Name of the Organization : Health & Disability Ethics Committees
Type of Facility : Applying For HDEC Review
Country : New Zealand
Website : https://ethics.health.govt.nz/home
Applying For HDEC Review :
Does your research require HDEC review?
Related : Health & Disability Commissioner Making a Complaint New Zealand : www.statusin.org/11957.html
All health and disability research must comply with established ethical standards.
However, not all health and disability research requires HDEC review. The complete definition of the scope of HDEC review is contained at section 3 of the SOPs for HDECs.
Your study is likely to require HDEC review if it involves:
1. human participants recruited in their capacity as:
** consumers of health or disability support services, or
** relatives or caregivers of such consumers, or
** volunteers in clinical trials; or
2. human tissue; or
3. health information.
Please contact us if you’re not sure whether or not your study requires HDEC review.
How do I apply?:
All applications to HDECs must be submitted through the Online Forms website. This site allows you to answer questions in the HDEC application form, upload documents, request electronic signatures from other parties involved in your research, and track the progress of your application.
Please refer to the Online Forms User Manual for detailed guidance on creating and submitting an application.
Apply Here : https://ethics.health.govt.nz/home
What happens after I’ve applied?:
First, your application is checked for validity.
All applications are checked for validity before being assigned for review. If your application is invalid (ie, either incomplete or outside the scope of HDEC review), we will advise you of this in writing.
Valid applications are assigned for HDEC review through one of two pathways.
Higher-risk applications are reviewed by the full review pathway. This means that a decision is made on the application at an HDEC meeting held in accordance with section 5 of the SOPs for HDECs. Final decisions on full review applications must be made within 35 days.
Lower-risk applications are reviewed by the expedited review pathway. This means that a decision is made on the application between meetings, by a sub-committee of HDEC members, including the Chair. Final decisions on applications reviewed by the expedited review pathway, which is described in section 6 of the SOPs for HDECs, must be made within 15 days.
If your application is valid, we will advise you in writing of the pathway by which it will be reviewed. If this is the full review pathway, we will also provide details of the relevant meeting, and invite you to attend in person or by phone.
Then, your application is reviewed by an HDEC, and a decision made on it:
The HDEC review process is set out in detail in the SOPs for HDECs.
HDECs must make one of the following decisions on each application they review:
Approve. This means that the HDEC is satisfied that your proposed research meets or exceeds established ethical standards.
Please note that HDEC approval alone is not usually sufficient to allow research to proceed. You may need to obtain other approvals (for example, from Medsafe, your university or polytechnic, or the localities where your research will be conducted) before you can start your study.
Decline. This means that the HDEC is not satisfied that your proposed research meets or exceeds established ethical standards. There are a number of options for challenging HDEC decisions to decline, which are set out in section 9 of the SOPs for HDECs. You can also contact us for more information about these options.
Provisionally approve. This means that the HDEC requires changes to (or further information about) your research in order to be satisfied that it meets or exceeds established ethical standards. You have 90 days to make these changes or provide this further information. Each application may be provisionally approved only once.
We will advise you in writing of the decision that has been made on your application.