Issue Briefs • The Rationing of Vaccines Against Pandemic Influenza • Informed Consent in Vaccination • Vaccination Requirements and Exemptions The Quest for an HIV Vaccine • Challenges in HIV Vaccine Development -- An Overview • Logistical and Ethical Considerations of HIV Vaccine Clinical Trials • HIV Vaccine Clinical Trials: The Standard of Care Debate

Informed Consent in Vaccination

The American Medical Association defines informed consent as “a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.”¹ The principle behind this process arises out of respect for patient autonomy and is particularly relevant to the administration of vaccines. The Declaration of Helsinki, the highly regarded international guidelines for research on human subjects, states that “considerations related to the well-being of human subjects should take precedence over the interests of science and society.”² While this was written with respect to biomedical research, it has been argued that a similar principle should be applied to vaccine policy. Many bioethicists, clinicians, and others argue that the decision to vaccinate should always be left to patients (or parents, in the case of children), despite years of evidence that mass immunization confers additional protection to the communities by reducing the spread of infectious disease, a phenomenon known as herd immunity. The principle of informed consent requires that a patient understand the risks and potential benefits of a particular vaccine before receiving it.

Vaccine information sheets and signed consent forms

Because vaccination in the U.S. is viewed as routine, the discussion between physicians and parents about immunization is often truncated, if not lost. Though no replacement for a meaningful dialogue between health care providers and parents, information statements produced by the Centers for Disease Control and Prevention are required to be available to parents whose children are vaccinated. Consent has legal meaning as well, as parents are responsible for medical decisions involving minor children. More controversial is whether “assent” – the approval from the child coming separately from parental approval – should play a role in the decision to administer a vaccine.

While much of the discussion involving vaccine policy focuses on pediatric vaccination issues, an increasing number of vaccines are available and recommended to older of populations. In the case of influenza and pneumococcal conjugate vaccines recommended for elderly populations, one paper suggested that a signed consent form – another strategy for ensuring informed consent – does not necessarily confirm that the patient understands the procedure.³ In fact, the requirement of signed consent forms for these vaccines may hinder efforts to immunize older and more susceptible populations, leading to unnecessary deaths from these increasingly preventable diseases.

HPV vaccine and consent

In 2006, Merck released Gardasil, a vaccine against strains of human papillomavirus (HPV) that are responsible for the majority of cervical cancer cases in the U.S. and worldwide. Since the virus is spread sexually, the vaccine is most effective when given before the individual begins sexual activity. It is unknown how long the vaccine remains effective against the virus. The Advisory Committee on Immunization Practices (ACIP) recommends that Gardasil be given to girls between the ages of 11-26 years, or as early as 9 years of age, based on the judgment of the physician.⁴

Some observers of Gardasil’s introduction have commented that it may be difficult to persuade parents to immunize their 11-year old daughters with a vaccine against a sexually transmitted disease. Critics have suggested that the vaccine may force parents to discuss sex in an uncomfortable context, or that by consenting to Gardasil, parents may be tacitly encouraging their daughters to engage in early sexual behavior, a charge unsupported by any empirical evidence to date.

Despite these early concerns, studies have shown that fewer than a quarter of parents are likely to deny consent for their daughters’ immunization, and those that do often change their minds in favor of Gardasil when they are given more information about HPV and its connection to cervical cancer.⁵

The unique aspects of Gardasil raise some ethical dilemmas. What if a well-informed young woman (still a minor) wishes to be vaccinated without her parents’ consent, either unbeknownst to them or against their wishes? The answer depends, in part, on the age of the minor, as most agree that the views of a 17-year-old regarding medical decisions should receive more respect than those of an 11-year-old, for example. According to a recent study, parents who support teenagers’ right to receive the HPV vaccine without parental consent do so to encourage responsible behavior, protect adolescents from ill-informed parents, and respect their confidentiality. Parents who support the requirement for parental consent cite as reasons the desire for adult responsibility in a child’s health, fear of erosion of parental rights, and respect for cultural and moral values.⁶

While this issue has not received significant attention yet, it is likely to be increasingly relevant as larger numbers of girls and young women receive the HPV vaccine.

Informed consent in research

Informed consent becomes particularly important in research. Many bioethicists agree that investigators should follow the ethical principle of the “practical imperative,” which states that a person cannot be used simply as a means, but also as an end.⁷ Participants in a vaccine clinical trial must be informed of the risks of possible adverse reactions and the potential benefits of the vaccine.

Several obstacles often hinder appropriate informed consent in research. Among them, consent forms can be complex and poorly designed, researchers may not spend enough time with the participants, or they may not communicate in a culturally or linguistically appropriate manner.⁸ Recently, some bioethicists have questioned whether informed consent is relevant as currently understood in developing countries with very different views of authority, particularly as it pertains to family and community units.⁹

-- By Ben Kleifgen, Temple University School of Medicine (bkleifgen@temple.edu)

For more information

• CDC Vaccine Information Statements: http://www.cdc.gov/vaccines/pubs/vis/default.htm

¹ American Medical Association website: http://www.ama-ssn.org/ama/pub/category/4608.html. Accessed 20 July 2007.
² World Medical Association. 1964, 2000. Declaration of Helsinki, as amended by the WMA 52^nd General Assembly, Edinburgh, Scotland, October 2000.
³ Kissam S et al. 2004. Is signed consent for influenza or pneumococcal polysaccharide vaccination required? Archives of Internal Medicine 164:13-16
⁴ CDC website: http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm. Accessed 25 July 2007.
⁵ de Melo-Martín, I. 2007. The promise of the human papillomavirus vaccine does not confer immunity against ethical reflection. The Oncologist 11:393-396
⁶ Brabin L et al. 2007. A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent. BMC Public Health 7:20
⁷ Edwards, S D, McNamee, M J. 2005. Ethical concerns regarding guidelines for the conduct of clinical research on children. J Med Ethics 2005 31: 351-354
⁸ Grady, Christine. 2004. Ethics of vaccine research. Nature Immunology 5:465-8.
⁹ Russell FM et al. 2005. A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials. Journal of Medical Ethics 31:490-494.