Find out if your study requires HDEC review
Information about when study proposals require Health and Disability Ethics Committees (HDEC) review.
Health and disability studies aim to generate knowledge for the purpose of improving health and independence outcomes. The HDEC checks that proposed health and disability studies meet established ethical standards in order to protect participants.
When review of a study proposal is required
Unless an exemption applies, most health and disability research requires HDEC review if it involves one or more of the following criteria:
Participants recruited as:
- consumers of health or disability support services, or
- relatives or caregivers of consumers of health or disability support services, or
- volunteers in clinical trials (including, for the avoidance of doubt, bioequivalence and bioavailability studies).
The use, collection or storage of human tissue (as defined by the Human Tissue Act 2008, unless:
- informed consent has been obtained for such use (which may include informed consent to future unspecified research) and the tissue will not be made available to researchers in a form that could reasonably be expected to identify the individual(s) concerned, or
- one or more of the statutory exceptions to the need to gain informed consent applies, as set out under either:
The use or disclosure of health information (as defined by the Health Information Privacy Code 1994), unless:
- this use or disclosure has been authorised by the individual(s) concerned, or
- health information will not be disclosed to researchers in a form that:
- could identify, or could reasonably be expected to identify, the individual(s) concerned, or
- would allow for the information to be matched with other data sets (for example, through the use of non-encrypted identifiers such as National Health Index numbers).
Scope of review
The HDEC scope of review is explained in more detail in Section 3 of the Standard Operating Procedures for the Health and Disability Ethics Committees.
The following exemptions to the main criteria may apply:
- studies on low-risk devices
- minimal-risk observational studies
- audits and related activities
- student-led research.
Possible exemptions are explained in more detail in Section 3 of the Standard Operating Procedures for the Health and Disability Ethics Committees.
Letter of confirmation that review is not required
If you require a letter confirming that your study is outside HDEC scope of review, please submit an application on the Online Forms website. This form needs to be completed and submitted so that we may confirm that it is outside the scope of HDEC review. Please see How to apply for review.
Email your completed form to: firstname.lastname@example.org