The 131st Annual Meeting (November 15-19, 2003) of APHA

Abstract #70427

Jennifer S. Bard, JD/MPH, Institute for the Medical Humanities, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-1311, 409-772-9394, jsbard@utmb.edu

Smallpox is a deadly virus that can easily be weaponized. Lawyers and policy makers are being asked to make unprecedented decisions about how best to prepare the nation for attack. Among the most vulnerable are American children who have not been vaccinated against smallpox since the 1970s following the diseases eradication first in the United States, then in the world. Children are, it seems, at equal risk of adults of contracting smallpox in case of attack. The need to protect children against smallpox has led to an urgent need to use children as research subjects. Recently a large-scale trial to test the dosage of the current Dryvax vaccine was terminated in large part because of ethical considerations. The history is an instructive lesson about decisions to come. A new vaccine is in active development and will need to be tested. Children are by law a vulnerable population entitled to protections as research subjects. 45 C.F.R. µ46. All regulatory protection is backed by the principle that there can be no research without parental consent. Recently, Maryland's highest court held that parents could not consent to risks beyond that inherent in a child's normal life. This begs the question of what is normal life in a time of bioterrorism. Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001). It will be up to the public health community to play a leadership role in developing sound legal and ethical policy to protect children against the risk of smallpox and other bioterrorism agents.

Learning Objectives:

• 1. Describe the information, skills, behaviors, or perspectives participants in the session will acquire through attendance and participation.
• Participants will acquire the information necessary to make informed judgments in balancing the need to test smallpox vaccine on children, the need to protect children from harm and the need to develop an effective, safe vaccine.
• 2. Clearly identify the outcomes or actions participants can expect to demonstrate as a result of the educational experiences.
• Participants will be able to demonstrate an understanding of the legal and ethical issues inherent in testing biodefense vaccines on children. This will prepare them to take on leadership positions in policy making.
• 3. Write the learning objectives that relate to these outcomes and that reflect the content of the session.
• A. Recognize the danger of a smallpox attack affecting children.
• B. Appreciate the legal and ethical issues inherent in all research on children.
• C. Describe the special risks involved in smallpox vaccine trials.
• D. Articulate appropriate standards for balancing the risk of testing smallpox vaccine on children and the risk to children if the vaccine is tested only on adults.

Keywords: Research Ethics, Health Law

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.