Hospital ethics committees in Japan: Current Status from an exploratory survey 2012–2015

doi:10.21203/rs.3.rs-1407045/v1

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Hospital ethics committees in Japan: Current Status from an exploratory survey 2012–2015

https://doi.org/10.21203/rs.3.rs-1407045/v1

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Background: Hospital ethics committees have gained importance in Japan. But there is no current status report for the last decade.

Aim: To ascertain the status of Japanese hospital ethics committees, to clarify whether the prevalence of such committees differs based on the number of hospital beds, and to identify the requirements for sustaining such committees in practice.

Subjects and Methods: A questionnaire survey was sent to 2,433 hospitals accredited by the Japan Council for Quality Health Care.

Results: Of the 472 participating hospitals (19.4% response rate), 394 (83.5%) had established/were establishing their hospital ethics committee at the time of the study. The main reason for this was the evaluation of hospital functions by the Japan Council for Quality Health Care. Clinical ethics consultations were performed in 239 out of 394 hospitals (60.6%). A full ethics committee was adopted by 149 out of 239 hospitals (62.3%).

Conclusion: Full ethics committees are common in Japan. Clinical ethics consultations have not yet been recognized as an activity for hospital ethics committees to carry out.

hospital ethics committees

clinical ethics consultation

questionnaire

full ethics committee

small team consultation

The main purpose of clinical ethics is to solve ethical issues related to clinical practice. This field involves identifying, analysing, and solving ethical issues encountered in patient care and clinical research, as well as providing ethics education for health care staff and medical students (American Society for Bioethics and Humanities 2011). Clinical ethics form a part of practice, education, and research. In practice, the activities pertaining to clinical ethics include organizing clinical ethics conferences, conducting clinical ethics consultations—led by clinical ethics specialists—at the request of medical care teams, performing ward rounds focused on ethical issues, etc.

Japanese ethics committees are unique because they act as both research ethics committees (RECs) as well as hospital ethics committees (HECs) (Akabayashi et al. 2007) . RECs review the ethical aspects of research, while HECs engage in discussing ethical issues in individual cases in the medical field (Nagao et al. 2005). Since the first ethics committee was established at the University of Tokushima School of Medicine in 1982, ethics committees have spread rapidly in Japan, mainly because of the administrative guidelines concerning medical research (Fukatsu et al. 1997). Therefore, ethics committees are considered as RECs in Japan.

Nagao et al. surveyed all resident-teaching hospitals in Japan with a focus on HECs in 2004 (Nagao et al. 2005). The survey response rate was 41.7% and 75.3% of the respondents did not have an HEC. In 2005, the Japan Council for Quality Health Care (JQ)—a non-governmental agency that evaluates hospitals—added clinical ethics items to their hospital evaluation instruments for the first time (The Japan Council for Quality Health Care 2005). In the 2009 revision, as part of the evaluation criteria, the evaluation instruments incorporated the establishment of HECs and the system of clinical ethics consultations (The Japan Council for Quality Health Care 2009). However, thus far, no survey has identified the extent to which Japanese medical institutions have been able to adopt such practices in the rapidly changing society. This study aims to ascertain the status of HECs in Japan, to clarify whether the prevalence of HECs differs based on the number of hospital beds, and to identify the requirements for sustaining HECs in practice.

A questionnaire survey was conducted to ascertain the status of HECs in Japanese hospitals. The questionnaire items were selected based on previous research by Fox, Myers, and Pearlman (2007) and the questions were developed in accordance with the situation prevailing at the time in Japan. The final questionnaire comprised questions on 50 topics based on a prior study by the authors and their research collaborators. There were 31 single answer questions, 18 multiple-choice questions (MCQs) that also included a self-reporting question, and 1 self-reporting question.

The 2,435 hospitals that were accredited and publicly listed by the JQ as of June 15, 2012, were selected for this study. Excluding two institutions that had closed down, we assigned specific numbers to the 2,433 hospitals. The authors sent request letters for participation in the web-based self-reporting questionnaire survey to these 2,433 hospitals by mail between December 10, 2012 and March 31, 2013. To avoid answering twice, a hospital-specific URL was included in the request letter for participation. The participants answered the questionnaire online anonymously.

Results of the questionnaire survey were entered into Microsoft Excel 2010 and subjected to simple aggregation.

Data from the free answers were also entered in Microsoft Excel 2010. Statistical analysis was performed using IBM SPSS Text Analysis for Surveys, and Microsoft Excel 2010 was used to aggregate the frequency of occurrence of phrases.

All participants provided informed consent. The study design was approved by the Research Ethics Committee of the Kyoto University Graduate School of Medicine (E1550 2012).

Demographic features

Of the 2,433 hospitals, 472 responded (response rate 19.4%). Of the 472 respondents, 328 (69.5%) were members of their ethics committees. Table 1 shows the demographic features.

As shown in Figure 1, the 382 hospitals of the 472 hospitals (80.9%) had an HEC, and 12 reported that they were preparing to establish it.

Among these 394 hospitals, 155 (39.3%) reported operating an HEC as an independent organization within the hospital, 33 (8.4%) reported operating it under the REC, and 19 (4.8%) reported operating it under other departments. The 394 hospitals were asked additional questions on the organizational structure and the actual activities of their HECs.

Reason for establishing an HEC

As shown in Figure 2, the main reason was the evaluation of hospital functions by the JQ. The smaller-bed-number group (20 – 99 beds) had higher percentage of the JQ evaluation than the larger-bed-number group (100 – 499 beds or ≥ 500 beds). On the other hand, the larger-bed-number group (≥ 500 beds) was more likely to choose the reason that requests from hospital staff members compared with the smaller-bed-number group (100 – 499 beds or 20 – 99 beds).

General information on HECs

The average number of HEC members was nine. By profession, the median values for HEC members were as follows: three medical doctors, two nurses, two clerical staff, and one individual who was not a hospital staff member (e.g., lawyer, university professor, or representative of the patients’ association).

Roles of hospital ethics committees

The HECs clarified that they engaged in multiple roles. In all, 840 multiple-choice answers were provided by 394 hospitals. The HECs of 288 out of 394 hospitals (73.1%) engaged in clinical ethics consultations, those of 279 (70.8%) engaged in formulating/updating ethical guidelines, those of 212 (53.8%) engaged in delivering in-service education, and those of 61 (15.5%) provided other services, such as a research ethics board, clinical trials, and organ transplants.

A total of 239 hospitals with HECs reported actually conducting clinical ethics consultations, and an additional 49 hospitals reported offering clinical ethics consultations but indicated that they had not performed these consultations as on the date of the survey. The average number of clinical ethics consultation requests in the 239 hospitals was 4.4 cases per year.

Methods of clinical ethics consultations

Various types of clients request clinical ethics consultations. We obtained 779 multiple choice answers from the 239 hospitals. The most frequent types of clients were heads of medical sections (222, 28.5%), other medical staff (197, 25.3%), doctors-in-training (92, 11.8%), patients (59, 7.6%), patients’ families (59, 7.6%), and others (150, 19.2%).

The methods of information collection regarding problems were investigated through an MCQ. Of the 551 multiple answers from the 394 hospitals that reported an existing or developing HEC, the most popular methods were interviews with the staff (173, 31.4%), medical records (141, 25.6%), and consultation forms (127, 23.0%). Conversely, interviews with patients and/or their families were adopted by 70 respondents (12.7%), and physical examinations by 40 respondents (7.3%).

Figure 3 describes how 239 hospitals operated a clinical ethics consultation. We also asked an open question about how hospitals operate their HECs. We obtained written answers from 25 employees who answered “none of above.” In the 25 answers, the most common way to operate the HEC was reported as altering the number of consultants depending on the cases (13 hospitals). On the other hand, eight hospitals reported that they adopted a small-team consultation and an individual consultant on a case-by-case basis.

Of the 223 hospitals that reported using discussions and other methods in the previous question, 201 (90.1%) held discussions to arrive at unanimous conclusions. However, other hospitals did not have face-to-face discussions. They reported that the administrators summarized the opinions of HEC members by email or returned all opinions to the clients.

Records of clinical ethics consultations

We asked the 239 HEC-operating hospitals how the clinical ethics consultation records were maintained in the department through an MCQ. We obtained 262 responses. Among them, 135 (51.5%) reported that they maintained simple records alone, while 101 hospitals (38.5%) reported that they maintained detailed records that included information on the discussion, the course of discussion, and outcomes. The remaining hospitals did not maintain any records in their departments.

We also asked the 239 hospitals about documenting consults in patient’s medical records. While only 59 (24.7%) of the 239 hospitals reported recording the consultation outcomes in patients’ medical records, 104 hospitals, the majority (43.5%), responded that recording the contents of the consultation in the medical records depended on the nature of each case, and 76 hospitals (31.8%) did not create any records. Hospitals in the small-bed-number category were more likely to record the consultation in patients’ medical records (16 of 32 hospitals, 50.0%) than the medium-bed-number category hospitals (32 of 166 hospitals, 19.3%); however, there was no statistical significance. In all, 163 hospitals made note of some details in their medical records. We found that medical doctors were responsible for this task in 108 hospitals (53.2% of the 203 responses), and nurses wrote them in 65 hospitals (32.0%). There were no significant differences between each bed-number group.

Enforceability of the HEC recommendations

Of the 239 hospitals, 85 hospitals (36.5%) reported that the clients must comply with the final decisions of its clinical ethics consultation. On the other hand, 148 (63.5%) regarded the decisions of its clinical ethics consultation as recommendations. There were no differences based on the number of beds.

Our inquiry into the follow-up process after the consultation found that 85 hospitals followed up on the outcome of a consultation. The reported follow-up methods were obligatory reporting of detailed accounts (25 of the 142 answers, 16.9%), obligatory reporting depending on the case (69 responses, 48.6%), and tracking subsequent progress (39 responses, 27.5%). The remaining nine responses indicated a choice of other methods.

The person with the ultimate responsibility for consultation cases was the hospital director in 149 responses, which was almost half of the 339 responses.

Reasons for not requesting clinical ethics consultations

As we mentioned previously, the 394 hospitals of the 472 hospitals had an HEC (Figure 1). But 153 hospitals had never executed clinical ethics consultations. We asked them why they did not undertake any clinical ethics consultations with the three MCQs and the open question (Table 2). We obtained the answers from 50 hospitals and 22 free-form descriptions. We conducted a text analysis on the contents. The results revealed six categories shown in Table 2.

Self-evaluation

In response to the request for self-evaluation of their HEC, 90 (19.1%) of the 472 respondents reported sufficient, 270 (57.2%) reported insufficient, and 112 (23.4%) responded that they did not know.

There were three principal reasons for considering their HECs sufficient. First, a system for scrutiny was already in place as a result of multidisciplinary external resources. Second, they assessed subjectively that their HECs worked effectively. Third, their HECs were functioning sufficiently because they had a few consultations each year.

We got 187 responses of the 270 hospitals considered their HECs as insufficient. The most-reported reason was inadequate system/response capabilities (100 respondents, 53.5%), followed by the lack of staff knowledge/interest (35 respondents, 18.7%). The third most-reported reason, provided by nine people (4.8%), was the limited number of consultations.

The reasons for choosing the option “I do not know” included the following: First, they did not have enough knowledge to evaluate whether their HECs were sufficient. Second, it was difficult to draw comparisons with other institutions. Finally, they had no experience with clinical ethics consultations.

The open descriptions revealed the difficulties encountered in conducting and administering clinical ethics consultations. Therefore, we categorized and counted the opinions from the open-ended questionnaires. We obtained 211 responses from 106 hospitals in all. The most-reported problem (62 responses) was “how to disseminate information about the existing clinical ethics consultation system,” followed by “how to provide a platform for fair discussions” (53 responses), and “how to identify latent ethical problems” (48 responses).

This was the first status survey to have been undertaken since the HECs were incorporated as a constituent item in hospital function evaluation in Japan. Before 2005, only 17.5% of medical school ethics committees and 32.2% of HECs were involved in clinical ethics consultations (Akabayashi et al. 2007). In 2004, 66 out of 640 hospitals each had an HEC (Nagao et al. 2005). In this study, 382 of 472 hospitals each had an HEC, and 12 hospitals were preparing to establish their HECs. Although we cannot simply compare this with the previous study, we may infer that HECs have become popular in Japan.

This study revealed that only 24% recorded consultations in their medical records in Japan, while 72% of the respondents always documented their consultations or details in medical records in the United States (Fox et al. 2007). The remaining respondents (76.0%) either did not enter details of consultations in medical records or did so only in specific cases. This indicates that the status of the HEC is not officially endorsed in Japanese hospitals yet, and its function is most likely treated as an informal activity.

This study’s results suggested that clinical ethics consultations in Japan aim to reach unanimous conclusions as determined in a previous study (Nagao et al. 2005). There are two main reasons for this tendency. First, ethics committees began as an ethical review board for medical research and later developed into a committee that performed the functions of both HEC and REC. Second, there was a shortage of clinical ethicists in Japan. Fox et al reported that small-team models were significantly preferred by clinical bioethicists, and full committee models were adopted by HECs without well-educated staff (Fox et al. 2007). These trends were likely to apply to Japan.

In 2004, only 25% of hospitals had HECs, but 89% of hospital administrators recognized the need for HECs. In this survey, 81% of hospitals had HECs, and 76% of respondents considered HECs necessary. This means that the participants in this survey were highly interested in HECs.

On the other hand, 57% of hospitals perceived their HECs as insufficient. One of the reasons was the lack of ethical knowledge. To compensate for the lack of medical ethics education, many postgraduate education programs have been held, including clinical ethics seminars sponsored by the University of Tokyo’s clinical ethics project (Center for Biomedical Ethics and Law The University of Tokyo 2008), clinical ethics introductory lecture courses sponsored by Kyoto University (Center for Applied Philosophy and Ethics of Kyoto University 2017), and debriefing sessions in hospitals. Furthermore, the multi-centered volunteer-based small-team ethics consultation by Prof. Asai et al. has continued for more than ten years (Fukuyama et al. 2008)(Asai et al. 2015). This tele-consultation system has continued thus far possibly because the medical ethics education problem has not been resolved yet and there is still a lack of clinical ethics consultants. This study is the first investigation into how HEC members gain the required knowledge and skills.

This survey revealed that the evaluation of hospital functions by the JQ significantly influenced the motivation for establishing HECs. No previous study has reported on reasons for establishing HECs. This trend was observed in hospitals with 20-99 beds and 100-499 beds, but not in hospitals with 500 or more beds. Large hospitals tend to have more medically and socially complicated cases requiring multifaceted care (Bishop et al. 2009). It is still not clear which department should be responsible for clinical ethics consultations and what experience the committee members should have in order to facilitate it. This is because each of Japan’s hospitals has attempted to develop its own system (Asai et al. 2008).

This study has several limitations. First, the low response rate may cause self-selection bias. The respondents may be highly interested in clinical ethics. Although the number of respondents is small, the results are based on their actual experiences. There are no previous studies on the activities of Japanese clinical ethics consultants.

Considering that there have been no reports on the spread and activities of HECs in Japan, we could consider this paper as an exploratory study. This study can facilitate a better understanding of the current situation and can help clarify future challenges.

Funding

This work was supported by JSPS KAKENHI (the Japan Society for the Promotion of Science) under Grant JP24610003. No potential conflicts of interest are reported by the authors.

Conflicts of Interest

All authors have no conflicts of interest.

Code availability

Results of the questionnaire survey were entered into Microsoft Excel 2010 and subjected to simple aggregation.

Consent for participation and publication

All participants provided informed consent and agreed with publication.

Ethics approval

The study design was approved by the Research Ethics Committee of the Kyoto University Graduate School of Medicine (E1550 2012).

Availability of data and material

The data will not be deposited on any repositories. But we can share our research data as request.

Authors’ contributions

[First author] contributed to the conception and design of the study, data collection, conducted the statistical analysis, interpreted the data, and drafted the manuscript. [Second author] and [Third author] contributed to the conception and design of the study, helped to draft the manuscript, and supervised the whole study process. [Forth author] critically reviewed the manuscript. All authors read and approved the final manuscript.

ACKNOWLEDGEMENT

We are grateful to all participants who engaged in this study.

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Table 1 and 2 is available in the Supplemental Files section.

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Hospital ethics committees in Japan: Current Status from an exploratory survey 2012–2015

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