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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

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

Can you hear us? The Queensland experience of health research with Aboriginal and Torres Strait Islander people0

 

There is growing concern in Queensland about the conduct of health research meeting Indigenous research ethical principles and standards. Key stakeholders raised these concerns during consultations within the national review of Indigenous research ethics commissioned by the National Health and Medical Research Council (NHMRC).

Although the final report is yet to be released, some discussions noted the absence of a Queensland based accredited ethics review body, like that of New South Wales Aboriginal Health and Medical Research Council (AHMRC) and Western Australia Aboriginal Human Ethics Committee (WAAHEC), to coordinate Indigenous ethical review of health research.

The establishment of such accredited state based Indigenous research ethics review committees indicates a lack of confidence by Indigenous peoples in other institutionally based research ethics boards and their review / approval processes. This also indicates that Indigenous people want to have leadership, control and appropriate representation in the review of research ethics applications.

This raises the question on whether there should be one centralised Indigenous research ethics review and approval process nationally or increase the number of state and territory based review bodies. As a researcher, I often lament on the number of approval processes that are required to undertake research with Indigenous people. However, given the number of research projects that have been undertaken in Indigenous communities that have not led to sustainable benefit or impact, one can see why there is disillusionment by Indigenous people about research “on” Indigenous people.

You can view Prof Adrian Miller’s Griffith University biography here.
You can contact Prof Adrian Miller at adrian.miller@griffith.edu.au

This blog may be cited as:
Miller, A. (2016, 24 March) Can you hear us? The Queensland experience of health research with Aboriginal and Torres Strait Islander people. Research Ethics Monthly Retrieved from: https://ahrecs.com/human-research-ethics/can-hear-us-queensland-experience-health-research-aboriginal-torres-strait-islander-people

A place for expedited ethics review of time-critical above-low risk research2

 

“Have you got ethics yet?” is a question asked frequently where health, social and behavioural sciences postgrads gather on campus. The amount of time human research ethics committees take to approve an application is also a common topic of conversation among university staff. Researchers often, it seems, grumble about delays in beginning their data collection while their ethics application awaits approval. As a recently retired chair of an ethics committee I confess that I rarely felt sympathy for these grumblers. Mostly, it seemed to me, they simply failed to plan their research time-line to match the clearly stated realities of the ethics application and approval process. However, I believe that ethics committees need to have in place processes which can take accommodate an important issue in need of research which has arisen unexpectedly and where data collection is time critical—such as following a disaster event where agencies need researchers to be in the field collecting data from those affected before the quality of the information is compromised with the passage of time.

Starting with the 2009 Victorian Black Saturday bushfires (173 deaths, 2029 homes destroyed) I have been involved in several post-bushfire field research interview surveys of affected householders about their pre-fire bushfire risk perceptions, plans and preparations, and their decisions and actions during the fire. The studies were conducted at the request of fire and emergency management agencies. No adverse incidents occurred. The findings have assisted agencies in reviewing and refining their community bushfire safety policies and procedures. A good case can be made that the timely information gained by the post-bushfire interview research has contributed to improved householder bushfire safety.

In the post-bushfire research where I was the chief investigator 2011 – 2014, approval of these above-low risk studies by my university’s Human Ethics Committee was speedy—within 72 hours. Each application was in the form of a modification of an originally-approved application from 2009. However, colleagues across a range of institutions have told me that it would be very difficult for them to undertake similar post-disaster research because of the time that would be required to obtain approval of such above-low risk research from their human research ethics committee. Concerned about this apparent situation, I decided to investigate how many Australian university human research ethics committees (UHRECs) had provisions for expedited review of above-low risk research.

In a collaboration with the Bushfire and Natural Hazards CRC, I sent a short survey questionnaire to all 39 Australian UHRECs in mid-2014. There were 28 responses (72%). Nine (32%) of the 28 reported having provisions for expedited review of above-low risk research; four described formal arrangements, five described ad hoc arrangements at the Chair’s discretion. Nineteen (68%) had no such provisions. Six of these 19 (32%) described possibilities if the circumstances were sufficiently compelling, the remaining 13 stated simply that they had no such provision. Six UHRECs described preferred arrangements for researchers to submit a generic application well in advance of an actual event and obtain provisional approval, and then submit a detailed application for modification when the specifics were known. A detailed report of findings is at http://www.bnhcrc.com.au/publications/biblio/bnh-1881

I believe that UHRECs which have no provisions for expedited review of above-low risk research do their institution, and the wider society, a disservice.

Jim McLennan is an adjunct professor in the School of Psychology and Public Health at La Trobe University, Melbourne. You can access Jim’s La Trobe University profile here and he can be contacted at J.McLennan@latrobe.edu.au.

This blog may be cited as:
McLennan, J. (2016, 22 February) A place for expedited ethics review of time-critical above-low risk research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/a-place-for-expedited-ethics-review-of-time-critical-above-low-risk-research

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