NSW Health encourages the widespread implementation of quality assurance (QA) programs as an essential part of a learning health care organisation. QA should be conducted as part of conventional clinical service delivery or ‘business-as -usual’. In almost all routine situations, QA projects should not require prior ethical review.
NSW Health adopts the distinctions between projects requiring ethical review and those that do not as set out in the NSW Health Guideline: GL2007_020 – Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW.
• Researchers conducting human research are required to submit their projects to a Human Research Ethics Committee as per NSW Health Policy.
QA practitioners should assess the characteristics of their project against the NSW Health Guideline to determine if any of the ethical risks described within are present in their project statement.
- If so, review by an ethics review body should be sought. If advice is required, contact should be made with their local Clinical Governance Unit.
- If not, QA practitioners are free to commence their projects, after adhering to any institutional requirements.NSW Health policy is that ethics review and approval is not required merely for the mechanism of obtaining publication in a journal [see Q16 in GL 2007_020].
However, NSW Health observes that an increasing number of journals have required from QA practitioners a statement by an ethics review body prior to accepting a manuscript for publication.
To ensure that potentially valuable findings resulting from QA activities are communicated to the broader clinical governance community and that those findings are tested in the peer review literature; should a journal require a statement in such a circumstance, NSW Health has developed the attached letter which an ethics review body (including a Human Research Ethics Committee) may issue to QA practitioners retrospectively to state that, given the characteristics of the project statement, the project did not contain any of the ethical risks set out in the NSW Health Guideline, and that in accordance with NSW Health policy, was not required to be submitted for review by an ethics review body.
The letter itself is not a statement of ethical approval of the project.
Updated 2 months ago