Informed Consent

Investigate Before You Vaccinate

By Sue Claridge (taken from Chapters 1 and 2 of Investigate Before You Vaccinate, 3rd ed).

For most parents in New Zealand taking their new-born baby along to their six week well-child check is standard procedure. Among other things, the doctor will give the baby two shots containing vaccines for six diseases. Most parents do not question this medical intervention. The vast majority will have grown up with vaccines and, along with the rest of the community, regard vaccines as something akin to a modern medical miracle. They accept all the “advice” from doctors, nurses, Plunket, family and friends, that this is not just the best thing to do for their baby but the “only” thing to do.

Some parents now question the idea that their babies must be vaccinated to ensure good health. In fact, many parents believe that, in reality, vaccination may leave their children sick, disabled or damaged for life, or worse still, may kill their children. Increasing numbers of parents are choosing to investigate before they decide whether or not they will vaccinate their children.

Vaccination is not compulsory!

Vaccination is not immunisation!

As a result of their own research increasing numbers of parents believe that vaccines:

  • are not necessary;
  • are not effective; and
  • are not safe.

Speaking about the polio vaccination campaign in the 1950s, Dr Paul Meier said:

“It is hard to convince the public that something is good. Consequently, the best way to push forward a new program is to decide on what you think the best decision is and not question it thereafter, and further, not to raise questions before the public or expose the public to open discussion of the issues.” 1

These comments were further reinforced when the United States Food and Drug Administration (FDA) quietly rushed through rule changes lowering the polio vaccine testing standards:

“any possible doubts, whether or not wellfounded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives.” 2

This epitomises the attitude of the Medical Establishment to vaccination and many other medical treatments. They do not want the public to educate themselves about vaccination issues for they fear that the public may not like what they find.

However, your right to provide truly informed consent to vaccination or any other medical procedure or treatment is enshrined in New Zealand legislation.

“Consent is a fundamental concept in the provision of health care services, including immunisation.” So says the Immunisation Handbook3 (see below). The critical issue is whether or not that consent is informed. Health professionals in New Zealand have a legal obligation to obtain informed consent before any medical treatment or procedure, including vaccination. Informed consent can only be provided by a patient or caregiver (parent) when the patient or caregiver has considered all the information pertaining to the risks and benefits of the proposed treatment or procedure.

While health professionals in New Zealand may consider that they obtain informed consent, many parents are not given all the information that they need to make an informed decision. Some doctors have told IAS that they have been threatened with the loss of their contracts if they do not promote vaccination (Pers. comm.). In 2002, Dr Colin Tukuitonga, the Director of Public Health, said that he believed that midwives who did not promote “immunisation” were in breach of their contracts as lead maternity caregivers,4 despite their clear obligation to provide information on the risks as well as the benefits of vaccination.

There is pressure on health professionals to provide only information that is sanctioned by the Ministry of Health (MoH). However, “official” information is incomplete and it is recognised by New Zealand consumer advocacy and health organisations (other than the IAS) that further information is necessary in order for people to be able to make an informed decision.5

Dr Jane Orient, Executive Director of the Association of American Physicians and Surgeons (AAPS) says that “Physicians have a duty to present the risks and benefits as accurately as they can, including an honest appraisal of gaps in our knowledge.”6 The AAPS voted to oppose mandatory vaccination (in the United States) in November 2000 and stated that “safety testing of many vaccines is limited and the data are unavailable for independent scrutiny, so that mass vaccination is equivalent to human experimentation and subject to the Nuremberg Code, which requires voluntary informed consent.”7 (this author’s emphasis).

In an environment where there is often no-one prepared to accept responsibility when medicine goes badly wrong, when ultimately it is the children and their parents who pay the price no matter who is to blame, it is crucial that the people on the receiving end of medical treatment (or their parents or caregivers) are satisfied that it is in their best interests and that the benefits outweigh all of the risks. This is what informed consent is all about.

Excerpt from the Ministry of Health’s Immunisation Handbook, 2006.

Consent is a fundamental concept in the provision of health care services. It is based on ethical obligations, which are, in part, supported by legal provisions (e.g. Health and Disability Commissioners Act 1994, Code of Health and Disability Services Consumers’ Rights 1996 and Privacy Act 1991). Consent is a process whereby the individual and/or their representative (if the patient does not have the capacity to consent) are appropriately informed and willing and able to agree to what is being suggested without coercion. It also includes the right to be honestly and openly informed about one’s personal health matters. The right to agree to treatment carries with it the right to refuse treatment. Regardless of age, an individual must be able to understand:

  • that they have a choice
  • why they are being offered the treatment
  • what is involved in what they are being offered
  • the probable benefits, risks, side effects, failure rates and alternatives.

The essential elements of the informed consent process are effective communication, full information and freely given competent consent. The Code of Health and Disability Services Consumers’ Rights that represent these three elements are:

Right 5: Right to Effective Communication.

Right 6: Right to be Fully Informed.

Right 7: Right to Make an Informed Choice and Give Informed Consent.

For example, section 7(1) of the Code states that ‘No health and disability service can be provided to a consumer without his or her informed consent.’ Health professionals have legal obligations to obtain informed consent. Unless there are specific legal exceptions to the need for consent, the health professional who acts without consent potentially faces the prospect of a civil claim for exemplary damages, criminal prosecution for assault (sections 190 and 196, Crimes Act 1961), complaints to the Health and Disability Commissioner and professional disciplining.

The patient or parent/guardian needs to understand the risks and benefits of vaccination, including risks to the child and community, in order to give informed consent.3

“The patient who is armed with information, who wants to ask questions, sometimes difficult and awkward questions, should be seen as an asset in the process of care and not an impediment to it.”

Sir Liam Donaldson, Chief Medical Officer in the
Department of Health, UK, Second National Service Delivery
and Organisation Conference, 19th March 2003.

References

1. Intensive Immunization Programmes, 1962: Hearings before the Committee on Interstates and Foreign Commerce, House of Representatives, 87th Congress, 2nd Session on H.R. 10541, Washington D.C., US Government Printing Office.

2. No authors listed, 1984: US Federal Register, Volume 49, No 104, June 1, 1984, Page 23007, middle column.

3. Ministry of Health, 2006: Immunisation Handbook 2006, Wellington, Ministry of Health.

4. Angela Gregory, 2002: Midwives accused of threat to babies, The New Zealand Herald, 19 June, 2002.

5. Parents Centre, Pers. comm., June 2002; Maternity Services Consumer Council, Pers. comm., June 2002.

6. Orient, Jane, M.D., 2001; Letter to NBC in response to an episode of ER and a call to boycott the television series, AAPS, www.aasponline.com (accessed October 2001).

7. AAPS, 2000: AAPS Resolution Concerning Mandatory Vaccines, Ethical Medicine, AAPS Annual Meeting, October 25 – 28, 2000, www.aapsonline.org (accessed July 2002).

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