Challenges of hospital ethics committees: a phenomenological study.

Medical ethics committees play an important role in examining and resolving ethical problems in hospitals by developing ethical guidelines and making ethical decisions. This study aimed at investigating the challenges that these committees typically face. This qualitative phenomenological study was conducted in 2020. Data was collected through semi-structured interviews with purposive sampling and participation of 19 ethics committees' members in Tehran hospitals. Then, data were analyzed by the content analysis method using MAXQDA-10 software. Challenges of hospital ethics committees were classified into three main themes including external factors, intra-organizational factors, and ethics committee structure, in addition to six sub-themes including inadequate supervision, lack of instructions, organizational culture, human resources, nature of the committee, and ineffectiveness of committees' decisions. Since many challenges are faced by ethics committees, plans should be developed and implemented to fulfill the following purposes: (i) strengthen the position of these committees in hospitals, (ii) continuous supervision over the formation and holding of the committees, (iii) their operation process, (iv) their decision-making process, and (v) process of sharing committees' decisions with all hospital stakeholders and staff.

Introduction

Hospital committees peruse several purposes: (i) improving the performance and solving the problems of hospitals, (ii) increasing the awareness and participation in decision-making, and (iii) easy communication with multiple units, and (iv) creating development opportunities for staff at all levels and gaining experience in supervisory skills. The committees are also involved in the process of improving hospital services as well as regular and continuous evaluation of hospital activities. According to the Ministry of Health and Medical Education, hospital committees are necessary for achieving the optimal quality in healthcare service provision.

The medical ethics committee, as one of the top ten priorities of medical ethics, is among the essential hospital committees to improve medical service quality (2, 3) and is the primary mechanism for reviewing ethical problems faced in the hospital. Ethical guidelines (4, 5) and these committees also play an important role in regulating patient-physician relationships, maintaining their mutual rights, promoting health, and creating mutual trust between healthcare service recipients and providers. These committees provide organizational guidance to help healthcare providers against legal issues, reduce moral tensions, maintain ethical performance, and achieve patient safety (6). The latest guidelines for the ethics committee and other hospital committees are related to the fourth generation of accreditation criteria, notified to hospitals in 2019, according to which hospitals should draft internal regulations for all their committees at the beginning of the year; in addition, according to the schedule of the committees, the documents of the committees should be regularly sent to the vice-chancellor of the relevant university for supervision (7).

The Medical Ethics Committee has been referred by various titles such as "Clinical Ethics Committee", "Patient Care Advisory Committee", "Institute Ethics Committee", and "Health Care Ethics Committee", and it has been active in hospitals since the early 1980s (4, 8). In Iran, according to the standard instructions for evaluation of public hospitals in the country from 1997, all hospitals are required to implement an ethics committee in the hospital (9). The structure and members of this committee are almost similar in different countries and include both medical and non-medical members as well as social workers, spiritual care providers, and legal advisors, whose membership is voluntary and, in some cases, appointed. The participation of various groups in the committee is required to examine all ethical aspects of the emerging problems and provide improved care to patients and their families. This committee is usually formed on a monthly basis in all hospitals, interacts closely with other hospital committees, as well as implements the standards of patient rights, controls compliance regulations, and provides facilities for religious rulings (10-12).

Various studies defined the functions of the ethics committee as follows: (i) developing guidelines, (ii) training healthcare providers and patients, (iii) counseling and commenting on controversial medical issues, (iv) policy development, and (v) developing frameworks to assist in decision-making, (vi) solving hospital and patient problems, (vii) resolving ethical problems in the hospital, (viii) cooperating in the investigation of medical malpractice cases, (ix) following patient rights and fulfilling them, and (x) leading studies and research (13-17).

Lack of knowledge about the ethics committee, duties and role of the committee in the hospital, their activity, superficial and unplanned formation of hospital committees to acquire accreditation points, reasons for the committee’s inefficiency in changing physician-patient relationship, differences in the committee's activities in various countries, discussion of different cases, as well as not reporting committee's approvals are among ethics committees’ challenges (9, 18-21). These committees, as the hospital’s think tank, include advisors and decision-makers of hospitals’ heads and managers. Moreover, according to the Ministry of Health, to achieve the desired quality in providing hospital services, hospital committees are necessary and should participate in preparing the hospital’s strategic and operational plans. Additionally, each plan must be evaluated and monitored to achieve the predetermined goals and to determine the executors. Hence, this study aimed at investigating ethics committees’ challenges to improve performance or decision-making in the face of ethical issues in hospitals.

Methods

In this study, a qualitative approach with content analysis method was used and data collection was through in-depth face-to-face interviews with participants chosen through purposive sampling. The participants were key informants of the medical ethics field at private and public hospitals in Tehran as well as managers, nursing management, nurses, educational supervisors, accreditation experts, and patient safety experts. An official letter from the vice chancellor for research at Tabriz University of Medical Sciences was previously sent to the key informants’ respective organizations for interviews.

Participants’ verbal consent was initially obtained, and interviews were conducted in a relaxing atmosphere. The purpose of the interview was fully explained to the interviewees, and, in each interview session, two interviewers asked questions, took notes, and recorded audios. Each in-depth interview lasted for 50 to 90 minutes, and a semi-structured questionnaire was prepared to guide the interviews. The initial questions were developed based on the available literature and finalized through three pilot interviews. The questions were targeted at the "Explaining the Hospital Ethics Committee’ Challenges" subject. The interview questions were open-ended and mainly focused on weaknesses and challenges of ethical committee in hospitals. The interview questions are listed in Table 1.

Table 1

Interview Guide

Interview Guide

1.  What do you know about the ethics committee in hospitals? 2.  What are the structure and description of the duties of the ethics committee, its members, and its work process? 3.  What are the challenges, barriers, facilitators, strengths, and weaknesses of the ethics committee in your hospital? 4.  Who can benefit from the ethics committee’s help? What are the ethics committee’s obstacles or facilitators? 5.  What factors lead to challenges in the ethics committee’s activities? 6.  Are there any solutions to improve the hospital ethics committee’s performance? 7.  Can the ethics committee have an impact on the implementation and observance of ethics in the hospital? 8.  If you have comments or suggestions regarding the hospital ethics committee, please mention them?

The interviews were transcribed verbatim, and initial content analysis was performed by inspecting transcripts and notes. After multiple reviews, three main themes were identified and entered into the MAXQDA-10 software. Then, subthemes were identified and reviewed by two experts in the field and then placed under subsets of the main themes in the MAXQDA-10 software. In case of no agreement between the two experts in the field for placing a sub-theme in a subset of the main themes, a third expert was consulted. To ensure the identification of all the sub-themes, the researchers reviewed the software implemented version. Axial coding permitted the refined sub-themes to be assembled to identify themes and relationships. During this process, the identification of the themes and sub-themes were validated by comparing the information provided by different respondents, obtained from the interviews, as well as observations and analysis of secondary documents (2). Finally, using the themes and subthemes and the researchers’ interpretations of the interviews, a framework of relations was constructed, representing the hospital ethics committee’s challenges.

To increase the consistency of the data and prevent prejudice, the researchers disregarded their presumptions about the subject during conducting interviews and data analyses (22). For the validity of the interview content and transparency of ambiguities, every interview was transcribed verbatim in the shortest possible time after the interview and then was sent to the interviewees for approval (23).

Results

Data saturation was reached after 18 interviews (Table 2) with ethics committee members, including the hospital's internal manager, nursing management staff, committee coordination experts, patient safety experts, a secretary of the medical ethics committee, and accreditation experts. Participants had doctoral, master’s, or bachelor's degrees and were working in private hospitals. The ethics committees’ challenges in hospitals were identified and classified into three main themes and six sub-themes. The main themes were categorized into external factors, internal factors, and factors related to the structure of the ethics committee (Table 3).

Table 2

Characteristics of the participants

Characteristics of the participants (n = 18)
Qualitative variables		Frequency	Percentage
Gender	Male	2	11.11
	Female	16	88.89
Age	<30	2	11.11
	30-50	15	83.33
	<50	1	5.56
Marital status	Married	15	83.33
	Single	3	16.67
Educational level	Bachelor’s degree	1	5.56
	Master’s degree	10	55.56
	Doctoral degree	7	38.89
Work experience	1-10	12	66.67
	11-20	5	27.78
	20-30	1	5.56
Work Place	Public hospital	3	16.66
	Private hospital	12	66.6
	Vice chancellor of treatment	3	16.6
Job position	Management	2	11.1
	Head nurse and supervisor	4	22,2
	Nurse	4	22.2
	Responsible for hospital committees (hospital and university)	3	16.6
	Accreditation expert	5	27.7

Table 3

Main themes, subthemes, and final codes

Main themes, subthemes, and final codes
Maine Themes	Subthemes	Final codes
External factors	Poor and irregular monitoring	Lack of monitoring the effectiveness of committees’ approvals
	Lack of integrated instructions	Failure to communicate the regulations of hospital committees by the Ministry of Health to hospitals
Internal factors	Organizational culture	Low and insufficient commitment of senior managers in the implementation of committees’ approvals Lack of appropriate atmosphere in the organization to implement the standards
	Human resources	Low awareness of the committee members about the description of the duties and purposes of the committee Lack of awareness of the hospital staff about professional ethics standards Lack of appropriate incentive and punitive system for the staff in enforcing committee approvals
structure of the ethics committee	The nature of the committee	Overlapping agenda of the medical ethics committee with other hospital committees Uncertainty of the ethics committee’s scope of authority and executive power Ineffective meetings of the ethics committee Lack of transparency of the ethics committee’s mission and goals Lower priority of the ethics committee’s formation process than other hospital tasks
	Ineffectiveness of the committees’ approvals	Low impact of the ethics committees on the implementation of professional ethics Lack of a clear and appropriate mechanism for the appropriate selection of committee members Absence or low attendance of physicians and other committee members in committee meetings Possibility of the ethics committee’s unfair judgments Failure to fully implement committee’s approvals

Lack of transparency of the raised issues was a major challenge of the ethics or other hospital committees, which confused committee members and such ambiguity did not require them to discuss key significant subjects. All topics should be considered in the committee’s regulations, including committee members’ specifications, their assigned duties, meeting time, and schedule. These regulations should be compiled at the beginning of the year for all committees and communicated to the committee members.

"The agenda of the ethics committee was wrong, and some people even think that it was accompanied by examining religious issues. But, according to the accreditation standards, the ethics committee has been used to fulfill patients’ rights, and its form has not been changed. National accreditation standards dealt with it broadly and generally, and it did not comment on

specific and well-defined tasks". (P.6)

All committee meetings’ approvals should be sent to the vice-chancellor for treatment of the covered universities in due time, but no feedback was provided by the vice-chancellor for treatment regarding the follow-ups of the committee approvals, the effectiveness of their implementation, or the corrective measures to be taken. The vice-chancellor for treatment did not supervise the holding of the committees and the implementation of their approvals.

"Records are sent to the vice chancellor for treatment and the university at the end of the month. When I sporadically did not send the committees’ records, surprisingly no one cared or complained. No one also paid attention to whether the enactment had been implemented or not". (P.5)

Sometimes, the implementation of committee's approvals required several financial and human resources, which often led to delays in the implementation or non-implementation of the approvals.

The organizational atmosphere and commitment of senior managers were important to make necessary follow-ups and to implement the committee's approvals. Sometimes, the erring staff is a physician and should only be warned by the head of the organization or technical assistant, which was rarely done, or if it was done, the physician would not admit the mistake.

"Even in cases where the patient complains to the doctor, the relevant managers do not have necessary cooperation because they cannot say anything to the doctor. Only complaint and incident records are documents, and such complaints can be repeated by another doctor “. (P.8)

"A major challenge in hospitals, especially in private hospitals, is that, often, the judges themselves are to blame. Self-judgment is difficult for them, which rarely happens. They do not judge honestly and fairly”. (P.10)

Moreover, committee members were often unaware of their job descriptions, which led to various issues and even their absence from the committee. The committee's primary mission was to deal with complaints, errors, and punishment, and the positive aspects and characteristics of staff work were not highlighted, leading to a negative view of the committee.

"Typically, committee’s physicians do not attend the meetings. Committee members do not have a full understanding of the raised issues”. (P.2)

The nature of the committee

Hospital committees, consisting of members appointed according to accreditation criteria in hospitals, should be formed according to a specific schedule. However, committees were often held superficially, ineffective in implementing approvals, as well as inefficient in holding meetings and choosing committee members. The ethics committee's mission was often unclear to committee members and overlapped with other hospital committees, which led to non-compliance with standards in the hospital.

“Lack of regular formation of hospital committees according to a schedule can be a major problem, causing the committee' performance not to be assessed and their effectiveness not to be approved”. (P.1)

Ineffectiveness of the committee approvals

All hospital committees output approvals that should be implemented while considering the organization’s problems and their effective implementation should be monitored by the committee members, especially the committee’s secretary. Many members reported that the extent of their authority in the hospital, as a member of the committee, was not well defined for the implementation of the approvals, which discouraged them from monitoring and enforcing the approvals or had a significant impact on fulfilling the patient rights’ standards. Moreover, committee approvals were not provided to other departments or wards so that they could be used as lessons learned to avoid repetition.

"If the importance of this committee in the hospital is emphasized and its executive power is increased, like other hospital committees, it can supervise the implementation of professional ethics among the hospital staff”. (P.12)

"The physicians participating in the committee, or even some other committee members, are not aware of these standards and do not take care of their full implementation, which leads to a lack of future attention and recurrence of many cases and problems”. (P.11)

Discussion

This study aimed at identifying the challenges of the medical ethics committee in hospitals, where the challenges were classified into three main categories: external factors, organizational factors, and factors related to the committee’s structure.

External factors related to the headquarters’ units and included supervisory roles and communication of integrated instructions. If such factors are communicated to the hospitals in a unified way, incoherency of the issues in the committee can be resolved. Moreover, the hospital committee’s approvals should be monthly sent to the vice chancellor for treatment, but they did not provide feedback on the implementation or non-implementation of approvals. In contrary to the present study, a study titled "Medical Ethics Committee in Norway" showed that the Ministry of Health, in addition to developing and communicating training instructions to the ethics committee, specified the priority of the committee's activities (24). Qarebaghian et al, (25) also stated that the regulations of the Blood Bank Committee were communicated to hospitals by the Ministry of Health to discuss the optimal use of blood products and their application, which led to satisfactory results. In a study by Haji Beigi et al., Blood Bank committees in private hospitals were not as much of those of the public hospitals reported to upstream organizations; in public hospitals, regulatory agencies’ role was relatively more significant (26). In that study, when public hospitals were compared against private hospitals, no significant difference was observed in the hospital committees’ performance and working conditions. Extra-organizational challenges in the functioning of ethics committees in hospitals were pervasive, regardless of the hospitals’ type and ownership, mainly related to the healthcare system’s macro-policy.

Intra-organizational factors included organizational culture and the organization’s human resources. The present study’s results showed that the organization’s atmosphere did not support performing activities as a team, and major activities were not implemented considering their real priorities. Lack of senior managers’ commitment and lack of enough budgets were the factors related to the non-implementation of the committee approvals. Moreover, the use of committee members with no training on medical ethics standards was a major committees challenge. A study by Nasiripoor and Kal in line with the present study, showed that although the Hospitals’ National Accreditation Program emphasized that the training of the ethics committee members, the number and variety of members, and the way of selecting members were not appropriately done in hospitals (27), due to a lack of attention to the importance and position of such committees in hospitals.

In line with this study, Gaudine et al. concluded that the lack of commitment of senior managers in organizations was due to the non-implementation of the ethical committee’s approvals and caused the committees not to be held seriously in hospitals (28).

Du Val et al and Larcher et al also concluded that lack of standard regulations, lack of managers’ support, incompetence of committee members, lack of committees’ documentation, and non-implementation of committees’ approvals are among ethics committees’ challenges (29, 30).

Amini et al. (31) also pointed out that professional principles such as professional ethics of the residents of Tabriz University of Medical Sciences were not at an acceptable level, demanding further inspection, formal training, and informal training. In other words, not enough investment was made to teach professional principles in universities, and at the hospital level, training in this area was not sufficient and effective. Often, residents are involved in various ethical issues in the hospital, and in the future, they will become members of these ethics committees as physicians working in the hospital. In line with the present study, Mousavi et al. stated that lack of formal and informal support of senior managers, lack of managers’ accountability regarding the raised issues, and sometimes their unjustified involvement in the committee led to ethics committee’ challenges (32). Moreover, the uncertain position of the ethics committees in hospitals can contribute to these challenges.

The ambiguity of the committee's position in the hospital, the overlap of the ethics committee's outputs and agenda with those of other hospital committees, and the ineffectiveness of ethics committee in enforcing medical ethics standards have made ethics committees unproductive in hospitals, whereas McGee et al. emphasized that a major task of the medical ethics committee in the hospital was policy-making. Diversity in the selection of committee members is required to teach standards and ethics to the hospital staff as diverse groups of staff work at hospitals (33).

According to the present study, the main reason for the non-implementation of approvals was the ethics committee’s low executive power and inefficiency in hospital’s policy-making, whereas Younger et al. showed that the ethics committee had a positive impact on facilitating decision-making on the raised ethical problems, had been effective in providing legal protection to hospital and clinical staff, and had also shaped the hospital’s ethical policies (34, 35).

As an advantage, the present research qualitatively studied the challenges of the professional ethics committees in public and private hospitals in Tehran. A limitation of the present study was the lack of previous studies regarding ethics committees in Iran, due to which further citation and comparison, as well as the preparation of a study guide were difficult or impossible. Moreover, all interviewees were from the employees of the hospitals in Tehran, and physicians did not participate in this study due to unwillingness and lack of time.

Conclusion

Given the identification of major challenges in the structure, development, and functioning of the hospital ethics committee, healthcare policymakers and senior managers should focus on the following factors: (i) facilitating committees’ activities, (ii) highlighting committees’ importance and purposes, (iii) strengthening committees’ position, (iv) supervising committees’ approvals, (v) obliging the implementation of committees’ approvals, and (vi) constantly monitoring committees’ activities. By promoting core tasks in organizations, organizational culture issues will be resolved. With the commitment of upstream organizations, guidelines and mechanisms can be developed to enhance the nature of ethical committees. Moreover, higher authorities should apply more control over the selection of committee members, the process of holding committees, the importance and position of committees in the hospital, and implementation of committees’ approvals, as well as training for senior hospital managers, physicians, and other stakeholders. Specific criteria should be developed and used for the selection of committee members, and an appropriate performance guarantee should be defined for the implementation of the approvals. Furthermore, the ethics committee’s outputs should be provided to the hospital staff and the target groups as learned lessons to prevent the repetition of similar issues.

Ethics approval and consent to participate

This study is part of a research project approved by the regional research ethics committee of Tabriz University of Medical Sciences; Approval

ID: IR.TBZMED.REC.1399.1167.