| Research - Frequently Asked Questions |
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| Who signs the Locality Assessment? |
| Who signs Part 4 Section 2? |
| Who signs the RRC Form? |
| Institutional Approval for Research at Auckland District Health Board |
| How do I obtain Maori Research Review Committee (MRRC) approval? |
| I have been approached to conduct a commercially sponsored clinical trial.
What is required for institutional approval? |
| Not sure if you need ethics review? |
| What is Audit? |
| What is Educational Research? |
| What is Quality Assurance? |
| What is Research? |
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| Who signs the Locality Assessment? |
| Full Ethics Application - Dr Woodnorth will sign the Locality Assessment once the study has been registered with the Research Office and allocated an A+ number and is accompanied by a copy of the Ethics Part 4 which MUST be signed by the ADHB clinical directors of the ADHB departments being accessed. If an Investigator in the study is also the Clinical Director then the Clinical Leader or Medical Director signature is required.
For University researchers and other external researchers - please note that we WILL NOT accept Ethics Part 4s signed by non-ADHB clinical directors (e.g. University Heads of Department / supervisors.) If the applicant submits an RRC form signed by the clinical director, this will suffice. Decisions to deviate from this lie with Manager Research only (or their deputy in their absence).
Observational studies for Expedited Reviews - LAF is not required. However, you must notify Research Office of your study proposal. |
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| Who signs Part 4 Section 2? |
| The Clinical Director of the Service where the study participants are located. If the Principal Investigator of the study is also the Clinical Director of the unit then section 2 will have to be signed by the Clinical Leader, or Medical Director or whom the Clinical Director reports to.
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| Who signs the RRC Form? |
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Only the Clinical Director,
Service Accountant and
Service Manager should sign
the RRC form.
Under Section A on the RRC
Application Form,
co-investigators names and
address have been amended to
ADHB co-investigators names
and address and also ADHB
contact to ADHB contact
(required for non-ADHB
researchers).
Section C on the Application
Form has been enlarged and
revised to allow further
clarification of what care
is standard and what is
extra for Research.
Please always download the
latest forms and guides
from our website for use:
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| Institutional Approval - is NOT the locality assessment or ethics approval. |
| 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 Company Policy. (Please refer to the Company Policy Manual: Research)
Please do not start your research project until you receive institutional approval from the ADHB Research Office. |
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| How do I obtain Maori Research Review Committee (MRRC) approval? |
This process automatically begins as soon as you email a copy of the research proposal (including information sheets and consent form) to researchoffice@adhb.govt.nz . At the end of the MRRC review process, you will receive a formal letter of support from the Committee.
Proposals must be received by the 20th of each month for review that month. If received after the 20th, they will be reviewed in the following month. |
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| I have been approached to conduct a commercially sponsored clinical trial.
What is required for institutional approval? |
- Firstly, do NOT sign any documentation with a sponsor, except a ‘confidentiality’ agreement for reviewing the protocol, or professional declarations that do not involve Auckland District Health Board.
- Commercially sponsored trials require specific documentation from the sponsor, such as: a financial agreement / a statement of indemnity and compensation. These documents MUST be approved by Auckland District Health Board and contracts may only be signed by Business or Service Managers with the delegated authority to sign contracts on behalf of Auckland District Health Board. Auckland District Health Board has a standard indemnity and compensation format for use by sponsors.
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NOT SURE IF YOU NEED ETHICS REVIEW? |
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Ask yourself ‘Is the project ethical?’ |
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Please refer to the Operational Standard for Ethics Committees (2006), section 3 “Matters Requiring Ethical Review” (http://www.ethicscommittees.health.govt.nz/moh.nsf/indexcm/ethics-resources-guidanceethicalresearch?Open&m_id=6.1) for an extensive explanation on matters that require ethical review. The following list is not exhaustive, but is intended to give a good idea of the sorts of issues that should require an ethical review before undertaking; |
- Does it involve the collection of new data?
- Does it involve obtaining / revealing any confidential and identifiable personal material / information without the informed consent?
- Is it likely to be considered by the participant to be sensitive or valuable in a personal, social, cultural or commercial sense?
- Is the information on potentially sensitive or distressing topics (for example loss of children, extreme forms of violence, about sexual behavior, about criminal activity)?
- Is the information wanted, on participants who are vulnerable people?
Will it require randomisation of participants?
- Is there a possibility for potential discrimination?
- Does it involve neonatal, mental health, sexual health areas?
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What is Audit? |
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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. |
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What is educational projects?
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A set of formal and structured educational requirements leading to an established designation or competency i.e. degree. [May require ethical approval from Educational Institution Ethics Committee and/or the Health & Disability Ethics Committee]
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What is Quality Assurance? |
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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. |
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What is Research? |
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Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge. [Requires ethical approval] |
ADHB Research Office - June 2011
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Ministry of Health
