title: Ethics of pharmacological research involving adolescents.
abstract: Pharmacological research in the adolescent population is not meeting adolescents' needs. Medication is still frequently prescribed off label, and studies especially in sensitive areas of adolescent health care are underrepresented. Adolescents did not benefit from the new knowledge gained in cancer research, and their outcome has essentially not improved during the last two decades in comparison to younger children and adults. There are many obstacles that make it challenging to enroll adolescents in pharmacological research. Access can be difficult. Confidentiality plays an essential role for minors and may be a hindrance, notably to studying sexual and mental health matters. Pharmaceutical companies may exclude the adolescent patient because of a lack of profit and in fear of a complex study design. Research concepts should be explained to the adolescent in a comprehensive manner, and assent and consent forms should be clear and understandable. New laws and incentives have been developed to encourage pharmaceutical companies to engage adolescents in their research projects. Centralization and collaboration of all parties involved may make the whole approach to adolescent research more efficient and uniform. The mature minor doctrine has facilitated the enrollment process. Parental consent may be waived for low-risk medical trials to promote recruitment. Ethics committees therefore play a major role in protecting the adolescent from harm from participating in research. In conclusion, pharmacological research in adolescents has to be encouraged. This will increase the safety of current medical treatment regimens and will allow this population to benefit from therapeutic advancements.
authors.affiliation: Department of Pediatric Cardiology, Western University, LHSC, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada, eva.welisch@lhsc.on.ca.
authors.forename: Eva
authors.initials: E
authors.lastname: Welisch
authors.forename: Luis A
authors.initials: LA
authors.lastname: Altamirano-Diaz
mesh_terms: D000293:Adolescent; D035843:Biomedical Research / Q000941:ethics*; D003219:Confidentiality / Q000941:ethics; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D033282:Parental Consent / Q000941:ethics*