ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
Search
Generic filters
Exact text matches only
Search into
Filter by Categories
Research integrity
Filter by Categories
Human Research Ethics

Resource Library

Research Ethics MonthlyAbout Us

HREC

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

COVID 19, human research and human research ethics review1

 

Prof. Colin Thomson AM
AHRECS Senior Consultant

We at AHRECS, like all our friends, colleagues and clients, are becoming more and more aware of the immediate and probably long-lasting impact of this pandemic on almost every part of our lives. It has compelled researchers to vary methodologies adopted for both ongoing and planned human research. It has also been forcing institutions to adapt human research ethics review processes to enable responsible social distancing.

In this brief item, we are opening a conversation to offer assistance, ideas, successes and strategies to achieve these changes while maintaining the ethics and quality of human research and ethics review.
.

Human research ethics review

A number of our clients have long been conducting ethics review meetings online because of geographical necessity. Australia’s regional universities have led these innovations and acquired considerable experience in managing to achieve effective, efficient and quality ethics review. They use different online platforms and have experience of the strengths and weaknesses of several of these in running both synchronous meetings and asynchronous review processes.

They also have experience of assisting those committee members who have been reluctant to review digital applications. The current crisis may compel further limitations on such assistance; for instance, institutions may be unable to print and dispatch agenda papers and members may be less willing to receive them. Experience in enabling less IT-savvy members to adopt online processes with comfort could be a value now to other institutions making these changes.

There may also be substantive issues in addition to these ones of process.  For example, how does COVID-19 change our perceptions of merit; what if it shifts the balance in an unfavourable direction after a project has been approved?

We have asked some of our clients who have these experiences to respond to this item and encourage others to either offer or seek assistance, not necessarily through AHRECS, but directly. This may be the time in which the development of broader community of human research ethics review practice will be more needed than ever.
.

Human research

For researchers, particularly those with approved projects that involve interaction with participants, the new restrictions on physical distancing and self-isolation are likely to present significant difficulties in continuing and completing their projects. They will need to change the manner of that interaction and the ways they collect the data they need so as to limit risks to participants and to themselves.

In normal circumstances, such changes would require prior ethics approval to conform to the conditions of approval that the National Statement requires (National Statement 5.5.6 (c)). However, the consequences for researchers of seeking prior approval may have a greater impact on the continuity and completion of their work and, in busy research institutions, lead to a significant workload increase in approval requests for urgent project variations.  In addition, those alterations to data collection will involve, in due course, changes in the manner in which data are stored, used and either retained or destroyed, all of which would, in normal circumstances, require consent from participants.

Other issues that researchers may face include:

  1. Identifying and fulfilling the responsibilities that arise when they have to close down their research, e.g. can they use data already collected? Do they inform participants and, if so, how?
  2. What obligations they may have to participants who are distressed by the current situation, especially when relevant to the research, as it is entirely foreseeable?
  3. How do they continue to engage in consultations to which they are committed, whether with communities or with all stakeholders?

In the situation that now presents itself, new strategies will need to be devised and it is likely these will depend more than ever on the ethics reviewers’ trust of researchers. For example, an institution could permit researchers to make urgent changes themselves to data collection methods in order to protect participants and meet COVID-19 limitations on condition that they notify the ethics reviewers as soon as practicable following the implementation of the change. That later application could also include a request for approval of changes to data use, management and retention or destruction.
.

Guidance for researchers

Australian governments at Commonwealth, State and Territory level have provided combined guidance for researchers, especially those conducting clinical trials and other institutions have combined to offer practical advice for researchers on how to negotiate needed changes and ethics review.
.

Research about COVID-19

The COVID-19 situation will generate research initiatives, not only in relation to the immediate medical needs such as vaccines, but also about the impact on health professionals, researchers, and families of those victims of infection, serious illness or death, as well as about the social impact of information, social distancing and self-isolation.

In vaccine projects, issues of justice in inclusion of participants are likely to be difficult to resolve: should all be included or only those capable of a voluntary consent.  And achieving an ethically sound consent will be complicated by the need to provide sufficient information, counter the possibility of social pressure to participate or the heightened influence of health professionals.  As Haaser says, “It is not easy to say no to a hero.”
.

An invitation

In this brief note, these are but early suggestions. We invite our readers to respond to these thoughts with ideas and experience of strategies that they, as researchers or ethics reviewers, have adopted to address the new needs.

Further, and more importantly, this invitation is to encourage institutions, ethics review administrators, ethics review committees and researchers to exchange their ideas and their experiences.  It may be ironic that one of the effects of the COVID-19 crisis is to promote a wider community of good ethical human research practice – but it would nonetheless be a very good outcome.

.

This post may be cited as:
Thomson, C. (18 April 2020) COVID 19, human research and human research ethics review Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/covid-19-human-research-and-human-research-ethics-review

Working flexibly through the Coronavirus: Continuing professional development in research integrity or human research ethics?0

 

Research ethics and research integrity professional development works best as a long-term commitment to building the capacity of the current and next generation of researchers. As universities extend their online capacity to educate coursework students in the face of the Coronavirus (COVID-19) and place restrictions on staff travel, there is little reason to close down all professional development for staff and research students.

We think there are a number of compelling reasons to conduct these workshops online.  Online workshops offer an opportunity to trigger research conversations among staff working remotely; their timing can be readily adjusted to meet availabilities and they can also be captured and reused in the institution over the next couple of years.

Using Zoom,[1] AHRECS can deliver online workshops for any number of HDR candidates, supervisors and early career researchers. The workshops would be tailored to your institution and your needs. We have run such workshops across Australia, New Zealand and the broader region.

The basic type of workshop lasts for 55 minutes and works best for up to 20 participants. This workshop costs $2000. https://www.ahrecs.vip subscribers receive a 10% discount. Such a workshop might be a 101 introduction or more advanced and practical. AHRECS can also run longer, more interactive workshops and run sessions for larger groups, on request.

Send an email to emquiry@ahrecs.com to discuss further.

[1] Zoom has the advantage of being free for the user and being accessible via computer, tablet and smartphone.  It also supports connection via phone. Sessions can be recorded.

Research ethics review during a time of pandemic0

 

Gary Allen, Mark Israel and Colin Thomson

COVID-19 is prompting changes to academic delivery, essentially intended to contain the spread of the virus and protect the most vulnerable from its effects. As more countries introduce travel restrictions and mandate self-isolation, it will no doubt change the way we conduct research.

Research ethics review needs to adapt to meet the needs of these trying times.

We have written previously about the use of proportional review and proportional processes to progress matters outside of a research ethics committee meeting.

But there will always be matters that need to be considered by a human research ethics committee.

One of the strengths of committee review and one of the reasons flying minutes are not favoured is that a committee’s membership brings together different perspectives, lived experience and knowledge.

It remains important that committees exercise their responsibilities in paragraph 5.2.31 of the National Statement.

5.2.31 Decisions by an HREC about whether a research proposal meets the requirements of this National Statement must be informed by an exchange of opinions from each of those who constitute the minimum membership (see paragraph 5.1.30). This exchange should, ideally, take place at a meeting with all those members present.

But, that does not mean committee members need to sit together in a room.  The same valuable results might be achieved with video conferencing packages like Zoom and MS Teams, Blackboard Collaborate, perhaps even aided by asynchronous online collaborations on feedback. AHRECS has worked with many institutions that already run their meetings successfully online.

Of course, institutions may need to assess their on-line or virtual meeting systems to ensure they enable chairs to be satisfied that there has been an exchange of opinion and not merely individual expressions that are unseen by other members.

In addition, AHRECS can help you take advantage of an online meeting by conducting a short professional development activity on a topic of your choice.  This would involve a further reading and reflection booklet, 15-minute pre-recorded presentation (e.g. Social Media and human research ethics) and 15 minutes of Q&A/discussion.  The cost of such an activity is A$900.

Email enquiry@ahrecs.com to discuss further.

 

Lost time may never be found again but is it time to talk about the duration of ethics approvals?0

 

“To everything there is a season, and a time to every purpose” a time to report on ethical conduct, a time to renew an approval, or a time to face misconduct proceedings.

Dr Gary Allen

What is the length of ethics approvals that your HREC grants?  In this article, I will discuss this question and some of the reasons for choosing approval periods.

A related question is, under what circumstances should an ethics approval be withdrawn?  Can/should research ethics review bodies withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report?

Australia is unlike the US where the conventional interpretation of the Common Rule is that ethics approvals are of one year.  Accordingly, US researchers must provide annual ethical conduct reports to maintain ethics approval and avoid needing to make a fresh application.

In Australia, the duration of approval is not specified by the National Statement and the only clear Australia-wide external requirement to provide reports in a certain time is paragraph 5.5.5 of the National Statement which provides that researchers should report to ethics review bodies at least annually.  As a result, approval duration is likely to be dictated by institutional policy and some have adopted maximum duration periods.  A short (e.g. 12 months) approval period and renewal requirement is one lever committees can use to compel researcher compliance to provide evidence that the needs for approval periods are being met.

There are, I suggest, four such needs that are served by a choice of duration of an ethics approval, namely:

  • Compelling a report from a researcher and allowing a review body to confirm that –
    1. a project is being conducted as per the approval, and
    2. the welfare and interests of participants are still being adequately provided for.
  • Providing an opportunity to reflect on any changes to national standards or institutional policies or pertinent cases that warrant a rethink of approvals.

Researchers can typically seek a long duration ethics approval because:

  • The design calls for repeated data collection across an extended period, such as a longitudinal ethnographic study;
  • The work is a component of a program of work focussed on a cure for a chronic condition; or
  • The work intends to compile an archive of biospecimens, data, document samples, audio-visual material or other items of historical/cultural significance.

The maximum duration of a research ethics approval would also appear to be connected to how long an HREC has operated and the amount of work the committee is undertaking. In Australia, institutional decisions on the matter can also be associated with changes in national ethics review requirements that occurred in 1999, 2007 and 2018 (and beyond).

Like other aspects of human research ethics practice in Australia, the approach to duration has reflected practice in the United States.  While Australia does not have the same kind of regulatory framework as the US where failing to maintain ethics approval can have consequences for institutions, the use of single year approvals is probably used as a way to promote adherence to the institution’s ethical conduct reporting requirement.

While understandable, such short-term approvals can punish conscientious researchers because of an institutional response to recalcitrant researchers.

However, early in a research ethics committee’s operation, it is not uncommon for it to grant approvals with durations of between one and three years.

This can reflect the committee’s confidence:

  1. in its role and decisions;
  2. and trust that researchers understand their responsibilities and will abide within the scope of the ethics approval; and
  3. that projects will progress as per applications or researchers will contact the institution’s research office if the unexpected occurs.

A low workload of a committee can serve as an incentive for short duration approvals and longer duration/longitudinal work is chunked out into two or more applications. Increasing the number of approvals may not allow the committee and research team to develop expertise before the committee commits to an extended period of research. Alternatively, a committee might be tempted to inflate its number of approvals artificially to attract either resources or credibility.

Conversely, when a research ethics committee is very busy, there may be more incentive to grant longer approvals to minimise the number of times the committee needs to review renewals of long duration projects.

Given, the National Statement (2007 updated 2018) is currently silent on the issue of the duration of ethics approvals, it might appear the Australian national framework should not impact on approvals. However, there is both a predictable impact and a real reason to rethink our current approach to the duration of approvals.

At this stage an update to Section 4 of the National Statement might be released in the next six months and an update to Section 5 will move out of the planning stage shortly.

Some institutions and committees tie the duration of ethics approvals and forced renewal around the timeframe during which the national arrangements might change (and perhaps inter alia institutional policy).  In Australia this might equate to around a five year approval duration.

The changed approach to updates to the National Statement means that such a cycle might not be especially helpful.

Suggested change to duration and monitoring procedures

We recommend institutions and HRECs do the following:

  1. Adopt a policy setting that the conduct of human research without prior ethics approval may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and of the institution’s research integrity arrangements. This would be consistent with the Investigation good practice guide.
  2. Adopt a policy setting that any proposed change to a project must be submitted for prior review, otherwise the conduct of a project in a manner not in adherence to its ethics approval may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  3. Adopt the practice of reminding researchers of their responsibility –
    1. to consider and safeguard the welfare of research participants
    2. to remain reflective of whether the risks of a project are justified by its benefits
    3. to remain reflective of the degree to which the project addresses the core ethical principles of the National Statement
    4. notify the HREC of any changes with regard to 3a-c.
    5. Notify the HREC if any participant raises a concern about the ethical design or conduct of a project. Including notifying the HREC if any participants withdraw consent because of a concern about ethical matters.
  4. Adopt a policy that a researcher who fails to meet the responsibilities described at 3 may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  5. Adopt a policy that an ethics approval can be approved for the planned duration of a project.
  6. Adopt a policy that researchers must submit an ethical conduct report every 12 months during the currency of an ethics approval. Extended/repeated failure to do so may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  7. Adopt a practice of timed reminders to researchers to provide overdue ethical conduct reports, culminating in breach proceedings[1].
  8. Adopt a policy and practice that every five years a clearance is active the research office/HREC assess whether there are circumstances that require a new ethics review of a project.

In most cases, a new review should not be required, but a standardised, clear checklist should be used to determine whether a new review is required. Subscribers to https://www.ahrecs.vip or https://www.patreon.com/ahrecs will find a suggested checklist for conducting such a check.

On this basis, I suggest research ethics review bodies/research offices can and should withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report.  This however must be based upon documented policy and procedure.  It must also be foreshadowed in ethics approval notifications, report reminders and resource material.

[1] The approach here might be constrained by the research management system the institution is using.  This includes usefully tracking correspondence between the researchers and the research office.

This post may be cited as:
Allen, G. (3 March 2020) Lost time may never be found again but is it time to talk about the duration of ethics approvals?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/lost-time-may-never-be-found-again-but-is-it-time-to-talk-about-the-duration-of-ethics-approvals

0