We asked a colleage, Hannah Rosebrock, to write a blog for us, thank you Hannah.
In Greek mythology, Cerberus guards the gate of the underworld to prevent the dead from leaving. In social and clinical science, this role is fulfilled by ethics committees who stand as guardian between researchers and participants and prevent the latter to be exploited by the former for the sake of science. The role of the Cerberus is a necessary one – although not very flattering, Cerberus is depicted as a three-headed beast. In the context of ethics committees, its three heads are called bureaucracy, officialdom and inefficiency.
According to the National Health and Medical Research Council (NHMRC) there are more than 200 HRECs operating in organisations and institutions throughout Australia (find a list of human Research Ethics Committees registered with NHMRC here). Although all HRECs base their decisions on the same principles deprived from the same National Statement on Ethical Conduct in Human Research, every HREC has its own application procedures, forms and processes. Further, gaining approval from one ethics committee is no vouch for approval from another ethics committee.
This lack of standardisation specifically affects multi-site projects which led to the founding of the National Mutual Acceptance Scheme (NMA) in 2013. Under the NMA scheme, multi-site research projects do not have to gain ethics approval from every site the project is conducted at but only once, from a NMA certified HREC. As of August 2017 the scope of the NMA scheme covers all human research conducted at a public health organisation in Queensland, New South Wales, the Australian Capital Territory, Victoria, South Australia, and – the latest addition to the scheme – Western Australia. Note: Northern Territory, Tasmania, and private health organisations are not included in the NMA scheme. Still, you might be tempted to think, that the NMA scheme has de-bureaucratised the ethics application process, and to some extent, this is true. There is certainly less duplication (if you don’t count private health organisations, Northern Territory and Tasmania). However, researchers are still fighting with a lack of standardisation, as every state has multiple NMA certified HRECs and application procedures vary between and within states. This multitude in ethics committees, applications processes and forms, seems unnecessarily confusing, given that they are all assessed and certified by the same body (the NHMRC) for their compliance with the same criteria based on the same National Statement of Responsible Conduct in Human Research.
Independent of the HREC approval, researchers have to seek approval from the relevant Research Governance office (RGO) for each site the project is conducted at. There is no such thing as a mutual acceptance scheme for research governance approval, every site has its own assessing criteria for determining the site’s suitability for conducting a given research project. This adds to the generally labour-some and tedious process of gaining ethics approval. In terms, this uses resources, and most commonly tax payer funded resources. In one Australian study, the cost of obtaining ethics and relevant approvals was $348,000 or 38% of study budget.
Applications for HREC approval are often no less than 63 pages; applications for Research Governance approval encompass about 23 pages – exclusive the extensive supporting documentation required, which can be up to another 150+ pages. Applications to both, HREC and RGO’s vary, with some still requiring submission in hardcopy by snail-mail, (additionally to email, USB and online forms) and will only be assessed, once received in hardcopy. This method is unnecessarily prone to error. To simplify, you must take steps away, rather than adding additional steps. The entire process is so focussed on detail that researchers, as well as assessing HREC and RGO officials can’t see the wood for the trees anymore. So much information is requested that even low-risk research projects that involve none to minimal involvement with participants, and thus hardly justify the use of the term ‘participants’, seem to turn into a second Stanford prison experiment throughout the process.