Technology Faculty Ethics Committee (TFEC) ETHICAL REVIEW APPLICATION FORM i) Proposal Title: ii) Is the research a. Staff b. Doctoral Student c. Masters Student iii) Principal Investigator (PI): iv) Co-investigator(s): v) Supervisor(s): vi) School / Department: vii) Proposed study start date1: 1 The exact date of starting may not be known, but please indicate the likely start date, mindful of the timescales for ethical review. TFEC viii) Funding details (if any) a. Fully funded by the University of Portsmouth. b. Jointly funded between UoP (X %) and …….. (Y %) c. Fully funded by ix) Peer Review - Please confirm if the proposed research has been peer reviewed and provide a copy of the reviewers’ response and the updated protocol / proposal. Your proposal will not be reviewed again but is for information to support ethical review. x) Lay summary of your proposed research (less than 300 words). This should explain the reason for the research and what the research involves. This should be comprehensible to a non-specialist reader. xi) Research Proposal (please attach if completed on an application form). Please supply full details of the proposed work, including aims, literature review, methodology, data handling and analysis procedures and dissemination\impact. If this is an external bid it is acceptable to attach the application form. xii) Recruitment and informed consent procedures (please consider coercion, dignity and participant independence, and include participant information sheets and consent forms)2. xiii) Safety of the researcher (please comment on any potential risks to the researcher/s). 2 Templates for participant information sheets and consent forms are available on the University Ethics Web Pages 2 TFEC xiv) Confidentiality (please describe how participant and or data confidentiality will be maintained). xv) Please identify any ethical issues and strategies to deal with them e.g. a. Deception b. Human tissue use (in terms of the Human Tissue Act) c. Vulnerable groups d. Sensitive cultural or scientific sites xvi) Risks and Benefits (please describe any potential risks and or benefits of participation in the study and comment on the balance of risks and benefits within the proposal). xvii) Please state any conflict of interests xviii) Conformation with current conventions (please confirm that the research has been designed and will be conducted according to professional and or national / international guidance, such as the Declaration of Helsinki etc.) 3 TFEC Notes for those completing the Technology Faculty Ethics Committee (TFEC) Ethical Review Application Form The Technology Faculty Ethics Committee (TFEC) is the recognised body for consideration of ALL staff, doctoral and MPhil research. The committee provides guidance for ethical review of undergraduate and taught post graduate research, but only reviews this level of study in exceptional circumstances. Although, School/ Departmental procedures apply to ethical review of undergraduate study; where, in exceptional circumstances, undergraduate studies require review, copies of these applications should be forwarded to the Secretary of the TFEC. Similarly, studies requiring mandatory review by external agencies are not reviewed additionally by TFEC, but you MUST send a copy of your application documents with a covering letter to TFEC for Faculty records. You are also required to send copies to TFEC of any further correspondence you have with the external agency, including decision letters, annual monitoring and or amendment reports and your final study report. The TFEC is not a technology peer review committee and consequently this application should be accompanied by a peer reviewed copy of your research protocol / proposal where required by the University. This may take the form of a copy of the protocol / proposal and the peer reviewers’ comments. Given the diversity of research within the Faculty, there is no single template for a research proposal / protocol and so individual versions are acceptable. You can find your school or departmental representative from the committee’s membership page, on the University Ethics Web Pages. You can also contact ethicstech@port.ac.uk or your Department’s / School’s TFEC members with any queries. Please submit this application and supporting documentation electronically to ethicstech@port.ac.uk. Please Note: The TFEC application form is designed as a standard Faculty Ethical review form and as such some of the questions may not be relevant to all areas of research; particularly questions of recruitment and consent where the research does not involve humans. For these questions, please briefly indicate if they do not apply and why. 4 TFEC Submission of Proposals to External Ethical Review Committees If your research involves: A i. xenotransplantation ii. ionising radiation iii. NHS patients and or carers iv. the use of ‘relevant human tissue’ v. mentally incapacitated participants aged 16 years or more You must make your application to an NHS Research Ethics Committee http://www.nres.npsa.nhs.uk/applications/ B Research within the Ministry of Justice and or HM Prison Service: i. For health and social care studies please make an application to an NHS Research Ethics Committee. http://www.nres.npsa.nhs.uk/applications/ ii. For all other forms of study please apply to the National Offender Management Service Research Ethics Committee http://www.justice.gov.uk/publications/research-and-analysis/noms C The social care sector, you may require approval from the Social Care Research Ethics Committee. http://www.screc.org.uk/index.asp D Live vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act please make an application to the University Ethical Review Committee. matthew.guille@port.ac.uk E The Ministry of Defence, your application must be submitted to the Ministry of Defence Research Ethics Committee www.science.mod.uk/engagement/modrec/modrec.aspx In each case, please make your application to the relevant committee above, and send copies of your application and any further correspondence to the TFEC for record only, you do not need to complete an TFEC application form. 5