Australian Government Department of Health and Ageing Immunisation HandbookAustralian Government Department of Health and Ageing crest. Link to the Immunise Australia Program homepage.

1.3 Pre-vaccination Procedures

1.3.3 Valid consent

Please note: due to continuous updates being made to the Immunisation Handbook, the page number on the electronic version will not always match the hard copy version.


Valid consent can be defined as the voluntary agreement by an individual to a proposed procedure, given after appropriate and reliable information about the procedure, including the potential risks and benefits, has been conveyed to the individual.3-7

For consent to be legally valid, the following elements must be present:8

  • It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.
  • It must be given voluntarily.
  • It can only be given after the relevant vaccine(s) and their potential risks and benefits have been explained to the individual.
  • The individual must have sufficient opportunity to seek further details or explanations about the vaccine(s) and/or their administration.

Consent should be obtained before each vaccination, once it has been established that there are no medical conditions that contraindicate vaccination.

Consent on behalf of a child or adolescent

In general, a parent or legal guardian of a child has the authority to consent to vaccination of a child.3,7 A child in this context is defined as being under the age of 18 years in all States and Territories except New South Wales, where the age is 14 years, and in South Australia and the Northern Territory, where the age is 16 years.

If they are of sufficient age and maturity to understand the proposed procedure and the risks and benefits associated with same, children at younger ages may be able to provide consent for procedures such as vaccination. Please refer to your own State or Territory immunisation service provider guidelines for more information.

Should a child or adolescent refuse vaccinations for which a parent/guardian has given consent, the child’s wishes should be respected and the parent/guardian informed.3

Consent on behalf of people with impaired decision-making ability

A responsible adult family member, preferably with authority to make medical decisions, may give consent for vaccination of an adult with a significant disability. For example, this may occur for influenza vaccination of an elderly person with dementia.

Resources to help communicate the risks and benefits of vaccines

Plain language should be used in communicating information about vaccines
and their use to an individual. The individual must be allowed to ask for further information and have time to make a decision about whether to consent or not.9,10 It is preferable that printed information is available to supplement any verbal explanations.11 The summary table Comparison of the effects of diseases and the side effects of vaccines inside the front cover of this Handbook provides some basic information necessary to communicate the risks and benefits of vaccination. The table can be photocopied and used freely as required.

More detailed information concerning vaccines and their use is available from the following sources:
  • www.immunise.health.gov.au
    The Immunise Australia website includes ‘Common questions and answers (fact sheets)’, ‘Understanding childhood immunisation’ and links to State and Territory Health Department websites. Several of these sites offer multilingual fact sheets.
  • www.ncirs.usyd.edu.au
    The National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases website includes fact sheets related to specific vaccines, vaccine-preventable diseases and vaccine safety.

See also Appendix 5, Commonly asked questions about vaccination.

Evidence of consent

General practice or public immunisation clinics

Consent may be given either in writing or verbally, according to the protocols of the health facility, but it must meet the criteria for valid consent. Evidence of verbal consent should be documented in the clinical records. If a standard procedure is routinely followed in a practice or clinic, then a stamp, a sticker or a provider’s signature indicating that the routine procedure has been followed, may be used. For paperless medical records, a typed record of verbal consent may be made in the patient’s file, or a copy of written consent scanned into the file.

Consent is often given and recorded at the first vaccination visit. Explicit verbal consent is required before subsequent vaccinations even when written consent has been given at previous vaccination encounters.

School-based vaccination programs

Consent is often given for the entire vaccination program and is valid for the number of doses to be given during a school-based vaccination program.

In school-based (and other large-scale) vaccination programs, the parent or guardian usually does not attend with the child on the day the vaccination is given, and written consent from the parent or guardian is desirable in these circumstances. However, if further clarification is required, verbal consent may be sought by telephone from the parent or guardian by the immunisation service provider. This should be clearly documented on the child’s consent form. Older adolescents may be able to provide their own consent for vaccinations.12 However, the vaccination program may vary between jurisdictions. Please refer to your own State or Territory immunisation service provider guidelines for more information.

References


3. The Medical Defence Association of Victoria Ltd (MDAV). Medicine and the law: a practical guide for doctors. Carlton, Victoria: MDAV, 2005.

4. Skene L. Doctors' duty to inform: debates pre- and post- Rogers v Whitaker: swings, roundabouts and pendulums. Australian Health Law Bulletin 2002;11:33-6.

5. Skene L, Smallwood R. Informed consent: lessons from Australia. BMJ 2002;324:39-41.

6. Rogers v Whitaker. Australian Law Reports (1992) 109 ALR 625 at 633.

7. Gulam H. Consent: tips for health care professionals. Australian Nursing Journal 2004;12:17-9.

8. Staunton PJ, Chiarella M. Nursing and the law. 5th ed. Sydney: Elsevier (Australia), 2003.

9. Bird S. Discussing benefits and risks with patients. PSA testing. Australian Family Physician 2004;33:266-7.

10. Bird S. Can children and adolescents consent to their own medical treatment? Australian Family Physician 2005;34:73-4.

11. National Health and Medical Research Council (NHMRC). General guidelines for medical practitioners on providing information to patients. Canberra: NHMRC, 2004. Available at: http://www.nhmrc.gov.au/publications (accessed Apr 2006).

12. NSW Association for Adolescent Health (NAAH). Working with young people. Ethical and legal responsibilities for health workers. Sydney: NAAH, 2005. Available at: http://www.naah.org.au/download_files/ACF5D0F.pdf (accessed Apr 2006).

Top of page