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IRB Expert Workshop, October 2002

The Expert Workshop on Human Subjects and Ethical Issues
Related to Treatment and Research in Youth Smoking Cessation

In response to concerns voiced by researchers and practitioners in youth tobacco dependence treatment about the challenges of understanding and implementing procedures to protect human subjects, The Robert Wood Johnson Foundation (RWJF) funded a workshop hosted by the Helping Young Smokers Quit initiative. Experts representing research ethics, tobacco treatment practices, youth-involved research, the national association of IRB administrators, and major public health funding agencies were brought together to articulate and help fill knowledge gaps between these IRB and ethics experts, and experts in the field of youth tobacco dependence treatment.

The participants discussed common issues and challenges encountered when designing and implementing research and treatment protocols with youth smokers, and identified specific strategies to address these challenges. The workshop included three presentations and open discussions for participants to share their own experiences and ask questions. The presentations focused on guiding principles from federal IRB regulations, front-line practices of IRB administrators, and front-line practices of youth tobacco researchers. Small group discussions followed the presentations, and the workshop concluded with the development of an action plan.

Common themes that emerged included:

• Improving communication between IRB administrators, researchers, and practitioners;
• Educating all on the relevant human subject issues encountered in youth tobacco cessation research and treatment;
• Developing resources that provide information on the issues encountered, such as successful examples of research and treatment protocols; and
• Conducting research on the implication of IRB requirements for youth tobacco research and treatment.

The workshop discussions and proposed action steps are described in the Workshop Summary.

As a result of this effort, two papers were published in the Ethics & Behavior 2004 special issue,  "Using Judgment in Conducting Human Research":

In Human participants challenges in youth tobacco cessation research: researchers’ perspectives, Diviak et al. provide a description of the ethical and IRB challenges faced by youth smoking cessation researchers and treatment centers, along with practical strategies used to address such challenges.

In Human participants challenges in youth-focused research: perspectives and practices of IRB administrators, Wagener et al. present the most important factors and greatest challenges that are identified by IRB administrators while reviewing research protocols with youth involvement.

Read these articles and others in our Publications.