Low risk study review process

All projects submitted to ethics must be registered at the Research Office as per Auckland DHB Research Policies and Procedures.

Complete the Auckland DHB application form for research approval of a Low Risk Study v2

The Application for approval of a Low Risk Study form and Low Risk Study Approval Guide are suitable for studies that are low risk for Auckland DHB in all respects and can be reviewed by an expedited pathway.

Below are the main definitions of low risk studies:

• Cost-neutral (no budget required at Auckland DHB)
  and either:
• Audit or minimal risk research that does not qualify for review by a Health and Disability Ethics Committee OR
• Low risk observational research reviewed by a Health and Disability Ethics Committee via the expedited pathway, except when any participants will receive non-standard care as part of the research OR 
• Low risk research by a non-Auckland DHB researcher reviewed by an institutional ethics committee.

Research involving more than low risk for Auckland DHB and all research projects requiring a budget must be formally reviewed by the Auckland DHB Research Review Committee. Use the Application form for approval of a research project at Auckland DHB .

Obtain approval at departmental/service level

Signatures can be provided either as:

1. Original signatures on the Auckland DHB application form for research approval of a Low Risk Study v2 OR
2. Email confirmation / endorsement from the appropriate people to the Research Office. The e-mail must have the project number and title within the message body so as to ensure the confirmation is allocated to the correct project OR
3. Electronic signatures on the Auckland DHB application form for research approval of a Low Risk Study v2.

If you are undertaking a review across two clear disciplines or service areas (ie, child oncology and adult oncology) then obtain signatures of both clinical directors. The signatures required reflect the service you are undertaking your research/audit within, not the service, department you belong to.

If the principal investigator or Auckland DHB contact person is also the clinical director of the department/service where the research is to be undertaken, Section F of the form will require the signature of the person the clinical director reports to, e.g clinical leader or medical director.

Register your project at the Research Office

Email theSend by post or bring in person the signed Auckland DHB Application Form for Research Approval of a Low Risk Study v2 and other required documents to researchoffice@adhb.govt.nz or to one of theLow Risk Study, Research Office research advisors if you have been communicating directly. Your signed application form can be scanned and emailed (no need to send paper copies) but for the sake of readability please also send the original Word version.Office, Level 14, Support Building, Auckland City Hospital.

Required documents:

1. Auckland DHB application form for approval of a low risk study , fully signed. 
2. If you need to submit an ethics application to either a Health and Disability Ethics Committee (HDEC) or an institutional ethics committee (e.g. a university ethics committee) provide the application form.
3. Project proposal/protocol, any participant information and consent forms, any questionnaires, data forms etc.
4. If the study involves Auckland DHB patients as active participants, the Research Office will arrange for your study to have Maori review. You may need to provide further information to the Maori Advisor for Research after initial review (the Research Office will advise).

You MAY NOT START your research before you receive Auckland DHB institutional approval. If your study requires an ethical approval this must be obtained before the Auckland DHB institutional approval letter will be issued.