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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Reflections on case: ‘Racist bus drivers project’0

 

All views expressed in this post are my own and not of my employer, the national committees which I have served on, nor my consultancy clients

The case relates to action taken by University of Queensland against Prof. Paul Frijters because of his alleged conduct of a project without appropriate ethical clearance. The project related to the deception of participants (Brisbane bus drivers) and the dissemination of findings that reflected on them poorly as a cohort. The Bissert determination overturned UQ’s actions on procedural grounds without comment on the underlying ethical issue of the conduct of the project without the appropriate ethical clearance.

It is understood (see http://www.brisbanetimes.com.au/queensland/uq-suppressed-bus-racism-study-academics-20150226-13q5lu.html) that Prof. Frijters disputes that university ethical clearance was required. The determination does reflect to some degree on the process followed to determine whether research ethics review and ethical clearance was required (e.g. provisions 286, 291 and 322-336). However it does not proffer a view as to whether prior research ethics review was required.

The substance of the Fair Work Act determination is that UQ failed to adhere to the misconduct provisions of its enterprise bargaining agreement, the framing its own research misconduct processes and denied Prof. Frijters procedural fairness.

The determination (pp21-22) rejects UQ’s assertion that the research misconduct procedure is exempt from the requirements/rights/redress articulated by the relevant enterprise bargaining agreement (EBA).

The case highlights the importance of carefully describing the interface between research misconduct procedures vis-à-vis the Australian Code and misconduct procedures as described in the Academic EBA (and indeed the general staff EBA for research assistants and student misconduct policies). This is perhaps most acute when the research misconduct process will be making the substantive determination that there is ‘a case to answer’ and the EBA process will largely be an operational application of punitive consequences of the finding of a case to answer.

The case also highlights that correspondence from a respondent (such as disputing the process or the findings of the reviewing officer) should be considered both in terms of its research integrity and its human resources (i.e. EBA process) implications. Another matter Bissert found troubling was the replacement and appointment of supervisors to Prof. Frijters, especially given the important role of supervisors described by the misconduct procedures.

The implications of the determination by Bissett are:

  1. the conduct of procedures to determine facts (e.g. whether research misconduct appears to have occurred) may be externally judged with regard to the appropriate industrial instrument (e.g. the academic EBA) even if a university contends those processes are specifically intended to operate outside of the EBA;
  2. (in light of i) the process for determining the review officer and decision maker may need to be more carefully framed;(*)
  3. (in light of i) a respondent should have access to a union or other representative;
  4. reviews and the provision of outcomes to respondents should be dealt with in a timely manner;
  5. correspondence from a complainant expressing dispute with proceedings should always be considered by a Human Resources Department staff member (to determine the EBA implications of the matters raised).

This may necessitate a complete rethinking of the approach many universities take to ‘Part B’ proceedings and allegations. The matters to consider include research integrity (e.g. adherence to the Australian Code), human resources (e.g. with regard to misconduct proceedings articulated by the relevant EBAs), and institutional compliance (e.g. as per the ARC/MHMRC deeds of agreement and annual compliance reporting).

Largely lost (except for provisions 286, 291 and 322-336) throughout the discussion about correct procedures and the EBA is the degree to which failure to seek ethical clearance is a serious matter especially as the project involved overt deception and risk. It also involved ‘agents acting on behalf of the researchers’ unlawfully seeking to evade paying for travel. The assessment of these matters requires a sophisticated understanding of the National Statement on Ethical Conduct in Human Research and Australian Code for the Responsible Conduct of Research. Arguably it appears the University did not adequately consider whether social science research (at least from one academic area) is being correctly submitted for prior research ethics review.

Update 15/06/16 – UQ economist Paul Frijters quits over strife from race study

(*) It is not entirely clear why the Head of School, as Prof Frijters’ line supervisor was not an appropriate person to conduct the investigation. At various points in the process, different reasons were offered. 

Contributor
Dr Gary Allen is a Senior Policy Adviser in the Office for Research at Griffith University
Click here for Gary’s AHRECS bio

This post may be cited as: Allen G. (2016, 13 June) Reflections on case: ‘Racist bus drivers project’. Research Ethics Monthly. Retrieved from:
https://ahrecs.com/research-integrity/reflections-case-frijters-vs-uq-racist-bus-drivers-project

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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