Vaccine Safety Study Act

Summary: Vaccine Safety Study Act - Requires the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH), to conduct a comprehensive study to: (1) compare total health outcomes, including the incidence and risk of autism, between vaccinated and unvaccinated U.S. populations; and (2) determine whether exposure to vaccines or vaccine components is associated with autism spectrum disorders, chronic conditions, or other neurological conditions. Requires the Secretary to seek to include in the study U.S. populations that have traditionally remained unvaccinated for religious or other reasons. Directs the Secretary to ensure the preservation of all data, including all data sets, collected or used for purposes of the study to facilitate further research by the Secretary or others. Declares that nothing in this Act shall be construed to authorize the conduct or support of any study in which an individual or population is encouraged or incentivized to remain unvaccinated.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Vaccine Safety Study Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Securing the health of the Nation's children is our 
        most important concern as parents and stewards of the Nation's 
        future.
            (2) The Nation's vaccine program has greatly reduced human 
        suffering from infectious disease by preventing and reducing 
        the outbreak of vaccine-preventable diseases.
            (3) Total health outcomes are the best measure of the 
        success of any public health effort, including security from 
        both chronic and infectious disease.
            (4) Childhood immunizations are an important tool in 
        protecting children from infectious disease.
            (5) The number of immunizations administered to infants, 
        pregnant women, children, teenagers, and adults has grown 
        dramatically over recent years.
            (6) The incidence of chronic, unexplained diseases such as 
        autism, learning disabilities, and other neurological disorders 
        appears to have increased dramatically in recent years.
            (7) Individual vaccines are tested for safety, but little 
        safety testing has been conducted for interaction effects of 
        multiple vaccines.
            (8) The strategy of aggressive, early childhood 
        immunization against a large number of infectious diseases has 
        never been tested in its entirety against alternative 
        strategies, either for safety or for total health outcomes.
            (9) Childhood immunizations are the only health 
        interventions that are required by States of all citizens in 
        order to participate in civic society.
            (10) Public confidence in the management of public health 
        can only be maintained if these State government-mandated, mass 
        vaccination programs--
                    (A) are tested rigorously and in their entirety 
                against all reasonable safety concerns; and
                    (B) are verified in their entirety to produce 
                superior health outcomes.
            (11) There are numerous United States populations in which 
        a practice of no vaccination is followed and which therefore 
        provide a natural comparison group for comparing total health 
        outcomes.
            (12) No comparative study of such health outcomes has ever 
        been conducted.
            (13) Given rising concern over the high rates of childhood 
        neurodevelopmental disorders such as autism and other chronic 
        conditions, the need for such studies is becoming urgent.

SEC. 3. STUDY ON HEALTH OUTCOMES IN VACCINATED AND UNVACCINATED 
              AMERICAN POPULATIONS.

    (a) In General.--The Secretary of Health and Human Services (in 
this Act referred to as the ``Secretary''), acting through the Director 
of the National Institutes of Health, shall conduct or support a 
comprehensive study--
            (1) to compare total health outcomes, including the 
        incidence and risk of autism, in vaccinated populations in the 
        United States with such outcomes in unvaccinated populations in 
        the United States; and
            (2) to determine whether exposure to vaccines or vaccine 
        components is associated with autism spectrum disorders, 
        chronic conditions, or other neurological conditions.
    (b) Rule of Construction.--Nothing in this Act shall be construed 
to authorize the conduct or support of any study in which an individual 
or population is encouraged or incentivized to remain unvaccinated.
    (c) Qualifications.--With respect to each investigator carrying out 
the study under this section, the Secretary shall ensure that the 
investigator--
            (1) is objective;
            (2) is qualified to carry out such study, as evidenced by 
        training experiences and demonstrated skill;
            (3) is not currently employed by any Federal, State, or 
        local public health agency;
            (4) is not currently a member of a board, committee, or 
        other entity responsible for formulating immunization policy on 
        behalf of any Federal, State, or local public health agency or 
        any component thereof;
            (5) has no history of a strong position on the thimerosal 
        or vaccine safety controversy; and
            (6) is not currently an employee of, or otherwise directly 
        or indirectly receiving funds from, a pharmaceutical company or 
        the Centers for Disease Control.
    (d) Target Populations.--The Secretary shall seek to include in the 
study under this section populations in the United States that have 
traditionally remained unvaccinated for religious or other reasons, 
which populations may include Old Order Amish, members of clinical 
practices (such as the Homefirst practice in Chicago) who choose 
alternative medical practices, practitioners of anthroposophic 
lifestyles, and others who have chosen not to be vaccinated.
    (e) Timing.--Not later than 120 days after the date of the 
enactment of this Act, the Secretary shall issue a request for 
proposals to conduct the study required by this section. Not later than 
120 days after receipt of any such proposal, the Secretary shall 
approve or disapprove the proposal. If the Secretary disapproves the 
proposal, the Secretary shall provide the applicant involved with a 
written explanation of the reasons for the disapproval.
    (f) Transparency.--To facilitate further research by the Secretary 
or others, the Secretary shall ensure the preservation of all data, 
including all data sets, collected or used for purposes of the study 
under this section.