Featured image “Diverging paths” by SDJ on Deviant Art.
I’ve just finished the first draft of my 13th article in the Clinical Teacher mobile app. It’s been a LONG time since I’ve managed to put some effort into this project, mainly for personal reasons (my second daughter was born in March last year and we moved house in September) but also because I found 2015 to be a very challenging year in terms of prioritising my writing projects (I have another post in progress where I talk about some new strategies for prioritisation in my workflow).
Anyway, here is the draft of my article on Informed Consent, which I’ll be publishing in the app within the next couple of weeks.
A successful relationship between patient and health care practitioner is based on trust, which is developed partly by respecting the autonomy of the patient i.e. their right to make their own decisions about their bodies. Informed consent is the exercise of informed choice by a patient who has the capacity to give consent and is therefore a component of developing a trusting relationship between patient and therapist (Wilders, 2013). Patients need complete and honest information about various aspects of their health care, including diagnosis, prognosis, treatment options, likely treatment outcomes, common or serious side effects, and the timescale of the treatment in order for them to give their informed consent (Tippet, 2005).
The patient is the one who determines what is in their best interests, not the practitioner. Practitioners may recommend a course of action but should not pressurise patients to accept their advice. The practitioner must ensure that their opinion is a balanced point of view, providing the patient with enough detail from the various perspectives that they are able to give their own, voluntary consent. It is possible for patients to nominate a third party (provided they are still competent to make such a decision) to give consent on their behalf. This must be provided by the patient in writing.
Health care professionals must be confident that they have received consent from a patient – or other valid authority – before they perform an examination or investigation, provide treatment, or involve patients in teaching and research (General Medical Council, 2008). It should be based on the sharing of correct information, appropriate communication, and understanding and agreement on the part of the patient. In order for the process of informed consent to be correct and legal, the patient must have (Wilder, 2013):
- Knowledge of the nature or extent of the harm or risk
- Appreciated and understood the risk
- Consented to the risk
The consent must have been comprehensive
All aspects of health care involves decision-making by patients and healthcare providers and the principles of informed consent apply to those decisions, from the treatment of minor conditions, to major interventions with significant risks or side effects. Whatever the context in which medical decisions are made, the health care professional must work in partnership with patients to ensure appropriate care. In order to achieve this, you should (General Medical Council, 2008):
- Listen to patients and respect their views about their health
- Discuss patients’ diagnosis, prognosis, treatment and care with them
- Share the information that patients want or need in order to make decisions about their health
- Maximise patients’ opportunities, and their ability, to make decisions for themselves
- Respect the decisions that patients make
Patients can express consent either orally or in written form. However, it is strongly recommended that consent be obtained in writing. This can be done either in the case notes, or on a specific consent form. The consent form should contain the information provided to the patient, specific requests by the patient and the scope of the consent given.
Once written consent has been given once, the practitioner can simply remind patients of the initial instance, if they present at a later date with a similar condition. However, this consent should be revisited regularly to ensure that the patient is still comfortable with the procedure. Verbal reminders and responses should still be noted in writing in the patient’s file. When a patient presents with a new condition, fresh consent must be obtained and appropriately documented.
Practitioners should use caution if relying on a patient’s compliance with a procedure as an indicator of consent because submission in itself may not indicate consent (Wilder, 2013). Just because a patient goes along with what is happening, does not mean that they understand the nature, extent and risks that are associated with it. Consent must be expressed explicitly at all times.
Informed consent is premised on the concept of sharing information with the patient. There is no single approach that will suit every patient, or apply in all circumstances. Some patients may want more or less information or involvement in the decision making process, depending on their needs. In addition, some patients may need additional support to understand information and express their views and preferences (General Medical Council, 2008).
The way you choose to discuss the various aspects of a patient’s condition, including diagnosis, prognosis and the treatment options that are available, can be just as important as the information itself (General Medical Council, 2013). When sharing information with a patient (or their family), you should:
Share information in a way that the patient can understand and when possible, in a place and at a time when they are best able to understand and retain it.
Be considerate when sharing information that the patient may find distressing.
Involve other members of the healthcare team in discussions with the patient, if this is appropriate.
Give the patient time to reflect, before and after they make a decision, especially if the information is complex or what you are proposing involves any risk.
Make sure the patient knows if there is a time limit on making their decision, and who they can contact if they have any questions or concerns.
Give information to patients in a balanced way. For example, if you recommend a course of action, you should explain your reasons for doing so but also be aware of putting unnecessary pressure on a patient to accept your advice.
Support your suggestions with written material or other visual aids (make sure the information is accurate and up to date).
Check to determine if the patient needs any additional support in order to understand the information you shared, to communicate their wishes, or to make a decision.
Bear in mind that some barriers to understanding and communication may not be obvious. For example, a patient may have certain anxieties that they have not mentioned before, or may be affected by pain or other underlying problems. Support for patients might include using an advocate or interpreter, asking those close to the patient about the patient’s communication needs, or giving the patient a written or audio record of the discussion and any decisions that were made.
The information provided to the patient should include the following:
- The nature and extent of the procedure, using language that the patient understands
- Whether students will be involved in the procedure, and the extent to which they will be involved
- Reminders that the patient can withdraw consent at any time i.e. change their minds
- Reminders that the patient can seek a second opinion
Details of the costs applicable (if relevant)
Possible reasons for not sharing information
Remember that patients are vulnerable and that overzealous truth-telling may be harmful to them. As a result they have an equal right to refuse to receive information about themselves and their condition (Tippet, 2005). From the General Medical Council (2008): “You should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm”.
If a patient has the capacity to make their own decisions but appears to not want to have relevant information shared with them, the health care practitioner should consider the following steps (General Medical Council, 2008):
No-one else can make a decision on behalf of an adult who has the capacity to give their consent. If a patient asks you to make decisions on their behalf or wants to leave decisions to a relative, partner, friend, carer or another person close to them, you should explain that it is still important that they understand the options open to them, and what the treatment will involve. If they do not want this information, you should try to find out why.
If, after discussion, a patient still does not want to know in detail about their condition or the treatment, you should respect their wishes, as far as possible. But you must still give them the basic information they need in order to give their consent to a proposed investigation or treatment.
If a patient insists that they do not want even this information you must explain the potential consequences of them not having it, particularly if it means that their consent is not valid. You must record the fact that the patient has declined this information making it clear to them that they can change their mind at any time.
You should not withhold the information that is necessary for making decisions for any other reason, including when a relative, partner, friend or carer asks you to, unless you believe that giving it would cause the patient serious harm. In this context serious harm means more than the patient simply becoming upset or deciding to refuse treatment.
If you withhold information from the patient you must record your reason for doing so in the patient’s medical records and be prepared to explain and justify your decision. You should regularly review that decision and consider whether you could give information to the patient later, without causing them serious harm.
Obstacles to sharing information
Because of time or resource limitations, it might be difficult to give patients as much information or support in the decision making process as you, or they, would like. To help with this, consider the role that other members of the healthcare team might play and what other sources of information and support are available. For example, do you have access to patient information leaflets, advocacy services, expert patient programmes, or support groups for people with specific conditions?
Do your best to make sure that patients with additional needs, such as those with disabilities, have the time and support they need to make a decision. In all cases, treat patients fairly and make sure that you do not discriminate against them by providing them with less detailed information than you might do for others. If you believe that limits on your time or the information that is available for patients is compromising their ability to make an informed choice, you should raise your concerns with your line manager or other authority (General Medical Council, 2008).
Conditions for consent
In order for a patient to give valid informed consent, there are three components that must be present; disclosure, capacity and voluntariness (Faden & Beauchamp, 1986). Disclosure requires the therapist to provide the patient with the necessary information to make an independent decision. However, it is not enough that the therapist merely provides the information; they must also ensure that the patients have adequate comprehension of the information they provide. This latter aspect of the process implies that the consent form be written in language that is understandable by the general population, in addition to determining the level of the patient’s understanding during the initial assessment. Capacity refers to the ability of the patient to both understand the information provided and to subsequently form a reasonable judgement of the potential consequences of their decision. Finally, voluntariness refers to the patient’s right to freely exercise their decision-making without being subjected to external pressure such as coercion, manipulation, or undue influence (Beauchamp & Childress, 1994).
Capacity to give informed consent
In order to give consent patients must be able to understand the procedure that is being recommended, apply reasoning to consider the consequences of the procedure and its alternatives, appreciate the way in which this information applies to them, and be able to make a subsequent logical choice. Although psychiatric illness, in and of itself, does not change the presumption that an individual is competent, a patient’s ability to appreciate the consequences of a particular decision maybe shaped by specific mental symptoms. Thus, cognitive deficits (e.g., due to dementia or associated with depression) can impair the ability to recall and understand information about the procedure, suicidal ideas can affect perceptions of mortality risks, and the ambivalence and indecision that often occurs with depression can limit patients’ ability to make a choice about treatment. If a patient lacks decisional capacity, substituted consent (possibly by a family member) or a judicial hearing may be necessary (Lapid, Rummans, Pankratz & Appelbaum, 2004).
Therapists must always work from the premise that every adult patient has the capacity to make decisions about their health. This includes the ability to make decisions about whether to agree to, or refuse, an assessment, investigation or treatment. You should only regard a patient as lacking capacity once it is clear that, having been given all appropriate help and support, they cannot understand, retain, use or weigh up the information needed to make that decision, or communicate their wishes. It is essential that the therapist does not make the assumption that a patient lacks the capacity to make a decision because of their age, a disability, their appearance, behaviour, medical condition (including mental illness), their beliefs, their apparent inability to communicate, or the fact that they make a decision that you disagree with (General Medical Council, 2008).
If patients are not able to make decisions for themselves, the health care professional must work with those who are close to the patient and with other members of the team. They must take into account those views or preferences that were expressed by the patient and must also be aware of the legal context when a patient lacks the capacity to make their own choices (General Medical Council, 2008).
Children and informed consent
As children often lack the ability or legal power to provide true informed consent for medical decisions, it falls on parents (or legal guardians) to provide permission for medical assessments or procedures to be conducted on children. This “consent by proxy” usually works reasonably well but can lead to ethical dilemmas. This is particularly true when the judgement of the guardians differ with the therapist with regard to what constitutes an appropriate decision.
Children who are legally emancipated and unemancipated minors who are deemed to have medical decision making capacity, may be able to provide consent without the need for parental permission, although this depends on the laws of the country the child lives in (Committee on Bioethics, 1995).
Children are usually presumed to be incompetent to consent, but depending on their age and the influence of other factors, they can sometimes be asked to provide Informed assent.
Informed assent means a child’s agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently.
De Lourdes Levy, Larcher & Kurz (2003)
Medical professionals are advised to seek the assent of older children and adolescents by providing age appropriate information to these children to help empower them in the decision-making process (Committee on Bioethics, 1995). It should be noted that only legal guardians are able to provide informed consent for a child, and not adult siblings. In addition, parents may not order the termination of a treatment that is required to keep a child alive even if they feel it is in the best interests of the child.
Responsibility for seeking consent
It is the responsibility of the practitioner who will be providing the treatment, to obtain consent, since they will have a comprehensive understanding of the process, how it is to be carried out and the risks involved. In cases where the responsibility to obtain consent must be delegated to another party, they must ensure that the person they are delegating to:
- Is suitably trained and qualified to take on the responsibility
- Has sufficient knowledge of the investigation or treatment, and understands the risks involved
- Understands, and agrees to act in accordance with established guidelines and legal frameworks that are related to issues of informed consent
If you delegate the responsibility of seeking consent to another party, you are still responsible for ensuring that the patient has been given enough time and information to make an informed decision, and has given their consent, before you start any investigation or treatment (General Medical Council, 2008).
Informed consent in research
Medical research is overseen by an institutional ethics committee that usually also oversees the informed consent process as part of any research project involving human beings or animals. Ethics clearance is applied for by researchers via a detailed proposal document, that lays out in detail – among other things – the ways in which the ethics inherent in the project are being considered.
Differences in local contexts (e.g. language and social norms) make the issue of informed consent in research a complex topic. There are five benchmarks for evaluating informed consent procedures in local contexts, with particular reference to developing countries (Emanuel, Wendler, Killen & Grady, 2004):
The community should be involved in drawing up recruitment and incentive procedures that are consistent with local cultural, political and social practices. For example, in some cultures an incentive might be expected, while in others it could be considered offensive.
Disclosure of information should be sensitive to the local context, using local languages, culturally appropriate idioms, and analogies that the local population will understand.
Researchers may need to obtain consent from a range of different “spheres”, including community leaders, elders or other respected community members, and the heads of family. Note that this is not to imply that these individuals grant consent on behalf of other adults, only that they give permission for the researchers to enter the community.
Researchers should use informed consent procedures that are contextually acceptable within a community but which also enable independent observers to verify that voluntary consent was obtained.
Individuals must be made aware that their right to refuse to participate, or to withdraw from the study is actually enforced. Community or familial coercion or retribution needs to be guarded against, especially if compensation for participation is offered.
The World Health Organisation (WHO) has published a series of templates for Informed Consent in a variety of contexts, including research that involves children requiring parental consent, qualitative and clinical studies. These templates may be used to guide principal researchers as they develop an approach to informed consent in their research practices.
Seeking consent in the research process brings with it another set of challenges, especially in the social sciences where there is often little or no risk to participants. In addition, the fact that participants are aware that they are involved in a study may cause them to change their default behaviour (the Hawthorne Effect). In cases where the researcher is concerned that seeking consent will modify the outcomes of the study, the requirement for consent may be waived. However, this is only done after an Ethics Committee has weighed the possible risk to the study participants versus the benefit to society, as well as whether participants are present in the study of their own will and that they will be treated fairly.
Informed consent – especially in the clinical context – should be thought of as an ongoing dialogue between patient and healthcare practitioner (Emanuel, et al., 2004). The decision made by the patient should be reviewed at different points before treatment begins, to ensure that the patient’s point of view is consistent and can therefore be relied on. Before beginning treatment you or a member of the healthcare team should check that the patient still wants to go ahead and you should respond to any new or repeated concerns or questions they raise. This is particularly important if:
- A significant amount of time has passed since the initial decision was made.
- There have been material changes in the patient’s condition, or in any aspect of the proposed investigation or treatment.
- New information has become available, for example about the risks of treatment or other treatment options.
You need to make sure that patients are kept informed about the progress of their treatment and that they are able to make decisions at all stages, not just in the initial stage. If the treatment is ongoing you should make sure that there are clear arrangements in place to review decisions and if necessary, to make new ones (General Medical Council, 2008).
Informed consent is an essential aspect of clinical practice and medical research. The process of sharing relevant information with a patient to ensure that they can make an informed choice about their bodies and their health, is a central principle of ethics. Patient autonomy is premised on the idea that they – not the healthcare practitioner – are best positioned to make decisions about the relative risks and benefits of choosing a particular course of action.
Sharing information is an important aspect of consent, although what information to share, how much and when, are sometimes difficult to determine, especially in cases where patients are not competent. It is the responsibility of the healthcare practitioner to ensure that consent is obtained before proceeding down a particular path of management, and in cases where the actual process is delegated, it is the practitioners responsibility to ensure that the person the task is delegated to is trained to carry it out.
Seeking informed consent is complex, time consuming, possibly frustrating, and may even require health professionals to reconsider the role of power in their patient relationships. However, not only is it a legal requirement to involve the patient in decision-making around management, but it is a foundational ethical principle to adhere to in clinical practice.
Beauchamp, T.L. & Childress, J.F. (1994). Principles of Biomedical Ethics (4th edition). New York: Oxford University Press.
Committee on Bioethics (1995). Informed consent, parental permission, and assent in pediatric practice. Pediatrics, 95(2):314-7.
De Lourdes Levy, M., Larcher, V., & Kurz, R. (2003). Informed consent / assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics. European Journal of Pediatrics. 2003 Sep;162(9):629-33.
Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. The Journal of infectious diseases, 189(5), 930–7.
Faden, R.R. & Beauchamp, T.L. (1986). A History and Theory of Informed Consent. New York: Oxford University Press.
General Medical Council (2008). Consent guidance: patients and doctors making decisions together.
Health Professions Council of South Africa (2008) Ethical rules, regulations and policy guidelines: Informed consent.
Lapid, M.I., Rummans, T.A., Pankratz, V.S. & Appelbaum, P.S. (2004). Decisional capacity of depressed elderly to consent to electroconvulsive therapy. Journal of Geriatric Psychiatry and Neurology, 17(1):42–46.
Spandorfer, J., Pohl, C. A., Rattner, S. L., & Nasca, T. J. (2010). Professionalism in medicine: A case-based guide for medical students. Cambridge University Press.
Tippett, V. (2005). “Trust me…I’m a medical student”: Truth and trust for student doctors. The Clinical Teacher, 2(1), 21–24.
Wilder, C. Seeking patients’ informed consent: The ethical considerations. Health Professions Council of South Africa news bulletin, March, 2013
World Health Organisation (n.d.). Informed Consent form templates.