Informed consent for medical student involvement in patient care: an updated consensus statement

It is a moral requirement that health systems in Aotearoa New Zealand and healthcare professional training institutions uphold principles of equity and social accountability, give effect to Te Tiriti o Waitangi and support patients’ rights. Medical students are expected to adopt these commitments. They are made aware of this during their sustained programme of medical ethics and law teaching and in clinical placements. Understanding and respecting the concept and process of consent is a central aspect of their professional development.¹

The legal requirement for consent is set out in the Code of Health and Disability Services Consumers' Rights (hereafter “the Code”).² The Code specifies 10 patient rights, including the right to be treated with respect (Right 1), the right to effective communication (Right 5), the right to be fully informed (Right 6) and the right to make an informed choice and give informed consent (Right 7). Consent is important for several reasons. It is an essential aspect of respecting patients and their autonomy, establishing rapport, building trust and promoting a positive doctor-patient relationship.^3,4 When managed well it empowers patients to actively engage with healthcare services and can increase patient participation in treatment.⁵ It can also support cultural safety,^6,7 vital for good patient care and emphasised in two recent Te Kaunihera Rata o Aotearoa Medical Council of New Zealand (MCNZ) statements.^8,9

Links between informed consent and Te Tiriti o Waitangi are evident in the Te Manatū Hauora – Ministry of Health’s Whakamaua: Māori Health Action Plan, which reiterates the role of Te Tiriti o Waitangi within health service systems and delivery.¹⁰ The positioning of article two of Te Tiriti o Waitangi within this document aligns with the concept of mana motuhake, the “right for Māori to be Māori (Māori self-determination), to exercise authority over their lives and live on Māori terms and according to Māori philosophies, values and practices including tikanga Māori” (p. 14).¹⁰

Involvement in patient care is essential in learning to be a doctor. The Code extends to circumstances when a patient is participating in the teaching and training of providers, including medical students. It specifies patients have the right to be notified of any proposed participation in teaching (Right 6[d]). The MCNZ statement on informed consent includes a requirement to obtain patients’ consent if students attend consultations or participate in their care (see Box 1). Specific consent for student involvement in care is necessary because it is important for patients to know who will be involved in their care and why. This is particularly significant in the case of student involvement because students are not registered health professionals. Failing to obtain consent to student involvement could seriously undermine patient trust and confidence and cause considerable distress. An indicator of mana motuhake within the health system is Māori patients having relevant and appropriate information to support confidence in providing informed consent, including who is involved in their care and the purpose for which they are involved.

In response to concerns about the adequacy of informed consent to student involvement in patient care,¹¹ a National Consensus Statement on Informed Consent specifically for medical students and supervisors was published in 2015.¹² It aimed to promote and guide a pragmatic, appropriate and consistent approach to seeking patients’ consent when medical students are to be involved in their treatment and care. Anecdotally, students find this consensus statement helpful and empowering. Nevertheless, some deficiencies persist in processes for obtaining consent for medical students’ involvement in patient care.^13–16

Addressing challenges

Medical students learning in clinical environments assume a range of roles and responsibilities, from passive observation through to directly providing care to an individual patient under supervision (in this statement “involvement in care” includes all such roles and responsibilities). As students transition from novice to senior, patient interaction becomes an increasingly important part of their learning. Senior students (trainee interns) are integral members of healthcare teams providing care in hospitals and general practices. Interactions between patients and medical students often occur in busy settings: clinical staff are under pressure, turnover of patients is rapid and opportunities to ask for consent are limited.

The variations in where and how students are involved in patient care affect how consent to their involvement can be obtained. Realising patient rights in such circumstances is not always straightforward. Policies to uphold patients’ rights regarding student involvement need to be tailored to each kind of learning environment, the different ways students interact with patients, and their increasing participation in healthcare provision as their learning progresses. Policies should centre on positive and engaging experiences for patients and their whānau, and be proportional to their needs and priorities. Overstating the impact of student involvement can have the perverse consequence of adding unnecessarily to patient stress. Pragmatic solutions are needed to ensure the consent process is not unsettling or arduous for patients, or unworkable for staff.

During 2020–2023 senior leaders of Aotearoa New Zealand’s medical schools, and faculty involved with teaching ethics and professionalism, met to discuss these issues. The aim was to gather expertise and reported experiences of peers working across a range of contexts, to identify factors influencing substandard practices and consider how these could be addressed. Various stakeholders were engaged at different stages to evaluate possible solutions and provide feedback on draft versions of the statement (these included chief medical officers, the Health and Disability Commissioner, the Medical Council of New Zealand, the New Zealand Medical Students' Association and the Council of Medical Colleges). This updated consensus statement is the outcome. It contains a list of key principles and considerations, including responsibilities for obtaining consent, the consent process and disclosure of information, documenting consent, sensitive examinations and procedures, patients who may not be able to consent, health information, care at home and remote care.

This statement does not establish new standards but outlines Aotearoa New Zealand’s existing cultural, ethical, legal and regulatory requirements, and considers how these may reasonably be met in some selected practical ways. It affirms proper consent processes as essential for culturally safe and Tiriti-informed care, incorporates recent MCNZ guidance, describes responsibilities of institutions and individuals to ensure consent processes are adequate and clarifies the level of information that should be provided and the processes that should be followed across the range of contexts in which medical students learn.

View Boxes 1–6, Table 1.

Key principles and considerations for obtaining consent for student involvement in patient care

1. Responsibilities for obtaining consent

Ensuring that student participation in patient care always occurs with the necessary consent requires coordinated efforts in healthcare systems. The levels of responsibility are outlined below.

1.1 The primary responsibility for ensuring consent is obtained for student involvement in a patient’s care lies with the registered health professionals responsible for that patient at the time.

1.2 Organisations providing healthcare have a responsibility to ensure appropriate consent is obtained for all aspects of patient management, including the involvement of medical students in the care of patients. The workplace environment should facilitate the gaining of consent and promote awareness that the organisation participates in teaching and that medical students might be involved in patient care. Healthcare organisations have responsibility:

a. for the overall healthcare system and ensuring consent processes can be carried out and patients’ rights to decide are respected;

b. for taking institution-wide measures to inform patients about teaching activities and their rights;

c. for ensuring processes for seeking consent are appropriate and proportionate; consent processes should be streamlined in so far as this supports patient rights, for example by including standard language in consent forms about proposed student involvement.

1.3 Students are classified as healthcare providers under the Code, and assume relevant obligations, including being accountable for ensuring consent has been given before they observe or become involved in a patient’s care (see Boxes 2 and 3). While many patients are ready to support students in their learning and are willing for them to be involved in their care, most expect to be asked, and some are less comfortable.^4,17–19 Medical students should actively assess how patients and their whānau feel about their involvement (see Box 3). If they perceive discomfort, they should have a low threshold for disengaging. This is a matter of basic courtesy, sensitivity and good practice. As part of supporting cultural safety, staff and students need to be aware of how implicit or explicit biases, values or assumptions may hamper their ability to identify a patient’s concerns.

2. The consent process and disclosure of information

The essential elements of consent are well established: patients who are competent must be given sufficient information and time to reach voluntary decisions regarding their healthcare. Patients whose competence is compromised must still be given information in a way they can understand and the opportunity to decide for themselves where possible. Here we lay out some ways these essential elements apply to consent to student participation in, and observation of, care.

2.1 Patient consent should be appropriately informed, i.e., the patient (or another person as legally appropriate) should understand what they are granting permission for. This requires conversation and communication, which includes listening to patients, appreciating how their cultural background may influence their decision making, as well as giving them information. It is important to be sensitive to and recognise perceived or real imbalances in power between patients and healthcare providers, and patients and others involved in their care, including whānau, friends, carers or employers. The most important element of obtaining consent is the two-way conversation between the doctor and the patient. Whānau may also need to be involved.

2.2 Consent from the patient should generally be obtained before a medical student is involved in any patient’s care, including observation of consultations and clinical procedures.^4,20 In almost all circumstances, students should only undertake an examination, provide treatment or perform a procedure when the patient has explicitly consented to this. The exceptions to this are very limited, e.g., time-critical situations where a patient is unconscious and the student’s involvement is urgently needed to provide or contribute to life-saving treatment. (See also 5.2 and 6.)

2.3 Where possible, patients (and those involved in their care) should be informed about the proposed extent and nature of student involvement. There are many ways in which student involvement might occur, ranging from reviewing notes and X-rays, observing on a ward round, taking histories and performing examinations, assisting in operations and conducting procedures under direct supervision or independently. Conducting a necessary procedure may be primarily for educational benefit if there is no shortage of trained clinicians to do the procedure. Conversely, students may contribute to care in ways that are primarily for the patient’s benefit, and yet the student will still gain valuable learning.

2.4 Patient consent is not a one-off event or simply an exercise in “ticking boxes”. Rather, it involves a process of building and maintaining a relationship, whether brief or sustained, based on communication and trust.³ Those involved should always remain sensitive to changes in each patient’s comfort with the presence of students and their involvement in care.

2.5 The consent process can and should be proportional to the involvement of the medical student, the nature of the interaction, and consequent risk or inconvenience to the patient. Proportionality entails assessing what a reasonable patient, in that patient’s circumstances, would expect to be informed about, and how. Consent can usually be simple, verbal, informal and taken in the context of routine verbal interactions between practitioners and patients, particularly when student involvement is limited.

2.6 When student involvement will be limited to observation or carrying out routine, low-risk procedures under supervision, broad patient consent can be sought. When the risks are higher for patients, or where student involvement is more significant or invasive (e.g., performing a sensitive examination or procedure), specific consent is required. More information about the proposed student involvement must be given, and the patient should have more time to consider their response. Broad consent must not be taken as consent to conduct sensitive examinations while under anaesthesia or procedures with material risk (see Table 1 and Boxes 4 and 5).

2.7 Consent can be sought verbally or in written form depending on the context. For instance, surgical consent forms could indicate proposed student observation of a procedure and minor participation, and enable a patient to indicate their decision.

2.8 In order to consent to student involvement, patients must understand what a medical student is and how their involvement might differ from that of registered doctors. Many patients do not understand the term “medical student” or “student doctor” unless it is explained. The former is preferable, and a brief clarification should be included in general informational material provided to patients. This should be emphasised during conversations about medical students’ involvement in patients’ care. Name badges clearly indicating the wearer is a medical student are also important.

2.9 Patients need to know they have a choice about the involvement of medical students, and they are entitled to change their mind at any time. Patients should never feel coerced or pressured into providing consent. Supervisors and students need to be considerate of the ways a patient may feel pressured to consent (e.g., a supervisor asking in front of a student may make it harder for a patient to refuse).²⁰

3. Documenting consent

3.1 Where reasonably practicable, verbal consent to (or refusal of) student involvement should be documented along with any limitations to the kinds of student involvement consented to. Written consent is required for student involvement in more substantive procedures performed under anaesthesia (including sensitive examinations).

3.2 Procedural consent forms should include a section to document broad patient consent to the involvement of medical students in observing or contributing to surgery, anaesthesia and other basic clinical activities undertaken in operating theatres, under direct supervision of an appropriate registered health professional (note Right 7.6 of the Code).

4. Sensitive examinations and procedures

4.1 Sensitive examinations bring students into contact with patients in ways that can make patients feel vulnerable. They require trust and attention to the patient’s responses to perform safely. If not performed with care, sensitive examinations can be experienced as violations. Examinations of certain areas of the body (breast, vagina, rectum, external genitalia) and procedures pertaining to those areas (e.g., catheterisation) are by their nature sensitive. Specific and documented consent is required for student involvement in such exams and procedures. However, sensitivity is not restricted to these areas of the body. Cultural groups and communities hold differing criteria for cultural safety, and with respect to what comprises a sensitive exam. For instance, the concept of tapu dictates within Te Ao Māori a person’s comfort with and acceptance of physical examinations. For people who have experienced assault or abuse, contact with parts of the body that may not be widely regarded as sensitive (such as the upper arms or wrists) may be traumatising. Clinical supervisors and students should be aware of the cultural and experiential nature of sensitivity and approach each patient encounter with due care.

4.2 Consent for sensitive examinations (including breast, rectal, vaginal or external genitalia examinations) and procedures (e.g., catheterisation) in competent awake patients can be verbal, but should be documented in the patient’s notes.^{21, 22} Extra care needs to be taken to avoid undue pressure (e.g., it may be harder for a patient to refuse if they are asked after undressing) (see Box 6).

4.3 Sensitive examinations under anaesthesia require written consent obtained in advance and signed by the patient. Without such consent, a student cannot undertake an examination or intervention on a patient under anaesthesia (see Box 5). In some instances where there are unexpected complications and a patient under anaesthesia needs more investigation or more extensive treatment than was anticipated, the student must consult their supervisor about whether to remain involved.⁶

4.4 In situations where patients or their whānau are particularly vulnerable, meticulous care is required in seeking and documenting consent for the involvement of medical students. These may include discussion of sensitive examinations (particularly under anaesthesia), withdrawal of life support, organ donation, catheterisation and the communication of bad news (which will be contextual for the patient).

5. Patients who may not be able to consent

5.1 Consent processes with children are complex and require judgement and expertise. In some situations, children can consent for themselves. Alternatively, the child’s parent or guardian may need to provide consent. Where this occurs, the assent (agreement) of the child should also be obtained, where appropriate and possible. The principles remain the same, but in many cases, e.g., neonatal intensive care, there may be a parental perception their child is too vulnerable to be examined by anyone other than an expert.¹⁹ This requires special sensitivity and reassurance. Often consent will be only for student observation of a staff member examining a child. It is important to invite the parents to be present if possible.

5.2 Where a patient temporarily or permanently lacks decision-making competence, consent should be obtained from the patient’s legal representative. If no legal representative exists, the patient’s view should be sought to the extent possible in the circumstances, as well as the views of suitable others interested in the patient’s welfare (this may include whānau members, a support person or carer). When there is no practical opportunity to obtain consent from a legal representative, the treating doctor should determine what, if any, student involvement is in the patient’s best interests. If the patient indicates discomfort with the student’s involvement, the student should immediately discontinue.

6. Health information

6.1 As part of the healthcare team, students will have access to patients’ health information. In some contexts, it is most practicable for students to review the patient’s health information prior to seeing the patient, and before the patient has had the opportunity to decide about student involvement. This could be required for educational reasons, but also as part of preparing students for a particular clinical situation. These factors must be weighed against potential harms relating to the patient’s privacy, and this balance may depend on context. This should be made explicit to staff and students. If a patient declines students access to their health information this must be respected.

6.2 One way to mitigate risks is to ensure staff are aware of the possibility some patients may decline student involvement or access to their information because of particular sensitivities or privacy needs, and in those situations, students should not have access to the patient’s information before receiving consent. Students must also be mindful of the need to treat health information as confidential and staff need to support them in meeting this responsibility.²⁰

7. Care at home and remote care

7.1 In primary care settings, students might accompany registered health professionals on visits to patients’ homes or residential aged care facilities. Verbal consent for the student to enter the house or room should be sought from the patient and/or whānau who might be present. Where possible, this should be done before the visit.

7.2 Students may have the opportunity to attend telehealth appointments. Verbal consent for the student to join the call should be sought prior to the student sitting in. Where possible, consent should be sought in advance of the appointment.

Conclusion

This statement outlines Aotearoa New Zealand’s existing cultural, ethical, legal and regulatory requirements for consent to students’ observation and involvement in patient care. It offers guidance about how these requirements can be appropriately met. The principles and considerations it contains are designed to guide policies, processes and practices of healthcare providers, clinicians and students to ensure patients’ rights are respected in relation to student participation in healthcare. Ongoing attention, training and review is required to ensure Aotearoa New Zealand’s legal and professional standards and societal expectations are consistently met. The authors call upon those involved in healthcare to work together to address the practical challenges in obtaining such consent for the betterment of patient care and medical training.

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