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Smarter proportional research ethics review0

 

Rushing toward a faster review decision should not mean relaxing standards or playing chicken with stricter central control

Gary Allen, Mark Israel and Colin Thomson

Too often, there is a danger that ‘expedited ethical review’ (a term not used in the National Statement since 1999) might equate to an approach that abridges the review process to the point where it’s little more than a friendly exchange between peers or a nod to seniority. We won’t call out the well-reported cases where it is hard to fathom how they were granted ethics approval. Such cases should make us uncomfortable, because they are invitations to replace institutional self-regulation with something hasher and unsympathetic.

Don’t get us wrong, we’ve spoken often and enthusiastically about the value of well-designed proportional review arrangements. We have assisted many clients, large and small, to design and implement such arrangements and believe that they form part of a well-conceived review system.

A proportional review arrangement can deliver a review outcome much faster than consideration by a human research ethics committee, but instead of a ‘Claytons’ or mock-review, it should have the following features:

  1. While there can, and should, be a mechanism to do an automated quick self-assessment of whether a proposed project qualifies for ethics review other than by a research ethics committee, the process should:
    1. not rely on questions along the lines of “Is this a low risk research project?”
    2. draw on, reference and link to guidance material.
    3. when using trigger questions, ensure they are nuanced, with probing sub-questions.
    4. include confirmation of a quick assessment by an experienced ethics officer or chairperson.
    5. retain an applicant’s responses, both as a record of what they said about the project, and for future evaluation of whether the arrangement is correctly assessing new projects and guiding applications along the correct review pathway.
  2. The process should preferably be online, easily (re)configurable, easily auditable, with information entered by applicants and ‘triaged’ by an ethics officer.
  3. A quality online system will populate committee papers and reports, will issue reminders and will populate with known information.
  4. While many projects may be reviewed outside of the human research ethics committee, the reviews should be conducted by experienced persons, who participate in annual professional development and who can draw upon internal and external policy and resource material.

In Australia, an institution’s proportional review arrangements might include the following pathways:

  1. Prior review– Research that has already been reviewed by another HREC, appropriately delegated review body, or an international body equivalent to an Australian research ethics review body.
  2. Scope checker– A test to confirm whether a proposed project is in fact human research.
  3. Exemption test– A test to determine whether the proposed research is a type an institution could exempt from ethics review as per the National Statement.
  4. HREC review required test– A test to confirm whether the research project is of a type the National Statement specifies must be reviewed by a HREC.
  5. Institutional exemption test– Many institutionsexempt some categories of human research from research ethics review (e.g. universities often exempt course evaluations and practical activities for a teaching-learning purpose).
  6. Negligible risk research– Subject to qualifying criteria an institution might establish a negligible risk review pathway in which applications are considered administratively.
  7. Low-risk, and minimal ethical issue research– Subject to qualifying criteria, proposed projects that are low risk and have minimal ethical sensitivity could be reviewed by the chair of the research ethics committee.
  8. Low-risk, some ethical issue research– Again subject to qualifying criteria, proposed projects that are low risk but have some ethical sensitivity could be reviewed by a small panel of the research ethics committee (including external member of the committee).
  9. HREC review – Only human research (see 2), that has not previously been reviewed (see 1) that is not exempt (see 3 and 4) and has not been classified as negligible risk (see 6) or low risk (see 7 and 8) needs to be reviewed by HREC.

An arrangement with the features listed above would allow for review that is proportional, timely, efficient and justifiable. Reviews that are merely expedited or fast places us all at risk. The increasing examples of “how could that have been approved?” makes it feel as though some institutions are gambling that a desire to meet researchers’ calls for quick, if superficial, review won’t be exposed by unethical practice. Perhaps they are correct, but every new reported review misstep makes us more nervous. Realistically, establishing a nationally administered reliable, robust and agile proportional review process requires substantial investment of time and other resources so is unlikely to happen.  But, what poor review processes could do is invite far more detailed direction on how institutions can design, conduct and monitor processes outside of a HREC. In our experience, there are greater and longer-lasting benefits that can accrue from an institution having a high quality approach to proportional review.

The above is a summary of the discussion we typically include in blueprint documents about establishing a robust proportional review arrangement. We have included some further notes on this topic on our https://www.ahrecs.vip and Patreon pages.

Please contact us at proportional@ahrecs.com if you would like to discuss how we might assist your institution.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (26 August 2019) Smarter proportional research ethics review.  Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/smarter-proportional-research-ethics-review

Update on the new subscribers’ area0

 

We are currently expecting the new service to go live prior to us sending the July 2019 edition of the Research Ethics Monthly.

It is being built by some talented designers and coders we are excited to be working with.

The service will be located at AHRECS.vip, will be far more easily browsed and used, with an annual subscription of $360 (Plus GST and a 2% charge if you pay by credit card).

We will have more about this new service in the next edition.  Email VIP@ahrecs.com if you have any questions.

“Reminder about service options and an easy way to pay AHRECS,” we say… aware of how corporate sleazy that sounds0

 

Dr Gary Allen, Senior Consultants AHRECS
Prof. Mark Israel
Prof. Colin Thomson AM
  
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Just in time for the end of the financial year (though we know many research institutions budget around calendar year), AHRECS has the capacity to receive payments by credit card. We thought this a good time to remind you of those of our services that lend themselves nicely to credit card payment.

In-meeting 30-minute professional development for HREC members ($900) – Workshops/briefings/guided discussion about your selected topic.  An easy way to tick the HREC member training box with minimum interruption to the work of a busy committee.  An experienced AHRECS team member will provide a PowerPoint with pre-recorded audio that could be played in a meeting (and retained for five years for viewing by absent and new members); the team member will ‘phone or Zoom into the meeting for Q&A/discussion. If so AHRECS can also record that component for your later use.

Access the new subscription area ($360) – Thank you to everyone who expressed interest and support for the new in-house subscribers’ area.  This is scheduled to go live in July/August.  By subscribing, you will get access to an impressive (and growing) set of HRE and RI resources that are Creative Commons so you can use them within your organisations as much as you want.

Bespoke webinar for your research community ($1500) – A one-hour webinar on a human research ethics or research integrity topic of your choice, tailored to your institution. The price allows for up to 200 attendees and provision of a recording for your later use.

3-hour orientation workshop for new RIAs ($2300) – Provide your new Research Integrity Advisers with a practical, topical and engaging orientation through this four-hour workshop.

Ten hours of on-call advice ($3400) – On-call advice can be used for both human research ethics and research integrity advice.  We can offer advice on everything from review feedback on a difficult application to commenting on a draft policy and providing advice on a tricky question with which the committee has been struggling.  In the research integrity space, we can suggest an appropriate investigation approach for an alleged breach, comment on a RI resource, or suggest references on a key topic.  The purchased time can be used in 15min, 30min, 1h, 4h and 8h blocks

Send an email to gary.allen@ahrecs.comif you have any questions.

The prices above exclude GST and a 2% credit card processing fee

Monitoring research is too important to be optional and too resource intensive to be manual0

 

Dr Gary Allen, Senior consultant AHRECS | Profile | gary.allen@ahrecs.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.

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Send an email to blueprint@ahrecs.com if you would like to discuss AHRECS conducting a Desktop Audit of your institution’s human research ethics and producing a blueprint for constructive change

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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.

This image (without the watermark) can be download by our USD3/month subscribers – https://www.patreon.com/posts/27006486

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

To summarise the recommendations we have made in those blueprints1 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 blueprint@ahrecs.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

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