Research governance refers to the processes used by institutions to ensure that they are accountable for the research conducted under their auspices. To be properly governed, research must be conducted according to established ethical principles, guidelines for responsible research conduct, relevant legislation and regulations and institutional policy. Research governance is also about credentialing and training of researchers and managing institutional risk.
Elements of research governance include:
- ethical approval
- compliance with legislation, regulations, guidelines and codes of practice
- legal matters, including contracts, and indemnity/insurance frameworks
- financial management, risk management and site-specific assessment
- institutional policies and procedures for responsible research conduct and managing research misconduct
- management of collaborative research
- reporting requirements.
Public health organisations are required to undertake a site-specific assessment (SSA) of each research project, thereby allowing the organisation to consider whether the project is suitable for the site, including whether it has the capacity to conduct the research at that site. This SSA involves consideration of such matters as physical resources, staff, insurance and indemnity requirements and other matters.
The SSA and HREC ethical and scientific review may occur in parallel, however the decision to authorise or not authorise the commencement of a research project is only made by the public health organisation when the responsible HREC has granted approval and the SSA has been satisfactorily completed.
All SSA applications must be made on the SSA form for that state or territory and submitted to the relevant officer within each public health organisation.
Clinical trial agreements
For medicines and devices research: Whether you are a researcher involved in a collaborative clinical trial project, a researcher involved in a commercially sponsored trial, or a contract research organisation, you will need to develop an agreement between the parties involved in the research. You may also need to arrange for indemnity for your research institution, ethics committee or research premises. Standard templates for clinical trial agreements and indemnities have been developed and should be used wherever possible in order to minimise the need for legal review. For medicines research, the templates for contracts and indemnities are maintained by Medicines Australia. For medical device research, the templates for contracts and indemnities are maintained by Medical Technology Association of Australia.
Insurance and Indemnity
Reaching agreement on insurance and indemnity arrangements is a key step in the clinical trial approval pathway. Understanding the way insurance and indemnity policies operate in relation to your research is critical to the feasibility of your clinical trial, and rules vary between institutions and jurisdictions. In 2014, NHMRC commissioned a review of insurance and indemnity arrangements in Australia. This can be viewed on the NHMRC website. Based on this review a document answering Frequently Asked Questions (FAQs) has been developed to assist you understand how insurance and indemnity arrangements may affect your clinical trials.