Reference no: EM132774389

Ethics Application for the dissertation

SECTION A - IDENTIFYING INFORMATION

A1) Title of the research (PLEASE INCLUDE A SHORT LAY TITLE IN BRACKETS).

A2) Principal Investigator OR DA/Supervisor (please check as appropriate)

A3) Co-applicants (including student investigators)

SECTION B - PROJECT DETAILS

B1) Proposed study dates and duration (RESEARCH MUST NOT BEGIN UNTIL ETHICAL APPROVAL HAS BEEN OBTAINED)

a) Starting as soon as ethical approval has been obtained (please check if applicable)

b) Approximate dates:

B2) Give a full lay summary of the purpose, design and methodology of the planned research.

B3) List any research assistants, sub-contractors or other staff not named above who will be involved in the research and detail their involvement (note that the use of research assistants in recruitment and/or data collection is not permitted in student research projects).

B4) List below all research sites, and their Lead Investigators, to be included in this study.

B5) Are the results of the study to be disseminated in the public domain?

B6) Give details of the funding of the research, including funding organisation(s), amount applied for or secured, duration, and UOL reference

B7) Give details of any interests, commercial or otherwise, you or your co-applicants have in the funding body.

SECTION C - EXPEDITED REVIEW

C1)
a) Does the study involve participants who are particularly vulnerable or unable to give informed consent? (e.g. children, people with learning or communication disabilities, people in custody, people engaged in illegal activities such as drug-taking, your own students in an educational capacity) (Note: this does not include secondary data authorised for release by the data collector for research purposes.)

b) Will the study require obtaining consent from a "research participant advocate" (for definition see guidance notes) in lieu of participants who are unable to give informed consent? (e.g. for research involving children or, people with learning or communication disabilities)

c) Will it be necessary for participants, whose consent to participate in the study will be required, to take part without their knowledge at the time? (e.g. covert observation using photography or video recording)

d) Does the study involve deliberately misleading the participants?

e) Will the study require discussion of sensitive topics that may cause distress or embarrassment to the participant or potential risk of disclosure to the researcher of criminal activity, dangerous behaviours, or child protection issues? (e.g. sexual activity, criminal activity)

f) Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study participants or will the study involve invasive, intrusive or potentially harmful procedures of any kind?

g) Will samples (e.g. blood, DNA, tissue) be obtained from participants?

h) Is pain or more than mild discomfort likely to result from the study?

i) Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life?

j) Will the study involve prolonged or repetitive testing?

k) Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?

C2)

a) Will the study seek written, informed consent?

b) Will participants be informed that their participation is voluntary?

c) Will participants be informed that they are free to withdraw at any time?

d) Will participants be informed of aspects relevant to their continued participation in the study?

e) Will participants' data remain confidential?

If you have answered ‘no' to all items in SECTION C1 and ‘yes' to all questions in SECTION C2 the application will be processed through expedited review.

If you have answered "Yes" to one or more questions in Section C1, or "No" to one or more questions in Section C2, but wish to apply for expedited review, please make the case below.

C3)

Case for Expedited Review - To be used if asking for expedited review despite answering YES to questions in C1 or NO to answers in C2.

SECTION D - PARTICIPANT DETAILS

D1) How many participants will be recruited?

D2) How was the number of participants decided upon?

D3)
a) Describe how potential participants in the study will be identified, approached and recruited.

b) Inclusion criteria:

c) Exclusion criteria:

d) Are any specific groups to be excluded from this study? If so please list them and explain why:

e) Give details for cases and controls separately if appropriate:

f) Give details of any advertisements:

D4)
a) State the numbers of participants from any of the following vulnerable groups and justify their inclusion

Children under 16 years of age:

Adults with learning disabilities:

Adults with dementia:

Prisoners:

Young Offenders:

Adults who are unable to consent for themselves:

Those who could be considered to have a particularly dependent relationship with the investigator, e.g. those in care homes, students of the PI or Co-applicants:

Other vulnerable groups (please list):

b) State the numbers of non-vulnerable volunteer participants:

Non-vulnerable Volunteers

D5) a) Describe the arrangements for gaining informed consent from the research participants.

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 representative in addition to the consent of the participant (e.g. HM Prison Service for research with young offenders, Head Teachers for research with children etc.).

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.)

d) Where informed consent is not to be obtained (including the deception of participants) please explain why.

D6) What is the potential for benefit to research participants, if any?

D7) State any fees, reimbursements for time and inconvenience, or other forms of compensation that individual research participants may receive. Include direct payments, reimbursement of expenses or any other benefits of taking part in the research.

SECTION E - RISKS AND THEIR MANAGEMENT

E1) Describe in detail the potential physical or psychological adverse effects, risks or hazards (minimal, moderate, high or severe) of involvement in the research for research participants.

E2) Explain how the potential benefits of the research outweigh any risks to the participants.

E3) Describe in detail the potential adverse effects, risks or hazards (minimal, moderate, high or severe) of involvement in the research for the researchers.

E4) 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/group discussions, or use of screening tests for drugs)?

E5) Describe the measures in place in the event of any unexpected outcomes or adverse events to participants arising from their involvement in the project

E6) Explain how the conduct of the project will be monitored to ensure that it conforms with the study plan and relevant University policies and guidance.

SECTION F - DATA ACCESS AND STORAGE

F1) 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 anonymisation procedures will be used)

Electronic transfer of data by magnetic or optical media, e-mail or computer networks

Sharing of data with other organisations

Export of personal data outside of or into the European Union

Use of personal addresses, postcodes, faxes, e-mails or telephone numbers

Publication of direct quotations from respondents

Publication of data that might allow identification of individuals

Use of audio/visual recording devices

Storage of personal data on any of the following:

Manual files

Home or other personal computers

University computers

Private company computers

Laptop computers

F2) Who will have control of and act as the primary custodian for the data generated by the study?

F3) Who will have access to the data generated by the study?

F4) For how long will data from the study be stored?

F5) Will you be transferring personal data into or outside the EU?

F6) Will you be collecting special category data (racial or ethnic origin, political opinion, union membership, religious or philosophical beliefs, genetic data, data concerning health, data concerning a person's sex life, sexual orientation, criminal convictions)?

SECTION G - PEER REVIEW

G1)

a) Has the project undergone peer review?

b) If yes, by whom was this carried out? (please enclose evidence if available)

SECTION G - CHECKLIST OF ENCLOSURES

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

Data protection risk assessment

Other (please specify)

Attachment:- Liverpool Ethics Application.rar