the Spanish Inquisition Human Research Ethics audit
Dr Gary Allen
When research with current ethics approval is periodically monitored, it is typically a passive process. Institutions, often via their research ethics administration, will ask researchers to self-report on the continued ethical acceptability of a project (and compliance with any conditions of approval). It would not be unreasonable to conclude that self-reporting is not the most effective way to identify if there have been problems with approved projects. Indeed, if things have gone wrong, it is at least possible that the most troublesome researchers might not be entirely honest about what has happened or why.
So, what is the alternative?
Conducting random audits of a small number of active projects can be a great way to obtain a snapshot of what is actually happening with approved research.
This need not be a statistically significant number of projects to be effective. The impact should be felt further than the projects actually being audited. The mere fact that researchers are on notice that they might be audited could have a positive impact of researchers realising that the committee will be interested in their project beyond the initial research ethics review. This can be achieved by placing a note in all research ethics forms that the project might be selected for audit. Those researchers who are audited may also tell their colleagues they were selected for random audit.
The audit process should be run in a way that it clear to researchers that they will have opportunities to provide feedback on their institution’s human research ethics arrangements. The annual report from the HREC to the institution should include a special section to provide feedback flowing from that year’s audits.
AHRECS suggests institutions establish a formula to determine which projects could be audited. For example:
- Project has an active ethics approval.
- Project has been running for at least for 12 months.
- Project still has at least six month to run.
- One project from each faculty/group/division/unit.
From each pool of projects chosen, at least one project should be randomly selected.
We have placed on https://www.ahrecs.vip and https://www.patreon.com/ahrecs an example of an audit operating procedure, in the next few weeks will post an audit report proforma. This is not intended to be a prescriptive template, just an example.
Here are some tips on how to make the most of research ethics audits:
- Audits should be conducted by a small panel of HREC members. This is an additional task and should be approached as such – for example, members who volunteer to participate in an audit should receive workload points or funds towards external professional development (perhaps even in human research ethics or research integrity).
- The HREC/research office should expect the institution to fund this kind of active monitoring.
- To make the audit 365 degrees, audited researchers should be invited to share reflections on the research ethics review process and the institution’s resources and guidance material.
- If the selected project is student research, both the student and the supervisory team should participate in the audit.
- If the institution has proportional or delegated review, a useful way to deploy the audit process might be to check the project was reviewed by the correct pathway and gave useful feedback. The intent here is not to re-run the review, but to assess if the review system is functioning properly.
- If a HREC is already concerned about a project and/or researcher, they might purposely select the relevant project for review.
- This mechanism might also be used to audit a batch of projects in response to a breach/complaint/serious adverse event.
- Redacted and aggregated results of the audit should be reported to academic governance
 Even a cursory review of the NHMRC’s reports suggests a significant proportion of institutions struggle to elicit an annual report from all researchers.
This post may be cited as:
Allen, G. (26 April) Nobody expects the
Spanish Inquisition Human Research Ethics audit. Research Ethics Monthly. Retrieved from: https://ahrecs.com/nobody-expects/