Checklist for Ethics Approval in Research Projects

Applicant Details

A checklist should be completed for every research project which is used to identify whether a full application for ethics approval needs to be submitted to your Faculty Ethics Committee.

1 Applicant details

2 Project details

3 Research checklist (to check if more than minimal risk)

Please answer each question by ticking the appropriate box:

1.Does the study involve students within the University?

2.Does the study involve employees of the University?

3.Does the study involve participants who are particularly vulnerable or unable to give informed consent: children, those with cognitive impairment?

4.Will the study require the co-operation of a gatekeeper for initial access to the groups or individuals to be recruited? (e.g. students at school, members of self-help group, residents of nursing home)

5.Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (e.g. covert observation of people in non-public places)

6.Will the study involve discussion of sensitive topics or illegal activity (e.g. sexual activity, drug use)?

7.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?

8.Will tissue samples (including blood) be obtained from participants?

9.Is pain or more than mild discomfort likely to result from the study?

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

11.Will the study involve prolonged or repetitive testing?

12.Will the research involve administrative or secure data that requires permission from the appropriate authorities before use?

13.Is there a possibility that the safety of the researcher may be in question (e.g. in international research: locally employed research assistants)?

14.Does the research involve members of the public in a research capacity (participant research)

15.Will any of the research take place outside the UK?

16.Will the research involve respondents to the internet or other visual/vocal methods where respondents may be identified?

17.Will research involve the sharing of data or confidential information beyond the initial consent given?

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

Research that may need to be reviewed by NHS NRES Committee or an external Ethics Committee

19.Will the study involve recruitment of patients or staff through the NHS or the use of NHS data or premises and/or equipment?

20.Does the study involve participants age 16 or over who are unable to give informed consent?

1.You must complete this form BEFORE you are entitled to commence your primary data collection

2.The form must be sent to your Course Tutor for approval

3.Your approved ethics form must be included in your final submission as part of your appendices. This is a University required and if the ethics form is not included your work may not be marked

4.If you have any questions or concerns regarding your research please contact your supervisor in the first instance.

Instructions for supervisors:

Please check the appropriate boxes.  Even if the student has answered ‘no’ to all questions in Section 3, the study should not begin until all boxes have been checked and the form counter-signed.

The student has been made aware of the University’s Code of Good Research Practice and relevant professional codes of conduct

The topic merits further research

The student has the skills to carry out the research

The participant information sheet or leaflet is appropriate (where applicable)

The procedures for recruitment and obtaining informed consent are appropriate (where applicable) x