The term Locality Authorisation refers specifically to the process used by the NZ Health and Disability Ethics Committees (HDECs)() for ascertaining that all local governance issues have been addressed at sites participating in a research project.
If Auckland DHB is a site for your research project (ie, one or more of the procedures described in the study protocol will be conducted at Auckland DHB) and your project requires approval from an HDEC, then you will need to request a Locality Authorisation from Auckland DHB via the HDEC online application system Online Forms()
The duration of the review depends on several factors. The single most important of these is the quality and completeness of the set of documents sent to the Research Office for review. Applicants should check the Essential Documents checklist. If the Research Office has a complete set of documents, all applications forms have been conscientiously completed, and the applicants have provided appropriate evidence of support from the service where the research will take place (i.e. sign off), this usually facilitates a smooth process.
Applications should be submitted before the deadline of the monthly Research Review Committee (RRC) meeting. Deadlines are two weeks prior to the meetings. After the meeting you can expect the Committees feedback with 3 working days. Auckland DHB Maori review will be organised for you when you have submitted your documents and will occur in parallel with the RRC review.
If you have an HDEC approval for your research it is a condition of that approval that you report on progress to HDEC, at least annually, until the conclusion of the study. When HDEC reviews and approves your annual progress report it will post a downloadable "Approved annual progress report" letter in the report's e-Submission screen. The letter will feature the next due date for annual reporting (typically 12 months since the previous due date) in bold. If your HDEC-approved study is active at Auckland DHB and you have an Auckland DHB locality authorisation (see above), the Research Office will be able to check that you are submitting annual reports in a timely way. Your Auckland DHB approval will be withdrawn if you don't respond to reminders to do so. Make sure you know your next due date for annual reporting and aim to submit the report two to three weeks prior to that date to give HDEC time to process.
All other HDEC Post-approval Forms (amendments, protocol violations, final reports etc.) are submitted (when required) via HDEC Online Forms in the same way as annual progress reports.
This is NOT the same as ethics approval or HDEC locality authorisation.
Clinical research conducted on the premises of Auckland District Health Board or involving its patients, clients or staff, is important to Auckland DHB. There are financial, human resource, ethical, legal, planning, quality and risk issues. The primary role of the Research Office is to provide a service to investigators and management to address these issues in accordance with Auckland DHB Policies and procedures.
You may not start your research project until you receive institutional approval from the Auckland DHB Research Office.
If your research involves human participants, with very few exceptions, it will need to be approved by an ethics committee before you can start. Auckland DHB uses two kinds of ethics committees; the Ministry of Health's Health and Disability Ethics Committees (HDECs) and The Auckland Health Research Ethics Committee (AHREC). AHREC is Auckland DHB's institutional ethics committee.
Ethics committees check that proposed health and disability research meets established ethical standards that aim to protect participants who are either patients, their family/whānau/caregivers, staff or volunteers in clinical trials.
Most health research, research involving access to patient information, and all high risk clinical research can be approved by an HDEC.
Very low risk research outside the scope or review for HDEC can be reviewed by AHREC.
An audit is an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies, operational procedures, and/or evidence based standards of care and to recommend, where necessary changes in controls, policies, or procedures to ensure those standards are met. Audits do not need approval from the Research Office.
The formal and systematic monitoring and reviewing of medical care delivery and outcome; designing activities to improve healthcare and overcome identified deficiencies in providers, facilities, or support systems; and carrying out follow-up steps or procedures to ensure that actions have been effective and no new problems have been introduced.
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge.(Requires ethical approval).