Ill-informed consent? A content analysis of physical risk disclosure in school-based HPV vaccine programs.

OBJECTIVES This study examines the accuracy, completeness, and consistency of human papilloma virus (HPV) vaccine related physical risks disclosed in documents available to parents, legal guardians, and girls in Canadian jurisdictions with school-based HPV vaccine programs. DESIGN AND SAMPLE We conducted an online search for program related HPV vaccine risk/benefit documents for all 13 Canadian jurisdictions between July 2008 and May 2009 including follow-up by e-mail and telephone requests for relevant documents from the respective Ministries or Departments of Health. The physical risks listed in the documents were compared across jurisdictions and against documents prepared by the vaccine manufacturer (Merck Frosst Canada), the National Advisory Committee on Immunization (NACI), the Society of Obstetricians and Gynecologists of Canada (SOGC), and a 2007 article in Maclean's Magazine. RESULTS No jurisdiction provided the same list of vaccine related physical risks as any other jurisdiction. Major discrepancies were identified. CONCLUSIONS Inaccurate, incomplete, and inconsistent information can threaten the validity of consent/authorization and potentially undermine trust in the vaccine program and the vaccine itself. Efforts are needed to improve the quality, clarity, and standardization of the content of written documents used in school-based HPV vaccine programs across Canada.