Negligible risk research is when there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Examples of inconvenience may include filling in a form, participating in a street survey, or giving up time to participate in research.
Low risk research is when the only foreseeable risk is one of discomfort. Examples of discomforts include minor side-effects of medication, the discomfort of measuring blood pressure or the anxiety induced by an interview.
Types of research that CANNOT be granted an expedited low or negligible risk review and require a full Human Research Ethics Committee (HREC) review are the following:
- a) All research that involves more than low risk; or
- b) Research falling under the following chapters of the National Statement:
- Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials and innovations;
- Chapter 3.5: Human genetics
- Chapter3.6: Human stem cells
- Chapter 4.1: Women who are pregnant and the human foetus
- Chapter 4.4: People highly dependent on medical care who may be unable to give consent
- Chapter 4.5: People with a cognitive impairment, an intellectual disability or mental illness
- Chapter 4.6: People who may be involved in illegal activities (except for those projects that only involve the collection of non-identifiable data and involve negligible risk)
- Chapter 4.7: Aboriginal and Torres Strait Islander Peoples
- Chapter 4.8: People in other countries (except where the risk to participants is low/negligible risk and/or the project does not involve participants who could be considered a vulnerable group in the context of the project)
The National Statement on Ethical Conduct in Human Research (updated 2018) (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 two individuals are classified as a case series and require ethics review.
To make changes to an approved study, (e.g. addition of a site, changes to the protocol, PICF or study personnel) all that is required is an outline of the changes and their justification in a cover letter from the Principal Investigator to the Chairperson of the relevant HREC. Changes require both HREC approval and local site approval before implementing the amendment/s. The letter should be accompanied by the updated documents in two forms: one with tracked changes and one clean copy.
The relevant documents should be submitted to the HREC and uploaded through the Online Forms website. The Chair will review the amendments and make a decision outside of the HREC meeting or refer the amendment to the next scheduled HREC meeting for review. Once approval of the changes is received by the HREC, the amendment documents and HREC approval can be forwarded to firstname.lastname@example.org for local site approval, after which they can be implemented.
If the amendment involves the addition of a site, then a new Site Specific Assessment will need to be submitted.
HREC decisions, or requests for additional information prior to an HREC decision, will be made in writing to the Principal Investigator with reference to the National Statement on Ethical Conduct in Human Research. If you disagree with the HREC ruling or have concerns about the ethical review process, it is recommended that you discuss your concerns with the HREC Chairperson or Coordinator in the first instance to ensure both parties are aware of the basis for the decision and the concerns raised.
Alternatively, and in all cases where the issue cannot be resolved via discussion, you should put your concerns, including the basis for these concerns, in writing to the Chairperson of the HREC to enable a formal review and response to occur.
Each HREC has a resolution process and the appropriate delegate should be notified of matters not adequately addressed by this process.
Yes, all research projects need a study budget completed as part of the site specific assessment (SSA) submission. In-kind contributions should be quantified in order for the health service to calculate the actual cost of research. For example, if you anticipate spending 20 hours on a research project during work hours as a Principal Investigator and Mackay Hospital and Health Service employee, you need to quantify the in-kind contribution (e.g. 20 hours x hourly salary) for the SSA study budget.
Business managers can assist with determining salary costs or with other queries relating to study budgets. Please discuss your research budget with the relevant departmental business manager or operations director.
All research projects that involve parties outside of MHHS require an agreement to cover matters such as confidentiality, intellectual property, ownership of data, insurance and indemnity. A suite of pre-agreed contracts for various projects, including non-commercial research agreements for higher degree students or university staff undertaking research involving resources from within MHHS are available; contact the MIRI Research Governance Officer early in the planning stage for advice and assistance. For sponsored studies, standard clinical trial research agreements are available at the Medicines Australia website.
All non-standard research agreements require review by MHHS legal services; queries should be directed via the MIRI Research Governance Officer.
Intellectual Property consists of legal rights arising from the outcomes of intellectual and creative activity such as written papers, new inventions, some databases and new methods of treatment. Some Intellectual Property rights are automatic and some require confidential registration.
Advice should be sought from MHHS legal services (contactable via the Research Governance Officer) in relation to the protection of any such outcomes, particularly where there is a proposed or expected future use of those outcomes. Intellectual Property will also be relevant in collaboration agreements between MIRI and other parties where it is proposed to distribute or deal with the outcomes of collaborative activity. As a statutory body, Mackay Hospital and Health Service is expected to give due consideration to the outcomes of intellectual and creative activity and to use its best efforts to ensure the future use of such materials in the public health system in Queensland.
Consideration should be given to Intellectual Property issues when any existing materials, inventions or confidential information is intended to be supplied by MIRI to another party in the course of collaboration. Such “Background IP” must be checked for provenance to ensure that MIRI has title to grant a license in such material. In this regard, please note that Intellectual Property created by MIRI, vests in the Department of Health and not MIRI.
An indemnity consists of one party holding another party harmless for future or potential loss, damage, expense, cost or liability of another party. Indemnity can be a complex area of law and involve significant financial implications.
Employee indemnity arrangements
Employees of MHHS are generally covered by section 27C of the in relation to acts and omissions made in the course of their employment. There are also indemnity and insurance arrangements that may apply to employees in specific instances, including Queensland Government Indemnity Guideline and . Generally, coverage of employees will require that the research activity is approved by MIRI, such as through the site authorisation process. For research involving parties external to MIRI, specific advice may need to be sought from Mackay HHS legal services (contactable via the Research Governance Officer).
Under the , MIRI is limited from giving indemnities without undertaking certain steps which may include obtaining approval from the Queensland Treasury. As a general rule, MIRI seeks to remove all indemnities from research collaborations. Certain template agreements already include indemnities, such as the Medicines Australia Clinical Trial Research Agreement, and processes have been put in place to comply with legislative requirements. The Research Governance Officer is the initial contact point for queries in regard to indemnity considerations with research agreements.