Reference Number : ______
School of Medicine, Dentistry and Biomedical SciencesResearch Ethics Committee
Checklist for submitting an application
Name:
Project Title:
You should ensure you include the following for consideration:
(Please tick appropriate boxes)
Project / protocol (compulsory) Yes ð Version (dated) included ______
Subject Information Sheet Yes ð No ð N/A ð Version (dated) included ______
Subject Consent Form Yes ð No ð N/A ð Version (dated) included ______
Questionnaire(s) Yes ð No ð N/A ð Version (dated) included ______
Peer Review(s) if applicable Yes ð No ð N/A ð Version (dated) included ______
Ethics application form to include: Yes
Section A (pages 1-2) please complete fully ð
Section B (pages 3-5) answer questions ð
Section C (page 6) signatures are required from:
Ø Researcher / Student (under or postgraduate) ð
Ø Supervisors ð
It is the responsibility of the supervisor to ensure this project
is entered on the University Human Subjects Research database (accessible to staff through the “My Research” option in Queen’s Online) if it involves human subjects
Ø Centre Director or Deputy ð
Please return all of the above information in two formats as follows:
1 One hard copy of all the above information, together with all the required signatures should be sent to:
Dr I Cooke, c/o Paula McDaid/Ruth McKeown, School of Medicine, Dentistry and Biomedical Sciences, Whitla Medical Building, 97 Lisburn Road, Belfast, BT9 7BL
2 Email all of the above information to
School of Medicine, Dentistry and Biomedical SciencesResearch Ethics Committee : Application Form
Please refer to the Checklist for submitting an application when completing this form.
This form and any attachments should be submitted to the Research Ethics Committee (REC) for consideration. If any of the above information is missing, the application will be returned.
SECTION AType of project for consideration (please tick one box)
Staff projectPostgraduate project
Undergraduate project
Yes / No
Is this project for an educational qualification?
If so, what is the qualification?
Name of Researcher(s)/ Student(s)including present position and qualifications
contact address and email
Name of Supervisor(s)
including Professional Title, Qualifications, contact address and email
Project Title
Estimated start date
Estimated duration of project
Estimated duration of involvement for individual participants (where appropriate)
Location of testing for participants (where appropriate)
Brief description of the project:
Please give a brief description of the project in lay language not exceeding 100 words
Abstract (not exceeding 200 words). Please use these headings.
· Aim of the project and its academic rationale;
· Recruitment: methods used; number; age; gender and exclusion/inclusion criteria for participants
· Outcome measures
· Statistical methods to be employed in the analysis and justification for the choice of sample size
SECTION BPlease answer the following questions.
If you indicate YES to Q1-9, it must be clearly illustrated in the relevant paperwork attached i.e. Participant Information Sheet, Consent Form, Debriefing Sheet, Separate Sheet(s)
If you indicate NO to any of Q1-9, please give a full explanation on a separate sheet attached to this form
Yes / No / N/A1 / Will you tell participants that their participation is voluntary?
2 / Will you tell participants that they may withdraw from the research at any time and for any reason, without having to give an explanation?
3 / Will you obtain written consent for participation?
4 / If the research is observational, videoed or taped, will you ask the participants for their consent to being observed, videoed or taped?
5 / Will you tell participants that their data will be treated with full confidentiality and that, if published, it will not be identifiable as theirs?
6 / Will participants be clearly informed of how the data will be stored, who will have access to it, and when the data will be destroyed?
7 / Will you debrief participants at the end of their participation (i.e. give them a brief explanation of the study)?
8 / Will you describe the main procedures to participants in advance, so that they are informed about what to expect?
9 / For questionnaires, interviews or focus groups, will you give participants the option of omitting questions they do not want to answer?
10 / Are any of the participants in a dependent relationship with the investigator (e.g. lecturer/student?)
11 / Will your project involve deliberately misleading participants in any way?
If Yes, give details on a separate sheet, state why it is necessary and explain how debriefing will occur.
12 / Are you aware of any conflict of interest as outlined in the University regulations? If yes, please give details
13 / Is this project funded yes/no? (If yes please give full name of funding body)
14 / Have you any peer reviews available for this project (please follow the University guidelines for peer review of Masters and PhD projects)? (Yes/No)
If you have peer reviews please include these with your application.
If you indicate YES to Q10, 11 or 12, please give a full explanation on a separate sheet attached to this form
RISK AND SAFETY Considerations
15 / Is there any realistic risk of any participants experiencing either physical
or psychological distress or discomfort? If YES, give details on page 5 and state what you will tell them to do if they experience any problems (e.g. who they can contact for help).
16 / Have appropriate chemical, radiation and biological (including GMAG)
risk assessments been submitted to the appropriate Safety committee for approval?
17 / Have appropriate MTA forms been applied for and submitted with this application?
18 / Have appropriate letters of permission to contact participants (whether within or outside of QUB) been applied for and submitted with this application?
19 / Do participants fall into any of the following special groups? If they do,
please refer to the Good Practice guidelines:
Children (under 18 years of age)
People with learning or communication difficulties
Patients (including carers of NHS patients)
People in custody
People potentially engaged in illegal activities (eg drug-taking)
20 / If working with children or vulnerable people, do you have a Police Clearance Certificate (a copy must be lodged with the Committee Secretary)
21 / Has external ethical approval been obtained, e.g. from the Office of the
Research Ethics Committees Northern Ireland (ORECNI), for the proposed project?
Please write a clear but concise statement of the ethical considerations (if any) raised by the project and how you intend to deal with them. It may be, in order to do this, that you need to expand on the Rationale given on Page 2, in which case your answers to questions 1-3 under Section B should be detailed below, not exceeding 1 page, 11 point font (You need to address any NO in Q1-9, any YES in either Q10, 11 or 12 and any other relevant ethical issue.)
There is an obligation on the lead researcher and supervisor to bring to the attention of the School Research Ethics Committee (REC) any issues with ethical implications not clearly covered by the above checklist.
SECTION CTo be signed by the researcher/student
§ Tick either box A or box B below
§ Provide the details required (as noted in the checklist) in support of your application.
§ Sign the form.
A I consider that this project has no ethical implications to be brought before the University Teaching and Research Ethics Committee (UTREC)
B I consider that this project may have ethical implications that should be brought before the UTREC, and/or it will be carried out with children or other vulnerable populations.
DECLARATION
I/We am/are familiar with the written MRC or BPS Guidelines for ethical practices in medical research (and have discussed them with the other researchers involved in the project). I/We confirm that I/we have read and agree with the contents of the above application
Student ………………………… Signature ……………..………………….. Date ……………………
printed
(add additional signature lines as appropriate)
To be signed by supervisor(s)
§ I agree the study is based on appropriate design, sample size and statistical methods, techniques or procedures
§ I have read the application
§ I have stated any conflict of interest in relation to the study
§ I have included this project on the University Human Subjects Research database for those involving human subjects
Supervisor ……………………….. Signature ……………………………… Date ……………………
printed
(add additional signature lines as appropriate)
To be signed by Centre Director (or deputy)
I agree that this project is:
§ supported by appropriate supervision and resources
§ compatible with the aims of the investigators and the requirements of the degree programme for which it is required
§ of minimal acceptable risk to the subjects or investigators
§ based on the appropriate methodology and techniques
Signature ……………………… Signature……….. ……………………….. Date ……………………
printed
OUTCOME OF ETHICAL REVIEW
Project TitleThis project (as above) has been considered using agreed University procedures and is now approved conditional upon the investigator ensuring that it is included on the University Human Subjects Research database (accessible to staff through the ‘My Research’ option in Queen’s Online) if it involves human subjects.
Revision requested
Referred to ORECNI
Not approved
Further comments if required
To be signed by convenor
Signature ………………………………………………. Date ……………………8