A Participant-Centered Approach to Understanding Risks and Benefits of Participation in Research Informed by the Kidney Precision Medicine Project

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2021.10.006 ◽

2021 ◽

Author(s):

Catherine R. Butler ◽

Paul S. Appelbaum ◽

Heather Ascani ◽

Mark Aulisio ◽

Catherine E. Campbell ◽

...

Keyword(s):

Precision Medicine ◽

Risks And Benefits ◽

Participation In Research

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Drawing the Line at Age 14: Why Adolescents Should Be Able to Consent to Participation in Research

The Journal of Law Medicine & Ethics ◽

10.1177/1073110517737527 ◽

2017 ◽

Vol 45 (3) ◽

pp. 295-306 ◽

Cited By ~ 1

Author(s):

Robert Schwartz

Keyword(s):

Decision Making ◽

Decision Maker ◽

Intellectual Development ◽

Human Subjects ◽

Federal Regulations ◽

Specific Nature ◽

Emotional Maturity ◽

Risks And Benefits ◽

High Level ◽

Participation In Research

This article argues that teenagers become fully capable of consenting to participation in most IRB-approved research involving human subjects at age 14, four years earlier than they are allowed to consent under virtually all states' laws, and, consequently, four years younger than they are able to consent under currently applicable federal regulations. In determining the age at which person is old enough to have decision-making authority, legal institutions look at the intellectual and emotional maturity of someone of the age of the decision-maker, the risks and benefits of allowing the decision to be made by someone of that age, and the risks and benefits of denying a person of that age the authority to make the decision. Given the high level of safety of participating in IRB approved research, the value of doing so for both the society and the teenage subject, and the psychological and neuropsychological research on the specific nature of emotional and intellectual development during the teen years, the balance comes out in favor of allowing younger teens, by the age of 14, authority to consent to participate as subjects in IRB approved research. The current process requiring both teen assent and parental permission should give way to a process that requires only a teen's consent.

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