Informed Consent to Immunization: The Risks and Benefits of Individual Autonomy

In the last two years there has been a dramatic movement toward disclosing the risks as well as the benefits of immunization to those vaccinated in mass immunization programs.The federal legislation establishing the 1976 swine flu immunization program included requirements that recipients of the swine flu vaccine be fully informed of the risks and benefits of immunization and that written consent forms be used.'Informed consent procedures have also been introduced in polio immunization programs administering vaccine purchased by the federal government, in order to comply with the contract with the vaccine manufacturer. 2 The Center for Disease Control (CDC) has 1977]CONSENT TO IMMUNIZATION 1287 drafted informed consent forms for measles, mumps, rubella, and DPT s vaccines and for the 1977-78 flu vaccine. 4 The final versions of these forms will be used in all mass immunization programs in which vaccines purchased by the federal government are administered. 5 The movement toward disclosure is in large measure a result of an expansion of the manufacturer's legal duty to disclose the known risks of vaccination. 6 Although these risks are generally remote, the argument for disclosure has prevailed in products liability suits alleging a breach of the manufacturer's duty to warn of the vaccine's risks. 7 These cases conclude that when the decision to immunize is not accompanied by an "individualized medical judgment," the patient is entitled to full information on the risks and benefits of the procedure whenever such knowledge would present the patient with a "true choice judgment." 8As a result, it appears that manufacturers will soon require a formal undertaking in all purchase contracts that vaccinees in mass immunization programs will be warned of the risks inherent in the vac-cinesYThe disclosure required of private physicians' ° administering vaccines is less well established.The cases establishing the manufacagency involved in the development, implementation, and evaluation of national vaccine programs.National Immunization Work Group on Consent, Report and Recommendations 30 (March 11, 1977), in Reports and Recommendations of the National Immunization Work Groups (March 15, 1977) (unpublished report submitted to the Office of the Assistant Secretary for Health) [hereinafter cited as Report on Consent]; National