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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

“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

Requesting your input0

 

We’re preparing to work on a new version of the subscribers’ area, so we’d appreciate hearing your thoughts and ideas.

Some of you have told us you’d like to subscribe, but your institution’s accounting rules don’t allow for open ended online subscriptions.  Some subscribers have told us that it would be helpful if the listed items were better organised.

We agree, but the Patreon platform doesn’t provide the kind of flexibility to make these kinds of sensible changes.

So, we’re exploring the cost and logistics of creating a subscribers’ area we control. While we work out its details, the key changes will be:

  1. Institutions that wish to access the contents in the subscribers’ area will be sent a tax invoice for a 12-month subscription which would be paid by EFT or PayPal.
  2. The area will be structured in two sections (Human Research Ethics and Research Integrity) each with five subsections:
    1. Commentaries
    2. Professional development material
    3. Images
    4. Audio files
    5. Video files
  3. There will be tools to link to related items, profile items and search the library.

Subscribers to the existing Patreon service can move to the new service at the same level for the remainder of whatever time they have remaining, at no extra cost.

Because we suspect some users of the Patreon service may prefer to stay there, we plan to continue posting items to both Patreon and the new service.

Is the new service something you’d recommend your institution subscribe to?  Before we spend the money to build it, we’re hoping to hear at least 15 institutions are interested in-principle.  Please send an email to patron@ahrecs.com.

Reflections on chairing a human research ethics committee0

 

Prof Colin Thomson AM

Chairing an HREC can be complicated, demanding, stressful and tiring but also stimulating, rewarding, satisfying and hugely enjoyable. In this article, I reflect on my experience of being a chair of four HRECs in universities, public health organisations and public sector agencies. Of course I accept, from watching a number of other committees, the ways chairs guide committees to their decisions vary widely, express different personal experiences and can be affected by an institutional environment. As a result, these reflections are not intended to appear as a set of instructions for other chairs.

 

The invitation

So, where to begin? One point is at the invitation: am I equipped to take on this role and what do I need to know about the committee and the institution it advises? An HREC chair requires some exposure and familiarity with the ideas that are central to the ethics of human research and a sense of what reaching a decision in an ethics review requires. Ethics committees are unlike typical administrative committees in some significant aspects. The central difference is the nature of the subject matter and the decisions that need to be made: of their nature, they are less definitive than administrative decisions but share, with those, the need for adequate reasons and justification. In this tension between ethical judgement and adequate justification lies their challenge.

AHRECS offers a coaching service for Chairs (and for HRECs/RECs).  This involves observations of 3 committee meetings, meetings with specialist  consultants and a written report. Email coaching@ahrecs.com to find out more.

Other personal considerations include not only do I have the time but what is important to me in the role? For me, this has not been one consideration but a blend. The intellectual challenge of sound ethical analysis, appreciation of the creativity and skill of good research design and the refinement of inter-personal skills: all harnessed toward enabling ethically sound human research.

 

Decision-making

HREC decisions are rarely clear approvals or rejections but tend to be conditional: of the ‘not yet approved’ kind. Notification of those decisions should provide clear reasons and  practical advice: committees show respect for researchers by providing reasons for the outcome and advice about responding. At the same time, outcomes should fairly reflect the position that the committee has come to – and this can be difficult.

I have always found it challenging recapping and summarising fairly and accurately what different members of the committee have said and blending those into a reasonably clear outcome that the HREC can agree to at the meeting. Doing so is much easier after the meeting when settling the minutes and providing advice to applicants. But are such clarifications what the committee has agreed to or are they expressing a chair’s preference for the outcomes?

One discussion strategy that I watched with admiration in in one committee and tried, with some success, to emulate was to follow the same order of issue category for each proposal:

  1. does the proposal have value and validity and, if not, what do we need to know to be satisfied that it does?
  2. what risks to participants or others does the project involve; how is it planned they will be mitigated and are we satisfied with the level of mitigated risk?
  3. how are participants being recruited and how is their consent being sought, gained and recorded?
  4. are there issues of fairness in the imposition of burdens of participation on a particular population?

This worked well because members who, for example, would always have questions about consent, knew that they did not need to raise them at the start of the discussion of that proposal because that subject matter would be addressed in due course.

It also made it easier to recap the committee’s discussion. Sometimes it can be useful to do this at the conclusion of the discussion of each category – doing so meant that I did not have to remember all that was said 15 minutes ago or rely on notes taken while I was listening. Further, I found that it could be as inclusive as starting with an open invitation for ‘any comments’ and also avoided disordered and repetitive discussion.

I did find that acceptance of such a structure by a committee used to lack of structure took longer and required constant reinforcement. I came to realise that it was practice, rather than prescription, that generated acceptance of the strategy but maintained a relaxed and comfortable informality.

 

Working with an HREC

Here, a skill that comes with getting to know a committee well is knowing who to refer to, of whom to ask questions, who is likely a waste time with irrelevant matters and how to courteously persuade them to desist. These are generic chairperson skills but the nature of discussion at an ethics committee can make them more sensitive because ethics opens a wide arena for personal yet legitimate and relevant opinions. Dismissing one of these requires tactical use of reasoned ethical analysis lest it be treated as merely personal.

A central feature of an effective chair is to have the ongoing confidence and support of all members of the HREC, even if there are differences of opinion as to proposed outcomes of a review. I have chosen not to introduce each application with my own analysis and my recommended conclusions. My preference has been for discussion and development of a consensus view rather than to aim for an outcome that, in anticipation, I would have preferred. Doing so reduces the risk of closing down discussion and, depending on the relative status or perceived status of the chair vis-vis other members, chilling some members’ input.

I learned very early that I lacked depth in a number of perspectives that are intended to be reflected in the composition of the committee. This is of central importance: the decision is a decision of the whole committee and one that the whole committee can agree to. Frequently, the outcome I foresaw in reviewing an application in preparation for a meeting was not the one that the HREC reached. In preparing for meetings, as a result of these experiences, I would identify issues that, in my view, needed more attention from the researcher but I learned to remain open to other issues that had not occurred to me.

Following a meeting in which such an outcome is reached, the ongoing challenge is to explain to an often disgruntled researcher why the committee reached that view and why further refinement or modification of the application is needed for approval. Here, the burden often falls on the chair and the HREC executive officer. However, where the difference between a researcher and the committee lies in, for example, the traditions of the research discipline involved, I have tried to include the appropriate researcher member of the HREC in order to demonstrate respect to the researcher and to the committee.

There is a tension between the authority that a chair is often seen to have and the humility that a chair needs to bring to the role. The authority of the chair is not the same as the authority of the committee, even if some researchers think that it is or should be. Because it is essential that a committee be seen to be the decision-maker, explaining those decisions often requires more input than just from the chair.

 

The background of a chair

Would these challenges be reduced if, unlike me, chairs were also active researchers? From a committee point of view a researcher-chair is likely to generate considerable respect from the members of the HREC but, because of her very expertise, may also chill contributions from those with far less research awareness. From an institutional point of view, appointment of a researcher does add status to the committee which is, in many people’s eyes, essentially a research activity. However, any researcher chair will have disciplinary boundaries and it can be difficult to represent the committee’s ‘not yet approved’ decisions to researchers from completely different fields. In my experience, this has generated unintended tensions for some chairs.

This raises another more general issue as to whether a chair should be an institutional employee or external to the institution. There are benefits and shortcomings in each. An internal chair will know the institutional landscape and culture and can bring stature to the committee: the appointment itself can testify to the importance that the institution attaches to the HREC. The shortcomings will often be related to research fields, as noted above. For external chairs, the degree of independence can also add to the status of the HREC, particularly where the reputation, professional status or achievements of the chair can signal to committee members and researchers the importance the institution places on the committee’s role. On the other hand, an external chair will usually have limited knowledge of an institution, of its ethos and its culture and this can limit effective communication: particularly in outreach activities.

Beyond the HREC processes, chairs can make significant and valuable contributions to an institution’s research culture by representing the HREC at governing body meetings; participating in outreach activities to promote awareness of (and debunk myths about) a committee and participate in professional development in human research ethics.

 

Enjoying meetings

My final comment echoes the final quality that I suggested at the beginning of this short reflection. HREC meetings should be enjoyable: it is a place where thoughtful, committed and articulate people come together and, so long as they respect and are willing to listen to one another’s points of view, can be an environment in which intelligent and enjoyable, even light-hearted (but not cynical), conversation adds to the fulfilment of an important and worthwhile role.

Contributor
Prof. Colin Thomson AM | Senior Consultant AHRECS | AHRECS profile | colin.thomson@ahrecs.com

This post may be cited as:
Thomson, C. (23 April 2019) Reflections on chairing a human research ethics committee. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/reflections-on-chairing-a-human-research-ethics-committee

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