- informed consent
the process of ensuring that the patient consents to being subjected to medical treatments.
Patients are asked to engage in informed consent prior to treatments or interventions, and when those treatments or interventions are part of a scientific study. Informed consent may involve verbal communication, and it may include written information that the patient is asked to review and carefully consider (Jordens, Montgomery & Forsyth, 2013). The patient is required to sign the consent form as evidence of having read about and agreed to the treatment.
To facilitate this process, informed consent documents contain accessibly written, scientifically determined, detailed information. This information covers the relevant treatment or intervention, its potential side effects, the various risks that may be involved, and a relatively linear account of the treatment trajectory (Franklin & Kaufman, 2009; Rid & Dinhofer, 2009).
This chapter discusses the principles of informed consent as it occurs in everyday communication in clinics, acute hospital wards and general practice. It considers how the decision-making of patients, their families, and their care providers is shaped not just by individuals’ personal preferences, but also by their socio-economic contexts, cultural backgrounds and expectations, personal experiences and emotions. Decisions are further likely to be shaped by the broader cultural climate created by health, legal and educational institutions which create policies, regulations, and professional cultures and subcultures in the healthcare system.
- socio-economic contexts
the social and economic circumstances that surround us. These circumstances may include ‘multi-cultural immigration’, ‘student strikes’, ‘the mining boom’ and the ‘global financial crisis’.
Introduction
Advances in medicine and technology produce many new treatment options for patients (Brown & Webster, 2004). In addition to this, the increased prevalence of chronic disease and co-morbidities in the population gives rise to new ethical and treatment challenges for patients, as well as for their families, and for healthcare providers. To come to terms with the implications of the various treatment options and with their own diseases, patients and their loved ones, in conjunction with their treating health professionals, need to deliberate about which treatments, interventions and kinds of research participation are preferable.
Informed consent is posited as the solution to some of these complex medical choices and related ethical problems. Informed consent is particularly important when it comes to making choices associated with as yet untested treatments when these are made available to patients in research clinical trials (Corrigan, 2003). Overall, informed consent has been shown to lead to greater patient satisfaction, improved patient outcomes, fewer medical errors, and lower rates of malpractice claims (Cordasco, 2013).
Informed consent: main principles
Informed consent is undergirded by the four bioethical principles: autonomy, beneficence, non-maleficence and justice (Beauchamp & Childress, 1994; Little, 2009). These principles guide how health professionals should treat patients, how doctors should undertake procedures in new fields such as regenerative, preventative and personalised medicine, and how the researcher should conduct innovative scientific and clinical trials.
In particular, scientific and clinical progress requires consent from patients, and this can be achieved only through effective communication between patients and their health professionals. For example, it is possible now to genetically screen embryos and foetuses for disease and disability (Boardman, 2013). But the information such screening produces about embryos and foetuses may have important implications for a woman’s current and future pregnancies (Hundt et al., 2006; Kerr & Franklin, 2006). It is important then for parents to engage in ‘genetic counselling’ where this information and its health implications are discussed, and where they can make informed decisions about their future.
Another example is the field of regenerative medicine and research, where there is a growth in demand for fresh eggs (oocytes) to be donated by young, fertile women. However, young women must give informed consent before they undergo invasive treatment with unknown effects on their future fertility (Carroll & Waldby, 2012).
It is important to recognise that consent may rest not just with the individual. Families and guardians may also need to be drawn into the consent process. Consider people in advanced industrialised nations: they are suffering more chronic conditions and co-morbidities, and they are living longer. They are more likely to live a long life and then die in a hospital where medical technologies and highly skilled medical, nursing and allied health professions will keep them alive for longer than in the past. It is in intensive care units where families are often faced with an uncertain prognosis of their unconscious or incapacitated loved one, and where they will need to make complex decisions about the withdrawal or continuation of treatment (Guyer, 2006; Mesman, 2008; Murray, 2000).
One bioethical concept that has special importance in informed consent is the principle of autonomy. Autonomy is the ‘respect for personal self-government’ (Naffine & Richards, 2012, p. 49). That is, autonomy harbours recognition of the role that a patient plays in decisions about their body and personhood (McGrath & Phillips, 2008). One of the ways in which autonomy is respected in medical practice is through seeking voluntary consent for medical treatments or procedures from a person who is mentally competent to understand and give consent (Jordens, Montgomery & Forsyth, 2013). Factors to consider include positive factors, such as the absence of coercion in the decision-making process, and negative factors, such as incentives (payment or discounted treatment in return for research participation).
While the notion of individual autonomy is basic to Western bioethics, Indigenous cultures of Australia place the family unit and community group at the core of decisions made about their care, treatment or interventions (McGrath & Phillips, 2008). This means that, rather than consulting just with the individual about an intervention, health professionals also need to include the family, and they may be required to include certain people in tribal positions (McGrath & Phillips, 2008). For this to succeed, it is important to have knowledge of the ‘right people’ in the family and community network to approach for informed consent (McGrath & Phillips, 2008).
The achievement of a ‘fully’ informed consent may not be possible. However, informed consent is said to be one given freely by the patient or research participant when there is full understanding of what is involved, with full knowledge of any risks and their likelihood, and without any coercion (Corrigan, 2003; Little, 2009). Informed consent also involves the care provider or researcher providing complete, accurate and understandable information (Little, 2009). This means that the information needs to be comprehended, weighed up and decided upon by the patient or research participant (Little, 2009; Little et al., 2008; Rid & Dinhofer, 2009).
Clearly, the person or people making the decisions will require certain linguistic and cognitive competencies. Ascertaining patient understanding of information presented during informed consent is not always possible or easy (Jordens, Montgomery & Forsyth, 2013). Therefore health professionals need to consider carefully how best to deliver information to patients and research participants to facilitate the decision-making (Mouce, 2013). Nurses, doctors and allied health staff are required to engage in different techniques and interventions to communicate more effectively, and plan how that information should be presented (Jordens, Montgomery & Forsyth, 2013; Mouce, 2013). This is all the more important because consent forms contain increasingly detailed information of risks and they are increasingly lengthy (Jordens, Montgomery & Forsyth, 2013). This means that health professionals need to consider how much information to deliver, how quickly and in what language, and how to ascertain the patient’s comprehension. Part of this process is that health professionals need to consider the likely effect of stress and anxiety on patients’ understanding and recall of the treatment information (Mouce, 2013).
It is just 48 hours after ‘Nancy’, a 25-year-old married woman, has given birth to premature twins (a boy and a girl).1 The twins were born 10 weeks before their due date and were severely growth restricted in utero. The twins have a very low birth weight (VLBW), particularly the baby girl. Both babies have been admitted to the neonatal intensive care unit (NICU). The twins are expected to survive; however, due to their prematurity and VLBW the neonatologist is particularly concerned about preventing necrotising enterocolitis (NEC). NEC is a severe and sometimes fatal disease of the gastrointestinal system which often occurs in premature and VLBW infants (Neu, 2011). Breastmilk is very important for premature babies because it has been found to prevent NEC (Sullivan et al., 2010). Donor breastmilk – breastmilk donated by lactating women – is recommended ahead of infant formula when a mother’s own milk is unavailable (American Academy of Pediatrics, 2012; World Health Organization UNICEF, 2003).
Nancy also has a five-year-old child, and while visiting the twins last night she told the NICU nurse that she had a lot of trouble producing sufficient breastmilk for her first child. The nurse identified Nancy’s anxiety, and provided her with information about donated breastmilk (DBM) from the human milk bank. The nurse also discussed Nancy’s lactation history with the neonatologist the following day during the morning ward round. They agreed that if Nancy could not produce sufficient volumes of breastmilk for both of the twins, it would be best to feed them with DBM from the hospital’s human milk bank.
During the morning ward round the neonatologist decided that the baby girl was medically stable but hungry. The baby was therefore ready to begin milk feedings later that day. In the afternoon the neonatologist approached Nancy and her husband Michael to begin informed consent for the use of DBM. Informed consent in this case centred not only on the written material provided to patients, but also involved a discussion with the neonatologist (Figure 14.1).
NEONATALOGIST: Now that she is breathing well without any tube in her nose or lungs, and she is a bit more than 48 hours old, it’s time for us to start thinking about giving her some milk. You already know that what we would like to do is give her breastmilk. The reason we particularly want to give her breastmilk is because for a long time she has been stressed while growing inside, and she hasn’t been growing well since about 26 weeks’ gestation. We know that babies who have been pretty stressed for a long time before they are born often take a long time for their bowel to start working properly again. So we like to give those babies human breastmilk. So any breastmilk that you are able to express and bring down, it will go to her first.
MOTHER: Fine.
NEONATOLOGIST: The nurse said you had difficulties with your first baby supplying enough breastmilk?
MOTHER: Yes.
NEONATOLOGIST: Because we really want to give her breastmilk I want to have a conversation with you about donor breastmilk.
MOTHER: Fine.
NEONATOLOGIST: I understand that yesterday you received an information pamphlet from the nurse?
MOTHER: Yes.
NEONATALOGIST: Had you heard that we had a breastmilk bank here at the hospital before?
MOTHER: No! [Laughs]
Neonataologist: Have you had time to read the breastmilk pamphlet?
MOTHER: I did today.
NEONATOLOGIST: Did that make sense?
MOTHER: Yeah, yes.
NEONATOLOGIST: So if there wasn’t enough breastmilk from your own expressing, what we would like to do is that rather than give her formula, and rather than keep the drip running unnecessarily, we would like to use breast milk from people who are donors.
MOTHER: Yes.
NEONATOLOGIST: So there are about 6–12 people who currently donate breastmilk to the breastmilk bank here at the hospital. There are very strict criteria: if you smoke you cannot donate, if you smoke marijuana you can’t donate, if you have more than two standard drinks of alcohol a day you get ruled out as well. If you have hepatitis B or C, HIV or a whole series of medical conditions, then you cannot donate. If you want to be a donor you have to undergo regular blood testing as well. If the blood tests are all good and you are in tip-top physical condition, the breastmilk that you donate is pasteurised. So if there are any bacteria or viruses in it, then they get removed prior to the milk being given to the baby. So, as a consequence of the blood tests and the pasteurisation, we believe the risk of babies getting any virus or bacteria are negligible. If you are unable to supply enough milk for your little girl then it would be really good to give her the rest of the milk as donor breastmilk.
MOTHER: Yep.
NEONATOLOGIST: Can you fill me in on your own expressing? Are you seeing a lactation consultant?
MOTHER: Yes. I saw them yesterday and I hand express every three hours. It is only day two since they were born, so I am getting a little bit stressed that nothing is coming out. In the meantime I am more than happy to do the donor milk.
NEONATOLOGIST: Your baby girl seems to be very feisty and strong which is really good. You have been given a consent form already!
MOTHER: Yes. I haven’t signed it yet.
NEONATOLOGIST: That is ok. Have you read it?
MOTHER: Yep.
NEONATOLOGIST: It reiterates what the information pamphlet says. It starts out by saying that human breastmilk is the best thing for the baby. Then it states that if there is not enough from mum we have available resources in our breastmilk bank. It outlines some of the risks associated with donor breast milk, and the steps we go through to reduce risks to negligible levels. My name is Dr Chris, and that is my signature, and so what I would like you to do is to write your name there and there and then sign.
MOTHER: [Signs the consent form] So when can she get the donor breastmilk?
NEONATOLOGIST: If she is hungry tonight, what we can do is start thawing some milk and give her some tonight. She is sucking furiously on her dummy and she is being very patient!
MOTHER: [Laughs] Ahhh she is a good girl!
After the informed consent the researcher briefly interviewed the parents about their informed consent experience with the neonatologist.
RESEARCHER: So when you first read about donor milk in the information pamphlet was there anything you were concerned about?
PARENTS: Infections. Yeah … infections.
RESEARCHER: Why did you not ask the doctor about these?
PARENTS: He told us it was negligible … and so he reassured us.
MOTHER: I am hoping that by giving her the donor milk now … I am hoping in the long run to have my milk and the donor milk together, if I don’t have enough. But we will see what happens.
RESEARCHER: Are there any extra bits of information about donor milk that you would have liked to have known but wasn’t covered in the consent form or the conversation?
PARENTS: No. It was all really covered. I think it will go well, and if I can’t express enough milk then I need to give her something. Donor milk is the next best thing to my own breastmilk.
Figure 14.1 Neonatologist (right) discussing informed consent documents with parents (left) in a neonatal intensive care unit. Informed consent is supported by both written material and opportunities to engage in discussions with health professionals.
Analysis and reflection
Practice example 14.1 provides an example of an appropriately negotiated and optimally informed consent. How do we know this? Let us weigh up what happened in the case study against the seven principles collated by Cordasco (2013) from a review of the informed consent scientific literature. These seven principles are useful for practitioners when needing to work toward a more complete informed consent process (Cordasco, 2013, p. 462):
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