Ethical Issues

Appendix H
National Children’s Study Assembly Meeting
Breakout Session Summary: Ethical Issues
December 17, 2003
Sheraton Atlanta Hotel
Atlanta, GA

Facilitators:
Marshalyn Yeargin-Allsopp, M.D., National Center on Birth Defects and Developmental Disabilities, CDC, DHHS
Danelle T. Lobdell, M.S., Ph.D., Office of Research and Development, EPA

Dr. Yeargin-Allsopp opened the session by asking participants to introduce themselves and to comment on what they viewed as major ethical issues for the study. The following are the highlights of ethical issues discussed by the group.

• Enrollment of adolescents was discussed. The discussion involved issues of assent of nonpregnant teens as well as issues related to pregnant teens. The group noted that not all states see pregnant teens as emancipated. Thus, in some states, if the Study were to enroll teens, it would be required to obtain parental consent of the teen for participation of the teen. The teen mother could, however, freely consent for her child, once born, to participate. There are many issues related to pregnant teens, including willingness to participate, given concerns of pregnant teens for privacy related to the pregnancy.
• The lifestyles, hence exposures and outcomes of participants in the Study, would be altered based simply on participation in the Study. This fact has to be acknowledged by the planners of the Study.
• A discussion on ways the Study could possibly affect communities included the following issues:
  • The "ethical" issue of whether or not researchers for the NCS have an obligation to intervene or provide an intervention when potential harm is discovered within a community and the impact of the intervention on Study results.
  • How would Study participation and results impact a community, financially and otherwise? (Example: if a particular company were spewing out contaminants into a particular community that were found to be harmful, how would closing this plant affect the lives of the community whose financial stability was based on this company?) This led into a discussion about the possibility of community consent. Could participants be concerned about stigma in the community due to their enrollment in the Study? The response was that confidentiality would be protected at the highest level possible within the Study.
  • How will results of the Study be returned to the community?
  • What is the possible impact of negative or even questionable results on individuals, for example, genetic findings that may affect insurability?
  • The issue of mandated reporting was raised. The response was that the Study would comply with laws on reporting; however, the Study is in the process of setting policies and procedures.
  • When should assent start? When should consent start (no longer needing parental consent)? The power of dissent for the child even though the child may not have the capability to assent was discussed.
• The issue of paternal consent was discussed, that is, whether or not the Study would need both parents’ consent. The assumption is that, more than likely, the Study will be obtaining consent for child participation from mothers because pregnant mothers will be recruited. Would the fathers’ permission also be needed?
• Sharing the results of paternity testing was raised as an issue.
• Discussion was held on whether or not to consent each time a participant came in for some Study function or to have consent once a year, for example.
• A proposal for incentives from private corporations was presented and discussed. There was no consensus as to whether this would be valuable or harmful to the image of the Study. It was suggested that if the Study chose to use incentives from private sources, it might be useful to think of these as sponsorships, rather than partnerships. One community member (the only one in the group) was against having "partnerships" with private companies because of loopholes in the law that might allow these companies to access "confidential information." Members of the group agreed that cash was the best incentive.
• Newly identified items for the Ethics Working Group to consider include paternal consent and community consent.

In Attendance:

Norma J. Allred, Ph.D., M.S.N., National Immunization Program, CDC, DHHS
Nancy Bethune, B.A., B.S., EPA
Arturo Brito, M.D., University of Miami School of Medicine
Diane R. Burkom, M.A., Battelle Memorial Institute
Krista Crider, National Center on Birth Defects and Developmental Disabilities, CDC, DHHS
Peggy Davies
Diane Dennis-Flagler, M.P.H., Agency for Toxic Substances and Disease Registry, CDC, DHHS
Gail Geller, Sc.D., John Hopkins University Medical Institutions
Laurie Moyer-Mileur, Ph.D., R.D., University of Utah Health Sciences Center
John Murray, Ph.D., Kansas State University
Jennifer Singh, M.P.H., Office of Genomics Disease Prevention, CDC, DHHS
Elizabeth J. Thomson, M.S., R.N., C.G.C., National Human Genome Research Institute, NIH, DHHS
Tineka Yowe-Conley, B.S., National Center on Birth Defects and Developmental Disabilities, CDC, DHHS