Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials

Mary Ott, Francis P. Crawley, Xavier Sáez-Llorens, Seth Owusu-Agyei, David Neubauer, Gary Dubin, Tatjana Poplazarova, Norman Begg, Susan L. Rosenthal

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12–14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalPediatric Drugs
DOIs
StateAccepted/In press - Feb 23 2018

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Parents
Clinical Trials
Research
Vaccines
Minors
Poverty
Neurosciences
Decision Making
Emotions
Health

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pharmacology (medical)

Cite this

Ott, M., Crawley, F. P., Sáez-Llorens, X., Owusu-Agyei, S., Neubauer, D., Dubin, G., ... Rosenthal, S. L. (Accepted/In press). Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials. Pediatric Drugs, 1-8. https://doi.org/10.1007/s40272-017-0280-y

Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials. / Ott, Mary; Crawley, Francis P.; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L.

In: Pediatric Drugs, 23.02.2018, p. 1-8.

Research output: Contribution to journalArticle

Ott, M, Crawley, FP, Sáez-Llorens, X, Owusu-Agyei, S, Neubauer, D, Dubin, G, Poplazarova, T, Begg, N & Rosenthal, SL 2018, 'Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials', Pediatric Drugs, pp. 1-8. https://doi.org/10.1007/s40272-017-0280-y
Ott, Mary ; Crawley, Francis P. ; Sáez-Llorens, Xavier ; Owusu-Agyei, Seth ; Neubauer, David ; Dubin, Gary ; Poplazarova, Tatjana ; Begg, Norman ; Rosenthal, Susan L. / Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials. In: Pediatric Drugs. 2018 ; pp. 1-8.
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