“Humanism” is the core of Chinese traditional cultural ethics,1 which are remarkably similar to modern bioethical principles. With the establishment of international bioethical guidelines, more and more institutional review boards (or ethics committees) have been set up in various organisations or government bodies, at various levels, and from developed to developing countries.2^–6

Ethics committees were first introduced to China in the 1980s. After that, a document, The Organizational Principles of Hospital Ethics Committees, was drafted by the National Academy of Medical Ethics of China in 1990. In 1994, this same group proposed to set up hospital ethics committees (HECs) in tertiary hospitals in order to promote virtue and morality among healthcare providers and keep up with the global development of bioethics committees. Since 1998, a number of regulations have been established in China to regulate medical practice and bioethical review of research involving human subjects. Included were such regulations as Approaches on Ethics Review of Biomedical Research Involving Human Subjects (Draft) (Ministry of Health); Good Clinical Practice for Drugs (State Food and Drug Administration); Regulation on Assisted Reproductive Technology (Ministry of Health). These regulations facilitate the development of hospital ethics committees (HECs) in China and indicate the roles that HECs should play in the operation of hospitals.7

The main objective of this study is to understand the current functions, structure and operation of HECs in Shanghai in order to find the gaps between the ideal and the real and to facilitate the improvement of HECs in China.

METHODS

A questionnaire survey, interviews with secretaries and on-site document reviews on HECs in Shanghai were adopted in the study. We developed the original questionnaires according to World Health Organization guidelines for committees reviewing research, related regulations in China such as Approaches on Ethics Review of Biomedical Research Involving Human Subjects (Draft) (Ministry of Health) and Good Clinical Practice for Drugs (State Food and Drug Administration) and revised the questionnaires according to the pre-survey results and consultation among 13 experts, including an International Bioethics Committee member of Unesco, an ethics expert from the Chinese National Human Genome Center at Shanghai, three experts from the Shanghai Medical Ethics Association, three HEC members, three officials of the Shanghai Municipal Health Bureau and two medical ethics experts from Fu Dan University.

Since all of the tertiary hospitals in Shanghai had HECs, 15 tertiary general hospitals and 15 tertiary specialised hospitals were randomly selected as sample hospitals from 19 tertiary general hospitals and 17 tertiary specialised hospitals in Shanghai. As only eight secondary general hospitals of 116 secondary hospitals in Shanghai had HECs and no secondary specialised hospital had an HEC, all of these eight secondary general hospitals were included in the survey. The data were collected from April to July 2007.

The questionnaire form on HECs in Shanghai consisted of 10 sections with a total of 183 questions, covering the hospital background, the HEC’s constitution and functions, the HEC’s position in the hospital, types of personnel, terms of appointment and quorum requirements, guidelines and procedures, bioethical review practice, documentation and archives, bioethical education and training, and the hospital’s financial and administrative support of the HEC. The questionnaire had single-choice, multiple-choice and open-ended questions. The questionnaire form was filled out by the HEC’s chairperson or the secretary assigned by the chairperson.

Through interviews with the HECs’ secretaries, the investigators collected more information about the independence of the HECs, the functions and operation of HECs, and the secretaries' attitudes and suggestions regarding HECs.

Meanwhile, the investigators reviewed the documents of each HEC, including guidelines, constitutions, procedures, meeting minutes and forms for ethical review.

Data collected were entered into Epidata, version 3.02, and Microsoft Excel 2003. The quantitative data were analysed with descriptive statistics and the qualitative data were described in words.

RESULTS

A total of 33 (86.8%) hospitals actually participated in the survey, of which 12 were tertiary general hospitals, 13 were tertiary specialised hospitals and eight were secondary general hospitals. Four (12.1%) surveyed hospitals had established HECs before 1998. All of the surveyed tertiary hospitals were affiliated with universities or medical schools and five of the surveyed secondary general hospitals were affiliated with medical schools or were the teaching sites of medical schools. Five of the tertiary hospitals’ HECs formed at least two committee panels. In addition, 17 (51.5%) hospitals were accredited by the State Food and Drug Administration as drug clinical trial sites and nine (27.3%) were in the process of accreditation (table 1).

Functions of HECs

According to the survey, 90.9% of the HECs had bioethical review of research involving human subjects, mainly referring to bioethical review of clinical trials on drugs (84.9%) and devices (66.7%); 69.7% of the HECs had bioethical review or consultation on medical care services and administrative decision-making, including bioethical consultation on clinical application of new technologies and/or administrative policy-making. There was also bioethical review on medical care services and/or bioethical ward round; 21 (63.6%) of the HECs also provided education and training on bioethics for the committee’s members, hospital health staff and/or patients and their relatives (table 2). Based on the survey, 14.3% of the HECs didn’t provide any formal bioethical training to their members. In addition, the members who had received bioethical training seldom got systematic and comprehensive training on bioethical review or bioethical consultation. Less than half of the surveyed hospitals provided bioethical training to their faculties, research subjects or patients.

Hospital ethics committee structure

The survey revealed that the average number of members of each committee was 10.4 (range 7–20) and the average number of non-affiliated members was 1.9 (range 0–5). Overall, 60.1% of the HECs’ members were physicians, 10.7% were lawyers, 6.32% were pharmacists and 3.6% were bioethicists. The survey also showed that 9.1% of the tertiary specialised hospitals and 42.8% of the secondary hospitals had no non-affiliated members. Most of the non-affiliated members were community or patients’ representatives, lawyers or bioethics experts from universities.

In the hospitals that answered the survey, 40.0% of the chairpersons, 45.0% of the associate chairperson(s) and 50.0% of the HEC members were directly appointed by the hospital. Others were determined by vote or negotiation. The research showed that 64.3% of the HECs had the formal replacement procedure.

Of the chairpersons who answered the question, 96.7% held other positions in hospitals, such as the presidents or vice-presidents of the hospitals or the directors of clinical departments. Only one tertiary specialised hospital appointed a retired professor of clinical medicine as chairperson. The educational backgrounds of chairpersons were mainly in the field of clinical medicine (73.3%) and healthcare management (20.0%); 26.7% had a master’s degree and 16.7% had a doctoral degree.

In Shanghai, 86.7% of the surveyed HECs appointed one or two secretaries to assist the committee’s administrative work, but only three tertiary specialised hospitals (10.0%) with a high review workload appointed one full-time secretary. While 71.4% of the HECs claimed that assistant staff was insufficient and they needed more assistant staff. In surveyed HECs, 65.6% of the secretaries were directors or associate directors of administrative departments of hospitals. Their educational backgrounds were also mainly in clinical medicine (51.5%) and healthcare management (21.2%). According to the interview, part time secretaries on average worked about 4.9 h per week for HECs.

Reviewing the HECs’ documentation, we found that 10 in the tertiary general hospitals and eight in the tertiary specialised hospitals had established standard operating procedures (SOPs) on the basis of national and international guidelines. But in some, especially some in the secondary hospitals or newly founded ones, the regulations or guidelines were very simple.

The surveyed HECs were predominately financed by the hospitals, while some (67.9%) of the HECs charged for bioethical review and three in tertiary hospitals charged for training members of other HECs. The committees’ office equipment, such as computers, filing cabinets, telephone and fax machine and printers, were mainly bought by the hospitals. However, 60.0% of the HECs had no independent office. In this situation, the HECs’ secretaries shared the office and office equipment with other hospital administrators.

Bioethical review by HECs

The survey revealed that 80.7% of the surveyed HECs had written requirements for application submission for the bioethical review of a research project involving human subjects. The requirements generally included the application form(s), the application material list, the number of copies to be submitted, and the application procedure. However, 28.6% of secondary hospitals and 25.0% of tertiary specialised hospitals declared that they had no written submission requirements and no written application procedure. Potential applicants could learn of these requirements through the hospital website (35.48%), ethical training by the HECs (35.48%), hospital notification (22.6%) and other sources.

According to the survey, 58.1% of the HECs held board meetings irregularly, usually depending on their workload. The average time taken for their members to receive protocols and related materials was 5.9 days (range 1–14 days) before board meetings. The average time that each board meeting lasted was 2.7 h (range 1–6 h). The average time for a committee to make an initial review in a board meeting was 1.4 h (range 0.5–4 h).

With regard to quorum requirements, 41.9% of the HECs required more than two-thirds of the members to attend the meeting, 25.8% required more than half, and 32.3% required at least five. According to the interview, some HECs arranged for alternative members to ensure that every meeting would meet the quorum requirements.

More than half of the surveyed HECs adopted the practice of using primary and secondary reviewers for biomedical research and healthcare services. These reviewers would then bring their assessments to the full board meeting for discussion during initial review. Usually, chairpersons assigned primary and secondary reviewers, and in some low-volume committees, the chairperson acted as a primary reviewer. To avoid conflict of interest, 89.3% of the HECs did not allow the members to perform a bioethics review where substantial conflict of interest was determined. But some HECs had no clear definition of what constituted conflict of interest.

Nearly half (48.4%) of the HECs would invite the applicants to present the proposal or elaborate on specific issues in a board meeting, but the applicants would leave the meeting room before the discussion and vote of the committee. All the HECs’ decisions related to bioethical review in the board meeting needed members’ votes.

In initial review, almost all the surveyed HECs reviewed the informed consent form and the protocol; 90.0% of the HECs reviewed investigators’ qualifications, but only 58.1% and 3.2% of the HECs reviewed advertising material for recruitment of participants and took account of community considerations (table 3).

Some HECs with a high workload, especially in tertiary general hospitals, adopted expedited review. Although some HECs had written procedures for expedited review, they did not conduct any expedited review, mainly because of a low volume of applications (fewer than 20 applications per year) and because they felt more confident of decisions made by the full board. The average time from application submission to notification of HECs’ decision for expedited review was 3.7 working days (maximum 7 working days).

We found that 44.4% of the HECs did not perform a continuing review, especially in secondary hospitals (66.7%). The average interval of any continuing review was 7 months (maximum 12 months). HECs usually asked investigators to send a report of research progress and seldom reviewed the report in detail. Only two HECs did a continuing review on site after the approval of the research.

The survey found that 44.4% of the HECs had definite rules for documentation and archiving, including the list of documents to be filed and archived and the access and retrieval procedure for the various documents. Nearly two-thirds (65.5%) of the HECs appointed a specific person to take the responsibility for documentation and archiving.

DISCUSSION

Development of the functions of HECs

Before 1998, only a few hospitals in Shanghai had set up HECs. But after the issuance of related national regulations, more and more hospitals established ethics committees in Shanghai, especially the tertiary hospitals and the hospitals with drug clinical trial sites accredited by the State Food and Drug Administration or in the application process for drug clinical trial sites.

Although the HECs in Shanghai combined the functions of research ethics committees and clinical ethics committees, as in some other countries they devoted more effort to bioethical review of research involving human subjects and less effort to other functions (bioethical review or consultation on clinical cases, bioethical consultation on hospital policy-making, and bioethical education and training).8 9 Three factors may explain the current situation of HECs in Shanghai. First, bioethical review of research involving human subjects is much more developed worldwide in terms of content and methods.10 Second, bioethical review of research involving human subjects is required by the regulations in China. HECs have the obligation to review this research, but the HECs’ functions on bioethical review or consultation for medical practice and hospital policy-making and education on bioethics are generally not required by regulations (except for organ transplantation, assisted reproductive technologies and a few others). Third, clinical bioethical review or consultation is more complicated. Its methods are not well developed, and no specific related guidelines in China are available.

Some experts indicated that it is undesirable to have research ethics and clinical ethics under one roof. Many countries have divided research ethics committees from clinical ethics committees. In the USA, too, research ethics committees and clinical ethics committees are strictly separated.11 But in Shanghai, hospitals, especially tertiary ones, undertake both medical care services and biomedical research, and they need scientific and bioethical review or consultation on both. From the survey, we found that some HECs in the tertiary general hospitals had created some panels with different specialties to make the HECs’ review or consultation more effective and efficient. In the survey, some experts put forward the idea that regional institutional review boards should be established to review research involving human subjects for the health institutions in the region and that HECs only undertake bioethics review or consultation on medical practice and hospital policy-making and education and training on bioethics. But in the current situation, it is difficult to split the functions of HECs in Shanghai, because there are not enough other institutions or bodies that can take care of all the bioethical review that is needed. In addition, if the bioethical review of the research in hospital was done by other institutions or bodies and the investigators had to pay for it, the cost of the research in hospitals would increase and this might hinder bioethical review of research involving human subjects.

Provision of formal training in bioethics for the members

This survey of HECs in Shanghai revealed an average membership of 10.4 and an average of 1.2 non-affiliated members. The membership included physicians, pharmacists and some non-scientific individuals. The membership of the committees in Shanghai met the national and international standards of membership criteria to some extent, but many of the members did not receive formal training on bioethics. This was especially true of the lay members serving as community or patient representatives. Those members may not fully play the expected roles as they should, because of their lack of necessary knowledge and skills.

The American Society for Bioethics and Humanities Task Force (“the Task Force”) developed a set of minimum “competencies” for those conducting bioethical consultation. The competencies are divided into skills (bioethical assessment skills, process skills and interpersonal skills) and knowledge including a knowledge of (1) moral reasoning and bioethical theory, (2) common bioethical issues and concepts, (3) healthcare systems and clinical context, (4) the local healthcare institution and its policies, (5) relevant codes of bioethics and professional conduct, (6) guidelines of accrediting organisations and (7) relevant health law.12 Although these skills and knowledge were developed for bioethical consultants, they are also useful and important for HECs’ members to play the roles in bioethical review or consultation on clinical cases and bioethical consultation on hospital policy-making.

The key to ensuring the quality of the service of HECs is to ensure the qualifications of their members. We should provide formal ethics training for HEC members, including initial training and continuing education. In addition, certification of training should be required for a person to be qualified as a member of an HEC.

Control of conflict of interest

Many chairpersons and members of the HECs in Shanghai were directly appointed and the selection criteria for these chairpersons and members were not clear. We found that the majority of the chairpersons had been in top administrative positions in the hospitals, such as hospital presidents or vice presidents, while most members and secretaries had been the directors of clinical or administrative departments or had worked in the hospitals’ critical care departments. Moreover, many HECs in Shanghai had neither regular funding nor separate independent offices in hospitals. These situations could have serious implications for the HECs’ functions, including unsustainable independence of review. We found that nearly 90% of the HECs did not allow members to make bioethics reviews where substantial conflict of interest was determined. However, with regard to conflict of interest, the HECs mainly considered whether the member was an investigator or an applicant of the reviewed research. In fact, there are many underlying but important conflicts of interest that can influence or challenge the independence of HECs.13

Need for SOPs

Many HECs in Shanghai had constituted some regulations of their own: for instance, quorum requirements, application procedure and some forms for review. But because of the lack of SOPs in many HECs in Shanghai, the operational performance among the HECs was quite varied. The survey shows the need for a framework for drafting SOPs to be set up to enable the hospitals in Shanghai to establish better SOPs, consistent with national regulations and international guidelines. In addition, the transparency of the committees’ operations and communication of experiences among HECs should be enhanced, and the secretaries of HECs should be appointed accordingly.

Improvement of bioethical review

All the HECs in the survey paid great attention to the informed consent form but not to its process. Obviously, this is rather insufficient, because informed consent is not merely a form. Informed consent covers important information that the subjects should understand well enough to provide the basis for their decision to consent. Guidelines issued by Council for International Organizations of Medical Sciences emphasise that investigators must convey information in a way that is appropriate to an individual’s level of understanding and also that they must bear in mind that the ability to understand the information necessary to give informed consent depends upon the individual’s maturity, intelligence, level of education and rationality.14 So the HECs in Shanghai should review informed consent forms and also the process of obtaining consent, so as to make sure the participants fully understand what they are agreeing to or declining.

According to the results of the survey, HECs in Shanghai often did not carry out continuing review of the research they approved. Sometimes they only required principal investigators to submit midterm reports, and continuing review usually did not include an on-site visit. As a result, the HECs could hardly know the actual behaviour of investigators clearly and in a timely manner. Thus the HECs’ ability to supervise and control the approval of research is weakened.15 In order to safeguard the welfare and rights of patients and participants, the HECs in Shanghai should regularly review the progress of the research projects both by report and by visiting the site. Through site visitation, HECs can communicate with the investigators, subjects and related hospital administrative officers, provide them with guidance and get the information for continuing review.

Study limitation

Although this survey helps us to understand the current status of the HECs in Shanghai, it has some limitations. According to our original survey plan, 38 hospitals should have been surveyed, but five sampled hospitals were unwilling to participate in our survey; therefore, the findings of the survey may have some bias. Some data for analyses were based on the responses of chairpersons or secretaries, so the survey’s findings regarding the HECs’ status in Shanghai may be better than the actual status.

CONCLUSIONS

HECs in Shanghai have developed in the past 10 years and they have played a great role in protecting the rights and welfare of patients and human subjects involved in research. But formal training in bioethics among HEC members, control of conflict of interest issues, establishment of SOPs for HECs and continuing review should be improved.