Appeal Applicants may appeal any HDEC decision to decline, suspend or cancel approval to the HRCEC. Appeal decisions of the HRCEC are final and binding on HDECs. Applicants who wish to appeal HDEC decisions should contact the HRCEC for further details of the process. 10. Locality authorisation Introduction The response to the Health clinical trials report requires updated SOPs for Government’s Committee’s HDECs to clarify that localities (such as district health boards (DHBs)), rather than HDECs, are responsible for checking local governance issues that may arise from the conduct of a study at a given locality. This section addresses that requirement. It replaces the current process ‘locality assessment’ described at section 7 of the . Key changes and clarifications include: defining more narrowly, to include only a subset of the organisations involved in the ‘locality’ conduct of studies making the DHB the natural unit for locality review within the public health system allowing one locality review to cover multiple sites (for example hospitals or departments) within a single locality clarifying and expanding the issues relevant to locality review; for example, to include issues relevant to a ability to meet its potential liabilities in intervention studies for which locality’s compensation is not available under the ACC Act. Key changes to this section following consultation include: expanding the definition of to include organisations involved in the conduct of ‘locality’ observational studies (while recognising that not all such studies will involve localities) clarifying that the study team as a whole (rather than the study sponsor) is responsible for ensuring that locality review is conducted by the appropriate individuals at a locality more clearly requiring that a chief executive officer authorise the person completing locality’s a locality review requiring locality review to be conducted afresh as soon as possible, rather than immediately following a change of the lead/principal investigator at a particular locality. HDEC approval and locality authorisation are separate processes HDEC review is the process by which an HDEC checks that a study meets or exceeds established ethical standards. If an HDEC is satisfied that this is the case, it approves the study.
Appeal Applicants may appeal any HDEC decision to decline, suspend or cancel approval to the HRCEC. Appeal decisions of the HRCEC are final and binding on HDECs. Applicants who wish to appeal HDEC decisions should contact the HRCEC for further details of the process. 10. Locality authorisation Introduction The Government’s response to the Health Committee’s clinical trials report requires updated SOPs for HDECs to clarify that localities (such as district health boards (DHBs)), rather than HDECs, are responsible for checking local governance issues that may arise from the conduct of a study at a given locality. This section addresses that requirement. It replaces the current ‘locality assessment’ process described at section 7 of the . Key changes and clarifications include: defining ‘locality’ more narrowly, to include only a subset of the organisations involved in the conduct of studies making the DHB the natural unit for locality review within the public health system allowing one locality review to cover multiple sites (for example hospitals or departments) within a single locality clarifying and expanding the issues relevant to locality review; for example, to include issues relevant to a locality’s ability to meet its potential liabilities in intervention studies for which compensation is not available under the ACC Act. Key changes to this section following consultation include: expanding the definition of ‘locality’ to include organisations involved in the conduct of observational studies (while recognising that not all such studies will involve localities) clarifying that the study team as a whole (rather than the study sponsor) is responsible for ensuring that locality review is conducted by the appropriate individuals at a locality more clearly requiring that a locality’s chief executive officer authorise the person completing a locality review requiring locality review to be conducted afresh as soon as possible, rather than immediately following a change of the lead/principal investigator at a particular locality. HDEC approval and locality authorisation are separate processes HDEC review is the process by which an HDEC checks that a study meets or exceeds established ethical standards. If an HDEC is satisfied that this is the case, it approves the study.
ADHB-SOPs-for-HDECs-v1.0.docx