Post approval reviewed The Northern B HDEC reviewed a of 586 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Northern B 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/NTB/10 Review Type: Intervention title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection Co-ordinating Investigator: Professor Murray Barclay Reference Reason 3.11 EGIS It was not clear to the Committee that the risks of the research were proportional to the benefits of the research. The researcher needs to be more explicit about the possible benefits of this study and how the risks might be mitigated. 5.30 EGIS Intervention studies should not be performed with vulnerable groups if they can be adequately performed with trial groups. 6.66 EGIS The investigators have an obligation to ensure the availability of health care services that are essential to the safe conduct of a study, for participants, study team and for the wider population. Reference: 13/NTB/128 Review Type: Intervention Short title: Metacognitive Therapy for Anorexia Nervosa: An open in the South Island Eating Disorder Service Co-ordinating Investigator: Associate Professor Janet Carter Reference Reason 5.4 EGIS The committee is unclear about the study design and therefore is unable to judge whether the protocol and information provided best answers the study question. It is not clear that the study minimises risk. 6.56 EGIS An independent Data Monitoring Committee should also be considered in early phase studies, whether or not randomised, of a high-risk intervention; for example: where vulnerable populations, such as children or people with mental illness, are studied 4.22 EGIS The potential conflict of interest between participant and researcher is not adequately covered, as well as any justification for recruiting during the first visit to the rehabilitation center.
Post approval reviewed The Northern B HDEC reviewed a of 586 post approval items. A graph of the different types reviewed is below. Post approval items reviewed during 2013 Reasons for declining The Northern B 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/NTB/10 Review Type: Intervention title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection Co-ordinating Investigator: Professor Murray Barclay Reference Reason 3.11 EGIS It was not clear to the Committee that the risks of the research were proportional to the benefits of the research. The researcher needs to be more explicit about the possible benefits of this study and how the risks might be mitigated. 5.30 EGIS Intervention studies should not be performed with vulnerable groups if they can be adequately performed with groups. 6.66 EGIS The investigators have an obligation to ensure the availability of health care services that are essential to the safe conduct of a study, for participants, study team and for the wider population. Reference: 13/NTB/128 Review Type: Intervention Short title: Metacognitive Therapy for Anorexia Nervosa: An open in the South Island Eating Disorder Service Co-ordinating Investigator: Associate Professor Janet Carter Reference Reason 5.4 EGIS The committee is unclear about the study design and therefore is unable to judge whether the protocol and information provided best answers the study question. It is not clear that the study minimises risk. 6.56 EGIS An independent Data Monitoring Committee should also be considered in early phase studies, whether or not randomised, of a high-risk intervention; for example: where vulnerable populations, such as children or people with mental illness, are studied 4.22 EGIS The potential conflict of interest between participant and researcher is not adequately covered, as well as any justification for recruiting during the first visit to the rehabilitation center. trial
northern-b-ethics-committee-annual-report-2013.docx