Research - Low risk study review process

All research projects Auckland DHB, its patients, staff or facilities, must be approved by the Research Office as per Auckland DHB Research Policy.

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  [DOC, 174 KB]and Low Risk Study Approval Guide [PDF, 160 KB] 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:
• Minimal risk research OR
• Low risk observational research reviewed by a Health and Disability Ethics Committee via the expedited pathway OR 
• Low risk research by a non-Auckland DHB researcher reviewed by an institutional ethics committee. IMPORTANT UPDATE The Auckland Health Research Ethics Committee (AHREC) has been created with the intention of streamlining ethical and institutional approvals and reducing duplication. If you are seeking ethical approval from AHREC for your low risk study you may also use the AHREC form for the Auckland DHB expedited approval process. A separate Auckland DHB low risk form is not required.

https://www.auckland.ac.nz/en/research/about-our-research/human-ethics/ahrec.html()

For research that is greater than low risk, 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 [DOC, 152 KB]. Types of research that are always considered greater than low risk are any study involving a clinical intervention or departure from normal care for patients.

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 (please note the Research Office does not require a paper copy - please scan and email signed pages) 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 within, not the service or 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 Director.

Register your project at the Research Office

Email the 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 the Research Office research advisors if you have been communicating directly. Your signed application form can be scanned and emailed (don't send paper copies) but for the sake of readability please also send the original Word version.

Required documents:

1. Auckland DHB application form for approval of a low risk study, fully signed, or AHREC form, fully signed. 
2. Health and Disability Ethics Committee (HDEC) Main Form or other institutional ethics committee application form where applicable.
3. Study 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 Māori review. You may need to provide further information to the Māori 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.