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Part 1 Items in Yellow boxes require action by students. DEVELOP DRAFT RESEARCH PROPOSAL. DOES THIS PROJECT INVOLVE AUDIT OR RESEARCH ?. TO ANSWER THIS QUESTION REVIEW THE FOLLOWING COREC GUIDANCE: AUDIT OR RESEARCH ? at http://www.corec.org.uk/recs/guidance/guidance.htm#audit
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Part 1 Items in Yellow boxes require action by students • DEVELOP DRAFT RESEARCH PROPOSAL. • DOES THIS PROJECT INVOLVE AUDIT OR RESEARCH? • TO ANSWER THIS QUESTION • REVIEW THE FOLLOWING COREC GUIDANCE: • AUDIT OR RESEARCH? • at • http://www.corec.org.uk/recs/guidance/guidance.htm#audit • Click on the link for ‘Differentiating audit, service evaluation and research ‘(COREC ethics consultation, e-group issues and arguments paper v1.0 03/10/05) • You should also discuss this with your allocated academic supervisor. • FURTHER ADVICE CAN ALSO BE OBTAINED FROM THE LOCAL RESEARCH ETHICS COMMITTEE ADMINISTRATOR: see http://www.leedsteachinghospitals.com/sites/research_and_development • AUDIT& SERVICE EVALUATION • DISCUSS SUITABLITY OF THIS KIND OF PROJECT WITH YOUR DISSERTATION MODULE MANAGER. • RESEARCH • Projects which involve the following: • -NHS staff • -NHS patients, tissues, organs, data (retrospective or prospective), NHS facilities • or equipment must conform to research governance requirements Part 2 Colour Coding: Yellow: student responsibility. Blue: Dissertation Module Manager Responsibility. Green: FRO responsibility STAGE 1 STAGE 2 & 3 CONCURRENTLY STUDENTS SUBMIT DRAFT RESEARCH PROPOSAL FOR ACADEMIC APPROVAL WITHIN THE SCHOOL OF HEALTHCARE.. • DEVELOP DETAILED RESEARCH PROPOSAL IN CONSULTATION WITH SUPERVISOR. • Timescale*** • REVIEW THE COREC Ethical Approval form at • http://www.corec.org.uk/applicants/apply/apply.htm • AND- CONTACT THE LOCAL RESEARCH ETHICS COMMITTEE (LREC) ADMINISTRATOR TO REQUEST A MEETING TO DISCUSS THE PROJECT AND OBTAIN ADVICE ON THE COMPLETION OF THE COREC FORMS. • NOTE ETHICAL APPROVAL AND NHS TRUST APPROVAL ARE TWO DIFFERENT THINGS. NHS APPROVAL IS FACILITATED BY THE FRO. • BEGIN ACCESS DISCUSSION WITH GATEKEEPERS (E.G.MANAGERS AND PHYSICIANS). • SUBMIT DETAILED PROPOSAL TO MODULE MANAGER. • By*** • COMPLETE THE COREC APPLICATION FORM. • Use http://www.corec.org.uk/applicants/apply/docs/Question-specific_Guidance.doc • SEE SHC GUIDANCE on COMPLETION OF QUESTIONS A35, A36, &A71, A72. • AN LREC ID NUMBER IS ALLOCATED ON SUBMISSION OF THE APPLICATION. • DETERMINE DATE TO SUBMIT. APPLICATION FOR LREC APPROVAL. A DECISION WILL BE MADE WITHIN 60 DAYS (SOMETIMES SOONER, DEPENDING ON THE PROJECT). • INFORM MODULE MANAGER OF LREC ID NUMBER. • DISSERTATION PANEL MEETS: • ACADEMIC SUPERVISOR ALLOCATED • DISSERTATION MODULE MANAGER SUBMITS PART A OF FACULTY RESEARCH OFFICE (FRO) Form SUBJECT TO LREC & TRUST APPROVAL COMMENCE DATA COLLECTION. • FRO GENERATE • APPROVAL LETTER and INDEMNITY STATEMENT and • SPONSORSHIP LETTER • CONTACT C SKINNER. • c.e.skinner@leeds.ac.uk • FOLLOWING TRUST APPROVAL R & D, ID NUMBER ALLOCATED. • PART B OF FRO FORM COMPLETED. • FRO SUBMITS LIST OF PROJECTS TO NHS TRUST (OR FACILITATES THIS). • THIS RESULTS IN NHS TRUST APPROVAL. • TAKES 1-3 MONTHS