Find out if your study requires 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.

You can fill out an application form in ETHICS RM(external link)(external link) . This form has replaced the old scope of review form. The first two pages are a screening questionnaire which will produce whether the study is in scope, and what pathway if so.

If you require a letter confirming your study is out of scope for HDEC review, you will need to create and submit an HDEC application form.

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
• human tissue
• health information.

Participants

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).

Human tissue

The use, collection or storage of human tissue (as defined by the Human Tissue Act 2008,(external link) 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:
  • section 20(f) of the Human Tissue Act 2008,(external link) or
  • Right 7(10)(c) of the Code of Health and Disability Services Consumers’ Rights 1996.(external link)

Health information

The use or disclosure of health information (as defined by the Health Information Privacy Code 2020(external link)), 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.

Exemptions

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.

Summary of HDEC scope

*These studies will also require submission to SCOTT and/or GTAC in addition to HDEC. Please check and confirm with these committees.

This is a high-level summary of the scope of HDEC’s review and their pathways as outlined in the Standard Operating Procedures for Health and Disability Ethics Committees(external link). Some research may not fit neatly under these headings. In these cases, please contact the Secretariat if it is still unclear where your study sits.

Studies out of scope may need Institutional Ethics Committee (IEC) consideration – the contact details for these committees are available here(external link).

If no IEC is available, alternate Committees are available but may charge a fee and should be enquired independently.