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

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

5035.0: Wednesday, November 19, 2003 - 9:10 AM

Abstract #70427

Balancing the Risks: Legal and Ethical Issues in Smallpox Vaccine Trials with Children

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,

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:

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.

Legal and Ethical Aspects of Smallpox Vaccination

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