Skip to content

ACN - 101321555 | ABN - 39101321555

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

AHRECS icon
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Menu
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Exclude terms...
Aboriginal and Torres Strait Islander
AHRECS
Analysis
Animal ethics
Animal Ethics Committee
Animal handling
Animal housing
Animal Research Ethics
Animal Welfare
ANZCCART
Artificial Intelligence
Arts
Australia
Authorship
Belief
Beneficence
Big data
Big data
Biobank
Bioethics
Biomedical
Biospecimens
Breaches
Cartoon/Funny
Case studies
Clinical trial
Collaborative research
Conflicts of interest
Consent
Controversy/Scandal
Controversy/Scandal
Creative
Culture
Data management
Database
Dual-use
Essential Reading
Ethical review
Ethnography
Euthanasia
Evaluative practice/quality assurance
Even though i
First People
Fraud
Gender
Genetics
Get off Gary Play man of the dog
Good practice
Guidance
Honesty
HREC
Human research ethics
Humanities
Institutional responsibilities
International
Journal
Justice
Links
Media
Medical research
Merit and integrity
Methodology
Monitoring
New Zealand
News
Online research
Peer review
Performance
Primary materials
Principles
Privacy
Protection for participants
Psychology
Publication ethics
Questionable Publishers
Research ethics committees
Research integrity
Research Misconduct
Research results
Researcher responsibilities
Resources
Respect for persons
Sample paperwork
sd
se
Serious Adverse Event
Social Science
SoTL
Standards
Supervision
Training
Vulnerability
x
Young people
Exclude news

Sort by

Animal Ethics Biosafety Human Research Ethics Research Integrity

Research Ethics Monthly | ISSN 2206-2483

A poor call and two missed opportunities, but otherwise not a bad proposed revision to NS s5

Posted by Dr Gary Allen
in Human Research Ethics
on October 20, 2020
0 Comments
Keywords Australia,Beneficence,Ethical review,Good practice,HREC,Methodology,Participant protection,Research Ethics Committees,Researcher responsibilities,Resourcing practice,Respect for persons
Wordcloud around the concept of 'BEST PRACTICE'

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.

Related reading

A checklist to assist a supervisor to check a candidate’s research ethics review application

A users perspective on the ethics application process in Australia-room for improvement

A preliminary geneaology of research ethics review and Māori

“Reminder about service options and an easy way to pay AHRECS,” we say… aware of how corporate sleazy that sounds

A call for a national inquiry into the burden of research ethics and governance

“More what you’d call guidelines”

Leave a Comment Cancel Reply

Your email address will not be published. Required fields are marked *

About the Corresponding Author

Admin

Sp-user Link
Facebook-f Twitter Linkedin-in Sp-mail User

About the blog

The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more…

Comment rules

We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more…

Related Links

Complaints against Research Ethics Monthly

Request a Takedown

Submission Guidelines

About the Research Ethics Monthly

About subscribing to the Research Ethics Monthly

A smiling group of multi-racial researchers

Random selected image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM.

Research Ethics Monthly Receive copies of the Research Ethics Monthly directly
by email. We will never spam you.

  • Enter the answer as a word
  • Hidden
    This field is hidden and only used for import to Mailchimp
  • This field is for validation purposes and should be left unchanged.
  • Home
  • Services
  • About Us
  • Contact Us
  • Home
  • Services
  • About Us
  • Contact Us
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Site Map
  • Site Map

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Facebook-f Twitter Linkedin-in