Objective To evaluate the knowledge and performance of surgical residents regarding the person from whom informed consent should be taken for surgery and from whom the consent is taken in practice.
Materials and methods This study was done in 2013. The population of this study was all residents of urology, surgery, orthopaedic surgery and gynaecology of Tehran and Iran University of Medical Sciences. The study tool was a self-administered questionnaire, containing questions on their knowledge and performance regarding informed consent acquisition from patients with different conditions in terms of age, sex, marital status and their capacity to make treatment decisions.
Results A total of 213 residents participated in the study (response rate=51.9%). The mean score of the participants’ knowledge was 72.95 out of 100. There was no significant correlation between the residents’ knowledge and performance. Regarding a competent married male patient, 98.2% of the residents knew that the person’s consent was enough, but only 63.6% obtained informed consent only from the patient. These percentages were 69% and 19.7% for a competent married female patient, respectively. For a competent single male patient, 90.9% of the residents were aware that the patient’s consent was enough, while only 40% of the residents obtained informed consent only from the patient. These percentages were 65.3% and 16% for a competent single female patient, respectively.
Conclusion Despite the residents’ average knowledge of patient autonomy, this right is not observed for female patients, and their treatment is subject to consent acquisition from other family members.
- informed consent
- decision maker
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According to the autonomy principle, patients have the right to participate actively in decision making regarding their health. However, studies have shown that a considerable percentage of the patients are deprived of this right by their physicians despite their willingness for engagement in decisions.1 2 Taking informed consent from the patient or his or her assigned substitute decision maker is an example of minimum respect for his or her autonomy.3
Respect for patient autonomy is also confirmed by the Iranian laws and Shia jurisprudence. According to clause 2 of article 158 of the Islamic Penal Code, any medical or surgical procedure without the consent of the patients, their parents, guardians or legal representatives is considered a crime.4
According to Shia Islamic jurisprudence, the humans have authority on their body, and without permission, no one shall intrude into another person’s body, even with therapeutic intent. The physician has to obtain the patient’s or his or her guardian’s permission for any treatment.5
However, family structure in the Middle East is mostly patriarchal.6 The family has a significant role in support of patient and helping patient in decision making. Physicians should not only facilitate patient–family communication for decision making, but also prevent family members from coercing the patient. The physician must seek consent from the patient directly, if he or she is competent. However, there are reports of refusal to perform invasive procedures (especially surgery) despite the patient’s consent, only because the patient’s family did not give consent. A study by Sheikhtaheri et al 7 in Iran showed that residents obtained consent from people other than the patient in 25% of the cases in which the patient had decision-making capacity. Ashraf et al 8 reported that most physicians seek consent from a person other than the patient.
According to disciplinary policy and procedures of Iran medical council, every private individual even if he or she is not the patient’s guardian could sue the physician.9 The legal action is a serious concern of physicians,10 so they may not get satisfied with patient consent and seek his or her relatives’ consent too.
One of the essential ethical issues in surgery is respecting patient’s autonomy and obtaining informed consent.11 Formal teaching of medical ethics is not included in most residency programmes in Iran and residents learn the behavioural norms mostly from their professors and senior residents as their role models.
Evaluation of the knowledge and performance of the residents regarding informed consent shows who they seek consent from and reveals the extent to which their performance weakness is related to lack of knowledge. In this study, we assessed the knowledge and performance of the residents regarding the person from whom consent should be taken for surgery and from whom they take consent in practice.
Materials and methods
In this cross-sectional study, all residents of urology, surgery, orthopaedic surgery and gynaecology departments of Tehran and Iran University of Medical Sciences were invited to participate in this survey to find out their knowledge about the person from whom consent should be taken for surgery legally and from whom they take consent in practice in different scenarios of the patient’s age, sex and capacity (table 1). This study was done in 2013.
The study population comprised 410 residents, including 90 orthopaedic surgery residents, 200 gynaecology residents, 100 general surgery residents and 20 urology residents. Participation was voluntary, and the questionnaires were anonymous and self-administered. This study was the thesis of the first author. Residents were invited by her to participate in her project, so they felt free to accept her invitation and fill the form voluntarily. Residents were informed that their participation and their response would not have any influence on their performance evaluation.
Data collection tool
A researcher-made questionnaire was used for data collection. In addition to demographic variables (sex, MD graduation university, specialty major and residency year), the questionnaire assessed knowledge and performance in seven scenarios; the residents were asked to determine from whom informed consent was to be taken. The choices for each scenario are presented in table 1. One of the response choices repeated in each scenario was that it did not matter who they asked. The questions in the performance sections were similar to questions in the knowledge section. The residents were asked to determine from whom they took informed consent in each scenario. In the performance section, the participants could select more than one choice. The scenarios related to incompetent patients were limited to cases for which law has determined a substitute decision maker. Male scenarios were excluded for gynaecology residents, and only four scenarios were asked in each section.
The validity of the scenario was assessed interviewing some surgeons from the same specialties. Then it was piloted on 20 residents from the same four specialties who were not included in the final sample to assess its clarity. Modifications were made according to their comments.
To assess the residents’ knowledge, the total number of questions answered correctly were calculated and converted to a score out of 100. In the performance section, if only the correct answer was checked, the performance was considered correct; otherwise, a wrong performance was considered if any other choices were made, including a wrong choice or a combination of correct and wrong choices.
Descriptive statistics were used to describe the variables. The Pearson test was applied to assess the relationship between qualitative variables and t-test, and analysis of variance was used to evaluate the correlation between quantitative variables (dependent and demographic variables). The correlation test was employed to investigate any association between the questions of knowledge and performance. A CI of 95% (α<0.05) was applied to all hypothesis tests.
Forty-one orthopaedic surgery residents (RR=45.5%), 103 gynaecology residents (RR=51.5%), 59 general surgery residents (RR=59%) and 10 urology residents (RR=50%) participated in the study (total, n=231, RR=51.9%). Table 2 presents the demographic characteristics of the participants.
Scenario 1: a 35-year-old competent married man
Most residents selected the correct answer in knowledge and performance sections. However, the rate was markedly higher for knowledge (table 3). The participants’ responses in knowledge and performance sections were not affected by demographic variables.
Scenario 2: a 20-year-old incompetent single man lacking capacity
In this scenario, the man had severe mental retardation. According to the law, his father is his guardian because of the incompetency remaining from childhood. Most of the residents selected the correct answer in knowledge and performance sections. In practice, the second most common performance was acquisition of informed consent from both parents as selected by 13 residents (11.8%).
Scenario 3: a 20-year-old competent single man
Despite appropriate knowledge, less than half of the residents obtained consent only from the patient in practice and 57.2% of them (n=63) also required his father’s consent. The selection of the decision maker for this patient was not affected by any of the demographic variables.
Scenario 4: a 20-year-old competent single woman
The performance and knowledge were both weak for this patient and showed a significant gap (table 3). One-third of the residents only required the patient’s father’s consent in practice and 141 residents (66.2%) required the consent of the patient and her father. A significant association was seen between the residents’ performance and their sex (P<0.001); in other words, more female residents (16.4%) obtained consent from the patient’s father than male residents (8.2%).
Scenario 5: a 20-year-old incompetent single woman
The gap between knowledge and performance was greater than scenario 2. In practice, 56 residents (26.3%) required the consent of both parents. The participants’ responses were not affected by any of demographic variables.
Scenario 6: a 35-year-old competent married woman
In the knowledge section, 65 participants (30.5%) wrongly selected ‘patients’ husband’ as the answer. In the performance section, 130 residents (61%) obtained the consent of the patient and her husband.
Similar to the scenario of a competent single girl, there was a significant association between the residents’ performance and their gender (P=0.038); 14.1% of female residents versus 28.2% of male residents selected the corrected answer (obtaining consent from the patient).
In this scenario, there was a significant association between the residents’ specialty field and their performance (P=0.005) and knowledge (P=0.032). A greater percentage of orthopaedic surgery residents selected the correct answer in knowledge and performance sections as compared with gynaecology residents (table 4).
Scenario 7: a 75-year-old competent married woman
Only 30 residents (14.1%) selected the correct answer in the performance section. One hundred and five residents (49.3%) sought the consent of both the patient and her husband, and 32 residents (15%) stated that they only obtained the patient’s husband’s consent.
Similar to other scenarios about women with capacity, there was a significant association between the residents’ performance and their gender (P=0.021); a lower percentage of female residents (8.6%) selected the correct answer as compared with male residents (22.4%). Moreover, we found a significant relationship between the residents’ knowledge and their sex (P=0.025); a lower percentage of female residents (n=69, 53.9%) selected the corrected answer as compared with male residents (n=60, 70.6%).
There was also a significant relationship between the residents’ knowledge and their specialty field (P=0.004); in other words, most orthopaedic surgery (82.9%) and general surgery residents (69.5%) selected the correct answer, while most of the gynaecology (51.5%) and urology residents (50%) selected ‘patient’s husbands’ as the answer.
The mean score of knowledge was 72.95 in all participants (table 5). Sex and residency field had a significant correlation with the score of knowledge; however, linear regression showed that only the residency field was a predictor of knowledge (P=0.034).
Since it was possible that the patient’s sex affected the female residents’ responses in the knowledge section, we performed another analysis to compare the score of knowledge solely based on four scenarios involving female patients. The mean score of knowledge was 68.77 of 100 in all participants, and there was a significant difference in the score of knowledge between gynaecology and orthopaedic surgery residents (P=0.033).
The MD graduation university has no correlation with participants’ response to any of scenarios.
Our study showed that residents had an average knowledge of the person from whom consent should be obtained for surgery. However, their performance was poor, and they practice conservatively in this regard. They prefer to seek consent from different people. According to the results of our study, the greatest defect in knowledge was related to practising the right to autonomy in female patients.
The reason for the huge difference between their knowledge and practice could be the way we asked them to respond. The knowledge questions were multiple choice questions of which they could choose just one so they could choose the person they thought it was most important to acquire informed consent form. However, for the practice questions, they could choose two or more options if they do such in their practice. Based on these differences, performance results looks more reliable. The result shows the greatest defect in their performance also was related to practising the right to autonomy in female patients.
Another finding was that gynaecology residents had a weaker knowledge and performance in this regard as compared with other residents, especially orthopaedic surgery residents. One reason for this difference could be the type of diseases gynaecology residents are involved in. Orthopaedic surgery residents encounter conditions like bone fractures, while gynaecologists deal with the health of female reproductive systems; therefore, gynaecology residents may recognise a right for the patient’s husband in medical procedures that may affect the fetus or the patient’s reproductive capability. According to the Iranian laws, women need the permission of their father (if unmarried) or husband (if married) for some activities like employment, custody or exiting the country, but not for receiving health and medical services.7 The presence of numerous laws that require women to seek the permission of their father or husband may pave the way for misunderstandings regarding the necessity of the husband’s consent for medical care. This is a wrong interpretation of the law because the law does not require the husband’s consent even for therapeutic abortion.
In many Middle East countries, seeking the husband’s consent is an unwritten law practised by many physicians. Studies have shown that this practice is common in Pakistan, India, Suadi Arabia, Nigeria and Mexico.8 12–17 It seems to be a social belief, not just the physicians’ belief. A study by Jafarey in Pakistan showed that the men’s consent was more valuable from the perspective of both men and women participating in the study, and most participants in the study clearly agreed that it is necessary to obtain the consent of a female patient’s husband or father before starting medical procedures.14 Raza et al 16 conducted a study on human papillomavirus infection in women with or without cervical cancer and reported that the principal reason for the low participation rate in the study was lack of husband’s permission.
Our results showed that a great proportion of the residents who were aware of the sufficiency of acquiring consent from the patient sought for the husband’s or father’s permission in practice. One of the reasons is that if adverse events occur, it is the husbands, and not the women, who press charges. The result of studies shows legal concerns has a great influence on physicians’ practice.18 19 Residents may believe consent acquisition from husbands before surgery would reduce the rate of complaints against them due to adverse events. Review of submitted complains in Tehran Medical Council shows only 30% of complaints were filed by patients themselves.20
Obtaining permission from the spouse is an obvious violation of patient autonomy and limits the women’s access to health services. Previous studies have shown that requiring the husband’s permission limits the women’s access to health services.21
Residents should receive the education that although husband and wife have the moral responsibility to apply family considerations in their treatment decisions, the physician is required to provide treatment only based on the patient’s consent.
The results of this study show the marked difference between moral and legal obligations of residents regarding informed consent acquisition. The results showed that if a patient over 18 years of age (male or female) with capacity for decision making needs elective surgery, consent is also taken from his or her father in addition to the patient, while the patient’s consent is enough. It is most probably related to the family-oriented characteristic of the Iranian culture. In Iran, children live with their parents until marriage, and their living and education expenses are covered by their parents. This culture may lead to the belief that parents are the guardians of their children at any age before marriage. Although it is important to respect the patient’s family, necessary treatments in competent patients should not be subject to their consent.
Our study showed that about two-thirds of the participating residents believed that the elderly had the capacity for decision making, but only one-seventh of them obtained consent from the patient herself and the rest also sought the permission of the elderly patient’s spouse or children in practice. Comparison of the residents’ knowledge and performance showed that even residents who knew from whom consent should be taken provided treatment subject to acquisition of permission from several persons, which is a violation of patient autonomy. These findings underline the necessity of educating residents about respect for autonomy. The results also showed that physicians have to learn to make an effective communication with patients and their families and persuade the patients to discuss their treatment options with their families instead of obtaining consent from several people who have no legal guardianship over the patient in order to prevent complaints.
Our study have some limitations. As mentioned earlier, residents were guided to choose one option in knowledge questions so their responses might not show their real knowledge. We only evaluated knowledge and performance in four major surgical fields, which is not indicative of the perspective of all surgeons and physicians. Moreover, demographic findings revealed that gynaecology residents comprised the majority of our participants, which could affect some results. We were unable to evaluate the reason for consent acquisition from other people when the patient had the capacity for decision making. Qualitative studies are required to evaluate why people with proper knowledge on the right person for consent acquisition seek the consent of other persons in practice in order to present suitable strategies for removing the obstacles to patient autonomy.
Our study showed that residents have a moderate knowledge on male patients and weak knowledge on female patients regarding the person from whom consent should be taken for surgery. A great proportion of residents with proper knowledge in this regard act differently in practice. Educational interventions are recommended to enhance the residents’ knowledge of female patients’ autonomy and correct their misunderstanding. Moreover, it is also necessary to conduct a study to evaluate the reasons for inconsistency between the residents’ knowledge and performance in informed consent acquisition for surgery to remove the barriers in this regard.
Contributors ZJ: data gathering, data analysis and writing the draft of the manuscript. FA: idea, reviewing the proposal, supervision of the study, critical review of the manuscript and reply to reviewers’ comments.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Not required.
Ethics approval Research Ethics Committee of Tehran University of Medical Sciences.
Provenance and peer review Not commissioned; externally peer reviewed.
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