Health Policy & Management / Centre for Global Health Research Ethics Committee

Revised version 18 February 2013

Health Policy & Management / Centre for Global Health Research Ethics Committee

Ethical Approval Application Form

PLEASE NOTE THE FOLLOWING:

Incomplete and/or late applications will not be processed and will be returned to the applicants.

Forms without the following signatures will not be processed: Applicant(s) signature, Research Supervisor signature (applicable in student application).

Forms without the checklist completed will not be processed.

Applicant Details

Name of Principal Investigator:
Status (delete as applicable) / Postgraduate Student / Staff
Staff / Student Number:
Email address:
Contact address and telephone number:
Primary Supervisor’s name and contact (if applicable):
Project Title:
For Which REC Meeting: / Meeting Date:______(Month / Year)
Other (Emergency / Re-submission)
Level of Submission (tick as appropriate): / New Application (Full Protocols)
Amended Application (Full Protocols)

Please complete the application form and return three signed hard copies to

Ms. Sheena Cleary

Secretary, HPM/CGH Research Ethics Committee

Please also email your application in full (application and appendices) to

by 5pm of the Application Submission Deadline Date.

LATE SUBMISSIONS WILL NOT BE ACCEPTED.

To process your application form efficiently you are required to fill in the checklist below. Do not leave any blanks. If this checklist is not completed, your application will not be processed.

Yes

/

No

/

N/A

1. / Is the rationale for the study clearly stated?
2. / Is the project design fully explained?
3. / Are the inclusion and exclusion criteria complete?
4. / Are members of a vulnerable population being studied?
If yes, please tick the vulnerable population being studied (please refer to section 3.4):
Children under 18 Years
Elderly / Persons in Restricted Environments (e.g. psychiatric facilities, nursing homes)
Prisoners / Youth Offenders / Persons with Diminished Capacity (e.g. cognitive impairment, learning disability, communication difficulties, etc.)
Others (Please Specify:
a. Is the justification for studying this vulnerable population adequate?
b. Have adequate provisions been made to ensure that the vulnerable population is not being exploited?
Have the risks vs. the benefits for the research participants been discussed in the research protocol?
When appropriate, do provisions exist in the protocol for counselling research participants during and after the research?

1. Have adequate provisions been made to ensure the confidentiality of data

and its ongoing protection throughout the study?

IF APPROPRIATE TO THE STUDY YOU SHOULD ATTACH THE FOLLOWING: / Attached / N/A
(a)the consent form you propose using
(b)the letter(s) to prospective participants seeking their co-operation with the study
(c)the participant information leaflet you propose using
(d)for the purpose of your proposed study, if you require access to: (i) a site outside your home department/School, and/or (ii) the person who is responsible for the welfare of your proposed participants,
please attach the letter seeking access
(e)If the study requires ethical approval by ethics
committees of any other institutions, outside of the
HPM/CGH committee, please attach a copy of the responses received from these committees
(f)If the project involves the use of a questionnaire, phone survey, focus group discussion and interviews please attach a copy of the tool(s) of data collection you propose using (Questionnaire / interview schedule / observation schedule/other)

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Revised version 18 February 2013

DETAILS OF RESEARCH STUDY & PARTICIPANT SELECTION

2.1Working title of proposed study

2.2Dates & Duration of Study

Proposed Start Date: /

Proposed End Date:

2.3 What are the primary location(s) for data collection? (e.g. classroom, participant’s home,

hospital/clinic, laboratory, place of convenience for participant – specify likely locations)

2.4State concisely the research aim(s) and objective(s), research question or specific hypothesis to be tested (as appropriate)

2.5Provide brief outline of the project (maximum 500 words, must include background, research approach, design, data collection methods, sampling – size of target population and if applicable indicate the method of sampling you intend to use and the sample size, data analysis and expected research outputs)

2.6Does your study involve gathering data from surveys, interviews, focus groups or service user records?

YES / NO / If No, please go to section 5.1

2.7List your exclusion/inclusion criteria for participant selection:

Inclusion criteria:
Exclusion criteria(for exclusions additional to not being in the inclusion criteria):

2.8State number of participants to be selected for each study within the project and reasons for choosing this number:

2.9 If appropriate please identify how participants will be recruited and what steps you will take to

access the sample, specifying details of people who will be contacted during this process:

2.10 Will payment be made to research participants?

YES / NONE OTHER THAN MINIMAL EXPENSES TO COVER TRAVEL COSTS ETC / NO

2.11If you answered YES to question 2.9, please specify for what purpose the payment will be made,

theestimated amount per participant and the funding source for such payments (including travel

reimbursements).

CONSENT, CONFIDENTIALITY (INCLUDING DATA PROTECTION)

3.1 Please provide information on how consent will be obtained from the research participants -

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 Guidelines and adapt examples accordingly to suit your study and participants)

3.2Will participants be given an interval of seven days or more between receiving information and giving consent?

YES / NO / If No, please justify

3.3Is deception involved at any stage of the study? If so, what are the justifications, how will it be done and what safeguards are in place for research participants?

3.4Will the targeted participants be members of any of the following groups (tick as appropriate):

(In many studies it is important to include participants from vulnerable populations. Where this is the case we require information on how this will be managed and reassurance that risks of harm are minimised.)

Targeted Participation
YES / NO
Children under 18 years of age
Adults with learning disabilities
Adults with communication difficulties
Adults with cognitive impairment (e.g. dementia)
Adults who are unconscious or severely incapacitated (though not terminally ill)
Adults with a terminal illness
Adults with mental illness
Adults in restricted environments (e.g. psychiatric facilities, nursing homes, etc.)
Prisoners
Young Offenders
Those who could have been considered to have a particularly dependent relationship with the investigator, e.g. those in care homes, students, service users under the direct care of the investigator, or subordinates to the investigator in the organisation/service in which they work
Other groups who may be considered vulnerable
(Please specify below)

3.5 If participants are to be recruited from any of the potentially vulnerable groups listed above, please give details of:

(a)The way(s) in which the participants are considered vulnerable for the purpose of research participation:
(b)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:
(c)Who will give consent (and/or assent as appropriate):
(d)How consent will be obtained (e.g. will it be verbal, written or visually indicated?):
(e)When consent will be obtained:
(f)The arrangements that have been made to inform those responsible for the care of the research participants of their involvement in research:

3.6 During and after the study, what steps will you take to protect the confidentiality of:

(a)Participant identities?
(b)Data collected (in particular, patient/client records if these are accessed)?
(c) Hardcopy records?

3.7 If your data are to be held electronically at any stage of the study, how will they be protected?

3.8 What other person(s) other than the researcher/team as listed will have access to the data collected

and what steps will be taken to protect confidentiality?

3.9If the study involves audio taping interviews, you must allow the participant access to the transcript, if they so wish. This must be included in the Informed Consent Form and Participant Information Leaflet (if these forms are being used). Will the participant be given access to a transcript of the audio tape interview?

YES / NO / N/A / If No, please explain Why

RISK, BENEFIT AND HARM

4.1Describe any foreseeable risks to the participants?

4.2Will individual or group interviews/questionnaires discuss any topics or issues that might be

sensitive, embarrassing or upsetting, or is it possible that criminal or other disclosures requiring

action could take place during the study (e.g. during interviews/group discussions, or use of

screening tests for drugs)?

If Yes, give details of procedures in place to deal with these issues

4.3 What is the potential for benefit for research participants?

5. Data Access and Disposal

5.1If anonymous secondary data is collected as part of this investigation, have you obtained the necessary permissions from the relevant data controller(s) to access data for the purpose of this investigation?

YES / NO / N/A / If No, please explain Why

5.2 Is there any potential confidentiality issue through identification of the study location?

5.3 How will information be retained and/or disposed at the end of the study?

FUNDING

6.1 Outline sources of funding for the study if applicable and how you will manage any possible

conflict between the funders of the study and the aims and results of the study if applicable?

6.2Please disclose any interests outside of research funding (financial or otherwise) that may give rise to potential concerns regarding research integrity. How will you manage such concerns?

ETHICAL APPROVAL FROM OTHER COMMITTEES

Ethical approval from the HPM-CGH Research Ethics Committee, if granted, does not supersede any requirements that outside bodies may have that similar applications be made to local ethical approval bodies in advance of the study commencing.

7.1Has ethical approval been sought from any other organisation(s) in which the study will take place?

YES / (If you answer YES go to question 7.2)
NO / (If you answer NO go to question 7.3)
N/A / (If N/A please explain why below)

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7.2If you have answered YES to question 7.1, where has approval been sought from and has ethical

approval been given? (Please supply a copy of relevant protocols and approval / exemption letters to the HPM-CGH Committee Secretary)

Name(s) of external ethics committee(s):
Approved / Exempted from Review / Awaiting
Reply / Rejected / If EXEMPTED FROM REVIEW OR Rejected, please explain Why

7.3If you have answered NO to question 7.1, is it your intention to seek ethical approval from the

organisation(s) in which the study will take place?

YES / NO / If No, please explain Why

DECLARATION OF APPROVAL AND SIGNATURES

LEAD INVESTIGATOR

The lead investigator must provide all data below and sign:

LEAD INVESTIGATOR DECLARATION:

I confirm that the information provided in this protocol is correct, that I am not aware of any other ethical

issue not addressed within this form and that I understand the obligations to and the rights of participants (particularly concerning their safety and welfare, the obligation to provide information sufficient to give informed consent, the obligation to respect confidentiality and all the obligations as set out in the Declaration of Helsinki (appendix attached) governing the conduct of research involving human participants) and/or other relevant guidelines (please refer to your Head of Department/School)

NAME:

(BLOCK CAPITALS)

STAFF / STUDENT I.D. No.

SCHOOL / DEPARTMENT:

COURSE OF STUDY:

(if appropriate) / YEAR

SIGNATURE:

/ DATE:

PLEASE NOTE THAT IF THERE IS MORE THEN ONE APPLICANT, ALL APPLICANTS MUST SIGN THE APPLICATION FORM.

NAME:

(BLOCK CAPITALS)

STAFF / STUDENT I.D. No.

SCHOOL / DEPARTMENT:

COURSE OF STUDY:

(if appropriate) / YEAR

SIGNATURE:

/ DATE:

NAME:

(BLOCK CAPITALS)

STAFF / STUDENT I.D. No.

SCHOOL / DEPARTMENT:

COURSE OF STUDY:

(if appropriate) / YEAR

SIGNATURE:

/ DATE:

NAME:

(BLOCK CAPITALS)

STAFF / STUDENT I.D. No.

SCHOOL / DEPARTMENT:

COURSE OF STUDY:

(if appropriate) / YEAR

SIGNATURE:

/ DATE:

NAME:

(BLOCK CAPITALS)

STAFF / STUDENT I.D. No.

SCHOOL / DEPARTMENT:

COURSE OF STUDY:

(if appropriate) / YEAR

SIGNATURE:

/ DATE:

RESEARCH SUPERVISOR

Student applicants are required to have their Research Supervisor complete this section.
Name of Primary Supervisor:______
(BLOCK CAPITALS)
Position: ______
State the educational value of this research:
As the student’s supervisor, I have read this application and accept responsibility for the ethical conduct of this project:
Signature of Primary Supervisor:______
Date: ______

Office Use Only:

Reference Number
HPM-CGH Research Ethics Committee Meeting Date
Recommended fast track application procedure
Approval / Conditional Approval / Rejection
To be resubmitted
Date

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