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

BMC Public Health

Sara Marino¹  Amanda Valdes Abuadili¹  Francesco Attena² 

[1] School of Hygiene and Preventive Medicine, Second University of Naples, via Luciano Armanni 5, Naples, Italy;Department of Experimental Medicine, Second University of Naples, via Luciano Armanni, 5, 80138 Naples, Italy

关键词: Infant vaccination;    Informed consent;    Information;   

Others  :  1132422
DOI  :  10.1186/1471-2458-14-211

 received in 2013-07-30, accepted in 2014-02-20,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Attena et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Piano Nazionale Prevenzione Vaccinale 2012—2014: Ministero della salute. http://www.salute.gov.it/imgs/C_17_pubblicazioni_1721_allegato.pdf webcite
• [2]Nutbeam D: Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century. Health Promot Int 2000, 15:259-267.
• [3]Bunge M, Mühlhauser I, Steckelberg A: What constitutes evidence-based patient information? Overview of discussed criteria. Patient Educ Couns 2010, 78:316-328.
• [4]Ball LK, Evans G, Bostrom A: Risky business: challenges in vaccine risk communication. Pediatrics 1998, 101:453-458.
• [5]Betsch C, Sachse K: Dr. Jekyll or Mr. Hyde? (How) the internet influences vaccination decisions: recent evidence and tentative guidelines for online vaccine communication. Vaccine 2012, 30:3723-3726.
• [6]Bodemer N, Müller SM, Okan Y, Garcia-Retamero R, Neumeyer-Gromen A: Do the media provide transparent health information? A cross-cultural comparison of public information about the HPV vaccine. Vaccine 2012, 30:3747-3756.
• [7]Henderson GE: Is informed consent broken? Am J Med Sci 2011, 342:267-272.
• [8]Lidz CW: Informed consent: a critical part of modern medical research. Am J Med Sci 2011, 342:273-275.
• [9]Schenker Y, Fernandez A, Sudore R, Schillinger D: Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making 2011, 31:151-173.
• [10]Parvizi J, Chakravarty R, Og B, Rodriguez-Paez A: Informed consent: is it always necessary? Injury 2008, 39:651-655.
• [11]Paterick TJ, Carson GV, Allen MC, Paterick TE: Medical informed consent: general considerations for physicians. Mayo Clin Proc 2008, 83:313-319.
• [12]Terry PB: Informed consent in clinical medicine. Chest 2007, 131:563-568.
• [13]Beauchamp TL, Childress JF: Principles of Biomedical Ethics. 6th edition. New York: Oxford University Press; 2009.
• [14]O’Neill O: Informed consent and public health. Philos Trans R Soc Lond B Biol Sci 2004, 359:1133-1136.
• [15]O’Neill O: Some limits of informed consent. J Med Ethics 2003, 29:4-7.
• [16]Parmet WE: Informed consent and public health: are they compatible when it comes to vaccines? J Health Care Law Policy 2005, 8:71-110.
• [17]Lee LM, Heilig CM, White A: Ethical justification for conducting public health surveillance without patient consent. Am J Public Health 2012, 102:38-44.
• [18]Rajput M, Sharma L: Informed consent in vaccination in India: medicolegal aspects. Hum Vaccin 2011, 7:723-727.
• [19]Verweij MF, van den Hoven MA: Influenza vaccination in dutch nursing homes: is tacit consent morally justified? Med Health Care Philos 2005, 8:89-95.
• [20]Vermeersch E: Individual rights versus societal duties. Vaccine 1999, 17(Suppl 3):S14-S17.
• [21]Flanigan J (Ed): A Defense of Compulsory Vaccination. HEC Forum; Published online 13 Aug 2013. doi:10.1007/s10730-013-9221-5
• [22]Arden N, Monto AS, Ohmit SE: Vaccine use and the risk of outbreaks in a sample of nursing homes during an influenza epidemic. Am J Public Health 1995, 85:399-401.
• [23]Kissam S, Gifford DR, Patry G, Bratzler DW: Is signed consent for influenza or pneumococcal polysaccharide vaccination required? Arch Intern Med 2004, 164:13-16.