken to minimize them.
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Section 7 – Indemnity and Confidentiality
Product liability and consumer protection legislation make the supplier and producer
(manufacturer) or any person changing the nature of a substance, e.g. by dilution,
strictly liable for any harm resulting from a consumer's use of a product.
30(a): What arrangements have been made to provide indemnification
and/or compensation in the event of a claim by, or on behalf of, a
participant for negligent harm?
N/A
30(b): What arrangements been made to provide indemnification and/or
compensation in the event of a claim by, or on behalf of, a
participant for non-negligent harm?
N/A
30(c): Will an undergraduate student be involved directly in conducting
the project?
Yes
No
31: In cases of equipment or medical devices, have appropriate
arrangements been made with the manufacturer?
(Please indicate NA if not applicable.)
Yes

No
N/A
If Yes, please give details.
32: Will the study be held on a computer?
Yes
No
N/A

If Yes, will the data be held so that participants cannot be identified from computer
files (i.e. no name, address, medical chart number or other potential identifier such as
GMS or RSI number)?

If No, give reasons:

Will records (preferably paper records) linking study
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participant ID numbers with identifying features be stored
confidentially?
Will the patient’s medical records be examined?
33:
Yes

No
If Yes, will information relevant to this study be extracted.
Yes
No
N/A

If extra information is to be extracted, please justify:

What, if any, additional steps have been taken to safeguard confidentiality of
personal records?
34:
Will the study include the use of any of the following?

Audio/videotape recording
Yes
No

Observation of participants
Yes
No

If “Yes” to either:
1. How are confidentially and anonymity to be ensured?
2. What arrangements have been made to obtain consent?
3. What will happen to the tapes at the end of the study? (Note: they should be stored for
data verification or transcribed)
35:
Will medical records be examined by research worker(s) outside
the employment of the RCSI?
Yes

No
If “YES”, it is the responsibility of the principal investigator to ensure that research
workers understand that information obtained about and from research participants is
confidential to the study and must not be divulged except in legitimate methods of
study data presentation or exceptional circumstances as discussed and agreed with
the principal investigator or other competent advisor.
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*Please ensure that you complete the checklist on the front cover
of the application form and include all relevant enclosures. **
Thank you -
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