Monitoring research is too important to be optional and too resource intensive to be manual

Dr Gary Allen, Senior consultant AHRECS | Profile | ga********@****cs.com

The National Statement specifies researchers submitting self-completed ethical conduct reports as the minimum acceptable institutional monitoring of approved human research projects (NS 5.5.5).  This reflects the importance of institutions monitoring the research conducted under its auspices and highlights the ethical responsibilities of researchers, and the host institution, continue beyond the research ethics review of a project.

[colored_box]Researchers providing annual self-reporting really isn’t an onerous requirement.  Except it seems it is.

Since 2008, AHRECS has been formally conducting consultancy work with research institutions.  This often includes a desktop audit of the institution’s human research ethics arrangements and then a blueprint for constructive change.  Pretty much in every case, Australian research institutions are struggling with the following challenges:

• Many researchers are recalcitrant in their annual reporting.
• The process of reminding researchers to provide an annual report and chasing overdue reports is time-consuming.
• Providing reports to the HREC wastes precious meeting time, wastes paper and often doesn’t produce anything substantive.
• The associated data entry, note taking and printing are significant burdens on an already stretched committee secretary and administrative support.

Such observations echo what we have seen in our practice over the decades.

To summarise the recommendations we have made in those blueprints^{1 2}:

1. The institution’s research management system (ethics module) should at a simple click send reminders to researchers via email.
2. Researchers should complete and submit their ethical conduct reports online with some fields automatically completed for them and validation on their response to some questions (e.g. minimum word count).
3. Report should be considered proportionate to certain criteria administratively, executively, by a panel of the HREC, and only a small proportion of reports considered at a committee meeting.
4. The phrasing of the automated reminders should be based upon escalating terseness depending on whether the email is the initial reminder, a 30 days overdue notice, 60 days overdue or 90 days overdue that might be considered a breach of the institution’s human research ethics arrangements (]and so a breach of the Australian Code (2018).
5. Online reporting to the heads of department listing researchers who have ethical conduct reports due, overdue, late or very late.
6. The institution’s research management system (ethics module) should produce automated committee papers
7. One of the labour savings of this approach is that it is the researchers who do the data entry(rather than it being rekeyed by the research office).This burden on researchers is offset by the convenience of the online system.

In an earlier post Prof. Colin Thomson AM discusses some areas of reported HREC activity that illustrate that some institutions are failing to adhere to the requirements of the National Statement– which are arguably perhaps too lenient.l

¹Our blueprints include more detailed text about ethical conduct reports including the conduct of proportional reviews and criteria for the different pathways.

² Included here is an image that summarises this approach. Inside the subscribers’ area is a version that isn’t watermarked.

In the subscribers’ area is a rough outline for an ethical conduct report.  Clients who engage AHRECS to produce blueprint are provided the full ethical conduct report (including help text) and AHRECS can liaise with your system administrators on its deployment.  Send an email to bl*******@****cs.com to discuss further.

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References

Thomson C. (2017, 22 March 2018) “More what you’d call guidelines”. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/more-what-youd-call-guidelines

National Health and Medical Research Council (NHMRC) 2007 updated 2018, National Statement on Ethical Conduct in Human Research.Available at: https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

National Health and Medical Research Council (NHMRC) 2018, Australian Code for the Responsible Conduct of Research.Available at: https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

This post may be cited as:
Allen, G. (21  May 2019) Monitoring research is too important to be optional and too resource intensive to be manual. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/monitoring-research-is-too-important-to-be-optional-and-too-resource-intensive-to-be-manual