Informed consent

The Code includes three rights that together form the elements of informed consent.  The three rights include: the right to effective communication (Right 5); the right to be fully informed (Right 6); and the right to consent freely given by a competent person (Right 7).

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Informed consent to screening is not simple. This is because:

• individuals who participate in screening consider themselves to be healthy and do not have any symptoms
• screening is not just a test for a condition.  A screening test is part of a pathway and may result in other interventions and treatment
• an individual may be harmed as a result of being screened, and may receive false negative or false positive results.

The New Zealand Medical Council's statement on informed consent in screening published in 2002 states:

"Doctors have a special duty of care when enrolling an apparently healthy asymptomatic person in screening programmes, to make him or her aware of the limitations of screening and the uncertainties, in particular the chance of false positive and false negative results. Before obtaining consent the doctor should explain, or give information to the patient that explains the purpose of the screening:

• the uncertainties
• any significant medical, social or financial implications for which the screening is done and,
• follow up plans, including the availability of counselling and support services".¹

The UK Medical Council has also issued a statement on informed consent in screening. Guidance from the UK's General Medical Council as set out in the November 1998 paper entitled "Seeking Patient's Consent: The Ethical Considerations" suggests the following key pieces of information need to be given to the person being asked to give their consent:

• information needs to be provided in the context of a person's values, culture and background
• consistent and helpful advice needs to be given in an easy to understand systematic form
• information must be given to the person being asked to give their consent about the benefits and risks involved
• information leaflets and/or other publications should be given to the person involved to assist them understand what is involved 
• ideally, a relative or friend should accompany the person involved in the consent discussion to assist them understand the relevant issues
• distressing information should be explained in a sensitive way
• other members of the health team should be involved in the consent discussion if the need arises
• any questions the person "being consented" wishes to raise must be answered openly and honestly
• the person with whom the consent discussion takes place should be given enough time to digest the information they have been given and to ask questions before they are required to make a consent decision.

¹Medical Council of New Zealand (2002).  Information and Consent.  Wellington, Medical Council of New Zealand. 

The Health Information Privacy Code 1994 (HIPC) sets specific rules for agencies in the health sector to better ensure the protection of individual privacy, addressing health information collected, used, held, and disclosed by health agencies.  For the health sector the HIPC takes the place of the information privacy principles in the Privacy Act 1993. 

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