Pediatric biobanking plays a critical role in optimizing health care for children. However, pediatric biospecimens carry specific challenges, a primary one being the issue of consent. While a child’s consent often defers to the parent or authorized guardian, research guidelines indicate that minors should be included in consent procedures.1,2 The few resources specifically geared toward pediatric biobank issues also recommend inclusion of children in consent procedures.3,4
There are currently no comprehensive studies of the role of minors in consent protocols, and actual practices vary widely. For this reason, Giesbertz et al. performed a multiple-case study to address this ethical question.5 To do this, the researchers collected data from four pediatric biobanks: LifeLines of the Netherlands, Prevention and Incidence of Asthma and Mite Allergy of the Netherlands, Young-HUNT3 of Norway, and the Oxford Radcliffe Biobank contribution to the Children’s Cancer and Leukaemia Group tissue bank of the United Kingdom. The accumulated data included textual sources, direct observations (e.g., during informed consent meetings), and 29 interviews with biobank staff, parents, children, and other stakeholders.
Giesbertz et al. report that four motifs emerged in their work:
- the biobank’s motives for involving the child in consent processes
- how the child receives information regarding consent
- how the biobank responds to dissent and assent/consent
- the voluntary nature of the child’s participation
The researchers found three basic motivations for involving children in consent policies: adherence to regulation (which varies by location), increasing the likelihood of the minor’s continued participation in the research program (particularly for programs requiring ongoing contributions), and respecting the child as a person (which went hand in hand with inspiring institutional trust). Interestingly, the last two motivations can exist in tension with each other. For example, researchers may have a vested interest in keeping children motivated to participate. This could lead to weak communication concerning the option to withdraw consent; however, respect for the child requires that those same researchers clearly communicate this option up front.
All four case studies included written information (research procedures, storage data basics, and option to withdraw data/samples at a later date) combined with verbal clarification by staff as the primary means of informing the child. The level of specific information the staff gave the children (versus relying on parents) varied.
All four biobanks indicated that a child’s dissent should be respected. The practical applications of this are less clear (particularly when the fourth motif comes into play). However, in some cases, minors’ refusal to participate in specific aspects of research protocols (blood withdrawal, for instance) have affected participation expectations (e.g., making blood samples optional). Assent (positive agreement) and consent (neutral permission) practices differ among institutions, largely because national laws and guidelines vary. One example is the implementation of age limits and/or competency assessments for consent. While some countries specify age guidelines, others apply a more subjective standard of measuring maturity (e.g., Gillick competence in the UK).
The child’s willingness to participate is perhaps the most nebulous theme. The team observed that when it comes to a minor’s participation, researchers and parents can both exert pressure on the child, potentially compromising the freedom with which the child gives consent. Even in cases without overt compliance pressure, some children may agree to participate in order to please authority figures or as an echo of the parents’ stated values.
Overall, Giesbertz et al. offer a compelling picture of how these ethical issues play out in actual pediatric biobanks. They assert that respecting the personhood of minors—including the right to dissent or withdraw without coercion—must form the ethical framework of procedures for obtaining consent. To this end, regulation imposed by national law or professional bodies may protect children’s interests as research participants. However, in the absence of a consistent legal framework, Giesbertz et al. observe that biobanks should primarily “take children seriously as persons” and use this value to inform the operations at every level of the organization. They affirm that this approach is not only ethically sound but also contributes to the sustainability of pediatric biobanks as a whole.
1. U.S. Department of Health and Human Services. (2009) “Human subject research (45 CFR 46, Subpart D). Protections for children involved as subjects in research,” available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
2. World Medical Association. (2013) “WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects,” available at http://www.wma.net/en/30publications/10policies/b3/
3. Hens K, et al. (2009) “Biological sample collections from minors for genetic research: A systematic review of guidelines and position papers,” European Journal of Human Genetics, 17 (pp.979–990).
4. Hens K, et al. (2013) “Developing a policy for paediatric biobanks: principles for good practice,” European Journal of Human Genetics, 21 (pp. 2–7).
5. Giesbertz, N.A. et al. (2014) “Consent procedures in pediatric biobanks,” European Journal of Human Genetics, doi:10.1038/ejhg.2014.267.