SECTION I: CHECKLIST (select as appropriate)
Does the project involve work with human tissue/body fluids?
If ‘NO’ skip to section (II)
Does the project involve work with animals and/or animal tissue?
If ‘NO’ skip to section (III) Does the project involve any of the following:
Recruitment of volunteers?
Questionnaires or interviews?
Observations of Participants?
If yes for either, complete the sections (IV)-(VI) below
If No complete section (VI) only
SECTION II – RISK OF HARM AND RELATED ISSUES (select as appropriate)
Is there any realistic risk of any participants experiencing either physical or psychological distress or discomfort? Are drugs, placebos, or other substances (e.g., food substances, vitamins) to be administered to study participants?
Is there any possible psychological risk to the researcher?
Will participants undergo sound exposure beyond the Lower Action Level of the Physical Agents Directive?
Does the project require the use of hazardous substances?
Is the use of radiation (if applicable) over and above what would normally be expected (for example) in diagnostic imaging?
SECTION III – VULNERABLE GROUPS AND FINANCIAL INDUCEMENTS (select as appropriate)
Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?
Will participants fall into any of the following special groups?
SECTION IV – OTHER (select as appropriate)
Are there any other potential significant ethical issues not covered above? If Yes, give details below:
How will you ensure ‘informed consent’ is gained from anyone involved in the research?
How will you approach General Data Protection Regulation issues during your research?
Does this project require that the researcher applies for a Disclosure Barring Service (DBS) check?
If you have answered YES above, cite the code and either include it as an appendix to this application or provide details below about where it can be consulted electronically.
What other ethical issues should you consider when conducting this research and how will potential ethical risk/harm be avoided?
Does the project involve human subjects (e.g. as volunteers or to take part in interviews/questionnaires) and/or animals and/or human tissue and/or animal tissue?
Does your study involve a clinical trial?
Has this project received external funding?
If YES, provide name of Research Council or other funding organisation: Do you use non-human genetic materials from outside UK for your research?
If YES, has this been collected since the 12th October 2014?
Does your study involve a clinical trial?
If YES, do you intend to register your trial on a clinical database?
