HDEC decision and approval process

Steps in the HDEC decision process

1. The application is checked for validity

The screening questionnaire portion of the HDEC application on ETHICS RM determines the scope of your submission. A successful submission is checked by an advisor before being assigned for review.

Invalid applications

If your application is invalid (that is, either incomplete or outside the scope of HDEC review), we will advise you of this in writing via a notification in Ethics RM.

An application is in Invalid if it is missing required authorizations or mandatory documents. You will be able to amend it and submit it back once these corrections have been made.

If your application is out of scope, it will be marked as such with a letter provided via Ethics RM.

Valid applications

Valid applications are assigned for HDEC review through one of these two pathways:

• full review pathway
• expedited review pathway.

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. Full applications are assigned on a schedule as outlined in the schedule of dates found here and you will not receive prior notification until an agenda has closed.

2. HDEC review

The HDEC review process is set out in detail in the Standard Operating Procedures for Health and Disability Ethics Committees (SOPs): Read more about the SOPs for HDECs.

Full review pathway

Higher-risk applications are reviewed by the full review pathway. This means that a decision is made on the application at an HDEC full meeting held in accordance with chapter 5 of the SOPs for HDECs. Final decisions on full review applications must be made within 35 days.

You can find more information on what to expect from full review here.

Expedited review pathway

Lower-risk applications are reviewed by the expedited review pathway. This means that a decision is made on the application online 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.

You can find more information on what to expect from full review here.

3. Decision made on your application

HDECs must make one of the following decisions on each application they review regardless of pathway:

• approve
• provisionally approve
• decline.

Definitions:

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.

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. Not responding to a request for further information will result in the submission being considered withdrawn. Each application may be provisionally approved only once.

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. For more information about these options: Contact us. A Decline means an applicant may submit to the HDECs again after making the changes requested to try again. There is no limit to how many times an applicant can re-apply after a Declined.

We will advise you in writing of the decision that has been made on your application via Ethics RM.