- Suat Chin Ng. MBBS, BMedSc, FRACS. Department of Surgery, Eastern Health, Melbourne, Australia.
- Wei Ming Ong MBBS Department of Surgery, Eastern Health, Melbourne, Australia.
- Shane Belvedere MBBS Department of Surgery, Melbourne Health, Melbourne, Australia
- Creski Gilong. MBBS Department of Surgery, Austin Health, Melbourne, Australia.
- Dr Nikolajs Zeps. BSc, PhD Research and Development, Epworth HealthCare, Melbourne, Australia. Eastern Clinical School, Monash University, Melbourne, Australia
- Philip Smart MBBS, D.Med.Sci, FRACS. Gastrointestinal Clinical Institute, Epworth HealthCare, Australia Department of Surgery, Austin Health, Melbourne, Australia.
Compliance with ethical standards is fundamental to conducting human research. While there is a need for a thorough review process to prevent unethical research, the administrative workload required can often be significant. Indeed, researchers largely regard the ethics process as an obstacle that needs to be overcome, rather than a key part of the research process itself. In a recent blog on the AHRECS website entitled “Research Ethics Review as a Box-Ticking Exercise”, A/prof Angela Romano identified a significant problem with our current approach to ethical review as being one that promotes a compliance mentality rather than one that actively encourages appropriate and useful ethical reflection throughout the lifecycle of a research project.
Health and Medical Research is aimed at providing new knowledge to improve the health and wellbeing of the community and the fruits of this work will hopefully translate into tangible benefits for everyone. Significant concerns have been expressed by others that the current processes employed to regulate this work in fulfilment of ethical and legal requirements can itself be unethical. For instance, in a recent Blog by Prof Julian Savulescu he comments that whilst no-one is suggesting that research should not be subject to appropriate regulation and ethical review, given the potential to unnecessarily delay important research, all review processes should be as efficient and proportionate to the risk as is possible. Whilst we cannot immediately fix the lamentable lack of investment in undergraduate and post-graduate training in and practical application of ethics, the processes for review of projects could, in our view, be vastly improved with some fairly low-cost interventions.
What are researchers supposed to do to obtain ethical approval?
We reviewed the webpages of 78 Human Research Ethics Committees (HREC) associated with both public and private health services that we identified from the NHMRC list of registered HRECs. This list is only current to 1st March 2018 and we noted that several of the listed HRECs have in fact closed leaving just 71 that could be assessed. We also excluded from our review websites of small clinics which appear to serve only their own needs, eg IVF clinics.
Our review aimed to assess the ease with which researchers could find the webpages of the HREC, or the office of research and/or governance responsible for research oversight, and the level of information provided in terms of 1) instructions relating to how to make a submission itself, and 2) instructions about ethical considerations that may assist researchers to make a sound submission along the lines of A/Prof Romano’s wishes. We scored these objectively using a binary score of 1 if they had a readily accessible website and 0 if they did not. We scored the information related to the submission process in the same way, that is it was either present or not. We decided to include whether or not there was a clear process for considering low risk research in an expedited way consistent with the National Statement as this provided an insight into whether or not the institution regarded such research in a proportionate manner. We further checked on some of the linked documents and policies provided by the HREC, such as guidance on reporting of Serious Adverse Events (SAEs), to check for consistency and whether they were up to date with current guidelines.
We were surprised to find that 8 of 71 hospital based HRECs did not have a website that we could find. In some instances, the information about the HREC was provided via a central state-based portal where elements of the submission process and key local contact details were provided for each of the HRECs. We checked all of the links present in these websites and found that many were broken and in over half of all cases the links to the relevant policies, procedures, and key guidance documents were significantly out of date.
In contrast, we did find several websites that provided excellent resources such as those provided by the St Vincent’s HREC based in Melbourne and the Bellberry private HREC, which are exemplary in the level of useful information and easily accessible guidance they provide to researchers. We observed that of all of the HREC websites reviewed, 30 of the top 37 HRECs which all had accessible websites with useful information about submission were certified HRECs. Only 6 of the bottom 31, with what we considered to be inadequate levels of guidance information, were certified. This raises an interesting question as to whether the need to become certified led them to invest significantly in all aspects of the administrative process, including the development of useful websites.
Table 1: Key findings overall
|Criteria||No of HRECs scoring 1 (total 71)|
|Easily accessible information about key functions||62 (87%)|
|Clear instructions about submission process||62 (87%)|
|Additional information to guide applicants about ensuring their project met ethical requirements||27 (38%)|
|Clear and proportionate pathway for low risk research||43 (61%)|
|Up to date policies and guidance documents||31 (44%)|
Our findings suggest that many health services that run HRECs could significantly improve the researcher experience by simply upgrading their websites to guide researchers more clearly about what is expected of them. As Angela Romano highlighted, the process should not be a box checking exercise and we suggest that if there was clear guidance about what was substantive ethical considerations that needed to be met rather than simply how to fill in the relevant forms we might achieve this, or at least take a step in the right direction.
Whilst we cannot provide any analytical evidence of a correlation it would not be surprising if the improved guidance provided by some HRECs meant that the time to approval was shorter due to a reduction in non-compliant submissions and perhaps even the quality of submission in terms of covering the substantive ethical concerns likely to arise. It is fair to argue that researchers themselves should take the time and effort to ensure that they find out what is expected of them but we suggest that it would be a highly cost efficient exercise to start by making the websites themselves more useful and geared toward this end.
Australia is committed to fostering health and medical research to improve the lives of patients as demonstrated by the State, Federal and charitable sector financial commitments that run to several billion dollars. Enhancing and harmonising website content would seem one way in which a small amount of effort would go a very long way to boosting our capability of doing ethically sound research.
National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.
Romano, A. (22 June 2019) Research Ethics Review as a Box-Ticking Exercise Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-review-as-a-box-ticking-exercise
This post may be cited as:
Ng, S. C., Ong, W. M., Belvedere. S., Gilong, C., Zeps, N. & Smart, P. (4 February 2020) A users perspective on the ethics application process in Australia-Room for improvement. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-users-perspective-on-the-ethics-application-process-in-australia-room-for-improvement