Post approval reviewed The Southern HDEC reviewed a total of 835 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Southern HDEC is required to clearly identify the ethical standard(s) that it considers not to be met by an application. These ethical standards are contained in the Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (GFUR), Ethical Guidelines for Observational Studies (EGOS) and Ethical Guidelines for Intervention Studies (EGIS). The references in the tables below are to paragraph numbers in these documents. Reference: 13/STH/44 Review Type: Observational Short title: Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas in Thickness ≤1mm Co-ordinating Investigator: Dr Ben Tallon Reference Reason 6.43 EGOS The main ethical discussed by the Committee is the use of stored human tissue for a purpose for which it was not initially submitted, without obtaining informed consent for this particular use. The Committee was concerned that informed consent would not be obtained from the patients, especially as this study may detect new or different information to what was initially reported to the patient. The Committee does not believe that the use of human tissue without consent has been adequately justified for this study and considers this does not align with the ethical guidelines. 6.42 EGOS The consent of participants should generally be obtained for using identified or potentially identifiable data for research. Issues and complaints This section outlines issues faced by the Committee during 2013. Issues causing difficulty in review Online system issues. Lack of appropriate peer review. Provisional responses not being submitted in tracked changes format. Action New online system updates have been drafted, tested and implemented. Peer review template developed and published on HDEC website. Newsletter containing reminder to track changes was published on HDEC website.
Post approval reviewed The Southern HDEC reviewed a total of 835 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Southern HDEC is required to clearly identify the ethical standard(s) that it considers not to be met by an application. These ethical standards are contained in the Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (GFUR), Ethical Guidelines for Observational Studies (EGOS) and Ethical Guidelines for Intervention Studies (EGIS). The references in the tables below are to paragraph numbers in these documents. Reference: 13/STH/44 Review Type: Observational Short title: Assessment of Tumour Mitotic Rate in Primary Cutaneous Malignant Melanomas ≤1mm in Thickness Co-ordinating Investigator: Dr Ben Tallon Reference Reason 6.43 EGOS The main ethical discussed by the Committee is the use of stored human tissue for a purpose for which it was not initially submitted, without obtaining informed consent for this particular use. The Committee was concerned that informed consent would not be obtained from the patients, especially as this study may detect new or different information to what was initially reported to the patient. The Committee does not believe that the use of human tissue without consent has been adequately justified for this study and considers this does not align with the ethical guidelines. 6.42 EGOS The consent of participants should generally be obtained for using identified or potentially identifiable data for research. Issues and complaints This section outlines issues faced by the Committee during 2013. Issues causing difficulty in review Online system issues. Lack of appropriate peer review. Provisional responses not being submitted in tracked changes format. Action New online system updates have been drafted, tested and implemented. Peer review template developed and published on HDEC website. Newsletter containing reminder to track changes was published on HDEC website.
southern-ethics-committee-annual-report-2013.docx