Ethics Research Application Form
Application for Approval of a Research Project involving Human participants, Human Data, or Human Material
Section A – Identifying Information
A1) Title of the research
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A2) Principal Investigator
Mr Mrs Ms Dr Other (Specify)
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FIRST NAME MIDDLE NAME LAST NAME
Organization: Click here to enter text.
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Email Address: Click here to enter text.
A3) Co-Applicants (including student investigators)
Mr Mrs Ms Dr Other (Specify)
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FIRST NAME MIDDLE NAME LAST NAME
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Email Address: Click here to enter text.
Section B – Project Details
B1) Proposed Study dates and duration
Start Date: Click here to enter a date. End Date: Click here to enter a date.
(dd/mm/yy) (dd/mm/yy)
B2) Give a full summary of the purpose, design and methodology of the planned research (attach in separate document)
B3) List any research assistants, sub contractors or any other staff not named above who will be involved in the research and detail their involvement.
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B4) List below all research sites and their lead investigators to be included in this study
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B5) Are the results of the study to be disseminated in the public domain?
If yes, please state how. If no, please give a reason why.
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B6) Give details of the funding of the research, including funding organization(s), amount applied for or secured and duration.
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B7) Give details of any interests, commercial or otherwise, you or your co- applicants have in the funding body.
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Section C – Participant Details
C1) How many participants will be recruited? Click here to enter text.
C2) How were the number of participants decided upon?
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C3) Describe how potential participants in the study will be identified, approached and recruited.
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· Inclusion criteria:
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· Exclusion Criteria:
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· Are any specific groups to be excluded from this study? If so please list them and explain why.
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· Give details for cases and controls separately if appropriate
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· Give details of any advertisements
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C4) State the numbers of participants from any of the following groups and justify their inclusion
Children under 16 years of age / Click here to enter text.Adults with learning Disabilities / Click here to enter text.
Adults with dementia / Click here to enter text.
Prisoners / Click here to enter text.
Young offenders / Click here to enter text.
Adults who are unable to consent for themselves / Click here to enter text.
Healthy Volunteers / Click here to enter text.
Those who could be considered to have a particularly dependent relationship with the investigator , e.g. those in care homes, students etc. / Click here to enter text.
Other vulnerable groups / Click here to enter text.
C5) a) Describe the arrangements for gaining informed consent from the research participants.
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b) If participants are to be recruited from any of the potentially vulnerable groups listed above, give details of extra steps taken to assure their protection, including arrangements to obtain consent from a legal , political or other appropriate representation in addition to the consent of the participant ( e.g. from the prison service for research with young offenders, head teachers …
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c) If participants might not adequately understand verbal explanations or written information given in English, describe the arrangements for those participants ( e.g. translation , use of interpreters etc)
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d) Where informed consent is not to be obtained (including the deception of participants) please explain why.
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C6) What is the potential for benefit to research participants, if any?
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C7) State any fees, reimbursements for time and inconvenience, or other forms of compensation that individual research participants may receive. Include direct payments, reimbursements of expenses or any other benefits of taking part in the research. Required.
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Section D – Risks and their management
D1) Describe in detail the potential physical or psychological adverse effects, risks or hazards (minimal, moderate, high or sever) of involvement in the research for research participants.
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D2) Explain how the potential benefits of the research outweigh any risks to the participants.
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D3) Describe in detail the potential adverse effects, risks, or hazards ( minimal, moderate, high or severe ) of the involvement in the research for the researchers.
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D4) Will 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/groups discussions, or use of screening tests for drugs)?
YES NO
If yes, give details of procedures in place to deal with these issues.
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D5) Describe the measures put in place in the event of any unexpected outcomes or adverse events to participants arising from their involvement in the project.
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D6) Explain how the conduct of the project will be monitored to ensure that it conforms to the study plan and relevant policies and guidance.
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Section E – Data Access and storage
E1) Where the research involves any of the following activities at any stage (including identification of potential research participants), state what measures have been put in place to ensure confidentiality of personal data (e.g. encryption or other anonymization procedures that will be used)
Electronic transfer of data by magnetic or optical media, email or computer networks / Click here to enter text.Export of data outside the region / Click here to enter text.
Use of personal addresses, postal codes, faxes, email or telephone numbers / Click here to enter text.
Publication of direct quotations from respondents / Click here to enter text.
Publication of data that might allow identification of individuals / Click here to enter text.
Use of audio/visual recording devices / Click here to enter text.
Storage of personal data on any of other the following:
Manual files / Click here to enter text.
Home or other personal computers / Click here to enter text.
University / school computers / Click here to enter text.
Private company computers / Click here to enter text.
Laptop computers / Click here to enter text.
Sharing data with other organisations / Click here to enter text.
E2) Who will have control of and act as the custodian for the data generated by the study?
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E3) Who will have access to the data generated by the study?
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E4) How long will data from the study be stored for?
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Section F – Check List of Enclosures
¨ Cover letter
¨ Study plan/protocol
¨ Recruitment advertisement
¨ Participant information sheet
¨ Participant consent form
¨ Research participant advocate consent form
¨ Evidence of external approvals
¨ Questionnaires on sensitive topics
¨ Interview schedule
¨ Debriefing material
¨ Other (please specify)
Medical Dental Council – Ethics Committee (MDC–EC)
Declaration
Principal investigator
· The information in this form is accurate to the best of my knowledge and belief and I take full responsibility for it.
· I undertake to abide by ethical principles and follow good practice guidelines in the proper conduct of research, together with the codes of practice laid down by any relevant professional or learned society.
· If the research is approved, I undertake to adhere to the study plan, the terms of the full application of which the MDC-EC has given favourable opinion, and any conditions set out by the MDC-EC in giving its favourable opinion.
· I undertake to seek an ethical opinion from the MDC-EC before implementing substantial amendments to the study plan or to the terms of the full application of which the MDCEC has given a favourable opinion.
· I understand that I am responsible for the monitoring of the research at all times
· If there are any serious adverse events, I understand that I am responsible for immediately stopping the research and alerting the MDC-EC within 24 hours of the occurrence via .
· I am aware of my responsibility to be up-to-date and comply with the requirements of the law and relevant guidelines relating to security and confidentiality of personal data.
· I understand that research records/data may be subject to inspection for audit purposes if required in the future.
· I understand that all conditions apply to any co- applicants and researchers involved in the study, and that it is my responsibility to ensure that they abide by them.
(Print Name)
Signature of Principal Investigator Date (dd/mm/yy)
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