We read the recent article by Bhoopatkar et al., Adherence to a national consensus statement on informed consent: medical students’ experience of obtaining informed consent from patients for sensitive examinations,[[1]] with great interest but also serious concerns regarding the quality and outcome of the findings.

Bhoopatkar et al.’s paper assesses two of the principles set out in the consensus statement: 1) whether signed consent was obtained before sensitive examinations on anaesthetised patients, and 2) whether informed consent was documented when performing sensitive examinations on conscious patients. It is a prospective survey over an underpowered sample size, and it carries an associated type II error: combination of a small cohort selection, inherent variability or bias in the data (participants are aware of the well-publicised paper on consent by Bhoopatkar) and potential random sampling error obscuring the population effect. Secondly, the study is largely based on students’ recollection and asks them if, prior to sensitive examinations, consent was documented for conscious patients and signed consent obtained in advance for anaesthetised patients. Responses were not cross-checked with patient files and it remains possible that medical staff on the team did in fact document consent or subsequently obtain verbal/signed consent prior to the medical student being asked to perform sensitive examinations. Bhoopatkar et al.’s paper reports no incidents of continuing examination despite patient refusal or physical withdrawal.

Despite limitations, the study shows serious shortcomings in obtaining consent. Following this, we undertook a snapshot survey at Taranaki Hospital to audit the adherence of students and senior medical officers (SMOs).

Anonymous e-surveys for medical students and SMOs was created based on the 19 principles derived from Bagg et al.’s[[2]] national consensus statement on the guidelines for medical students and obtaining informed consent, prepared by the Auckland and Otago Medical Schools, Chief Medical Officers at district health boards, the New Zealand Medical Students’ Association and the Medical Council of New Zealand. We considered both sensitive and non-sensitive consent issues. The survey was distributed by email and was open for 3 weeks. Two reminder emails were sent. Responses were based on a five-point Likert scale, ranging from: “always” (100% of the time), “most of the time” (75% of the time), “usually” (50% of the time), “rarely” (25% of the time) and “never”, or not applicable (N/A).

Out of 35 Year 5 and 6 medical students, 24 responded (68.5% response rate). Out of 120 invited SMOs, 66 responded (55% response rate). Full results are shown in the appendices.

Our study’s results are better than Bhoopatkar et al. in terms of our 75% full student compliance to the consensus statement regarding obtaining signed consent prior to sensitive examinations, whereas in Bhoopatkar et al.’s study full compliance rates ranged from 12.5% to 36.4% for rectal, breast and genital exams, with the exception for pelvic exams which was 84.7%. Our study shows similar deficiencies in documentation of obtaining consent in conscious patients with only a 24% student compliance, which is slightly better than Bhoopatkar et al.’s results ranging from 16.7% to 22% full compliance for rectal, breast and genital exams with the exception of pelvic exams, which are 30.6% (not in labour) to 32.7% (in labour). As Bhoopatkar et al. pointed out, one reason the compliance rates for consent of pelvic exams is much higher than other sensitive exams could be due to the distribution of mandatory stickers at the start of student’s Obstetrics & Gynaecology rotation. These stickers are placed on the operative consent sheet and already include a pro-forma statement for obtaining consent for a pelvic exam. Without these signed stickers, the student is not able to begin the pelvic exam.

Our results show consenting processes for medical student involvement are still not done well. Students indicated they often failed to document consent for medical student involvement in patients’ notes. Students felt SMOs were not making it clear that patients can refuse student involvement, or explaining the extent to which students are involved, or taking proper measures when involved in the care of a patient who cannot consent. SMOs were found to be less likely to clarify with a patient that they could refuse student involvement, or explain student access to patient records, or take sufficient measures to gain consent in those patients who were unable to verbally do so.

Participants’ comments provided insight into student and SMO attitudes towards obtaining consent and their understanding of the consensus statements:

“Asking for consent is to me less important than the need to make it implicitly understood to patients that medical students are a part of their clinical teams… [they need] to be involved to a certain degree without the need for specific consents.” – Medical student

“There is usually an implied consent that students and doctors in training will be involved in medical care, if you are getting your care at a teaching hospital. Obviously any time it involves a sensitive exam we would get extra consent.” – SMO

This study shows that there is a need for better education for both doctors and medical students regarding their responsibilities in gaining and ensuring appropriate consent for medical student involvement in patient care, and also a need to ensure that patients are better informed through signage and leaflets that they are entering a teaching hospital and medical students will be part of their medical team. We acknowledge that due to our small sample size, our study is also underpowered and has limited generalisability and applicability. However, the results pertaining to obtaining signed consent for sensitive examinations under anaesthesia are better than the results from Bhoopatkar et al.’s study. A reason that may explain the better compliance of consent for Taranaki Hospital is that it has a specific question in its consent forms that asks patients if they agree to medical students performing sensitive examinations; this must be ticked yes or no. It serves also as a reminder for the SMO to include medical students while consenting for the operation or procedure. A standardised surgical consent form for all hospitals could therefore prove useful.

Further suggestions to improve consenting rates include those listed below. We acknowledge a patient’s right to refuse student involvement and our suggestions reflect this sentiment:

1. A team auditing process to ensure the consent forms are being properly documented is important. Currently, we are performing a retrospective audit of 100 forms to evaluate how often doctors “skip” the medical student consent question at Taranaki Hospital.

2. Checking if consent for students to participate in the surgery should be part of the standard pre-op checklist and WHO “time out” process at the start of the surgery.

3. Medical students should be mandated to complete an online module about consenting prior to clinical placement. An educational module on consent will provide students with more confidence to ask for consent. Gaining consent would be an educational experience for medical students. Ultimately, gaining consent for medical student involvement in patient care lies with the registered healthcare professional.

4. Both our and Bhoopatkhar et al.’s studies show SMOs are not clear on the standards contained in the Consensus statements for consent to student involvement. This could be both because they are unaware that such statements exist or are unclear on the requirements and execution of the principles. Consenting guidelines from Te Kaunihera Rata o Aotearoa Medical Council of New Zealand[[3]] and the Health and Disability Commission,[[4]] are clear that the responsibility of consent for medical student involvement in patients’ care lies with the SMO and that consent must be gained from patients by SMOs. It may be beneficial for SMOs to undertake a workshop on obtaining consent in a non-coercive manner for the involvement of medical students and doctors in training. This would aid in clarifying the legal responsibilities for obtaining consent, streamlining the obtainment of consent so SMOs feel at ease consenting, and would also help shift attitudes to better appreciate the need for a good consent process. A 3-yearly refresher course should be recommended to all relevant staff who consent patients.

5. A statement should be added in patient appointment letters advising patients of their rights to all or partial involvement of medical students. Taranaki Hospital intends to increase the presence of posters in clinical areas advertising the rights of patients with respect to informed choice for student participation.

6. Following on from the success of the consent stickers in Obstetrics & Gynaecology, mandatory stickers with a pro-forma statement for consent for sensitive examinations should be distributed to students in other rotations where sensitive examinations are likely, such as General Surgery or General Medicine.

In conclusion, Bhoopatkar et al.’s paper highlighted serious issues in obtaining consent for students. Some of the issues are relevant to house surgeons and non-training grade doctors. Despite the limitations of the published article, lessons are identified. Interventions can be introduced to improve compliance of consent—for better patient care and training of our next generations of doctors.

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View Appendices.