University of Sheffield University Scientific Review Application Form It is a requirement of the Department of Health’s Research Governance Framework for Health and Social Care that all UK-based health care research projects are scientifically approved, via an independent scientific review process, prior to commencing. Please complete this form if your proposed health care research project is internallyfunded and if the University of Sheffield (the University) is the project’s ‘research governance sponsor’ and return the form to the person who is administering your department’s internal scientific review procedure. If you are from the School of Medicine, Clinical Psychology, or the School of Nursing and Midwifery then please follow your department’s scientific review procedure. Note on externally-funded health care research projects: In the case of externally-funded health care research projects, it is the University’s position that the scientific review process is managed by the external research funder (e.g. the grant award letter doubles up as evidence of independent scientific approval). However, if you have reason to believe that the external funder of your research does not scientifically review research that it funds (e.g. no peer review mechanism in place) then it is recommended that you complete this form. 2008 2007 1 University of Sheffield University Scientific Review Application Form Part A A.1 Basic Details: A1.1 Research Project Title: A1.2 URMS (University Research Management System) reference number: (this is a 6 digit number) A1.3 Contact person (normally the Principal Investigator in the case of staff-led research projects; the student in the case of supervised-student research projects): Title: Post: Email: A1.4 First Name/Initials: Department: Telephone: Last Name: Is this a supervised-student research project? If yes, please provide the Supervisor’s contact details: If yes, is it undergraduate research? If yes, is it post-graduate taught research? (e.g. dissertation) If yes, is it post-graduate research? (i.e. PhD): A.2 What is the research question? (should be clearly defined and answerable) A.3 Describe the background to the project (justification): (include evidence of whether the research has previously been undertaken, and whether all sources of evidence, especially systematic reviews, have been fully considered. In the case of staff-led projects explain how the project fits in with the research strategy of the academic department to which the member of staff belongs). A.4 Project Plan: A.4.1 Methodology A.4.2 Design A.4.3 Analysis including statistical methods (if appropriate) A.4.4 Outcome measure(s) A.4.5 Setting Insert date here: Insert applicant’s name here: 2 University of Sheffield A.4.6 Human participants: method used to identify, approach, recruit and consent (For guidance, you may choose to consult section 2 of the University’s ‘Ethics Policy for Research Involving Human Participants, Data and Tissue’: www.shef.ac.uk/external/content/1/c6/03/25/85/v1109238506/user/ethics_policyvs2.pdf A.4.7 Sample: viability and representativeness of the sample A.4.8 Intervention (if appropriate): Flow chart indicating human participant's involvement throughout the course of the project A.4.9 Justification of use of screening tools/questionnaires etc. A.4.10 Project plan with timescale and clearly delineated milestones A.5 Management (describe what arrangements have been made to manage the project) A.6 Expertise (i.e. of the researcher and, if applicable, of the research team) A.7 Involvement of service users (if applicable): (describe their involvement in the design of the project) A.8 How will the project’s research results be disseminated? (For guidance, you may choose to consult section 3.11 of the University’s ‘Good Research Practice Standards’: www.shef.ac.uk/content/1/c6/03/25/82/collatedGRP.pdf A.9 What arrangements are in place for owning, protecting and exploiting potential intellectual property that might arise from the project? (For guidance, you may choose to consult section 3.3 of the University’s ‘Good Research Practice Standards’: www.shef.ac.uk/content/1/c6/03/25/82/collatedGRP.pdf or the Research Office’s intellectual property webpage: www.shef.ac.uk/researchoffice/support/commercialisation/property/ip-protection.html) A.10 Cost schedule (if applicable): (if there are costs then you should attach the approved URMS costing record) A.11 Explain the agreement with the academic department for the use of resources: (if a staff-led project) A.12 Lay summary of the key issues contained in the project: Insert date here: Insert applicant’s name here: 3 University of Sheffield University Scientific Review Application Form Part B – Declaration Full Research Project Title: insert title here I confirm my responsibility to deliver the research project in accordance with the University’s policies and procedures (which include the University’s ‘Financial Regulations, ‘Good Research Practice Standards’, the ‘Ethics Policy for Research Involving Human Participants, Data and Tissue’ and ‘Procedure for Investigating and Responding to Allegations of Research Misconduct’). In signing this scientific review application form I am also confirming that: The form is accurate to the best of my knowledge and belief. Subject to the research being approved, I undertake to adhere to the protocol outlined in this form without unagreed deviation. I undertake to inform the University’s research governance support staff (in the Research Office) of any significant changes to the protocol outlined in this form. If applicable: If this is an application for a ‘generic’ project all the individual projects that fit under the generic project are compatible with this application. I understand that the project (including research records / data) may be subject to inspection for audit purposes, if required in future. There is no potential material interest that may, or may appear to, impair the independence and objectivity of researchers conducting this project. I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines relating to security and confidentiality of personal data, including the need to register when necessary with the appropriate Data Protection Officer (within the University the Data Protection Officer is based in Corporate Information and Computing Services – CiCS). I understand that personal data about me as a researcher in this form will be accessed by the people involved in the independent scientific review process (i.e. the administrator and/or University accredited scientific reviewers) and that this will be managed according to the principles established in the Data Protection Act. Name of the Principal Investigator (or student’s Supervisor): insert name here Name of student (if applicable): insert name here Signature of the Principal Investigator (or student’s Supervisor): sign here Date: insert date here Please complete the form in full and return a signed, dated version of Part B to the person who is administering your department’s internal scientific review procedure 2007 1