Review of medical sciences ethics applications

Purpose:

This policy establishes the guidelines for the submission of ethics applications to conduct research including sponsored trials, clinical trials and clinical research. This policy applies to research being undertaken in Macquarie University Hospital (MUH), Australian School of Advanced Medicine (ASAM), and the Departments of Chiropractic and Physiotherapy. It will apply to other research projects at the discretion of the Director, Research Ethics.

Overview:

Macquarie University is committed to conducting its research in an ethical and accountable way. In accordance with the MUH Clinical Research Policy and research policies and by-laws, Macquarie University must ensure human research is compliant with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007),the Australian Code for the Responsible Conduct of Research (2007), and other relevant guidelines and legislation.

This policy sets out the requirements for the submission of ethics applications to the Macquarie University Human Research Ethics Committees (HRECs) for review.

Definitions and acronyms:

Human Research: Any research activity that is conducted with or about people, or involves the use of their data and tissue.

Clinical Trial: Any research that prospectively assigns participants to one or more health-related interventions to evaluate the effects on health outcomes is considered to be a clinical trial. A medical intervention can include any intervention used to modify a health outcome and can include drugs, surgical procedures, devices, behavioural treatments, etc. (Definition taken from the Australian New Zealand Clinical Trials Registry (ANZCTR) FAQs

Sponsored Trial: Commercially-sponsored clinical trials including co-operative/collaborative trials with commercial sponsorship.

Clinical Research: Research undertaken in combination with patient care with one or more of its components designed to confer diagnostic, prophylactic or therapeutic benefits on the individuals involved in addition to the development of new health knowledge.

Non-Clinical Research: Research undertaken on patients or other participants, or with their data, with the sole intention of contributing to knowledge.

National Statement on Ethical Conduct in Human Research (2007): The National Statement clarifies the responsibilities of institutions, researchers and review bodies for the ethical design, review, conduct and dissemination of results of human research.

Australian Code for the Responsible Conduct of Research (2007): The Code provides guidance to institutions and researchers about responsible research practices.

Greater than Low Risk: According to the National Statement a risk is “the likelihood that a harm (or discomfort or inconvenience) will occur” and “the severity of the harm, including its consequences”. Any application which may lead to harms for the participants is considered to be greater than low risk.

ASAM: Australian School of Advanced Medicine

HREC: Human Research Ethics Committee

MQ: Macquarie University

MUH: Macquarie University Hospital

NEAF: National Ethics Application Form

NHMRC: National Health and Medical Research Council

Scope:

This policy applies to Macquarie University (MQ) and MUH researchers and their students, visiting academics or medical personnel and other personnel involved in the conduct of health research includingsponsored trials, clinical trials and clinical research in the following areas:

  • MUH
  • ASAM
  • Physiotherapy
  • Chiropractic
  • Any research with human tissue
  • Other research, at the discretion of the Director, Research Ethics

Policy:

This policy applies to researchers conducting the following types of research:

  1. Single or multi-site research including clinical trials, sponsored trials and clinical research at a public hospital, where MQ and/or MUH is not a site.

Single or multi-site research must be approved by any of the following NHMRC-approved HRECs:

  • NSW Health HRECs (or state-equivalent) or Lead HRECs
  • Cancer Institute NSW Clinical Research Ethics Committee

Providing research will not be conducted at MUH,theMQ External HREC Application Approval Form can be submitted with a copy of the external ethics application form, the final approval letter from the external HREC and all correspondence between the investigator and the external HREC. In this instance the external ethics approval will be accepted by the Committee.

  1. Research involving a public organisation where there is a fully-constituted HREC and public organisation participants and where the research will not be conducted at MQ or MUH.

If the research has been approved by any of the following HRECs:

  • Justice Health
  • Australian Government (including Department of Veterans Affairs, Medicare etc.)
  • Another University

and includes non-MQ or non-MUH participants, providing the research will not be undertaken at MQ, researchers can submit the external application form together with their ethics approval form. This will be considered by the Committee Executive and the external approval will be accepted.

  1. Multi-site research including sponsored trials, clinical trials and clinical researchconducted at public health and/or other institutions that include MQ personnel and where MUH or MQ is listed as a site.

If the research has been reviewed by a NSW, or state-equivalent, public health HREC or another University, and MQ and/or MUH is to be included as a site, researchers must obtain HREC approval from MQ in addition to approvals already obtained from other sites.

  1. Single-site or multi-site research including sponsored trials, clinical trials and clinical research where MQ and MUH personnel are listed as investigators and where all the participating sites are private (that is, not part of the public health system), which may or may not include MUH.

If the research is conducted at multiple sites by MQ or MUH personnel then researchers must obtain HREC approval from MQ in addition to approvals obtained from other institutions.

All research being conducted at MUH and ASAM must be signed off prior to submission by the Dean, Professor Simon Foote.

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Appendix A: Table documenting approval requirements for MQ

Public institution/site(examples) / MQ/MUH as site / Staff/Students / Application Type / Documents / Review Process / Decision
Government Department / x /  / Request to access participants in Government organisation, e.g. Veterans / Government Department application form & MQ external review form / Executive review / HREC accepts and approves
NSW Health and Cancer Council / x /  / Notifying HREC of external project of which MQ researchers affiliated / NSW Health NEAF & MQ external review form / Executive review / HREC accepts External Review
NSW Health and Cancer Council /  / 
(MQ supervisor not included on external research protocol) / Request for student to access dataset as part of postgraduate research / NEAF & letter from NSW Health granting approval for MQ supervisor to access data in supervisory role / Executive review / Accept and approve
NSW Health and Cancer Council / x /  / Request for researcher to access dataset as part of research / HREC meeting review / MQ application (to request access to dataset) / Approve
NSW Health /  /  / Request to include MQ /MUH as a site in multi-site research project already approved by NSW Health / NSW Health NEAF and MQ Expedited Approval Form for MUH/MQ. / HREC Expedited Review / Approve
Research at MUH/MQ /  /  / Request to conduct research at MQ/MUH or including MUH/MQ / Submit full application to HREC for review / MQ HREC review / Approve

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