ࡱ> O vbjbjCC ER)e)e, , qqqqq8\JB^E[[GA l 8AAAAAAA$D^GAq GG Aqq[4Ba$a$a$ jq[qAa$ Aa$a$R;!e?[,HuFO!=AB0JB>!<e?e?Hqy?< a$ AA#B JB H , 7:  ֮ Faculty of Health & Life Sciences Faculty Research Ethics Committee AMENDMENT/EXTENTION APPLICATION FORM PLEASE READ SUBMISSION GUIDELINES BEFORE COMPLETING THIS FORM DO NOT USE if original application was submitted via Worktribe Further information application forms and training resources available at  HYPERLINK "http://www.dmu.ac.uk/research/ethics-and-governance/faculty-specific-procedures/health-and-life-sciences-ethics-procedures.aspx" http://www.dmu.ac.uk/research/ethics-and-governance/faculty-specific-procedures/health-and-life-sciences-ethics-procedures.aspx. For further information or advice please contact the Research and Innovation Office, Faculty of Health and Life Sciences, 2.14 Heritage House, Phone: 0116 207 8228 / 0116 257 7864 or email:  HYPERLINK "mailto:hlsfro@dmu.ac.uk" hlsfro@dmu.ac.uk Amendments may include changes to the terms of the FREC application, the protocol or any other supporting documentation for the trial. Applicants should consider; Any change in the research proposal The safety or physical or mental integrity of the subjects of the trial The scientific value of the trial The conduct or management of the trial The quality or safety of any investigational medicinal product used in the trial 1. Applicant(s) name(s): 2.Postal & email address:  Supervisor(s) or co-applicant(s): 4. Programme of Study (if applicable): Supervisor (s): Co Applicant(s):  5. Title of Research Project:  6. Original Approval 7. Start date for the project 8.Expected end date for the project: Reference number; (FREC must be advised upon completion)  9. Brief description of proposed amendment  10. Rationale for the amendment  11. Please list each potential ethical issue relating to your study and state how these will be addressed: include potential risks to participants and research staff  SUPPORTING DOCUMENTS (all documents should have a version number and date) Compulsory  FORMCHECKBOX  Research proposal (suggested headings are listed in submission guidelines) Where applicable  FORMCHECKBOX  Permission from external organisation  FORMCHECKBOX  Consent form (see submission guidelines for example)  FORMCHECKBOX  Participant information sheet (see submission guidelines for example)  FORMCHECKBOX  Data collection tools (eg draft interview schedule, survey questionnaire)  FORMCHECKBOX  Recruitment flyer or advertisement  FORMCHECKBOX  Participant response slip  FORMCHECKBOX  Human Tissue Information: Arrangements for storage, disposal, tracking, tracing, and recording.  FORMCHECKBOX  Tissue Bank details, including details of their application procedures and a copy of their HTA licence  FORMCHECKBOX  Drug information: list of proprietary or commercial drugs to be used, including formulation, dosage and route of administration and known adverse side effects Authorisation By signing this form, you confirm that you have read, understood and will comply with the above ethical guidelines. Please refer to the Electronic Submission Requirements as below. Signature of applicantDate:Signature of supervisor (if applicable) Date:Signature of clinical or workplace supervisor (if applicable)Date: SUBMISSION OF COMPLETED FORMS Applicant type:Taught Undergraduate, Postgraduate and Masters Students: Staff, Postgraduate Research Students (PhD, DHSci, MRES), and external applicantsSubmission requirements:Application forms to be submitted electronically with all supporting documents to supervisor, module or programme leader as instructed. 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