Gary Allen, Mark Israel and Kim Gifkins
Senior Consultants, AHRECS
In recent years in Australia, we have seen some painful cases where research ethics review delegated to a non-HREC review body has failed to guard against projects that proved to be embarrassing for their host institution (see, for example, the ‘Racist bus driver’ and ‘Laughing at the disabled’ projects).
For some institutions, it might be time to centralise governance, and democratise knowledge and ownership. It might also be time to change distributed practices that might have been in place for decades.
Delegated non-HREC review done well can be just as nuanced, probing and rigorous as HREC review. It can bring in external perspectives and manage institutional risks effectively. Such reviews can be far more rigorous than the processes that those who resist delegation might fear – e.g. cursory nods to senior colleagues and bewildering ‘captain’s calls’. There is perhaps an argument in the biosciences that we need to evaluate and closely monitor how well a risk has been mitigated. On the other hand, in many of the social sciences, there are risks that can be largely removed. For example, consider a research project investigating the relationship between team leaders and staff. If the comments of a team member became known to their supervisor, this could expose them to serious risk (e.g. employment, social, legal or financial risk). This risk could be minimised by masking the identity of speakers. Another useful strategy would be to conceal who was approached about participating and then who agreed to participate. A thoughtful research design that recognises the potential risk and employs strategies such as those mentioned above would reduce the risk to a minimal level. We argue that it is this residual level of risk that should be used to determine the process for review. Of course, this argument is much stronger when an institution has good guidance material with regard to reflective approaches to risks.
Consequently, the provision in the draft update of Section 5 of the National Statement (5.1.11) that hypothetical moderate or high risks trigger HREC review, even if a project design would reduce that risk to a minimal level could unhelpfully see a large proportion of minimal risk projects being sent for HREC review… we think unnecessarily. It also poses the rather obtuse question of when is a moderate risk identified and mitigated – and when is it minimal. The well-known thought experiment asks the question:
If a tree falls in the forest, and there’s no-one around to hear it, does it make a sound?
In the example above, if the identity of a speaker were never known to others, was it ever a moderate risk? In practice, do we really care whether a falling tree makes a sound?
Chapter 2.1 of the National Statement refers to the role of participant groups in assessing and gauging risk. We would also argue that projects that include consumers and community members as co-researchers and/or a local reference group could do as well as a HREC in identifying risks and evaluating how well the risks have been mitigated. Which takes us to our next disappointment: Consumer/community involvement.
Section 5 could be a great place to discuss the involvement of consumer and community members in the conception, design, conduct and reporting the result of research projects. This is especially important given the revision to the Australian Code for the Responsible Conduct of Research, which dropped what was already cursory language in the previous edition of the Australian Code.[1] Is Section 5 the right place for such a discussion? On its own, possibly not. We recommend the participation of consumer and community members should be first discussed in the introduction and then be revisited across Sections 1, 2, 3, 4 and 5 of the National Statement.
There is much to like in the rest of Draft Section 5. For example, the discussion about research that may be eligible for exemption from review (5.15-18) is both easier to understand and more straightforward for institutions to implement. We also welcome to shift in language from ethical review to ethics review (compare the Preamble of the National Statement with the Draft Section 5) on the basis that the language of ‘ethical review’ prejudges the ethical nature of a review process and threatens to delegitimise critique of the actions of reviewers. For those who find such a view pedantic, we would point to debates about the shift in language from research subject to research participant.
We suggest the drafters of the revised Section 5 took the wrong lesson from the painful blunders by a small number of reviews that occurred outside of HRECs. We do not need to limit the situations where a non-HREC level of review can occur, though we do need to improve the rigour and robustness of those reviews.
If you agree or disagree with us or have views about the proposed revisions to Sections 4 and 5, please make a submission to the review (by 30 October 2020).
This post may be cited as:
Allen, G., Israel, M. & Gifkins, K. (20 October 2020) A poor call and two missed opportunities, but otherwise not a bad proposed revision to NS s5 Research Ethics Monthly. Retrieved from: https://ahrecs.com/a-poor-call-and-two-missed-opportunities-but-otherwise-not-a-bad-proposed-revision-to-ns-s5/
[1] See the article by Gary Allen and Carolyn Ehrlich on this topic. Israel, Hersh and Shiggins will be returning to the ethics of Patient and Public Involvement (PPI) in health research in a future article for Research Ethics Monthly.
