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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Navigating ‘Research Fatigue’0

 

In human research, some groups of people (grouped by identity, association, condition and/or location) may become over-represented as research subjects in a particular discipline, or in research generally. These people may develop a sense of ‘research fatigue’ (Clark, 2008) – in simple terms, they’ve been over-researched and now they’re just over it. It is likely that a sense of being mistreated by researchers, a lack of trust between participants and researchers/institutions, and/or a failure of research to return any kind of benefit to the participant community, may exacerbate research fatigue. Subsequently, they may be reluctant to participant in any further research (Clark, 2008).

People belonging to marginalised or vulnerable groups may be particularly susceptible to over-research and research fatigue. This is partly because such groups may be identified as having persistent problems social or medical researchers may be hoping to help, and perhaps also because people in these groups have disproportionately suffered from poor and unethical research practices. For example, in Australia, Aboriginal and Torres Strait Islander Peoples have frequently been the subjects of research conducted without permission, or without due consideration to appropriate and ethical processes (Knight, Comino, Harris, & Jackson-Pulver, 2009; Martin, 2003).

I conducted my PhD research with an over-researched community. The people of North Stradbroke Island/Minjerribah – particularly (but not exclusively) the Quandamooka and other Indigenous Peoples of the Island -are suffering from research and consultation fatigue, and many had complaints about the way they had been treated by earlier researchers, or the fact that the issues they prioritised were being ignored.

Several months after my field work concluded, a colleague of mine – Rachael Cole-Hawthorne, another PhD student – began her fieldwork on North Stradbroke Island/Minjerribah with the Quandamooka Peoples. She encountered an unanticipated ethical difficulty; participants in my research (or people who had heard about me and my research – it’s a small community and people talk!) sometimes mistook her for me. We were PhD students from the same institution, after all, and bore a passing resemblance to one another. The issue of mistaken identity was always laughed off, however it meant that the anonymity of some of my participants had been unintentionally compromised; if they hadn’t mistook Rachael for me, they may not have mentioned their participation in my project.

It also became clear to Rachael that the success of her research rested, to a degree, on the goodwill I had developed. If I had treated participants poorly, or if they found participation unpleasant or uncomfortable, she may have encountered difficulties in recruitment.

As a result of these experiences, Rachael and I are working together on the topic of ethical research with over-researched communities. Our (very) preliminary thoughts, based on a review of the literature and our research experiences to date, suggest a few key considerations for researchers. Firstly, one should not dismiss the possibility of engaging with an over-researched community on that basis alone, but there is a particular onus on the researcher to justify why this site/these people, including to the participants themselves. Obvious relevance and utility, and clear links to the ‘uniqueness’ of that community that makes them the best pool of participants may help overcome initial wariness (and weariness). There is, perhaps, extra impetus to demonstrate a genuine commitment to the over-researched group, and focus additional attention on the building and maintaining of relationships. For me, this included spending as much time as I could on the Island, for blocks of time, rather than making day trips or just talking to people on the phone. Finding ways to connect potential participants to the research topic, and finding ways to deliver meaningful and useful outcomes for them, is also of heightened concern in research fatigued communities. Exploring alternative epistemologies and methodologies may help, including those that allow participants to influence the research approach, analysis, and products. Not only may alternative approaches help create a less exploitative and more mutually beneficial research relationship, the sheer novelty of them may help overcome fatigue. And, as always, researchers should be prepared to hear ‘no’, to respect that answer, and should have a Plan B in case they just can’t overcome research fatigue.

Rachael and I are collaborating with some of our research participants, particularly amongst the Quandamooka community, in putting together an open access publication that will explore these issues. In that vein, we hope to present a few different perspectives on the topic of research fatigue, illuminate some of the issues for researchers to consider when seeking to engage with an over-researched group, and identify some principles and guidelines for ethical practice in this area that are grounded in the experiences of those who are subject to over-research. Stay tuned!

References

Clark, T. (2008). ‘We’re Over-Researched Here!’: Exploring Accounts of Research Fatigue within Qualitative Research Engagements. Sociology, 42(5), 953-970.

Knight, J. A., Comino, E. J., Harris, E., & Jackson-Pulver, L. (2009). Indigenous Research: A Commitment to Walking the Talk. The Gudaga Study – an Australian Case Study. Bioethical Inquiry, 6(4), 467-476. doi: 10.1007/s11673-009-9186-x

Martin, K. B. M. (2003). Ways of knowing, being and doing: A theoretical framework and methods for indigenous and indigenist re-search. Journal of Australian Studies, 27(76), 203-214.

Dr Natalie Osborne,
School of Environment, Griffith University,
View Natalie’s ResearchGate profile,
n.osborne@griffith.edu.au

This blog may be cited as:
Osborne, N (2015, 2 November) Navigating ‘Research Fatigue’. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/navigating-research-fatigue

Do we need consent for the continued use of children’s biological samples and data in research – and what if the grown up children cannot be located?1

 

Parental consent is sufficient to authorize research involving infants and young children who do not have the capacity to take part in such decisions. But what happens when the children grow up and the research is ongoing?

According to the National Statement, where research is ‘complex or long-running, or participants are vulnerable’, consent ‘may need to be renegotiated or confirmed’ so that research participants are ‘given the opportunity to continue their participation or withdraw’. This suggests that at some point, researchers will need to get consent from the children themselves. The difficulty is that when children reach an age where they can consent for themselves and parental consent no longer applies, they may not know that they are involved in such research.

A study clarifying ethical responsibilities in the Australian paediatric biobanking context, reports that the responsibility to inform children when they are able to decide for themselves, belongs to no one: “Most children at 18 wouldn’t know about samples” and there is “no onus to inform people”. This state of affairs will likely cease to be a problem as new biobanks and studies get set up and better procedures are put in place. Currently though, we are left with questions about whether it is ethically acceptable for researchers to use samples and data, given with parental consent, from children who are now grown up and who cannot be located.

A U.S. study has addressed this very topic. It reports that most adults are not concerned about continued use of their samples and data collected during childhood but they want to be asked and they are generally willing to provide consent. Nevertheless there were 26% who think it is not acceptable to use their samples and data if they cannot be contacted. The authors conclude that adults have an interest in decision-making and that should be respected. Their consent for continuing research should be sought, but if they cannot be located, ‘it is generally acceptable to continue to conduct research’. The authors concede though that the scenario they use in the interviews lacked detail about things that would affect people’s attitudes – things such as risks, the type of study and identifiability.

So, how should researchers and Human Research Ethics Committees respond if the source of the sample cannot be found? Can researchers use the sample or should they throw it out?

The answer is – it depends. The National Statement reminds us that there is a need for researchers and HRECs to engage in ‘deliberation on the values and principles’, exercise their judgement, and have ‘an appreciation of context.’ What this means is that to arrive at an ethically defensible position for continuing without consent, researchers will need to explain their position, giving reasons for continued use without consent.

In order to justify using previously collected samples/data where the source cannot be located, researchers need good ethics based reasons for using this sample rather than a different sample from someone who has given consent or is willing to donate a new sample. There may be good reasons. For instance, good ethics based reasons may be to do with rare conditions and limited number of samples. Whatever the reasons, these reasons will be weighed against reasons for not using the sample without consent. Reasons in support of the need for consent after sources become adults, are autonomy based i.e. participation should be a reflection of that person’s own choices or reasons, not that of parents or researchers. A different but important reason is that proceeding without consent poses a threat to public trust and confidence in research – and the success of this type of research depends on the support of the public and their willingness to contribute. Reasons to continue without consent based simply on costs, time and inconvenience for researchers do not do the job.

References

Goldenberg, A. J., Sara, C. H., Botkin, J. R., & Wilfond, B. S. (2009). Pediatric Biobanks: Approaching Informed Consent for Continuing Research After Children Grow Up. The Journal of pediatrics, 155(4): 578-583

NHMRC (2007) National Statement on Ethical Conduct in Human Research. Accessed 4 September, 2015, from http://www.nhmrc.gov.au/guidelines-publications/e72

Spriggs, M., and C. Fry. 2015. Clarifying ethical responsibilities in paediatric biobanks. AJOB Empirical Bioethics Available early online at: http://www.tandfonline.com/eprint/QDVEzAwZsTqT9QkwvBjB/full

Dr Merle Spriggs BA (Hons), M.Bioeth., PhD
ARC Research Fellow
Children’s Bioethics Centre / Centre for Health Equity,
University of Melbourne.

This blog may be cited as:
Spriggs, M (2015, 4 September) Do we need consent for the continued use of children’s biological samples and data in research – and what if the grown up children cannot be located?. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/do-we-need-consent-for-the-continued-use-of-childrens-biological-samples-and-data-in-research-and-what-if-the-grown-up-children-cannot-be-located

Dr Merle Spriggs (mspriggs@unimelb.edu.au) is a Research Fellow at the Children’s Bioethics Centre, Royal Children’s Hospital; the Centre for Health Equity, Melbourne School of Population and Global Health, University of Melbourne; and an Honorary Research Fellow at the Murdoch Childrens Research Institute. She has developed substantial educational resources about consent for Human Research Ethics Committees (HRECs) and researchers who conduct research involving children. Other recent research includes ethical issues and responsibilities in paediatric biobanking, e-health ethics, specifically the ethics of internet-based research and the ethical issues of electronic health records. Merle has over 20 years experience on hospital and university Human Research Ethics Committees and she has been an expert witness for two US law firms in cases involving child research. She is also a member of the Royal Children’s Hospital Clincical Ethics Committee and Clinical Ethics Response Group.

Current projects: Merle is part of a team working on an ARC Discovery Project: Involving children in social research: Balancing the risks and benefits; she is also leading a project titled: ‘Using research participants as co-researchers: Ethical considerations” funded by the University of Melbourne, Ethics and Integrigy Development Grant Scheme.

The perils of anonymous online research and risk: Two hands tied behind your back1

 

Online research offers many advantages. If well designed, a web survey/task or other data collection tool can collect robust data from large populations, incorporating validations and other tools (including anonymous cookies to minimise the risk a participant submits more than one set of responses). These techniques can ensure any data collected is more likely to be useful and reliable. Collecting data online also means that participant responses to survey questions/performance in tests can be directly added to the data set for analysis (rather than transposed later).

Another apparent ethical advantage of online research is that it can be collected anonymously so that not even the researchers know who disclosed what. This anonymity can seem especially attractive when individuals are to be asked embarrassing questions, asked about sensitive matters and/or where there are risks associated with the collected data. It might then seem easy to respond to the risk questions in an application for ethical review:

“There are no risks, no matter requiring attention because the researchers won’t have data that can be traced to an individual.” Right?

Ordinarily, if a participant used an interview to disclose significant mental anguish an experienced interviewer could suspend the data collection to counsel a participant and to urge them to seek help from someone with appropriate training. If an interviewer was sufficiently worried that there was reason to believe there was imminent and serious risk to the interviewee or others they could decide to alert the appropriate authorities.

Neither options are available to a researcher conducting anonymous online research. This enables a researcher to evade any mandatory reporting requirements to which she or he might be ordinarily subject. But, is this the right thing to do?

The same argument might be true for offline research (such as an anonymous paper & pencil survey). However the very wide scope of online data collection and the degree to which people appear very willing to disclose things online, does appear to increase the likelihood such disclosures will be made in online data collection.

I have seen this happen, where a participant used an online anonymous survey seeking views on an apparently innocuous psychological subject to disclose an intention to self-harm. Not only were the researchers unable to take any action, their powerlessness to act caused the research team (especially the junior members) a great deal of distress.

The implications of this case might be that there are some subjects and potential participant pools where data should never be collected anonymously. This might be the case even when the informed consent material urge participants to seek expert support if they are distressed. In fact in the case I am referring to above, such a statement was in fact present in the informed consent materials. Consequently, perhaps we should consider whether there are circumstances where data should initially be collected in an identified form, only to be de-identified once the researchers have determined there are no compelling reasons obligating them to act.

Of course such a mechanism raises its own ethical, risk, consent and legal considerations.

Gary Allen,
Office for Research,
Griffith University
Gary’s AHRECS profile
Gary’s Griffith University profile

This blog may be cited as:
Allen, G (2015, 7 August) The perils of anonymous online research and risk: Two hands tied behind you back. AHRECS Blog. Retrieved from https://ahrecs.com/uncategorized/the-perils-of-anonymous-online-research-and-risk-two-hands-tied-behind-you-back

Is the pre-recruitment of research participants potentially an ethical issue in Australia? (David Hunter)1

 

I’ve recently published a paper focused on the UK looking at some ethical issues faced by a practice that has developed for the recruitment of research participants there, called pre-recruitment. http://jme.bmj.com/content/early/2015/02/19/medethics-2014-102639.abstract. Given the difficulties recruiting research participants, companies have formed who source research participants for researchers, particularly for pharmaceutical research. They do this primarily by recruiting potential participants onto lists and then selling access to these lists to researchers.

This is hardly a new practice, informally researchers often keep lists and contact details for previous participants so they can recruit them onto future studies which is a form of pre-recruitment in itself. However having become a commercial business worrying trends have emerged in the UK regarding the information provided to the pre-recruited, where they may be promised that they will earn thousands of pounds, help cure cancer and be heroes if they just agree to volunteer.

What is problematic about this is that no research ethics committee in the UK and I suspect none here either would approve a project which made such statements in its recruitment literature. However because this is pre-recruitment it is entirely unregulated. And worse still the research ethics committee reviewing the actual study that draws on this pool of pre-recruited participants will probably not know they have been pre-recruited, nor what information they were given prior to their recruitment to a specific study. This is problematic both because it makes a mockery of the careful provisions we have established regarding informed consent to ensure it is valid (avoiding explicit incentives, emotive language and over promising results) but also because it presents the participants with conflicting information, which turns the consent process into a game they play to get to the results (a fortune, cure for cancer etc) rather than a careful reflection on whether they want to participate.

Like in the UK, presently in Australia the pre-recruitment of research participants is entirely unregulated – specifically the National Statement wouldn’t apply to pre-recruitment since it is not directly the recruitment of research participants though we might think best practice in pre-recruitment would follow the norms established by the National Statement and enforced by Human Research Ethics Committees (HRECs) for the direct recruitment of research participants in Australia.

So how should HRECs respond to pre-recruitment? Pre-recruitment is difficult to regulate both because it is prevalent and because unlike research itself it does not have a public output at the end of it. I’d suggest that the best way forward is for a section on pre-recruitment be added to the National Ethics Form. This should ask if any research participants have been pre-recruited, and if they have copies of the recruitment literature and materials should be provided to the HREC reviewing the research. If the HREC considers that material to be misleading or inadequate it can then turn down the study, or at least require a different recruitment method. This is likely to quickly change the practices of pre-recruitment companies since if researchers can’t get ethical approval if they use pre-recruiters their business model will swiftly fail.

Dr David Hunter
Associate Professor of Medical Ethics
Southgate Institute,
School of Medicine,
Flinders University
David.hunter@flinders.edu.au

This blog may be cited as:
Hunter, D (2015, 11 June) Is the pre-recruitment of research participants potentially an ethical issue in Australia? AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/is-the-pre-recruitment-of-research-participants-potentially-an-ethical-issue-in-australia-david-hunter

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