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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

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

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

Taking Time in the Midst of a Crisis: Prior Informed Consent, Sociability and Vulnerability in Ethnographic Research3

 

As an anthropologist, the way I work has particular features which are, in my view, both empowering and paralysing. This is especially the case when working with people who define themselves or who are defined as vulnerable, and in field contexts which are challenging, difficult or unpredictable. In this post, I would like to address Prior Informed Consent procedures as an example of the ethical challenges that I need to address in my new project which aims to interact and collaborate with one of the most vulnerable populations entering the European Union today: undocumented pregnant refugees and migrants.

My ERC-funded project, entitled ‘Intimate Encounters in EU Borderlands: Migrant Maternity, Sovereignty and the Politics of Care on Europe’s Peripheries’ is a comparative study of maternity care delivery towards undocumented pregnant migrants in EU Borderlands. Research will be carried out in 7 maternity care services located in the densely crossed borderlands of 4 EU Member States. Most of the maternity care services in question are in the Mediterranean, in Italy, Spain and Greece, but two field sites are also located in Overseas France, in French Guiana and Mayotte (in South America and in the Indian Ocean respectively). All of the field sites are to be found on Europe’s external borders, in remote peripheries which have very specific social and economic identities in relation to the rest of the country. My main interest lies in studying doctor-patient interaction from a moral and biographical point of view, and in documenting life in these peripheries from the perspectives of the full range of actors involved. Ethnographic data will be collected during a 16 months long fieldwork period which will span the second and third years of the project, and which will involve all project team members (that is myself and three other researchers).

Research will be carried out through long-term participant observation of everyday life in the field locations. Commitment to the research from all research participants will have to be total, as my team and myself will have to physically move (taking our families along with us) to the field sites for the whole duration of the fieldwork. Working times will vary according to circumstances, but could involve day and night-time work, every day of the week. This kind of research requires flexibility, adaptability and resilience.

Long-term participant observation is peculiar: it is an ecosystem of its own, which may appear intense and exotic, but which often feels awkward, lonely and frustrating. Time takes on a different texture and daily routines are upset by the turns of events. Building social relations based on amity at first, and trust in the long-term with a wide range of people is not generally something which can happen overnight. For this reason I am convinced that when working with vulnerable subjects, the investment of time affords a great advantage in contributing to ethically-sound research.

Anthropologists approaching a field site have to prepare their fieldwork through an extensive, collaborative, multi-level process of introduction, presentation, authorisation and consent, which works concurrently at communal and individual level. It is very common to hear that for anthropologists fieldwork starts at home, as they slowly gather the first contacts and points of reference, through which they will seek affiliations, authorisations, permits, and translate their research objectives according to the audiences they deal with.

As anthropologists, our entry into a field context often follows a gradual scoping process based on information and presentation, which navigates several levels of leadership and authority. Only once all authorisations are cleared can fieldwork at community-level begin. And from community-level, one can approach individuals or family units. Because the personal and emotional involvement of fieldwork is so high, the social bonds which develop through long-term fieldwork are deep and long-lasting. In this context, consent in research is to be considered as a flexible, long-term commitment to the well-being of the source communities, and their regular updating on the progress of the research. This commitment can last a lifetime.

In the context of my new research project, a good proportion of the persons I will be working with belong to a highly mobile and invisible population with whom the nurture of social bonds may not be easy to maintain, to say the least. My ERC-funded project includes, among other research participants, undocumented migrants. Some of these migrants will be pregnant, others may be minors, and some will be both. This means that they represent another category of vulnerability than people I had been previously working with who belong to remote ethnic minorities (I have been working with Amerindian communities of northern Amazonia in Suriname and French Guiana since 2003). The social and political contexts in which research is carried out are always shifting, and there is no single definition of vulnerability, nor one single form of social interaction during ethnographic fieldwork. Approaching each specific social context requires good prior knowledge and a great deal of flexibility. For instance the pregnant patients I might have to interview are generally likely to have higher levels of literacy than the indigenous women with whom I was sharing the intimacy of daily life in the interior of Suriname. It may be easier to establish some form of initial communication, since there are likely to be more common cultural references. Personal, emotional and physical circumstances may however be extremely different. Moreover, whereas I have been working since 2005 in clinical contexts, these can vary greatly, and medical environments can be extremely hierarchical structures in which self-determination and agency can be challenged by the most simple acts.

In such challenging research environments, single solutions are impossible to envisage as circumstances can change very rapidly. As others have noted, ‘prior informed consent of research participants does not in itself make human-subject research ethical’ (Rosenthal 2006: 119), nor does it guarantee that all research participants and other human subjects will behave ethically. Obtaining prior informed consent in such challenging contexts first of all requires time. Having time to use the appropriate channels to seek authorisations in due course, to develop an extensive web of social contacts, and only gradually to approach the most vulnerable research participants. To ensure as independent and unbiased a process as possible, researchers in the field have to be aware of local circumstances and dynamics, and resist the temptation to rush into a challenging research environment currently at the centre of a media frenzy over what is often portrayed as an escalating EU migration crisis.

Reading a newspaper in Italy – and any other EU Member State for that matter – is a painful experience. I am constantly exposed to images of despair and tragedy unfolding in my country’s territorial waters. I often feel like rushing there to finally get started documenting the voice of those who remain invisible, but rushing is not the way to go about it, despite the climate of crisis and urgency. Ethically-sound research takes time, even more so in the midst of a crisis.

Reference:

Rosenthal, J. 2006. ‘Politics, Culture, and Governance in the Development of Prior Informed Consent in Indigenous Communities’, Current Anthropology 47(1): 119-142.

Vanessa Grotti
European University Institute
Vanessa’s EUI page
Vanessa.Grotti@EUI.eu

This blog may be cited as:
Grotti, V. (2016, 26 January) Taking the Time in the Midst of a Crisis: Prior Informed Consent, Sociability and Vulnerability in Ethnographic Research. AHRECS Blog. Retrieved from: https://ahrecs.com/human-research-ethics/taking-the-time-in-the-midst-of-a-crisis-prior-informed-consent-sociability-and-vulnerability-in-ethnographic-research

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