The informed consent in Southern Italy does not adequately inform parents about infant vaccination

BACKGROUND: Vaccination centres in the Campania Region, southern Italy, vaccinate children with a hexavalent vaccine that contains the mandatory vaccines diphtheria, tetanus, poliomyelitis, and viral Hepatitis B. This vaccine also includes two non-mandatory vaccines, pertussis and Haemophilus influenzae type B. Information about these optional vaccines should be communicated to the parents, and informed consent should be obtained from parents before vaccination. We explored whether informed consent was delivered to the parents, whether they signed the consent form, and whether they read and acquired the information about the vaccination that their child would receive. METHODS: Childhood immunisations are provided at specific public health vaccination centres, "Unità Operative Materno-infantili’s" (UOMIs). We selected four UOMI from the Campania Region where we interviewed 1039 parents bringing their children for the 1st, 2nd, or 3rd doses of hexavalent vaccine. The consent forms were collected from the four vaccination centres and were analysed with respect to clarity and completeness. RESULTS: Most of the respondents (89.5%) were mothers between 20 and 39 years of age (80.4% vs 59.6% of the fathers), they were married (87.2% vs 93.5% of the fathers), and only one-half of them were employed (50.2% vs 92.6% of the fathers). The informed consent form was received from 58.1% of the parents and signed by 52.8%, but read by 35.0% of them. Only 1.5% of parents knew which vaccines were mandatory, and 25.0% of them believed that the entire hexavalent vaccine was mandatory. When we asked the parents which non-mandatory vaccinations were administered to their children, only 0.5% indicated the Haemophilus influenzae type B and none indicated the pertussis vaccine. Thirty-six per cent of the parents replied that their child had not received any non-mandatory vaccines. No parents were informed by the operators that their children would receive non-mandatory vaccines. CONCLUSION: In our study, consent procedures did not allow parents to acquire correct information about vaccine options for their children. Furthermore, not one health care provider informed parents that their child was receiving non-mandatory vaccines. The informed consent process and the individual health care providers did not properly inform parents about the vaccines administered to their children.