Requesting a Waiver of Human Research Ethics Committee review for a Quality Assurance / Audit Activity
The National Statement on Ethical Conduct in Human Research (paragraphs 5.1.22 and 5.1.23) defines research that can be exempted from ethics review as negligible risk research that involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
Following are examples of types of research exempt from ethics review:
- Systematic reviews and meta-analysis of published and non-identifiable data
- Studies that involve data available in the public domain
- Experimental or laboratory studies that do not involve data collected from or about humans or animals
Non-research activities exempt from ethics review include quality assurance activities and the publication of case reports. Quality assurance activities where there is intent to publish findings may be submitted to the HREC Chairperson for exemption of ethics review. Individual patient consent should be obtained for the publication of case reports; however, ethics review is not required (HREC Chairperson advice can be sought, if required). Case reports involving more than 2 individuals are classified as a case series and require ethics review.
Submitting a request:
The following information is required for requests to the Children’s Health Queensland (CHQ) Human Research Ethics Committee for a waiver of Human Research Ethics Committee review for a Quality Assurance / Audit activity with intent to publish:
1. Cover letter addressed to the Chair of the CHQ Human Research Ethics Committee containing the following:
- Statement of what is being requested, e.g. “I am writing to seek a waiver of Human Research Ethics Committee review for the following Quality Assurance activity with intent to publish the findings”;
- Descriptive title of the activity;
- Brief summary of the activity with justification of why this is a Quality Assurance / Audit activity rather than a research study (refer to National Statement section 2.3 for relevant considerations in providing justification);
- Contact details (postal address, telephone number and e-mail address) of the applicant.
2. A proposal document containing the following:
- Descriptive title of the activity;
- Investigators involved (e.g. to the level of potential authorship on any resultant publication);
- Aim and Background: Why is this activity being undertaken? What are the standards of care that apply? How will the results be used?
- Method: Details on participants to be included (inclusion / exclusion criteria, numbers involved, relevant time periods); what, if anything, participants will be asked to do; variables to be reported on, including outcomes of interest; method of data collection (e.g. chart review); methods used to maintain confidentiality / anonymity; the form the results will take (e.g. descriptive statistics); study timelines; how the exercise might be fed back into an audit or service improvement cycle; where the results are anticipated to be presented external to the institution; references (where relevant).
The proposal document may be brief (1 – 2 pages). A research protocol template can be used and modified as appropriate (e.g. sample size calculations may not be relevant).
3. Any associated study materials (e.g. data collection tools, patient satisfaction questionnaires).
Submit one hard and one electronic copy of all documents to the following:
Human Research Ethics Committee
Children’s Health Queensland
Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
South Brisbane QLD 4101
You will receive correspondence from the Chair or the HREC Coordinator with one of the following outcomes:
- A letter of exemption from full HREC review;
- A request for further information;
- If considered not Quality Assurance / Audit Activity, a request to submit via the research pathway (i.e. completion of a Low or Negligible Risk Research Application for Ethics Review or a National Ethics Application Form).
Institutional approval procedures for Quality Assurance / Audit activities, where relevant, must be followed. However, a Site Specific Assessment application (which is only required for research studies) is not required.