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When is research not research?0

 

Most institutions have processes for differentiating between Quality Assurance/Quality Improvement (QA/QI) activities and those that can be considered to be research. Unfortunately, much of the debate about which is which has been driven by regulatory needs, as a categorization of QA/QI leads to a project not requiring ethics committee review, a preference for many where the low risk pathway is still considered burdensome. Avoidance of ethics review for bureaucratic reasons though is a less than satisfactory motive.

In large scale genomics projects a vast amount of the work being done is in the enabling technologies, that is, the sequencing itself as well as the computational methodologies that are at the heart of the bioinformatics that makes sense of the vast quantities of raw data generated. To develop robust and reliable informatics approaches one can run simulations but ultimately they must be done on real data to ensure they are fit for purpose. The question arises then, is using the data generated from a person’s cancer as well as their normal DNA sequence for the purposes of establishing valid computational tools research? On this topic Joly et al (EJHG 2016) provide a perspective with regard to the International Cancer Genome Consortium (ICGC), which has sequenced more than 10000 patient’s cancers from across 17 jurisdictions. The authors of the paper, of which I am one, are members of the ICGC Ethics and Policy Committee (EPC), which provides advice to ICGC member jurisdictions on matters of ethics relating to the program.

Using two activities, both of which are effectively a means to benchmark how variants and mutations are identified in the genome, we explored how a variety of international jurisdictions viewed the activity and whether they were helpful in defining whether it was a QA/QI activity or one that was more properly regarded as research. Both were identified as having potential risks to confidentiality and both wished to publish their findings. For these reasons they ended up being called ‘research’ and underwent appropriate review. However, recognizing that this may create hurdles for such work that are disproportionate to the true risk of the activity, we reviewed jurisdictional approaches to this topic as well as the literature to see if a more helpful framework could be established to guide appropriate review.

The exercise proved particularly useful as it shone a critical light on some of the more widely used criteria, such as generalizability, which whilst being used by many organizations and jurisdictions as a key distinction between research and QA/QI is in fact a flawed criterion if not used carefully. In contrast, risk to a participant stands up as an important factor that must be evaluated in all activities. Four other criteria (novelty of comparison, speed of implementation, methodology, and scope of involvement), were also reviewed for their utility in developing a useful algorithm for triaging an appropriate review pathway.

The paper proposes that a two step process be implemented in which the six identified criteria are first used to determine whether a project is more QA/QI, research or has elements of both, followed by a risk-based assessment process to determine which review pathways is used. Expedited review, or exemption from review, are options for very low risk projects but, as the paper highlighted from a review of the pathways in four ICGC member countries (UK, USA, Canada and Australia), there is no consensus on how to apply this. The challenge therefore remains establishing more uniformity between jurisdictions on the policies that apply to risk-based evaluation of research. Nevertheless, simple categorization into QA/QI vs Research is not particularly useful and a greater emphasis on evaluation based on criteria that define risk of harm to participants is the way forward.

Further reading

Joly Y, So D, Osien G, Crimi L, Bobrow M, Chalmers D, Wallace S E, Zeps N and Knoppers B (2016) A decision tool to guide the ethics review of a challenging breed of emerging genomic projects. European Journal of Human Genetics advance. Online publication. doi:10.1038/ejhg.2015.279
Publisher: http://www.nature.com/ejhg/journal/vaop/ncurrent/full/ejhg2015279a.html
ResearchGate: https://www.researchgate.net/publication/291341753_A_decision_tool_to_guide…

NHMRC (2014) Ethical Considerations in Quality Assurance and Evaluation Activities http://www.nhmrc.gov.au/guidelines-publications/e111

Contributor
Dr. Nik Zeps
Dr. Zeps is Director of Research at St John of God Subiaco, Murdoch and Midland Hospitals. He was a member of the Australian Health Ethics Committee from 2006-2012 and the Research Committee of the National Health and Medical Research Council (NHMRC) from 2009-2015. He is a board member of the Australian Clinical Trials Alliance and co-chair of the international Cancer Genome Consortium communication committee. His objective as Director of Research is to integrate clinical research and teaching into routine healthcare delivery to improve the lives of patients and their families.
Nikolajs.Zeps@sjog.org.au

This post may be cited as: Zeps N. (2016, 30 June) When is research not research?. Research Ethics Monthly. Retrieved from:
https://ahrecs.com/human-research-ethics/research-not-research

Comparing research integrity responses in Australia and The Netherlands3

 

Last year, I was invited by Tracey Bretag to contribute a chapter to the Handbook of Academic Integrity. The invite was a little unusual – find another author and work with him or her to compare how research integrity has been dealt with in your two jurisdictions. It could have gone horribly wrong. It didn’t, for two reasons. First, I was delighted to be partnered with Pieter Drenth whose career happens to include a period as Vice-Chancellor of VU University Amsterdam, and President of both the Royal Netherlands Academy of Arts and Sciences and the ALLEA (All European Academies). Secondly, the exercise of comparing research integrity strategies in Australia and The Netherlands actually proved to be highly productive, helped me understand some of the strengths and weaknesses of the Australian response, and was a timely reminder of the value of assessing critically what might be happening in research integrity beyond the borders of our own countries.

The chapter has just been published (Israel and Drenth, 2016). In it, we argue…

In Australia and the Netherlands, research institutions and their funders, as well as academics, state integrity agencies, judges, governments, and journalists, have contributed to the development of rules and procedures that might help prevent, investigate, and respond to research fraud and misconduct. Both countries have experienced scandals and have ended up with codes, investigatory committees, and national research integrity committees.

National policy has created a series of expectations for research institutions. However, in both countries, the primary responsibility for research integrity remains with the institutions under whose auspices the research is carried out, as well as with the researchers themselves. Research institutions have to decide how to respond to misconduct, albeit in ways that are open to scrutiny by national advisory committees, the media, courts, and state accountability mechanisms. As a result, many institutions have amended and sharpened their own codes and regulations; refined their mechanisms for advising staff, reporting and investigating suspected misconduct, and responding to findings of misconduct; improved their protection rules for whistleblowers; regulated data storing and archiving; and sought to foster greater transparency in both their research and research integrity procedures. However, while researchers have been encouraged to embed awareness and acknowledgment of these principles through teaching, supervision, and mentoring of students and junior staff, less effort has been placed on resourcing good practice, tracing and understanding the causes of misconduct, and on fostering and entrenching a research culture invested with the values of professional responsibility and integrity.

Other chapters in the research integrity part of the Handbook compare combinations of Austria, Canada, the United States, Argentina, Brazil, China and Korea, and there are plenty of other contributors to the volume from Australia, including Brian Martin (with one chapter on plagiarism and another on the relationship between integrity and fraud – a topical issue, given the recent sentencing of Bruce Murdoch) and David Vaux (scientific misconduct).

Reference
Israel, M & Drenth, PJD (2016) Research Integrity in Australia and the Netherlands. In Bretag, T (ed.) Handbook of Academic Integrity. Springer. ISBN 978-981-287-097-1 http://www.springer.com/gp/book/9789812870971

Contributor
Mark Israel is professor of law and criminology at The University of Western Australia.
Click here for Mark’s AHRECS bio
Click here for Mark’s UWA page

This post may be cited as: Israel M. (2016, 17 May) Comparing research integrity responses in Australia and The Netherlands. Research Ethics Monthly. Retrieved from:
https://ahrecs.com/research-integrity/comparing-research-integrity-responses-australia-netherlands

We would all benefit from more research integrity research1

 

Paul M Taylor1 and Daniel P Barr2

1Director, Research Integrity, Governance and Systems
Research and Innovation, RMIT University (paul.taylor@rmit.edu.au)

2Acting Director, Office for Research Ethics and Integrity
Research, Innovation and Commercialisation, The University of Melbourne (dpbarr@unimelb.edu.au)

We need more research into research integrity, research misconduct and peer review. This is not a controversial statement, and few would argue against it. So, this is a short blog post then…

It’s worth thinking about why we think that more research into these areas is important and needed. The research that has been reported in the literature is valuable to us and has produced some fascinating insights. We see differences in attitudes in different countries and career stages, and evidence about the impacts of research misconduct. Like all good research, the material already in the literature prompts us to ask more questions than it answers.

But, do we think that the same surveys about the incidence of research misconduct or attitudes to research integrity would reveal the same results for humanities and social science researchers as those in STEM disciplines? Are biomedical researchers in Australia or the UK as likely or more likely to commit research misconduct? Do RCR training packages help prevent misconduct? Is this even what we want RCR training to do? How do we best design and implement research integrity policies? Are principles really better than rules in this context? There’s a handful of grant applications right there!

Perhaps a research integrity ecosystem view would help. What are the challenges that some of the key stakeholders in research integrity are facing and how could research help?

We can start close to home by thinking about the role of institutions in research integrity. The most obvious role of institutions in this area is in responding to allegations of research misconduct. This role is entirely reasonable because of the nature of the relationship between researchers and their workplaces – employment contracts can compel people to provide evidence, and institutions may have better access to data and records that can make the difference in allegations being properly resolved. Certainly compared to other players, institutions are in the best position to consider concerns about the integrity of research. We know that there is not uniformity though in the way institutions respond. Our friends at COPE have talked about the difficulty that publishers face in sometimes even identifying a place to direct concerns. What’s the opportunity for research here? Analysis of institutions to identify traits that are found in ‘good responders’ would help those institutions trying to improve their operations in this area. How critical is the role of senior leadership? What are the impacts, at an institutional level, of a high profile or public misconduct case? How does this impact differ for highly-ranked, ‘too big to fall’ institutions compared with younger organisations? What are the factors that people see that makes them think an institution produces responsible and trustworthy research (if the institution plays that much of a role at all)?

This leads to a second and equally important role for institutions in promoting the importance of responsible and ethical research. It extends way beyond compliance (although this is obviously important). The products of research, as many and varied as they are, must be trustworthy because of the positive impacts that we all hope research will have. So, if an institution decided it wanted to revamp its research governance framework or Code of Conduct for Research, what should it focus on? What evidence do we have, in the research context, to support the idea of Codes of Conduct? Are high-level, principles-based documents that cover most research disciplines useful or are more discipline-focussed rules-based governance structures more effective? How do institutions best engender a strong culture of research integrity?

The role of training here is intuitive and probably right, but can we show that this makes a difference and results in more trustworthy, higher quality research, or does it just make us feel better? Publishers and funders too could benefit from the added insights that research would reveal. Perhaps for both of these players, understanding better the pitfalls of peer review, or development of rigorous alternative models? Research into peer review is already happening, but there could and should be more. What is the best way to distribute mostly decreasing pools of funds to highly competitive funding applicants? How consistent is the decision-making of grant review panels or journal editors? How influential are locations or institutions and ‘big names’ on manuscript or grant review processes and should all reviews be double-blind? Decisions based on peer review are intrinsic and integral to the research process. We should thoroughly understand how these processes are working and what we should do to try and make them work better.

The final group to talk about here are the researchers themselves, perhaps the most important part of the research integrity ecosystem. Given an opportunity, most researchers enjoy talking about the way research works and their own research practice. Listening to conversations between microbiologists and historians about publication rates and funding challenges, data generation and curation, and team research or sole-trader models is intriguing and very interesting. Research about attitudes towards research integrity and how it fits (or doesn’t fit) the way researchers do their research would be valuable. Fundamentally, researchers critically assess new or existing information to find new ideas or solutions. It should come as no surprise when the same critical assessment is applied to proposals for them to reconsider the way they do their research. ‘Research integrity research’ would help to support changes in behaviour that increase the trustworthiness and quality of research. This is really the goal of research integrity.

There’s no shortage of questions to answer. There’s growing awareness of research integrity as a discipline in it’s own right (perhaps it the ultimate interdisciplinary research area). There’s new places for this research to be found (like Research Integrity and Peer Review). The benefits are compelling and clear. What are we waiting for? *Paul is a member of the Editorial Board of Research Integrity and Peer Review. Aside from that, neither Paul nor Dan have any conflicts of interest to disclose, but they hope to in the near future.

This blog may be cited as:
Taylor P and Barr DP. (2016, 10 May) We would all benefit from more research integrity research. Research Ethics Monthly. Retrieved from https://ahrecs.com/research-integrity/benefit-research-integrity-research

A Note on the Importance of Sensitising the Novice Researcher to the Realities of Ethics in Practice0

 

Discussions of research ethics have begun to centre increasingly on how research guidelines translate into ethical practice during the research process. In the paper which prompted the invitation to contribute to this blog (McEvoy, Enright & MacPhail, 2015), my experiences as a novice researcher conducting focus group interviews with a group of young people are illustrated and discussed. The consequence of a limited experiential base in research and not having previously read deeply on the topic of research ethics was that I encountered difficulties in recognising or determining the best course of action when faced with what Guillemin and Gillam (2004, p. 263) refer to as ‘ethically important moments’ in the research situation.

It is clear that unless researchers are sensitised to how research practices such as confidentiality, informed consent, etc. manifest in research encounters, on-the-spot decisions can test the veracity of a research project’s ethical promises. I am certainly not suggesting that experienced researchers hold the monopoly on research ethics, or that it is not possible for novice researchers to behave ethically. Rather, due to the immediacy of ethically important moments it is often a researcher’s instincts or reflexes which are operative. Therefore, just as when we learn any skill and certain elements become automatic with experience, it is important that researchers starting out on their careers are given every opportunity to develop and challenge their ethical practice in a way that ensures that those elements of their practice which become ingrained have the best chance of being ethically sound.

In reflecting upon the ethically important moments I encountered, and in reading the associated literature, I certainly improved my ethical sensitivity and understanding of how ethics are enacted in practice. However, from the perspective of the research participants in the given project, it was far from ideal that my learning was the product of ethical difficulties in the field. So how might novice researchers hone their skills and reflexes without exposing research participants to the possibility of ethical breaches borne of inexperience? We may certainly begin by providing research students with a wealth of examples of ethical dilemmas, discussing our research encounters with them, what we did or didn’t do, said or didn’t say, and prompting them to question what they would do or say in the given situation. Further, we can ensure that we educate novice researchers regarding the deeper thinking behind the principles of research ethics and the various ethical stances that abound (e.g. virtue ethics, relational ethics, feminist ethics, situational ethics, etc.) so that when faced with a less clear-cut ethical dilemma they will have the resources to adapt to the context by upholding the spirit of a given principle. The immediacy of the research situation requires instant decisions but that same immediacy results in the likelihood that such decisions are in fact the result of that which comes before the research situation itself. It is perhaps in the preparation that ethics is won or lost.

References:

Guillemin, M., and Gillam, L., (2004). Ethics, reflexivity, and “ethically important moments” in research. Qualitative Inquiry, 20, 261.

McEvoy, E., Enright, E., & MacPhail, A. (2015). Negotiating ‘ethically important moments’ in research with young people: Reflections of a novice researcher, Leisure Studies, doi: 10.1080/02614367.2015.1119877

Eileen Mcevoy
PhD student at the University of Jyväskylä, Finland and also works as a research co-ordinator in Ireland. She has co-ordinated research projects at the Physical Education, Physical Activity and Youth Sport (PEPAYS Ireland) Research Centre, as well as various other Irish educational institutions.
epmcevoy@gmail.com

This blog may be cited as:
Mcevoy, E. (2016, 22 April) A Note on the Importance of Sensitising the Novice Researcher to the Realities of Ethics in Practice. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/note-importance-sensitising-novice-researcher-realities-ethics-practice

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