Module232025

07/05/2025

References (2)

11. Wiertz, S. et al (2022). Evaluating models of consent in changing health research environments. Med, Health Phil., 25, 269-280; Burr, L. (2022) Big Data & Society, Jan-Jun, 1-15. 12. Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland). See https://www.supremecourt.uk/cases/uksc-2013-0136 13. Freyre, E.A. et al (2002) Tanner’s pubic hair staging is not applicable to all adolescents. J Adolesc Health 30, 144-145. 14. Michaud, P.A. et al (2020). Including adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication: a challenge for paediatricians and researchers. Swiss Med Wkly 150:w20333. 15. Moon R.J. et al (2023) Confidence, consent and chaperones for pubertal staging examinations: a national survey. Arch Dis Child, 108:31–35. 16. Coleman L , Coleman J . (2002) The measurement of puberty: a review. J Adolesc;25(5):535–550. 17. Caldwell J.C. et al (1998) The construction of adolescence in a changing world: implications for sexuality, reproduction, and marriage. Stud Fam Plann;29(2):137–53; Kao T.S. et al (2012) Cross-cultural variations in adolescents’ perceived maternal expectancy and sexual initiation. J Transcult Nurs. 2012;23(4):377–388. 18. Gaspar, N, et al . (2018) Joint Adolescent - Adult Early Phase Clinical Trials to Improve Access to New Drugs for Adolescents with Cancer Proposals from the Multi-stakeholder Platform - ACCELERATE. Ann.Oncol. doi: 10.1093/annonc/mdy002. 19. Chuk, M.K., et al (2017) Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents. Clin.Cancer Res., 23: 9-1; Drilon, A., et al . (2018) Efficacy of Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children. N.Engl.J.Med., 378:731-739. 20. Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. Guidance for Industry. (2018)

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Acceptable Levels of Risk and Burden on Participants Guide to accessing in risks and burden in relation to the benefit – EU Guidance

NO

Relevance • Does the clinical trial address an important scientific question? • Does the clinical trial address a question that has not been previously answered?

Subsidiarity • Is it necessary to conduct a clinical trial with human subjects to answer the research question? • Is it necessary to conduct the clinical trial with (this particular group of) children to answer the research question? • Is it impossible to conduct the clinical trial in a less risky or burdensome way? YES

NO

Classification Question: part I • Does the clinical trial provide a prospect of direct benefit for the minor concerned? YES

NO

Standard treatment • Do standard treatment(s) exist for the condition under study? • Can the risks and burden of the clinical trial be considered as minimal in comparison to the standard treatment(s)? YES YES Classification question: part 2 • Does the clinical trial provide a prospect or some benefit for the population represented by the minor concerned? NO

YES

NO

Balance • Do the benefits to the participating minor outweigh the burden?

YES

NO

Proportionality • Do the anticipated benefits to public health or for the participants justify the foreseeable risks and burden of the clinicaltrial?

NO

YES

The trial has acceptable levels of risk to and burden on participants

Don’t do the trial

Modified from: Ethical considerations for clinical trials on medicinal products conducted with minors , Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536?2014 om clinical trials on medicinal products for human use: Rev. 1: 18 Sep 2018

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