Preliminary Ethical Assessment Form Please complete this form for every internally or externally funded research application project SECTION 1: PROJECT DETAILS Project Title: BH Number (If externally funded project): SECTION 2: APPLICANT DETAILS Name of Researcher (Applicant): Email Address: Contact Address: Telephone number: SECTION 3: APPROVAL Question 1: Does the research involve any of the following? YES NO Patients and Users of the NHS Relatives or carers of patients and users of the NHS Access to data, organs or other bodily material of past and present NHS patients Fetal material and IVF involving NHS patients The recently dead in NHS patients The use of, or potential access to, NHS premises or facilities NHS staff- recruited as research participants by virtue of their professional role Vulnerable people unable to make their own decisions If you answered yes to any of the above, then you need to submit an application for ethical review to the appropriate external health authority ethics committee through the National Research Ethics Service (NRES) – see http://www.nres.npsa.nhs.uk for the process. Question 2: Does the research involve human participants e.g use of questionnaires YES NO If you answered ‘No’ to question 2 please go directly to section 4. If you have answered ‘Yes’ to question 2, then you need to complete the following section: Ethics Preliminary Assessment form v 11 070809 Page 1 of 3 Preliminary Ethical Assessment Form YES a Does the study involve participants who are particularly vulnerable or unable to give informed consent (e.g. children, people with learning disabilities, your own students? b 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 a self-help group, residents of a nursing home) C Will it be necessary for participants to take part in the study without their knowledge and consent at times? (e.g. covert observation of people in non-public places) d Will this programme/project involve deliberately misleading participants in any way? e Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use) f Are any 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 blood or tissue samples be obtained from subjects? 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 l Will the research involve the use of sensitive economic, social or personal data about individuals who could be identified? NO If you have answered ‘no’ to questions a-l: Your project does not require ethical approval and you should send copies of the form to your School Ethics Co-ordinator, Faculty Ethics Co-ordinator and if externally funded to the appropriate Grants and Contracts team along with the blue form. If you have answered ‘yes’ to any of questions a-l: You will need to describe more fully how you plan to deal with the ethical issues raised by your research by completing the full ethics approval application form, usually at award stage. This does not mean that you cannot do the research, only that you will need to seek and satisfy an ethical opinion from a University Research Ethics Committee. You should now send the completed and signed form to your School Ethics Co-ordinator, Faculty Ethics Preliminary Assessment form v 11 070809 Page 2 of 3 Preliminary Ethical Assessment Form Ethics Co-ordinator and the appropriate Grants and Contracts team along with the blue form and, if awarded, you will be advised when you need to apply for ethical approval. Question 3: Does the research involve the use of animals of other organisms covered by the Animals (Scientific Procedures) Act? YES NO If you answered yes to question 3, then you need to submit an application for ethical review to the University Ethical Review Committee. SECTION 4 Name of Principal Investigator Signed Date If you have any queries about this or any other ethical issue, please contact your Faculty Ethics Coordinator or appropriate Grants and Contracts team. -------------------------------------------------------------------------------------------------------------------------For office use only: Date received in G&C: Ethics Preliminary Assessment form v 11 070809 Requires full approval: YES/NO Page 3 of 3