Title of Study: | Type the short title of your study here |
Lead researcher: | Type the name of the applicant here |
- This document MUST be completed and submitted as part of the application form. Please ensure ONE copy of each document, as detailed below, is attached as an appendix to this application form in the order that they appear on the list. ALL appendices MUST have dates and version numbers clearly marked.
- Indicate ‘yes/no’ as applicable, and continue your document list on a separate continuation sheet if necessary.
Document | Enclosed? | Appendix № | Version № | Date |
Applicant’s Checklist (this form) | Mandatory | |||
H&SC FRESC application form | Mandatory | |||
List of references (APA format) | Mandatory | |||
Summary C.V. for lead researcher | Mandatory | |||
Letter(s) of invitation to participants | Y / N | |||
Participant Information Sheet(s) [PIS] | Y / N | |||
Participant consent form(s) | Y / N | |||
Information sheets / letters to other relevant personnel | Y / N | |||
Written permission(s) from relevant personnel/organisation (eg. to use facilities and/or access participants) | Y / N | |||
Interview schedule(s) or topic guide(s) | Y / N | |||
Validated questionnaire(s) | Y / N | |||
Non-validated questionnaire(s) | Y / N | |||
Gannt Chart/Timeline | Y / N | |||
Copies of recruitment advertisement material(s) | Y / N | |||
Risk Assessment form(s) | Y / N | |||
Copy of CRB Certificate (if applicable) | Y / N | |||
Signature of Supevisor(s) | Y / N | |||
Have you signed and dated form? | Y / N | |||
Other documents (Please specify below, as necessary) |
Y / N | |||
Y / N | ||||
Y / N | ||||
Y / N | ||||
Y / N | ||||
Y / N |
|
Title of study: | Insert full title of research proposal here |
Application version: | Insert version number of application |
Date of application: | Insert date application was written |
Date of FREC meeting to which application is being submitted: | |
Insert meeting date (this can be found on IBIS) | |
2. Will you require ethical approval from another source?
|
Yes No
|
If Yes, which other ethics committee approval do you require? i.e. NHS (IRAS, R&D) Local Authority (social work) etc. |
_______________________________________________________________________ |
Part 2: The research
Please indicate whether the proposed research is: |
|||
Quantitative | Qualitative | Both | |
If other please detail: |
|
||
Please provide a brief outline of the proposed research under the sub-headings below.
|
|||
i. Aims and objectives Type your response here
|
|||
ii. Hypotheses and/or research question(s) to be addressed Type your response here
|
|||
iii. Rationale, to include a brief synopsis of the background to the research
|
|||
iv. Study design, to include recruitment and sampling strategy, inclusion/exclusion criteria, sample size and justification Type your response here
|
|||
v. Proposed method(s) of data collection
Type your response here
vi. Proposed method(s) of data analysis Type your response here
|
|||
vii. Description of site(s) / facilities required
Type your response here
|
|||
Please summarise what you think are the ethical issues inherent in this study. The questions that follow will give you the opportunity to demonstrate how you will manage these issues in the conduct of your research.
|
|||
Type summary here
|
|||
i. Are there any potential risks or adverse effects to participants?
As well as any physical risks or adverse effects, you should consider the potential for discomfort, distress, inconvenience or change in lifestyle for the participants, and explain how these will be managed.
|
|||
Type your response here
|
|||
ii. Are there any particular requirements or abstensions that will be imposed on participants? (Eg. multiple attendance sessions; abstention from alcohol, tobacco, etc.).
|
|||
Type your response here
|
|||
iii. Are there any potential benefits to participants, or to the wider society?
|
|||
Type your response here
|
|||
iv. Are there any potential risks or adverse effects to researchers themselves? | |||
Type your response here
|
|||
v. Please indicate whether participants will receive payment or reimbursement for taking part in the research study (including reimbursement of expenses). If so, what amount?
|
|||
Type your response here
|
|||
vi. Please state the relationship, if any, which may/will exist between the researcher(s) and potential participants. (Eg. will any of the participants be students, subordinates or colleagues of the investigator, or staff members of the University?)
|
|||
Type your response here
|
|||
Will informed consent be obtained from the research participants?
|
|||
Yes No
|
|||
If ‘YES’, please give details of who will obtain consent and how this will be done, including how long participants will have to decide whether or not to take part. If ‘NO’, please explain why not.
|
|||
Type your response here
|
|||
Children
Can you confirm that, where the participant is 16 years old or over, consent to participate in the research will be obtained from the young person themselves.
|
|||
Yes No
|
|||
Can you confirm that, where the participant under 16 years of age but is judged to have the maturity and capacity to understand the nature of the research, consent to participate in the research will be obtained from the young person themselves.
|
|||
Yes No
|
|||
Please state the manner in which any apparent objection to participation by a minor will be handled.
|
|||
Type your response here
|
|||
Please state whether and how parental consent, or consent of the legal guardian or order/declaration of the court, will be sought in relation to the participation of minors.
|
|||
Type your response here
NB. Copies of the consent form(s) and Participant Information Sheet(s) to be used in the research must accompany this application.
|
|||
Type your response here
|
|||
Type your response here
|
|||
What measures will be taken to protect the confidentiality of participants’ data? You should consider data in hard copy, electronic and audio/audio-visual form. You should explain how the anonymity of participants is protected during the data collection process, during data analysis and at the end of the research project.
|
|||
Type your response here
|
|||
Who will have control and act as custodian of the data used in / generated by the research?
|
|||
Type your response here
|
|||
Can you confirm that the data will be retained in accordance with the University of Chester’s Research Governance Handbook, which states that “data generated in the course of research should be kept securely in paper or electronic format, as appropriate, for a minimum of ten years from the date of final publication”?
|
|||
Yes, I confirm that data will be stored securely and confidentially for a minimum of 10 years.
|
|||
Are you specifically recruiting participants from any of the following groups?
|
|||
Children under 16
Pregnant women The elderly Persons suffering from mental disorder Adults with learning disabilities Prisoners Young offenders Other vulnerable groups |
|||
Please explain why it is necessary to conduct research involving such participants, and whether the required data could be obtained by any other means.
|
|||
Type your response here
|
|||
Please state what special or additional arrangements, if any, will be applied, particularly in relation to Participant Information Sheets and gaining informed consent, to safeguard the interests of such participants.
|
|||
Type your response here
|
|||
Please state whether, and if so, how participation in the proposed research may/will be of personal benefit to individual participants.
|
|||
Type your response here
|
|||
|
|||