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 Standard Operating Procedures forms.

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

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:

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.

 

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