ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Research Ethics MonthlyAbout Us

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?

 


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.

This is interesting. Merle’s blog attached took ten years off my life. The issues she raises stem from an adolescent’s right to consent for tissue taken from them as a child—when their parents had given the consent when the child was 16 or so.

Barry Smith and I were on the HDEC when we argued the child had the right to re-consent at the age of 16. The NZ Min of Health brutally slammed our committee’s decision.

Tolich, Martin and Barry Smith (2015) The Politicisation of Ethics review in New Zealand Dunmore Press, Auckland page 61-62 cut and pasted here

Tissue banking for unspecified research

Whether or not to consent to future unspecified research proved to be the MREC’s first controversial decision. Within months of operation the Multi region HDEC took a stand approving research involving future unspecified research with one stipulation: Any tissue storage approved by a parent would need to be re-approved by a child when they reached the age of 16. The Multi-region Ethics Committee Annual Report 2004–2005 (http://ethics.health.govt.nz/about-committees/archived-minutes-and-reports-pre-2012/multi-region-committee p.11) detailed the objection:

The use of tissue for future unspecified research, particularly where children are concerned, presented a considerable challenge for the committee and researchers as a number of studies were affected by the committee’s decision not to give ethical approval for tissue to be stored for future unspecified research. Some studies transferred to the Multi-region Ethics Committee had previously had ethical approval for tissue to be stored in this way from other ethics committees. A further related issue was whether a child should have the option to request that tissue be removed, or express such a wish, once they reach the age of 16, when the parent or guardian has given prior written consent. The Multi-region Ethics Committee considered that a child has a right to make this choice and consequently did not approve the anonymity of tissue where consent was given by a parent or guardian. As the Operational Standard did not provide sufficient guidance for this new and expanding use of tissue, the Ministry of Health agreed to prepare guidelines on unspecified future use of tissue in consultation with the National Ethics Advisory Committee. In the interim, the Multiregion Ethics Committee provided a statement of its position on these issues to assist researchers in preparing applications, or amendments to applications, for the committee’s review (Our emphasis).

The wording of this annual report is not clear. It would seem the MREC asked the MOH to write guidelines and they agreed to this action. The guidelines were instructions from the MOH to the MREC to overturn the MREC’s position and stated that the storage of tissue approved by parents need to be approved by children at age 16.

In June 2006, the Ministry of Health released the Guidelines on the Use of Human Tissue for Future Unspecified Research Purposes: Discussion Document (Ministry of Health, 2007) for public consultation. The discussion document contained information about the regulatory framework and requirements for the use of human tissue for future unspecified research. It outlined the consent, ethical and cultural issues surrounding the use of human tissue for future unspecified research and invited feedback on the proposed Guidelines on the Use of Human Tissue for Future Unspecified Research Purposes. [[I add this now ttps://www.google.co.nz/search?sourceid=navclient&ie=UTF-8&rlz=1T4ADFA_enNZ420NZ421&q=tissue+banking+Zealand]]]]]

In this first dispute the Ministry of Health guidelines usurped the Multi region ethics committee unanimous opinion that failing to give a child, upon reaching the age of 16, the right to re-consent to their continual participation in research was not ethical. No MREC member resigned over the issue. However, there would be other battles to be fought and won with the Ministry of Health.

Martin Tolich



Leave a Reply

Your email address will not be published. Required fields are marked *

captcha

Please enter the CAPTCHA text

0