Assent in Research: The Voices of Adolescents

Abstract

Purpose Adolescents join clinical research after investigators obtain their positive agreement, or ‘assent.’ Although intended to respect adolescents, little is known about the views of adolescents or their parents regarding assent or research enrollment decisions. This study aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission. Methods Structured interviews were conducted with 13 through 17 year old teens, enrolled in clinical research at NIH or Seattle Children’s Hospital, and separately with one parent. Results 177 adolescent-parent pairs were interviewed. Teens were well distributed by age and gender, represented a wide variety of research and illnesses ranging in severity from mild to life-threatening; 20% were healthy volunteers. Teens and parents were generally satisfied with the assent/permission process. Normally, they made the enrollment decision together and teens wanted parents’ input and support. About 25% of teens reported pressure to enroll, from parents or relatives, but also from doctors/nurses/research teams. Only 2% of teens preferred not to sign a consent form. Conclusions Despite some differing views about how decisions should be made, the current assent/permission process is perceived as satisfactorily respectful by most teens in research. Many teens want to sign consent forms and teens’ signatures should generally be sought. Flexible guidance allows research teams and IRBs to customize the assent process for teens in particular studies in order to facilitate an appropriate balance between giving teens a voice reflective of their emerging independence and enabling supportive collaboration with parents.

Do Pediatric Patients Have a Right to Know?

“…Legally, the answer to the question of whether Adam has a right to know is "no." Due to his status as a minor, he is not legally authorized to consent (although many institutions require assent of minors, especially for research participation [33]), and hence he is not entitled to be informed of the benefits and burdens of the proposed therapy as his surrogates (i.e., his parents) are. And it would be unwise to cast his right-legal or moral-in terms of a multitude of elaborated human rights, only some of which inhere in persons who lack decisionmaking capacity (such as Adam) [34], as that would potentially distort or even trivialize the moral power that we have accorded rights by amplifying their breadth and scope.…”

Adolescent and Parent Willingness to Participate in Microbicide Safety Studies

“…It is also important to recognize that discordance is not necessarily negative, which is exactly the argument for requiring parental permission and adolescent assent. Parents and adolescents may weigh features of studies differently, 12, 13, 19, 20 and conversations between adolescents and parents can be used to foster developmental growth for the adolescent. 12 Particularly for studies involving sensitive topics or those studies focused on behaviors that the parents may be unaware of (such as sexual activity or substance use), it is critical to address the appropriate role of parents.…”

“…Other research has supported that adolescents and parents can be satisfied with a consent process that supports adolescent involvement and parental permission. 20 Thus, we must simultaneously advocate for adolescent participation and look for new models for parental involvement and consent.…”

Healthy or unhealthy lifestyle: A thematic analysis of iranian male adolescents' perspectives

“…Furthermore, the findings corresponded with other studies and showed that having the ability to say “No” decreases risky behaviors, such as smoking. [232425]…”