Failure to Obtain Informed Consent for Intimate Examinations by Medical Students

Objective: To study medical student's attitudes towards intimate physical examination during clinical rotations. Design: The study was performed at a University hospital setting during the years 2008-2009. Sample: The study included 100 medical students. At the time of the survey the students were at their clinical rotations of medical school. Methods: The students filled a questionnaire about their attitudes towards patients' pelvic examination by students. Setting: 4 Campuses of an academic hospital Main outcome: The rate of full patients’ informed consent obtained for intimate examinations by medical students. Measures: Rate of students’ reports about consent, importance, emotional and ethical aspects of intimate physical examination. Results: We have found that the practice of performing an intimate physical examination during anesthesia is without obtaining a specific consent is still common in our University Hospital setting. About a third of the examinations have been obtained without a patient's consent. Ninety percent of the medical students object this practice. The students are aware and encourage a change. They appreciate the importance of the intimate physical examination for their medical education but only thirty percent have discussed the emotional aspects related to issue. About ninety percent of the female medical students appreciate the importance of patient communication on the subject more than male students 49% (p<0.005). About half of the students would decline being examined by medical students themselves if theoretically they were patients more if the examiner would be from the opposite gender. Conclusions: The clinical task of performing an intimate examination is not receiving the appropriate teaching. Patient’s informed consent is not obtained in many cases and not obtained appropriately in other.


Introduction
The pelvic examination of a patient by a student is an educational event which intersects four important aspects of medical education. The first is the physical examination of the patient and the clinical knowledge obtained by it. The second are the communication skills required for a gentle, non stressful intimate examination. Thirdly is the ethical challenge the student confronts in order to obtain the patient's consent for the examination. The last aspect is the confronting the psychological own impact on him/herself especially when examining patients from the other gender. It is the medical educators' responsibility to properly prepare the students for such task, a preparation not always performed [1].
Successful coping with the challenge will encourage the medical student to become a more sensitive, empathetic, self and mutual aware to other needs thus becoming a better physician. (http://cll.mcmaster.ca/, 2010) Neglect and unawareness to the significance of the interaction may perpetuate the problem.
Pelvic examination under anesthesia is performed to feel anomalies and pathology and to mitigate the embarrassment and physical discomfort. Patients are mostly asked for a "general" consent for being examined as part of being admitted to a teaching hospital.
In the recent years few publications and guidelines have addressed the concerning problem of performing a pelvic examination by medical students in anaesthetized patients.
In a recent audit from Ireland, 26% of women did not consent to a pelvic examination by a student while asleep [2]. Furthermore they found that only the minority of the units in Ireland actually have a dedicated written consent form for patients undergoing intimate examinations under anesthesia.
The studies reveal that in many training programs patient's consent for pelvic programs is not properly and fully obtained [3]. Furthermore participation in clinical rotation decreased the importance obtaining an informed consent in the student's eyes. Obviously this problem intrudes the patients' autonomy but it also affects the students' ethical boundaries.
We and others have studied patients' attitudes towards intimate examinations by medical students. Nevertheless; little information in the literature was obtained about the students' attitude and especially about the differences between male and female medical student's approaches to intimate educational physical examination. This study focuses on these topics.

Methods
The prospective observational study was performed at a University hospital setting during the years 2008-2009. 100 medical students in the clinical years of medical school (4th -6th of 6 years program) participated in the study. The medical students took part in clinical rotation at least in one of the following departments; obstetric and gynecologic, urology or surgery located in four campuses.
The questionnaires that were circulated were anonymous and students. The compliance rate of the students for answering the questionnaire was 70%.
The questionnaire was written in Hebrew and went through a validation process (Appendix 1). The questionnaire addressed ethical, attitudes and experiences of intimate examinations by medical students.
Breast examinations were not included in the survey because we considered breast examinations different with respect of breaching the patient's intimacy compared with genital or rectal examination.
An institutional IRB approval according to Helsinki declaration was obtained for the survey. Every student has expressed a verbal consent for participation in the study .The questionnaire was circulated by a medical student (S.S) and not by a staff member.

Statistical methods:
The sample size of 100 students was calculated based on a previous study results with 95% confidence interval (0.4-0.6) [3].
Statistical significances of the differences were determined by a Student's t test, using paired data. Mann Whitney test, was used for two non-parametric test and Kruskal-Wallis when comparison of three non parametric tests. Since the study was performed, national and institutional guidelines have been re-circulated and the problem was published in national newspapers. Status was not retested after these actions [4].

Results
The average age of the students was 25.8 years (range 21-34). 57% were male and 43% female students. 22% were in their 4th, 28% in 5th and 50% in 6th year of medical school respectively. 76% have had a clinical clerkship in Obstetrics and Gynecology, 71% in surgery and 40% have completed Urology clerkship prior to filling of the questionnaire. 80 % of the students reported discussing with their teachers, ethical conflicts for the patient about intimate examination during medical school. Only 30% reported that emotional concerns of the students have been discussed. Other emotional aspects of medical education like, patient death, student caused error etc 'are specifically addressed in the curriculum of our medical school. All the students that have had a clinical rotation in Obstetrics and Gynecology have performed a pelvic examination. Most of them in a clinic setting as well as in the operating room. 29% of all vaginal examinations and 27% of rectal examinations in the operating room were performed without the patient's consent.
90% of the students do not agree with the policy of the minority of the staff not to obtain informed consent for having an intimate examination under anesthesia. 70 % thought it's not appropriate to perform a rectal examination under anesthesia without consent. There was no statistically significant difference in the importance of consent for vaginal compared with rectal examination. In the questionnaire we did not address the reasons the students did not share their views with the staff when they thought it is wrong.
50% of the students believe that the patients would have consented if properly explained about the importance of the examination by the student. 89% of the female students felt that an explanation would assist in getting the patients' approval while only 49% of the male students thought so (P< 0.005 Fisher's exact test) 85% of the students thought it would be easier for female students to obtain an informed consent from female patients compared with a male student.
The same group of students was asked if they themselves would have consented to be examined by a medical student they don't know in person for educational purposes.
60% agreed to be examined by a medical student of their own sex but only 40% agreed to be examined by a student of the opposite sex.
We compared the importance medical students related to vaginal examination prior to clinical rotation with those that have had a clinical rotation (Obs & Gyn). We have not found significant statistical difference (P>0.05) between the groups.
Neither have we found statistically significant difference of the importance when comparing the attitudes of male and female students.

Discussion
Physical examination is an essential part of medical education and practice. Intimate physical examination training is a medical, emotional and ethical challenge to the medical students and the teaching staff. As in the last decades medicine has evolved from paternalistic approach towards patient centered medicine. Aspects of patient autonomy, the emotional and wellbeing of the patients and students following the pelvic examination and other intimate examinations (breast, testicular, pelvic and rectal) were addressed [5].
In our view an appropriate intimate physical examination by a medical student includes several issues. Initially, a thorough explanation of what is physically included in the examination .If a medical student/s is taken part; it should specifically be told to and consented by the patient. A verbal and not a written consent should suffice but this should be an institutional decision. In a study on patient's concerns we found that fear of physical harm during the physical examination is a major concern of the patients [6]. Reassurance of the patient of this point should not be difficult. The pro and cons of the patient's consent should be discussed. The patient should be encouraged to express its anxiety and concerns. If the patient declines the examination it should be reassured that it's their right and this will not affect their medical care. The patient genitals should be covered by a sheet so that their dignity is respected and is showed in public. This action may not be possible in the operating room after the patient is cleansed. No unprofessional comments about the patient should be expressed when the patient is under general anesthesia [8].
We would argue that universal criteria for all examinations under anesthesia, especially but not only intimate examinations, should be written.
Several programs focused on anxiety reduction for patients and students [8]. About 30% of the students have been found to have problems in the patient encounter .The program has been highly rated by the students [9]. In our setting approximately 30% of the intimate examinations under anesthesia are being performed without the patient's consent. The Ministry of health of Israel has published a guideline ordering the requirement for patient's consent and the option to refuse an examination by a medical student [4]. These guidelines were re-circulated to hospital staff and the public after the issue came to the public's attention in the media. Other national and international guidelines have been published in order to provide a framework and protect patients as well as the medical students from unethical events [10,11].
Although these guidelines have been published, our study as well as others shows that the implementation of the guidelines is partial and patients are today still being examined under anesthesia without consent in considerable numbers. In a way, the medical students in our program are illuminating the road. The vast majorities 90% are aware and respect the patients need for consent. Rightly, the students understand that patient explanation and consent are the right tools for patient's participation in student's medical training. The necessity of obtaining a specific permission of the patient is emphasized in other studies [1,5,12]. Some authors advocate that a student should participate only in an examination of a patient that the student is taking an active role in the surgical team. Furthermore he argues that pelvic examination is performed "solely for educational purposes" by students is not appropriate and should be part a clinical examination that the patient benefits from. Some medical schools have implemented programs for increasing awareness among students for patients as well as students' emotional needs. One program focused on the opportunity of patients to express their anxiety about the examination [13]. Another program focused on the use of drapes and another on the ethical approach during intimate examination [14].
We found that most female students thought that student -patient communication on the topic is effective while only half of the male students felt so. This finding is not surprising although we could not find other studies addressing this issue. Female students may be able to better sympathies with the patients concerns probably because they themselves have had the experience of an embarrassing pelvic examination. Male students are unlikely to have rectal/genital examination at their age. We have not found difference between male and female student with regards to the importance of the intimate physical examination and both thought it is highly important for medical education.
The fact that the students estimate that about 50% of the patients would have declined intimate examination should raise concern in the medical society. Furthermore, male medical students are declined from pelvic examination by women much more then female medical students. This reflects gender bias by the patients. A clear statement against gender discrimination (of males) should be published by medical organizations. If this would not be to provocative we would argue on going through an intimate physical examination yourself as a medical student by another medical student from your same sex like students practice other physical examination on themselves before performing it on patients. This proposal may serve two goals: One for medical education benefit and the second to provide the student a sense of what a patient is experiencing during such an examination.
When being asked this question 60% theoretically, agreed to be examined by a student of their own gender and 40% by a student of the opposite gender.
Professional paid patient instructors were introduced to medical schools to try and eliminate several of the conflicts described above [15]. This change has ameliorated the ethical and emotional conflicts that patients and students have been confronting. Nevertheless only the minority of medical schools has adopted this solution. The pros of simulated patients for intimate physical examination are numerous .it reduces the student's inhibition in front of a real patient. It allows feedback from the simulated patient to the student which is difficult to obtain from real patients and it eliminates the need to obtain an informed consent .The disadvantages are that dealing with a difficult patientstudent interaction is a challenge for the students and educates for increasing awareness, sensitivity and addressing ethical obstacles .The difficult real patient examinations task is postponed for later in the professional life perhaps with better skills and experience [5].
In this study we have found that the practice of obtaining an intimate physical examination during anesthesia is still common in our University Hospitals. Based on other studies it is still common in other institutions as well. The students are aware for the need of change. They appreciate the importance of the intimate physical examination for their medical education. Female medical students appreciate the importance of patient communication on the subject more than male students. Many of the medical students would have declined to be examined by a medical student if they were patients themselves.
Medical schools should be aware of student's attitude towards this delicate and significant issue in medical education. They should take the measures to assure a safe respectful and consented examination for the patients as well as a positive ethical, educational and emotional experience for their students.