APPLICATION FOR APPROVAL OF A PROJECT

RESEARCH ETHICS COMMITTEE

APPLICATION FOR APPROVAL OF A PROJECT INVOLVING

HUMAN PARTICIPANTS, HUMAN DATA, OR HUMAN MATERIAL

This application form is to be used by researchers seeking approval from the University Committee on Research Ethics. Applications, with the specified attachments, should be submitted electronically to: [email protected]

Classification And Types Of Burns

RESEARCH MUST NOT BEGIN UNTIL ETHICAL APPROVAL HAS BEEN OBTAINED

The expectation is that medical research involving human participants, human data, or human material, will comply with the latest guidelines set out in the Declaration of Helsinki (accessible through \file1Research4. Research Policies and FormsResearch Ethics or http://www.wma.net/en/30publications/10policies/b3/index.html.) Other forms of research involving human participants, human data, or human material, will conform with XJTLU General Guidelines on Research Ethics (accessible through (\file1Research4. Research Policies and FormsResearch Ethics). For reference, the model consent form of University of Liverpool could be accessed here Model Consent Form.

Declaration of the:

Principal Investigator OR Other investigator (please check as appropriate)

The information in this form is accurate to the best of my knowledge and belief, and I take full responsibility for it.

I have read and understand XJTLU’s General Guidelines on Research Ethics

For medically-related research, I undertake to abide by the ethical principles underlying the Declaration of Helsinki

I undertake to seek an ethical opinion from the University Research Ethics Committee before implementing substantial amendments to the study plan or to the terms of the full application agreed by the Committee.

I understand that I am responsible for monitoring 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 Research Ethics Committee within 24 hours of the occurrence, via [email protected]

I am aware of my responsibility to comply with the requirements of the law applicable to the research 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.

I understand that personal data about me as a researcher in this application may be held by the University.

I understand that all conditions apply to any co-applicants, researchers and/or students involved in the study, and that it is my responsibility to ensure that they abide by them.

Signature of Principal Investigator or Other investigator : ……………………………………

Date: (dd/mm/yyyy)

Print Name:

Post:

SECTION A – IDENTIFYING INFORMATION

A1) Title of the research (please include a short lay title in brackets).

A2) Principal Investigator OR Other Investigator

(please check as appropriate)

Title:
Forename/Initials:		Surname:
Post:		Department:
Telephone:		E-mail:

A3) Co-applicants

Title and Name	Post / Current programme	Department/ School/Institution	Phone	Email

A4) Students involved in the research

Title and Name	Post / Current programme	Department/ School/Institution	Phone	Email

[Continue on separate sheet if necessary]

SECTION B – PROJECT DETAILS

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

Approximate dates:

Start date:

End date:

B2) Give a full summary, understandable to a non-specialist, 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.

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

Research Site	Individual Responsible	Position and contact details

B5) Are the results of the study to be published or otherwise made publicly accessible?

YES NO

If not, why not?

B6) Are you aware of any conflict of interest, commercial or otherwise, associated with the research?

SECTION C – STUDY DETAILS

C1)


a) Will the study involve recruitment of participants outside China?	/No*
b) 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.)	/No
c) Will the study require obtaining consent from a ”research participant advocate” in lieu of participants who are unable to give informed consent? (e.g. for research involving children or, people with learning or communication disabilities)	/No
d) 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)	/No
e) Does the study involve deliberately misleading the participants?	/No
f) 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 or child protection issues? (e.g. sexual activity, criminal activity)	/No
g) 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?	/No
h) Will samples (e.g. blood, DNA, tissue) be obtained from participants?	/No
i) Is pain or more than mild discomfort likely to result from the study?	/No
j) Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life?	/No
k) Will the study involve prolonged or repetitive testing?	/No
l) Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?	/No

* Delete as appropriate

C2)


a) Will the study seek written, informed consent from the participants?	Yes/*
b) Will participants be informed that their participation is voluntary?	Yes/
c) Will participants be informed that they are free to withdraw at any time?	Yes/
d) Will participants be informed of aspects relevant to their continued participation in the study?	Yes/
e) Will participants’ data remain confidential? (see Note 1)	Yes/
f) Will participants be debriefed?	Yes/

* Delete as appropriate

Note 1：It is obviously acceptable to publish data involving human material. However, care should be taken that the published data does not allow an individual participant to be identified unless permitted.

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:

D4)

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):

State the numbers of healthy volunteer participants:

Healthy 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, 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 OR LEGAL IMPLICATIONS AND THEIR MANAGEMENT

E1) Describe in detail the potential physical or psychological adverse effects, risks, legal implications 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, legal implications or hazards (minimal, moderate, high or severe) arising from this research to the researchers or anyone else.

E4) What precautions will be in place to minimise the risks identified in E1 and E3?

E5) 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)?

YES NO

If Yes, give details of procedures in place to deal with these issues.

E6) Describe any measures in place in the event of any unexpected outcomes or adverse events to participants arising from their involvement in the project

E7) Explain how the conduct of the project will be monitored to ensure that it conforms with relevant University policies and guidance.

SECTION F – DATA ACCESS AND STORAGE

F1) It is good international practice to maintain data confidentiality (see Note 1). With this in line, please 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 or individuals
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 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?

SECTION G – PEER REVIEW

SECTION G – CHECKLIST OF ENCLOSURES

Study Plan / Protocol

/No

Other relevant document 1

Name: ……………………………………………………

/No

Other relevant documents 2

Name: …………………………………..………………..

/No

[Where necessary, name additional enclosed documents]

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