Application for Ethical Approval (Research)

St Mary’s University

Ethics Sub-Committee
This form must be completed by any undergraduate or postgraduate student, or member of staff at St Mary’s University, who is undertaking research involving contact with, or observation of, human participants.

Undergraduate and postgraduate students should have the form signed by their supervisor, and forwarded to the School Ethics Sub-Committee representative. Staff applications should be forwarded directly to the School Ethics Sub-Committee representative. All supporting documents should be merged into one PDF (in order of the checklist) and clearly entitled with your Full Name, School, Supervisor.

Please note that for all undergraduate research projects the supervisor is considered to be the Principal Investigator for the study.

If the proposal has been submitted for approval to an external, properly constituted ethics committee (e.g. NHS Ethics), then please submit a copy of the application and approval letter to the Secretary of the Ethics Sub-Committee. Please note that you will also be required to complete the St Mary’s Application for Ethical Approval.

Before completing this form:
• Please refer to the University’s Ethical Guidelines. As the researcher/ supervisor, you are responsible for exercising appropriate professional judgment in this review.
• Please refer to the Ethical Application System (Three Tiers) information sheet.
• Please refer to the Frequently Asked Questions and Commonly Made Mistakes sheet.
• If you are conducting research with children or young people, please ensure that you read the Guidelines for Conducting Research with Children or Young People, and answer the below questions with reference to the guidelines.

Please note:

In line with University Academic Regulations the signed completed Ethics Form must be included as an appendix to the final research project.

If you have any queries when completing this document, please consult your supervisor (for students) or School Ethics Sub-Committee representative (for staff) .
St Mary’s Ethics Application Checklist

The checklist below will help you to ensure that all the supporting documents are submitted with your ethics application form. The supporting documents are necessary for the Ethics Sub-Committee to be able to review and approve your application.

Please note, if the appropriate documents are not submitted with the application form then the application will be returned directly to the applicant and may need to be re-submitted at a later date.
Enclosed?
(delete as appropriate)
Version
No
Document Yes Not applicable
1.Application Form Mandatory
2.Risk Assessment Form
3.Participant Invitation Letter
4.Participant Information Sheet Mandatory

5.Participant Consent Form Mandatory
6.Parental Consent Form
7.Participant Recruitment Material – e.g. copies of Posters, newspaper adverts, website, emails
8.Letter from host organisation (granting permission to conduct the study on the premises)
9. Research instrument, e.g. validated questionnaire, survey, interview schedule
10.DBS included
11.Other Research Ethics Committee application (e.g. NHS REC form)

I can confirm that all relevant documents are included in order of the list and in one PDF document entitled with you: Full Name, School, Supervisor.

Signature of Applicant:
Signature of Supervisor:
Ethics Application Form
1) Name of proposer(s)

2) St Mary’s email address

3) Name of supervisor
4) Title of project
5) School or service

6) Programme ( if undergraduate, postgraduate taught or postgraduate research )

7) Type of activity/research ( staff / undergraduate student research / postgraduate student )
8) Confidentiality

Will all information remain confidential in line with the Data Protection Act 1998
YES/NO

9) Consent

Will written informed consent be obtained from all participants / participants’ representatives?
YES/NO

10) Pre-approved protocol

Has the protocol been approved by the Ethics Sub-Committee under a generic application?

YES/NO/ Not applicable

Date of approval:
11) Approval from another Ethics Committee

a) Will the research require approval by an ethics committee external to St Mary’s University?

YES/NO/ Not applicable
b) Are you working with persons under 18 years of age or vulnerable adults?

YES/ NO
12) Identifiable risks

a) Is there significant potential for physical or psychological discomfort, harm, stress or burden to participants?

YES/NO

b) Are participants over 65 years of age?
YES/NO

c) Do participants have limited ability to give voluntary consent? This could include cognitively impaired persons, prisoners, persons with a chronic physical or mental condition, or those who live in or are connected to an institutional environment.

YES/NO

d) Are any invasive techniques involved? And/or the collection of body fluids or tissue?

YES/NO

e) Is an extensive degree of exercise or physical exertion involved?

YES/NO

f) Is there manipulation of cognitive or affective human responses which could cause stress or anxiety?

YES/NO

g) Are drugs or other substances (including liquid and food additives) to be administered?

YES/NO

h) Will deception of participants be used in a way which might cause distress, or might reasonably affect their willingness to participate in the research? For example, misleading participants on the purpose of the research, by giving them false information.

YES/NO

i) Will highly personal, intimate or other private and confidential information be sought? For example sexual preferences.

YES/NO

j) Will payment be made to participants? This can include costs for expenses or time.

YES/NO
If yes, please provide details

k) Could the relationship between the researcher/ supervisor and the participant be such that a participant might feel pressurised to take part?
YES/ NO
13) Proposed start and completion date

Please indicate:

• When the study is due to commence.
• Timetable for data collection.
• The expected date of completion.

Please ensure that your start date is at least 3 weeks after the submission deadline for the Ethics Sub-Committee meeting.
14)Sponsors/Collaborators
Please give names and details of sponsors or collaborators on the project. This does not include you supervisor(s) or St Mary’s University.

• Sponsor: An individual or organisation who provides financial resources or some other support for a project.

• Collaborator: An individual or organisation who works on the project as a recognised contributor by providing advice, data or another form of support.
15. Other Research Ethics Committee Approval
• Please indicate whether additional approval is required or has already been obtained (e.g. the NHS Research Ethics Committee).
• Please also note which code of practice / professional body you have consulted for your project
• Whether approval has previously been given for any element of this research by the University Ethics Sub-Committee.

16. Purpose of the study
In lay language, please provide a brief introduction to the background and rationale for your study.

• Be clear about the concepts / factors / performances you will measure / assess/ observe and (if applicable), the context within which this will be done.
• Please state if there are likely to be any direct benefits, e.g. to participants, other groups or organisations.

17. Study Design/Methodology
In lay language, please provide details of:
a) The design of the study (qualitative/quantitative questionnaires etc.)
b) The proposed methods of data collection (what you will do, how you will do this and the nature of tests).
c) You should also include details regarding the requirement of the participant i.e. the extent of their commitment and the length of time they will be required to attend testing.
d) Please include details of where the testing will take place.
e) Please state whether the materials/procedures you are using are original, or the intellectual property of a third party. If the materials/procedures are original, please describe any pre-testing you have done or will do to ensure that they are effective.

18. Participants
Please mention:
a) The number of participants you are recruiting and why. For example, because of their specific age or sex.
b) How they will be recruited and chosen.
c) The inclusion / exclusion criteria’s.
d) For internet studies please clarify how you will verify the age of the participants.
e) If the research is taking place in a school or organisation then please include their written agreement for the research to be undertaken.

19. Consent
If you have any exclusion criteria, please ensure that your Consent Form and Participant Information Sheet clearly makes participants aware that their data may or may not be used.

a) Are there any incentives/pressures which may make it difficult for participants to refuse to take part? If so, explain and clarify why this needs to be done

b) Will any of the participants be from any of the following groups?

? Children under 18
? Participants with learning disabilities
? Participants suffering from dementia
? Other vulnerable groups.

c) If any of the above apply, does the researcher/investigator hold a current DBS certificate? A copy of the DBS must be included with the application.

d) How will consent be obtained? This includes consent from all necessary persons i.e. participants and parents.
20. Risks and benefits of research/ activity
a) Are there any potential risks or adverse effects (e.g. injury, pain, discomfort, distress, changes to lifestyle) associated with this study? If so please provide details, including information on how these will be minimised.

b) Please explain where the risks / effects may arise from (and why), so that it is clear why the risks / effects will be difficult to completely eliminate or minimise.

c) Does the study involve any invasive procedures? If so, please confirm that the researchers or collaborators have appropriate training and are competent to deliver these procedures. Please note that invasive procedures also include the use of deceptive procedures in order to obtain information.

d) Will individual/group interviews/questionnaires include anything that may be sensitive or upsetting? If so, please clarify why this information is necessary (and if applicable, any prior use of the questionnaire/interview).

e) Please describe how you would deal with any adverse reactions participants might experience. Discuss any adverse reaction that might occur and the actions that will be taken in response by you, your supervisor or some third party (explain why a third party is being used for this purpose).
f) Are there any benefits to the participant or for the organisation taking part in the research (e.g. gain knowledge of their fitness)?
21. Confidentiality, privacy and data protection
a) What steps will be taken to ensure participant’s confidentiality?

• Describe how data, particularly personal information, will be stored.
• Consider how you will identify participants who request their data be withdrawn, such that you can still maintain the confidentiality of theirs and others data.

b) Describe how you manage data using a data a management plan.

• You should show how you plan to store the data securely and select the data that will be made publically available once the project has ended.
• You should also show how you will take account of the relevant legislation including that relating data protection, freedom of information and intellectual property.

c) Who will have access to the data? Please identify all persons who will have access to the data (normally yourself and your supervisor).

d) Will the data results include information which may identify people or places?
• Explain what information will be identifiable.
• Whether the persons or places (e.g. organisations) are aware of this.
• Consent forms should state what information will be identifiable and any likely outputs which will use the information e.g. dissertations, theses and any future publications/presentations.

22. Feedback to participants
Please give details of how feedback will be given to participants:

• As a minimum, it would normally be expected for feedback to be offered to participants in an acceptable to format, e.g. a summary of findings appropriate written.
• Please state whether you intend to provide feedback to any other individual(s) or organisation(s) and what form this would take.
The proposer recognises their responsibility in carrying out the project in accordance with the University’s Ethical Guidelines and will ensure that any person(s) assisting in the research/ teaching are also bound by these. The Ethics Sub-Committee must be notified of, and approve, any deviation from the information provided on this form.

Signature of Proposer(s)

Date:
Signature of Supervisor (for student research projects)

Date:
Approval Sheet
Name of applicant:

Name of supervisor:

Programme of study:

Title of project:
Supervisors, please complete section 1 or 2. If approved at level 1, please forward a copy of this Approval Sheet to the School Ethics Representative for their records.

SECTION 1

Approved at Level 1

Signature of supervisor (for student applications)……………………………………………………………….

Date……………………………………………………………………………………………………………………………..

SECTION 2

Refer to School Ethics Representative for consideration at Level 2 or Level 3

Signature of supervisor…………………………………………………………………………………………………..

Date…………………………………………………………………………………………………………………………….

SECTION 3

To be completed by School Ethics Representative

Approved at Level 2

Signature of School Ethics Representative………………………………………………………………………..

Date……………………………………………………………………………………………………………………………..

SECTION 4

To be completed by School Ethics Representative. Level 3 consideration required byt the Ethics Sub-Committee (including all staff research involving human participants)

Signature of School Ethics Representative………………………………………………………………………..

Date……………………………………………………………………………………………………………………………..

Level 3 approval – confirmation will be via correspondence from the Ethics Sub-Committee
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