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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A related question is, under what circumstances should an ethics approval be withdrawn?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

The F-word, or how to fight fires in the research literature0

 

Professor Jennifer Byrne | University of Sydney Medical School and Children’s Hospital at Westmead

 

At home, I am constantly fighting the F-word. Channelling my mother, I find myself saying things like ‘don’t use that word’, ‘not here’, ‘not in this house’. As you can probably gather, it’s a losing battle.

Research has its own F-words – ‘falsification’, ‘fabrication’, different colours of the overarching F-word, ‘fraud’. Unlike the regular F-word, most researchers assume that there’s not much need to use the research versions. Research fraud is considered comfortably rare, the actions of a few outliers. This is the ‘bad apple’ view of research fraud – that fraudsters are different, and born, not made. These rare individuals produce papers that eventually act as spot fires, damaging their fields, or even burning them to the ground. However, as most researchers are not affected, the research enterprise tends to just shrug its collective shoulders, and carry on.

But, of course, there’s a second explanation for research fraud – the so-called ‘bad barrel’ hypothesis – that research fraud can be provoked by poorly regulated, extreme pressure environments. This is a less comfortable idea, because this implies that regular people might be tempted to cheat if subjected to the right (or wrong) conditions. Such environments could result in more affected papers, about more topics, published in more journals. This would give rise to more fires within the literature, and more scientific casualties. But again, these types of environments are not considered to be common, or widespread.

But what if the pressure to publish becomes more widely and acutely applied? The use of publication quotas has been described in different settings as being associated with an uptick in numbers of questionable publications (Hvistendahl 2013; Djuric 2015; Tian et al. 2016). When publication expectations harden into quotas, more researchers may feel forced to choose between their principles and their (next) positions.

This issue has been recently discussed in the context of China (Hvistendahl 2013; Tian et al. 2016), a population juggernaut with scientific ambitions to match. China’s research output has risen dramatically over recent years, and at the same time, reports of research integrity problems have also filtered into the literature. In biomedicine, these issues again have been linked with publication quotas in both academia and clinical medicine (Tian et al. 2016). A form of contract cheating has been alleged to exist in the form of paper mills, or for-profit organisations that provide research content for publications (Hvistendahl 2013; Liu and Chen 2018). Paper mill services allegedly extend to providing completed manuscripts to which authors or teams can add their names (Hvistendahl 2013; Liu and Chen 2018).

I fell into thinking about paper mills by accident, as a result of comparing five very similar papers that were found to contain serious errors, questioning whether some of the reported experiments could have been performed (Byrne and Labbé 2017). With my colleague Dr Cyril Labbé, we are now knee deep in analysing papers with similar errors (Byrne and Labbé 2017; Labbé et al. 2019), suggesting that a worrying number of papers may have been produced with some kind of undeclared help.

It is said that to catch a thief, you need to learn to think like one. So if I were running a paper mill, and wanted to hide many questionable papers in the biomedical literature, what would I do? The answer would be to publish papers on many low-profile topics, using many authors, across many low-impact journals, over many years.

In terms of available topics, we believe that the paper mills may have struck gold by mining the contents of the human genome (Byrne et al. 2019). Humans carry 40,000 different genes of two main types, the so-called coding and non-coding genes. Most human genes have not been studied in any detail, so they provide many publication opportunities in fields where there are few experts to pay attention.

Human genes can also be linked to cancer, allowing individual genes to be examined in different cancer types, multiplying the number of papers that can be produced for each gene (Byrne and Labbé 2017). Non-coding genes are known to regulate coding genes, so non-coding and coding genes can also be combined, again in different cancer types.

The resulting repetitive manuscripts can be distributed between many research groups, and then diluted across the many journals that publish papers examining gene function in cancer (Byrne et al. 2019). The lack of content experts for these genes, or poor reviewing standards, may help these manuscripts to pass into the literature (Byrne et al. 2019). And as long as these papers are not detected, and demand continues, such manuscripts can be produced over many years. So rather than having a few isolated fires, we could be witnessing a situation where many parts of the biomedical literature are silently, solidly burning.

When dealing with fires, I have learned a few things from years of mandatory fire training. In the event of a laboratory fire, we are taught to ‘remove’, ‘alert’, ‘contain’, and ‘extinguish’. I believe that these approaches are also needed to fight fires in the research literature.

We can start by ‘alerting’ the research and publishing communities to manuscript and publication features of concern. If manuscripts are produced to a pattern, they should show similarities in terms of formatting, experimental techniques, language and/or figure appearance (Byrne and Labbé 2017). Furthermore, if manuscripts are produced in a large numbers, they could appear simplistic, with thin justifications to study individual genes, and almost non-existent links between genes and diseases (Byrne et al. 2019). But most importantly, manuscripts produced en masse will likely contain mistakes, and these may constitute an Achilles heel to enable their detection (Labbé et al. 2019).

Acting on reports of unusual shared features and errors will help to ‘contain’ the numbers and influence of these publications. Detailed, effective screening by publishers and journals may detect more problematic manuscripts before they are published. Dedicated funding would encourage active surveillance of the literature by researchers, leading to more reports of publications of concern. Where these concerns are upheld, individual publications can be contained through published expressions of concern, and/or ‘extinguished’ through retraction.

At the same time, we must identify and ‘remove’ the fuels that drive systematic research fraud. Institutions should remove both unrealistic publication requirements, and monetary incentives to publish. Similarly, research communities and funding bodies need to ask whether neglected fields are being targeted for low value, questionable research. Supporting functional studies of under-studied genes could help to remove this particular type of fuel (Byrne et al. 2019).

And while removing, alerting, containing and extinguishing, we should not shy away from thinking about and using any necessary F-words. Thinking that research fraud shouldn’t be discussed will only help this to continue (Byrne 2019).

The alternative could be using the other F-word in ways that I don’t want to think about.

References

Byrne JA (2019). We need to talk about systematic fraud. Nature. 566: 9.

Byrne JA, Grima N, Capes-Davis A, Labbé C (2019). The possibility of systematic research fraud targeting under-studied human genes: causes, consequences and potential solutions. Biomarker Insights. 14: 1-12.

Byrne JA, Labbé C (2017). Striking similarities between publications from China describing single gene knockdown experiments in human cancer cell lines. Scientometrics. 110: 1471-93.

Djuric D (2015). Penetrating the omerta of predatory publishing: The Romanian connection. Sci Engineer Ethics. 21: 183–202.

Hvistendahl M (2013). China’s publication bazaar. Science. 342: 1035–1039.

Labbé C, Grima N, Gautier T, Favier B, Byrne JA (2019). Semi-automated fact-checking of nucleotide sequence reagents in biomedical research publications: the Seek & Blastn tool. PLOS ONE. 14: e0213266.

Liu X, Chen X (2018). Journal retractions: some unique features of research misconduct in China. J Scholar Pub. 49: 305–319.

Tian M, Su Y, Ru X (2016). Perish or publish in China: Pressures on young Chinese scholars to publish in internationally indexed journals. Publications. 4: 9.

This post may be cited as:
Byrne, J. (18 July 2019) The F-word, or how to fight fires in the research literature. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/the-f-word-or-how-to-fight-fires-in-the-research-literature

We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects?1

 

By
Dr Gary Allen| Senior Policy Officer, Office for Research Griffith University | Ambassador Council the Hopkins Centre|
Ambassador MS Qld | Member Labor Enabled| Senior Consultant AHRECS

Associate Professor Carolyn Ehrlich| the Hopkins Centre| Research fellow at Griffith University

On behalf of the consumer inclusion in ethics research project, The Hopkins Centre, Griffith University

Much has already been said about the significance of the 2018 update to the Australian Code for the Responsible Conduct of Research. The Australian Code describes the national framework for the responsible conception, design, conduct, governance and reporting of research. Collectively this is referred to as research integrity. The Australian Code has changed from a 37-page book of detailed and prescriptive rules to a six-page book of high-level principles and responsibilities.

This is not another piece arguing the pros and cons of the flexibility of principles or the certainty of a single national standard.

Instead, this is a discussion about an important idea, which was present in the 2007 version of the Australian Code, but that was discarded without explanation or acknowledgement in the 2018 update. This important idea relates to consumer and community participation and its extension to consumer and community involvement in research.

At provision 1.13 of the 2007 version of the Australian Code there was a simple statement that Australian research institutions and researchers should encourage and facilitate consumer and community participation in research. The provision was included in the 2007 version as one part of the implementation of the Statement on Consumer and Community Participation in Health and Medical Research (NHMRC and Consumers’ Health Forum of Australia Inc, 2002) and went on to underpin the updated version of that statement, which was released in September 2016.  The absence from the 2018 version of the Australian Code of even a brief reference to consumer/community participation in research is (or SHOULD be) a significant cause for concern.

That brief encouragement provided support for consumer-guided designs, research participants as co-researchers and action research across most disciplines. With a few sentences, it mainstreamed the Statement on Consumer and Community Participation in Health and Medical Research and reinforced the importance of consumers and communities beyond ‘just’ research subjects in medical research.

Examples of that participation include the role of consumers and community members:

  1. On a reference/advisory group (including providing lived-experience with regard to the focus, objectives and deliverables of a project)
  2. As co-researchers
  3. In providing lived-experience into the significance of risks, harms and burdens, and the degree to which the risks are justified by the anticipated benefits (see Pär Segerdah 2019).
  4. In providing valuable insights for service/clinical decisions (see Carlini 2019 for an example).

A real example of this working well is of Cancer Australia which mandates the inclusion of consumers in their funding scheme, both in terms of applicants articulating how consumers are engaged (in the ways outlined above and also as reviewers and members of the review panels that evaluate grants). The inclusion of consumers improves projects immeasurably.  Cooperative cancer trials groups have a consumer advisory panel or committee. It would be unimaginable to do cancer trials without consumer involvement in their design. Such community participation is also evident in the recently approved research strategy at Epworth Health.

The above matters (such as whether a project is addressing a genuine community need and whether the risks of the project are justified by its benefits) can be especially significant for vulnerable individuals, especially persons living with ‘invisible conditions’, whereby people may have symptoms or disabilities that might not be immediately obvious to others, and/or when the ‘subjects’ of research are vulnerable, over-researched, or historically disenfranchised. Rather than protecting them from harm, and without a clear mandate for involving them more fully in the co-design and co-production of research that directly impacts their lives, there is a real risk of unintended consequences whereby these people may become even more disenfranchised, over-researched and vulnerable research ‘subjects’.

It is important to acknowledge that the 2016 Statement remains in place, the National Statement on Ethical Conduct in Human Research (2007 updated 2018) continues to articulate the core values of justice and respect, and the new Chapter 3.1 of the 2018 update of the National Statement on Ethical Conductmentions co-researcher designs. More specifically, paragraphs 1.1(a) and 2.1.5 identify community engagement as an important element in research design and planning. The omission from the Australian Code (2018) is out of step with the National Safety and Quality Health Service Standard which calls (2012 p15) for consumer and community involvement in deliberations about risk.

What is a concern now is that the overarching Australian Code for the Responsible Conduct of Research no longer urges publicly-funded research institutions to encourage consumer and community participation in research beyond them being the subjects of research.  On balance, this appears to be inconsistent with other relevant national research standards issued by the same agencies as the Code.

Those voices and perspectives were around before the 2007 version of the Australian Code and hopefully, they will continue to be into the future. That is true because it is becoming more widely accepted that consumers, such as people living with a chronic disease or disability and their carers, have a valuable perspective and a voice that should be listened to. One way a research project can have impact is by heeding those voices and meeting the needs of those Australians. However, in the 2018 update of the Australian Code, there is no longer an obligation on Australian institutions and researchers to encourage and facilitate consumer and community participation in research.

But will the same amount and scope of consumer and community-engaged research be conducted without that encouragement in the Australian Code?

It seems we are about to find out. We just wished there had been a national discussion about that change first – including targeted engagement with the populations who are now no longer encouraged to collaboratively participate in research, and who will potentially be relegated back to a position of being a subject within researcher designed projects and studies.

One way the current situation could be addressed would be in a good practice guide. The Australian Code (2018) is complemented with good practice guides, which suggest how institutions and researchers should interpret and apply the Australian Code’s principles and responsibilities to their practice. A good practice guide for collaborative research could reinforce the importance of consumer and community participation in research.

REFERENCES

Carlini, J. (18 January 2018) Consumer Co-design for End of Life Care Discharge Project. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/consumer-co-design-for-end-of-life-care-discharge-project

NHMRC(2007) Australian Code for the Responsible Conduct of Research

NHMRC(2007 updated 2018) National Statement on Ethical Conduct in Human Research

NHMRC (2016) Statement on Consumer and Community Involvement in Health and Medical Research

NHMRC (2018) Australian Code for the Responsible Conduct of Research

NSQHS (2012) National Safety and Quality Health Service Standards

Pär Segerdah (2019) Ask the patients about the benefits and the risks. The Ethics Blog. Retrieved from: https://ethicsblog.crb.uu.se/2019/01/16/ask-the-patients-about-the-benefits-and-the-risks/

ACKNOWLEDGEMENTS

With grateful thanks to the following people for their contributions:

Delena Amsters, QHealth
Mark Israel, AHRECS
Mandy Nielsen, QHealth
Michael Norwood, Griffith University
Maddy Slattery, Griffith University
Colin Thomson AM, AHRECS
Nik Zeps, AHRECS, Epworth Healthcare

This post may be cited as:
Allen, G. & Ehrlich, C. (21 June 2019) We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects? Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/we-respect-you-we-just-dont-need-to-hear-from-you-any-more-should-the-consumer-and-their-community-participate-in-research-as-partners-instead-of-just-being-subjects

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.

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