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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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Kids tell us that making decisions can sometimes be hard (anyone who has taken a child to an ice cream shop can attest to this). Adults don’t often give children choices and kids tell us that when they do it can be confusing: ‘what am I being asked?’, ‘can I really say no?’, ‘do they seriously care?’ and ‘what will happen if I make a decision the adult doesn’t like?’ are questions that might spring to mind. After all, they tell us that it’s not usual for adults to seek out children’s views, to let them make big decisions or to give up some of their ‘adult power’ and act on children’s wishes.

And yet children are required to ‘assent’ to research, often with little information about what research actually is and what they will be required to do. In most cases, they know that their parents have already given permission for them to be involved – which may be reassuring but also a bit daunting (how often is it that kids can say ‘no’ when their parents have already said ‘yes’?) – but in most cases a complete stranger comes into their home or schoolroom and pulls out a note pad and asks them whether their happy to answer a few questions. “Um OK?”

Since the Helsinki Declaration there has been an expectation that children provide assent to their participation in research. Often this entails providing them with a long-winded, legalistic and ‘pretty boring’ information letter, telling them that if they agree they might get a movie voucher or at least a packet of chips and a can of soft drink before asking them to tick a box to show that they agree. As a child in one of my studies reported, the process is ‘kinda like’ the terms and conditions process they go through when downloading a new app from i-Tunes. Like 73% of Terms and Conditions non-readers, kids in research often have no idea what they are signing up for and what their rights are when things go wrong.

In a recent study my colleagues and I conducted for the Australian Royal Commission into Institutional Responses to Child Sexual Abuse we got advice from children and young people about how to best help kids understand and consent to participating in research on a fairly sensitive topic. Based on this advice we conceptualized consent as an ongoing process that included six steps: (1) present information in a child-friendly and accessible way; (2) make sure they understand what research is and what they are expected to do; (3) give them the choice to participate (or not) and ask them to formally agree; (4) give them lots of opportunities (and the skills or tools) to bow out of the research (particularly after they’ve got a ‘feel’ for what they are being asked to do) or to change the way that they are participating; (5) be aware of the ways that kids resist or ‘dissent’ (yawning or sneaking out of the room might give it away) and constantly ‘check in’ with them in child-friendly ways (6) Get an agreement with them at the end of the research activity that they are still happy for their input to be included in the study and negotiate what, if anything, they’re happy for the researcher to share with their parent, teacher or older sibling who is standing behind the door.

In the paper “More a marathon than a hurdle: towards children’s consent in a safety study” my colleagues and I outline how we went through these steps with kids, we describe how we used felt toys, ‘stop signs’ and ‘rights posters’ to help children and young people consent and, most importantly, quote advice and feedback from children and young people on how adult researchers might best help kids to make decisions within the research context.

One tool we feature in the article is our “Charter of Rights” poster which we provide kids in our studies. The poster informs them of what they should expect from us, as researchers, and what to do if they are unhappy. The poster is given to the children prior to them meeting with our staff and is further explained before assent is sought. On the advice of children and young people who have advised our projects, the rights charter has also been used as the basis of a series of games and activities that can be used to help children understand their rights in research (and in welfare practice). More detail about these can be found here. My team at the Institute of Child Protection Studies are working with peers from the Centre from Children and Young People (Southern Cross University), UNSW and the University of Melbourne to progress ethical research with children and young people. We’re currently hosting a survey on ethical decision-making – take a minute to fill it in! We’re keen to chat with others who are grappling with how to meaningfully engage kids in research (and support them to make good decisions) and would love to hear from you. *Terms and Conditions Apply.

Contributor
Dr Tim Moore
Senior Research Fellow | Institute of Child Protection Studies, ACU
Bio page at ACUTim.Moore@acu.edu.au

This post may be cited as:
Moore T. (2017, 21 July) Terms and conditions apply; Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/terms-conditions-apply

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.

Sprinting to the start line: concerns with expedited ethics review2

 

Allow me to start with a short story.

A recent conversation I had with an established academic evolved as follows. The academic had funding to explore how involvement with classical music impacted a child’s development. He planned to interview parents of children, aged 2-13, who played musical instruments. The interviews were exploring how music was involved in the children’s daily schedule. The questions were likely to centre around everyday activities and conversations the parents had with their family and friends, so he considered the research low risk. Expedited ethics review was gained, and the research was approved almost immediately. Upon ethics approval, the researcher then explained how he used the amendment process to include children in the research; something he had planned to do all along. The amendment involved a small submission explaining how the research was differing and what some of the new potential ethical issues might be. The interviews with the children would be about their experiences playing musical instrument. They were likely to mimic conversations the children had daily. This manipulative even blasé approach to ethics review concerned me. The researcher here took advantage of the low risk expedited review, using it as a short cut to dodge full ethics review which would have involved lengthy paperwork. When I asked him about his approach he claimed it was fairly common practice in his department. It saved time and avoided unnecessary ethical bureaucratic practices.

As a budding researcher and novice ethicist, I want to make it clear from the beginning that I am not against expedited ethics review process for low risk projects, nor do I think all projects involving children are high risk. After completing and submitting a handful of ethics applications for various projects in my postgraduate studies and research assistant work, I understand the benefits of expediting low risk projects. I do, however, have some concerns with what may be lost in the rush to expedited review, particularly if expedited review is being used as a loophole.

Typically ethics committees tend to be protective of groups deemed ‘vulnerable’, children included. So my curiosity grew when I heard the ethics committee not require the academic to resubmit a full ethics application. Many ethics committees would see red flags because of the children and require a completely new application. Ethics committees’ idiosyncrasies are discussed often enough in ethics literature, and perhaps magnified through their approaches to expedited review. Yet, little explanation around the decisions to accept or reject amendments is offered. Would other ethics committees have reacted differently to the amendment submitted?

I am apprehensive that expedited ethical review may render the primary purpose of ethics review secondary. Ethics review was originally created to protect participants from harm. Expedited ethical review has definite benefits for the researcher and ethics committee, decreasing the time review takes, and reducing the workload for committee members. But does it come at a cost to participant protection?

I have two main concerns: the level of ethical scrutiny applied during expedited review; and the temptation for expedited review to be used as a ‘shortcut’. One of the main benefits of full ethics review is that research proposals are scrutinised by multiple sets of eyes, and critiqued and examined by members with different skill sets, concerns, and expertise. I am unsure how during expedited review, one or two ethics committee members can ensure the same level of review is applied. In the past, expedited review of applications I have submitted certainly missed some key mistakes which I found after receiving ethics approval. Furthermore, I am unsure if just one member of the ethics committee can identify all the potential risks of low risk projects.

The second main concern I have with expedited review is that it may be used as a ‘shortcut’. Expedited review may be seen as a way to obtain ethics review quickly. “The identification of ‘doing ethics’ with ‘getting through ethics review’ creates a risk that ethics questions focus on data gathering, with the result that (re)use of data is either seen as ethically unproblematic or ignored” (Morrow et al 2004 p. 4). Israel (2015) argues qualitative researchers are frustrated with ethics procedures that do not understand qualitative methods. The researcher’s approach to ethics review above may be a result of this frustration. However, finding loopholes and using or abusing the expedited review process should not be the answer.

My short reflection of this expedited review process is not intended to criticise ethics committee members’ work. I simply cannot fathom the volume of work they undertake each month. Introducing systems such as expedited review may be a productive way to reduce the monthly workload ethics committees face. Rather, I have questioned how thoroughly expedited review can explore a complex project. Perhaps we should be asking not if projects reviewed through an expedited review process offer the same level of ethical scrutiny as a full review process, but rather how this shortened review process can ensure projects are still reviewed sufficiently?

References

Israel, M. (2015). Research ethics and integrity for social scientists: Beyond regulatory compliance (2nd ed.). London: Sage.

Morrow, V.; Boddy, J.; Lamb, R. The ethics of secondary data analysis: Learning from the experience of sharing qualitative data from young people and their families in an international study of childhood poverty. Institute of Education, University of London, UK (2014) 24 pp.

Amber Chambers
Otago University MA graduate
Research assistant at Griffith University
Centre for Governance and Public Policy, Nathan

This blog may be cited as:
Chambers, A (2015, 23 August) Sprinting to the start line: concerns with expedited ethics review. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/sprinting-to-the-start-line-concerns-with-expedited-ethics-review

 

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