Testimony of David Satcher, M.D., PH.D., Centers for Disease Control and Prevention

mistake on the consent form of the study, acknowledging that the parents who enrolled their
children in the study were not adequately informed.
CDC, in collaboration with Kaiser Permanente, is continuing follow-up of children who
participated in the original study and analysis is ongoing. Analyses are expected to be completed
by the summer of 1997, at which time CDC will convene a group of experts to review the results.
Following the experts' review, CDC will inform parents about the conclusions from the study.
We acknowledge that we were in error by not fully informing parents of children who participated
in the EZ measles vaccine study. In addition to the steps taken to inform parents and following
the report of OPRR, CDC developed written information for investigators about the IRB review
process which included a checklist of elements to be included in consent forms. The number of
IRBs was increased, an additional member from the community was added to each board, the
number of staff who work with the IRBs was increased, and training on human subject
protections was implemented.
Evaluation of the Safety, Immunogenicity and Protective Efficacy of an Inactivated Hepatitis A
Vaccine in Healthy Children (North and South Dakota)
Now I would like to discuss the studies CDC and its collaborators conducted to evaluate the
performance of inactivated hepatitis A vaccine prior to its licensure. These studies were done
primarily among American Indian populations living in North and South Dakota.

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