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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

 

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

An Open Invitation to Research an Ethics Committee1

 

Jay Marlowe and Martin Tolich have had an article published (in press) in Research Ethics examining the first year of the not for profit New Zealand Ethics Committee (http://www.nzethics.com/.) They claim NZEC is unique: it reviews applications focusing solely on an application’s research ethics and not as traditionally practiced on research governance. Whilst university and health based researchers in New Zealand are compelled to submit their research for review by ethics committees, local/central government, NGOs and community based researchers are exempt from this process; they usually do not have access to this level of support or review. Though many social scientists have found research governance a frustration in ethics reviews, this article asks if an ethics review committee can function outside an institutional frame focusing solely on research ethics. Does NZEC represent a novel paradigm moving ethics review beyond a risk management exercise of gate keeping to that of bridge building between parties? Their article reports on NZEC’s first year of operation (2013) by interviewing (via a third party) the 14 applicants who voluntarily sought ethics review. They sought to ascertain why these applicants gained ethical review when not mandated to do so and if they experienced this review process as a new paradigm. In 2014 NZEC received 22 applications and as of April 30, 2015 they have received 19 expecting to review 50 applications in 2015. Members of the NZEC invite researchers to research their ethics review processes.

Marlowe, J. & Tolich, M. (in press). Shifting from Research Governance to Research Ethics: A Novel Paradigm for Ethical Review in Community Based Research, Research Ethics

Associate Professor Martin Tolich, Sociology, University of Otago has three recent books. These are

Joan Sieber and Martin Tolich (2013). Planning Ethically Responsible Research Sage, Thousand Oaks.

Martin Tolich and Barry Smith (2015). The Politicisation of Ethics review in New Zealand, Dunmore Press, Auckland

Martin Tolich editor (in press 2015). Qualitative Ethics in Practice, Left Coast Press, Walnut Creek, CA.

This blog may be cited as:
Tolich, M (2015, 11 July) An Open Invitation to Research an Ethics Committee. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/an-open-invitation-to-research-an-ethics-committee

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