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A group of teenagers (ages 15-17) request to participate in phase 2 clinical trials of a novel SARS-CoV-2 vaccine. Typically, this would initially be restricted to individuals 18 and older; however, in the setting of a global pandemic, this group of teenagers is expressing a strong desire to contribute to the vaccine development effort. They argue that the magnitude of the crisis dictates that usual protocol be suspended, and that adolescents be involved in initial vaccine trials given the role children and adolescents may play in transmission of the virus even when asymptomatic or with only mild symptoms.
Clinical trials typically consist of three phases. In phase 1, the vaccine is administered to a small number of healthy individuals, and data is collected regarding side effects, and relationship between dosage and side effects. In phase 2, a larger group of individuals are administered the vaccine, and monitored for side effects and efficacy of the vaccine. Phase 3 involves an even larger group of individuals, and focuses on confirming efficacy, comparison to other treatments if applicable, and continuing to monitor side effects.
Subpart D (“Additional Safeguards for Children in Clinical Investigations”) of the Code of Federal Regulations makes the distinction between clinical investigations that do or do not present the prospect of direct benefit to individuals subjects. Clinical trials are sorted into 3 categories, all of which require procedures for obtaining children’s assent and parental permission.
· 45 CFR 46.405 For trials with the prospect of direct benefit and greater than minimal risk to subjects, this may involve children if the risk is justified by anticipated benefit to the subjects, and the anticipated benefit is at least equal to the benefits offered by other approaches.
· 45 CFR 46.406 For trials with no prospect of direct benefit to individual subjects but which are likely to offer generalizable knowledge about the subjects’ disorder or condition, and which involve greater than minimal risk, this may involve children if the risk represents only a minor increase over minimal risk; the participation involves an experience that is comparable to participants’ usual situation; and the intervention is expected to produce generalizable information about the subjects’ disorder or condition “that is of vital importance for the understanding or amelioration of the subjects’ disorder or condition.”
· 45 CFR 46.407 For trials that are “not otherwise approvable” but which offer an opportunity to “understand, prevent, or alleviate a serious problem affecting the health or welfare of children,” a trial may proceed if an institutional review board (IRB) deems that the study offers a “reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children,” and will be “conducted in accordance with sound ethical principles.”
1. Which category of Subpart D determinations best encompasses this request?
2. Should these adolescents be allowed to participate in phase 2 clinical trials for a SARS-CoV-2 vaccine?
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