To us, acting ethically does not just mean doing “the right thing”, but acting in the right spirit out of an abiding respect and concern for others. SSRI is intent on protecting all those who participate in research because we truly appreciate that this is essentially an act of altruism.
Ethical Review of Research Projects
Almost any research activity that involves human participation (including completing a questionnaire, being interviewed or providing human tissue etc.) is considered “human research”.
All human research must conform to the National Statement on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research (2007). For research conducted in New South Wales, there is also the NSW Supplement to the National Statement (2008) provides further guidance for investigators with regards lawful and ethical conduct of research.
Every human research project undertaken by Sydney Shoulder Research Institute is reviewed by a Human Research Ethics Committee (HREC). An HREC will review a research proposal that involves human participants to ensure it is ethically acceptable and in accordance with relevant guidelines and standards.
An HREC is usually established by public, not-for-profit or private organisations that conduct research involving humans. Universities and hospitals are the most common of these organisations. As SSRI is a small organisation and we conduct our studies at various hospitals within the lower north shore region of Sydney we typically utilise the services of the relevant local HREC.
Generally speaking, an HREC should consist of no less than eight members and must include members of the general community in addition to those with expertise in specific areas. Some organisations seek expressions of interest from people wishing to become members of an HREC by advertising in newspapers or on their website.
Depending on where the research will take place, a project will be reviewed by one or a combination of the following:
For a research project to be deemed ethical and granted approval to be undertaken, an HREC must be satisfied that all aspects of the research comply with the standards and guidelines and bear no significant risk to any participant.
For further information regarding how research is conducted at the various institutions just click on the HREC name above to be taken to the relevant web pages.
Governance Review of Research Projects
Once ethical approval of a project has been granted, governance review must also be undertaken at each site the project will be undertaken before research can officially commence. This is also known as Site Specific Assessment and has a different purpose to, and is therefore separate from, ethical review. By whichever name it is known, it includes determination of:
compliance of the proposed project with all relevant legislation, regulations, guidelines and codes of practice (including Privacy Laws);
access to all required resources and expertise (such as facilities, equipment and appropriately qualified research personnel;
adherence to site-specific policies (such as sign-offs from appropriate Heads of Department);
adherence to other administrative and legal requirements (such as evidence of adequate insurance, indemnity, budget and relevant contracts).
Applications for Ethical and Governance review of SSRI projects are generally made concurrently and submitted anywhere from 3 to 9 months prior to commencement of a project. The reasons, like research itself, vary from project to project and wherever possible we try to accommodate the research ideas of our visiting surgeons (Fellows). These Fellows are often limited in the amount of time they are able to spend with us (typically 12 months) so wherever possible we collaborate with them to set up their project ahead of time so that upon arrival they can commence research straight away.
For further information regarding Human Research Ethics Committees, you can visit the Australian Government’s National Health and Medical Research Council website. The NHMRC is Australia’s leading expert body in providing information and support (including funding) for medical research.
Good Clinical Practice
As well as adhering to all the standards and guidelines outlined above, SSRI also designs each of their studies to meet the requirements of Good Clinical Practice (GCP). The principles of GCP have their origin in the World Medical Association’s Declaration of Helsinki which came about in response to the revelations of the Nuremberg trials following World War II. The proponents of the Declaration sought to ensure that any future human research participant would have their rights, safety and well-being placed above all other research considerations.
Good Clinical Practice guidelines detail requirements for trial documentation, protocol amendments, indemnity, reporting of adverse events and provision of medical care for trial participants.