Open Journal Systems

ETHICS AND BIOETHICS

Received: January 27^th 2015

Accepted: March 4^th 2015

Ethics committees in the experience of the IMSS: a Latin American instance

Edith Valdez-Martínez,^a Guadalupe Mata-Valderrama,^a Miguel Bedolla,^c Germán Enrique Fajardo-Dolci^b

^aCoordinación de Investigación

^bUnidad de Educación, Investigación y Políticas de Salud

^cUTSA Policy Studies Center, San Antonio, Texas, USA

^a,bInstituto Mexicano del Seguro Social, Distrito Federal, México

Communication with: Edith Valdez-Martínez

Telephones: (55) 5727 6900, extensions 21074 y 21076

Email: edith.valdez@imss.gob.mx, edithvaldez@prodigy.net.mx

Background: The aim of this article is to identify the current state of hospital bioethics committees and local research ethics committees of the Mexican Institute of Social Security (IMSS).

Methods: A descriptive cross-sectional study was performed that included all hospitals of the IMSS (N = 262). Two self-administered questionnaires were e-mailed between october and november 2014 to the hospital directors: one for hospital bioethics committees and another for local research ethics committees. Both questionnaires had five sections: committee location, date of committee set up, activity situation, composition, functions, and experience.

Results: The response rate was 85 %. It was reported 150 active hospital bioethics committees and 67 active local research ethics committees. In both groups physicians and executive directors dominated committees’ membership, and lay people were reported only in seven hospital bioethics committees. The primary function of hospital bioethics committees was case consultation, and their primary goal “to improve the quality of medical care”. Local Research Ethics Committees reported as primary function “to evaluate health research protocols and rule of them”, and as their primary goal “to protect the rights and wellbeing of the research subjects”.

Conclusions: Both groups of committees ought to be assessed regularly through audit cycles in order to identify the educative actions that enhance their efficiency.

Keywords: Bioethics; Ethics committees; Health services, Mexico

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Although medical ethics has always been considered an integral and essential part of everyday clinical practice, it has gained considerable visibility from the Nuremberg Trials and the publication of the code of the same name.¹ This development has accelerated in the past four decades from the creation and extraordinary development of this unique structure called the ethics committee.

Historically, the first call for there to be research ethics committees appeared in the first Declaration of Helsinki (1975)² in response to the fact that, despite the Nazi experience, abuses in biomedical research continued to be reported. The first research ethics committee that can be documented began in 1975 at Johns Hopkins University.³ Then in the seventies, in response to the American research scandals publicized in the Belmont Report,⁴ and research ethics committees begin to grow in number in some European countries (Belgium, France, Great Britain).⁵ Currently, research ethics committees exist worldwide, evaluating research protocols based on moral rules inspired by international ethical guidelines (1947 Nuremberg Code, Helsinki Declaration of 2013, etc.).

In Mexico, the protection of research subjects was established by the Reglamento en Materia de Investigación of the Ley General de Salud of 1982.⁶ declaring in December 2011⁷ the obligation to have a research ethics committee in any establishment where human research is conducted in accordance with the criteria (for integration and operation) established by the Comisión Nacional de Bioética.⁸

Besides scientific research ethics, there are ethical and bioethical issues that arise in daily clinical practice, such as: the distribution of scarce resources; access to health care; the doctor-patient relationship and its impact on morbidity and the costs of medical care; developing new public policy strategies, etc. It then becomes logical to imagine the possibility of submitting to collective discussion, the ethical problems that arise in everyday clinical practice.

Hospital bioethics committees (HBC) first appeared in the United States in the 1980s, although its legal requirement for a hospital to be certified began in the early 90’s.⁹ At the time, the purpose of these committees was to help doctors clarify ethical problems and also help them make morally acceptable decisions. Today, although most countries have created clinical ethics committees or hospital bioethics committees as part of the structure of their hospitals, these have developed in different ways in different countries, and even within a country can have wide variation in structure and function.¹⁰ In Mexico, in December 2011 it became mandatory to have a HBC in all hospitals in the health sector with more than 30 beds,^7,11 and to operate according to the Comisión Nacional de Bioética guidelines, which issues the guidelines and criteria for its integration and operation.¹²

The Mexican health system is comprised of a combination of health institutions: public, private and social security. The Instituto Mexicano del Seguro Social (IMSS) provides medical care to 58 million¹³ of the 123 million inhabitants in the country;¹⁴ its system of medical care units is organized into three levels: the first level corresponds to family medicine units; the second level consists of regional hospitals and district general hospitals, where patients are referred to for diagnosis from family medicine units; and the third level of care, consisting of medical units with high specializations and technology. In late 2005, the Dirección de Prestaciones Médicas of the IMSS launched a strategic plan for the establishment of a formal system of ethics committees in all health care units of the country.¹⁵ 

In the IMSS, health research constitutes one of the core activities of the institution¹⁶ (together with the provision of medical care), so its organizational structure includes the national commission on scientific research, the ethics committee for health research, and the biosafety committee, all as single entities; and a network of local health research ethics committees (LHREC), who perform their duties in accordance with the policies of the Dirección de Prestaciones Médicas through the Coordinación de Investigación en Salud.¹⁷

Thus, the national commission for scientific research is to evaluate and determine the protocol when:

• the use of medicines, equipment or medical supplies are proposed.
• institutional policies have changed.
• other national or foreign institutions, or two or more units of the IMSS are involved.
• the pharmaceutical industry is involved.

This research committee asks for the opinion of the research ethics committee. The ethics commission then evaluates two areas of the research projects: risks and benefits, and the informed consent forms. The biosafety committee is responsible for evaluating protocols that involve genetic engineering technology, the use of radioactive swabs and ionizing or electromagnetic radiation devices. The LHREC’s assess and dictate the research projects carried out in their unit, provided they do not include the categories referred to above for the national research commission.

The IMSS is the largest social security institution in Latin America, 16 and unlike other health institutions it is the only one with a formal system of LHREC;^17,18 It was also the first institution to set up a system of clinical ethics committees to address ethical issues in daily clinical practice.¹⁵

The aim of the national survey reported here was to document the performance and experience of the HBC and LHREC of the IMSS in order to generate evidence that could help making necessary decisions for the development and/or improvement of its operational procedures and policies.

Methodology

Quantitative, cross-sectional descriptive study performed using a self-report survey. Two self-administered questionnaires were designed based on previous assessments of these committees.^15,18,19 Questionnaires were refined by three researchers. The final versions of the questionnaires were piloted to prove their validity, acceptability, and the time required to respond. The questionnaires contained 22 questions, addressed to the presidents of each of the committees. The study was evaluated and approved by the National Bioethics Commission.

Site and study population

Presidents of the HBC and of the LHREC of all IMSS hospitals in the country, as well as the president of the Comisión Nacional de Investigación Científica of the same institution.

Procedure for data collection

In October 2014 a letter of invitation (which described what would be done, that participation was voluntary, and the details of how the confidentiality of their responses would be maintained), along with the two questionnaires were sent via email to all IMSS hospital directors.

Two research assistants (technicians), previously trained, were responsible for sending and receiving the questionnaires. Research assistants corroborated by telephone the receipt of the documents. A reminder to all hospital directors of was sent by telephone and/or e-mail three and six weeks after the initial invitation message. No incentive was offered to encourage their participation. Since the invitation noted that participation was voluntary, the fact that a questionnaire was completed and returned it was considered informed consent.

Data analysis

Data was processed using SPSS version 20. Absolute and relative frequency measures of central tendency and dispersion were calculated, depending on the type of variable analyzed.

Results

Of the 262 hospitals in the IMSS, 223 completed the survey (response rate = 85%) (Table I). All geographic regions are represented. Of the 223 participating hospitals, 86% (192/223) reported having at least one committee, of which 80% (154/192) were reported as active. Having both committees active (HBC and LHREC) was associated with a greater number of beds and a higher level of care (Table II). None of the subzone hospitals (4 to 64 beds) reported having both HBC and LHREC active (Table III).

Structure of active HBCs’s (n = 150)

These HBC’s were established between 2001 and 2014 (median = April 2013). Table IV shows the demographic characteristics of active HBC. The male to female ratio was 1: 1 by committee; only one HBC was all-male. 8% (12/150) of HBC reported having members with a masters and/or doctorate in bioethics. 2% (3/150) of HBC had philosophers among its members. And 5% (7/150) of HBC said its members have a layperson representative ('patient'). In general, the vast majority of members have a clinical specialty (468/1171, 40%) or college degree (433/1171, 37%) as their highest level of education (Table IV).

Although 95% (142/150) of the HBC had a multidisciplinary membership, in 57% (86/150) of them, more than half of its members were doctors. Six HBC were bi-disciplinary (doctors and nurses), of which 73% of its members were doctors. Another two uni-disciplinary HBC were composed only of physicians.

51% (76/150) of HBC reported that between 1 and 10 of its members were directors of the hospital to which the committee belonged: directors, deputy directors, department heads, and clinical education and health research coordinators. 51% (76/150) of HBC were chaired by senior staff of the hospital to which they belonged.

The number of members (median and interquartile range) was 7 (of 6-10 members) per HBC. Time of membership of the members of the HBC (median and interquartile range) was 12 months (5-20 months). The number of meetings attended by the members in the year before the survey (median and interquartile range) was four (two to nine meetings).

Role and experience of active HBC (n = 150)

Goals

Determining goals by committee, this was 2: 1; in order of frequency: to improve the quality of care (95/150, 64%); to educate hospital health personnel in bioethics (91/150, 61%); identify the best solution from the point of view of medical ethics (87/150, 58%); increase the satisfaction of the patient/family (47/150, 32%); and reduce the risk of lawsuits (24/150, 16%).

Procedure

94% (141/150) HBC identified one to five functions (median = 2) per committee; these were to analyze clinical cases with ethical problems (97/141, 69%); promote continuing education in bioethics (91/141, 65%); protect the rights of patients (77/141, 55%); revise or develop guidelines, rules, and/or protocols for medical care (35/141, 25%); issue a moral solution (31/141, 22%); and assess and determine clinical research protocols (11/141, 8%). Most HBC (114/141, 81%) mentioned that among its functions is to follow up on its recommendations.

Experience

97% (145/150) of HBC reported one to eight different ways to find out about the ethical/bioethical problems of the hospital to which they belong (median = 2). Most said they found out through requests from health professionals at their hospital (95/145, 66%) and in meetings with the governing body (66/145, 50%). Also, through the review of medical records (61/145, 42%); requests by patients/relatives (40/145, 28%); complaint boxes (4/145, 3%); an ethics consultant (4/145, 3%); during shift change reporting (1/145, 1%); and through the quality and patient safety committee (1/145, 1%).

Moreover, 93% (140/150) of HBC reported having had (median and interquartile range) six meetings (between 3-10 sessions) in the year prior to the survey. Table V shows the reasons for the meeting, highlighting the case studies with ethical problems (99/140, 71%).
Table VI illustrates the range of issues that formed the basis of the cases analyzed by HBC in the year prior to the survey, which were primarily related to: the choice of treatment (61/108, 56%); the criteria of best interest (37/108, 34%); the completion of treatment (32/108, 30%); and the quality of the doctor-patient relationship (44/108, 41%). The top 10 medical conditions of the cases analyzed by the committee were: pregnancy (34/108, 31%); cancer (22/108, 20%); chronic renal failure (22/108, 20%); diabetes mellitus (15/108, 14%); mental retardation (9/108, 8%); organ transplantation (8/108, 7%); blood transfusions for Jehovah's Witnesses (7/108, 6%); traumatic brain injury (7/108, 6%); and hypertension (6/108, 6%).

29% (44/150) of HBC mentioned having reviewed or developed guidelines, guides, and/or medical care procedures in the twelve months preceding the survey. 93% (41/44) of them mentioned having done so to improve the quality of care; 30% (13/44) to improve palliative care; and 23% (10/44) to reduce the prevalence of risk factors for chronic diseases.

Inactive HBC’s

17 HBC were reported inactive. Reasons in order of frequency were: changes in management or operational staff of the hospital staff that owns the HBC (n = 8); for lack of registration issued by the National Bioethics Commission (n = 5); lack of participation of members of the HBC (n = 1); and temporary absence of the hospital director (n = 1). Two HBC did not mention the reason for their inactivity.

Local health research ethics committees (LHREC)

Active LHREC structure (n = 67)

The active LHREC reported being established between January 1990 and May 2014 (median = October 2012). Table VII shows the demographic characteristics of the active LHREC. The male female ratio was 1: 1 by committee; only two LHREC were composed exclusively of men.

While most members of the LHREC had a clinical specialty (203/476, 43%) or masters (152/476, 32%) as highest level of education, none reported LHREC members with master's or doctorate in bioethics, and no citizen representatives (Table VII).

40% (27/67) of the LHREC had a bi-disciplinary membership (mainly doctors and nurses) of which 82% of its members were physicians. 31% (21/67) had a multidisciplinary membership; in these, 61% of its members were physicians. And 28% (19/67) were uni-disciplinary composed only of doctors. Overall, in 93% (62/67) of LHREC, more than 50% of members were doctors.

Almost all LHREC (65/67, 97%) included as active members, 1-4 hospital managers, i.e. directors, deputy directors, department head, and clinical education and health research coordinators. In all these committees (65/67, 97%), the president was the hospital director. The remaining two LHREC mentioned having as presidents, one, a doctor of the operational area, and another, a priest.

The number of members reported per committee (median, interquartile range) was 7 (5 to 10 members). Time of membership in the LHREC (median, interquartile range) was 23 months (range 15-32 months). The number of meetings attended by the members in the year before the survey (median, interquartile range) was 12 meetings (8-16 sessions).

Role and experience of active LHREC (n = 67)

Goals

Once the goals of the committees were determined, they were 3: 1, in order of frequency: ensuring the development of health research protocols according to internationally recognized guidelines (n = 63/67, 94%); protecting the rights and welfare of research subjects (n = 55/67, 82%); educating health personnel hospital on the ethics of research involving humans. (N = 44/67, 66%); and reducing the risk of legal liability (n = 25/67, 37%).

Features

A total of 66 LHREC reported one to three functions (median two) by committee: to evaluate and determine research protocols (64/66, 97%); help researchers to the optimum execution of their protocols (57/66, 86%); and review and develop guidelines or procedures for health research (27/66, 41%). Almost all LHREC (65/67, 97%) reported that among its functions was also monitoring the implementation of research protocols that they had approved.

Experience

The number of meetings held –by committee- for the year prior to the survey (median, interquartile range) was 12 (10 to 19 meetings). 67 LHREC reported a total of 2696 research protocols assessed and audited in the year before the survey. Also reported 299 rejected projects. The number of research protocols -by committee- evaluated and audited in the same period (median, interquartile range) was 30 (from 16 to 58 protocols).

Table VIII shows the topics and research methods approved by LHREC protocols. Most of the research projects were aimed at addressing health problems associated with malignancies (329/2696; 12%); diabetes mellitus (240/2,695; 9%); infectious and parasitic diseases (236/2,696; 9%); and reproductive health and perinatal medicine (208/2,696; 8%). The three most frequent modes or types of investigation (Table VIII) were: clinical epidemiology (1467/2,696; 54%); basic (446/2,696; 17%); and clinical trials (441/2,696; 16%).

Inactive LHREC

Three LHREC were reported inactive, the reasons cited were: the absence of the general director, change of president, and the retirement of the technical secretary.

Comisión Nacional de Investigación Científica (CNIC)

Structure of the CNIC

23 health researchers form the CNIC; with a male-female ratio of 5: 1. 74% (17/23) of them had executive duties (three hospital directors, 13 heads of research units, and a department head). The members had PhD level (19) or master’s (4) maximum level of education. Time belonging to the CNIC (median, interquartile range) was 48 months (24-72 months). The number of meetings attended by its members the year prior to the survey (median, interquartile range) was 16 (from 10 to 26 meetings).

Roles and experience

The goal pursued by the CNIC is to protect the rights and welfare of research subjects. They reported as functions of CNIC: evaluating and determining research protocols and monitoring the development of approved protocols.

For the year prior to the survey, the CNIC reported 45 meetings, 132 projects evaluated, of which 29% (38/132) were rejected. Most research protocols were aimed at addressing health problems related to malignant neoplasms (36/132, 27%), infectious and parasitic diseases (17/132, 13%) and diabetes mellitus (15/132, 11%). Modalities or types of research most frequently reported were: basic research (53/132, 40%), clinical trials (46/132, 35%), and clinical epidemiology research (17/132, 13%).

Discussion

Hospital Bioethics Committees

This study shows that the number of HBC has increased: 150 HBC assets at the time of the survey (2014) compared with 78 identified in 2007.¹⁵ The prevalence of these committees is high, over 70% of hospitals with 100 beds have ≥ one active HBC. Although the quality or effectiveness of the work of HBC in Mexico is unknown, and although its existence is the result of both internal recommendation of the IMSS in 2005¹⁵ and the law issued in December 2011.⁷ The increase in the number of HBC could suggest a greater awareness of the importance of incorporating ethics into clinical practice.

The fact that 50% of HBC were chaired by senior staff of the hospital where the committee was, and that those same committees had as secretaries or members of management staff of the hospital shows that, for many, these HBC are responsibility of the high levels of administration of medical units. This bias in composition may increase the effects of power and domination by a subgroup during HBC deliberations, and create the risk that the decisions made are more aligned with the needs of these subgroups than with the purpose for which they were created: "Being independent, interdisciplinary and pluralistic bodies to provide a forum for reflection, discussion and education ..."¹¹ Without the autonomy that naturally belongs to HBC, their work becomes a rigid and obsolete ritual.²⁰ In Mexico, HBC are subject to the current legislation and the criteria established by the National Bioethics Commission, which proclaims "... they must not include administrative staff ... or people in management positions".¹¹ The adherence to official standards is also needed to produce the results expected by law, and to prevent these from becoming a ritual disconnected from the purposes of its operation.

Another important bias is given in its membership: a high proportion of physicians, and a minimum number of lawyers, bioethicists, philosophers, priests or other ministers of religion, and representatives of the public. This raises ethical questions about the methodology with which the deliberation of cases is made; for example, information relevant to patients and/or family may be inadvertently excluded, or at best, obtained second hand. The basic idea is that everyone's interests are equally important, from a moral point of view there are no privileged persons, and when cases are deliberated exclusively from a medical standpoint these interests are at risk.

It is not surprising, then, that the primary goals of HBC were in support of clinicians: "improving the quality of health care" (64%); educating health personnel in bioethics "(61%); and "identifying the best solution from the point of view of medical ethics" (58%); rather than being aimed at patients and their relatives or the wider community hospital. This finding runs in parallel with the fact that some HBC have identified the goal of "reducing the risk of lawsuits" (8%); the latter, although it could be seen as an end which implies improving the quality of health care, also speaks of bias in the composition of the HBC.

Most HBC reported two main functions: analysis of clinical cases in which there is an ethical/bioethical problem, and education (bioethics) of health personnel at the hospital to which the committee belongs. The analysis of clinical cases has historically been the role that has prevailed in these committees since 2005.¹⁵ and it is consistent with the provisions of the national regulations: "The HBC are consultative bodies ...".¹¹ A function little performed by HBC was the revision or development of guidelines, rules, and/or procedures for medical attention. All this indicates that they perceive their role more as reactive to what happens in the moment (because they focus more on isolated cases where there is an ethical/bioethical problem) than as proactive (because they overlook the importance of screening and prevention of ethical/bioethical issues of the hospital unit to which they belong).

A nationwide survey, which involved the entire health sector, conducted in 2005,¹⁹ reports 101 committees to address the ethical issues in clinical practice; of these, 58% also evaluated and dictated health research protocols. The main change observed was that in the current survey only 8% of HBC recognized among its functions that of evaluating and determining clinical research protocols.

The ways reported of finding out about of ethical/bioethical issues arising from clinical practice were most often at the request of health professionals (66%); through the governing body (50%), and by reviewing medical records (42%). It was rarely at the request of patients/family (28%). This reflects the predominance of medical and managerial staff among members of the HBC, since they make up the governing body, and are also part of other hospital committees. Also, it could reflect that patients and their families are not being educated about their rights.

The variety of issues and medical conditions that formed the basis of the cases analyzed by the HBC is related to health problems that often occur in the clinic;²¹ however, the quality and efficiency with which the HBC recognize and handle the cases analyzed is ignored, as well as how to act to prevent and reduce ethical problems arising from the context of the hospital unit to which they belong.

Local research ethics committees in health research

The recent survey identified 67 active LHREC, while the national survey of 2002 reported 238 active LHREC. The validity of the IMSS LHREC depends on their productivity, and according to the manual for the integration and operation of these committees,¹⁷ they should document the evaluation of at least 10 health research protocols per year to remain in force. This explains the difference in the number of LHREC.

When the characteristics of its members are analyzed, some weaknesses are evident such as bias in their membership. Although most LHREC were bi-disciplinary (40%) and multidisciplinary (31%) doctors predominated, as well as hospital managers belonging to the committee; in addition, there were no representatives of the people. The exclusive presence of professionals in the LHREC makes these committees less sensitive to vulnerable populations when these populations are considered within the criteria for selecting a research project.²² Also, the presence and influence of management as LHREC members as in the case of the HBC already analyzed, increases the risk of losing the purpose for which these committees were created, which is "to protect the welfare and rights of research subjects",² promoting their transformation and shift to serving powerful groups,²³ who may be more interested in protecting the interests of the institution.

Other important findings: first, most LHREC identified as primary goals "ensuring the development of health research protocols" (94%); "protecting the rights and welfare of research subjects" (82%); and educating health personnel hospital in ethics of research (66%). Some LHREC (37%) also identified as a goal: "reducing the risk of legal liability." Moreover, these committees cited two main functions "evaluate and determine health research protocols" (97%), and "help researchers to the optimum execution of their research protocols" (86%). These findings, together with the fact that they are made up only of health professionals, highlight the possibility that LHREC are more interested in maintaining their validity that really protecting the welfare and rights of research subjects. To understand what LHREC are actually doing and how well they are doing qualitative research is needed.

Although the themes and forms of approved research protocols are consistent with the health problems of the country, 21 membership, relations with positions of authority and decision-making process of the LHREC should be evaluated regularly. Monitoring that does not depend solely on verifying adherence to regulations, is desirable to understand the relationship between quality of LHREC and quality of approved research.^24,25

The National Commission for Scientific Research

The results also here made clear bias in its membership: most of its members were male and had managerial positions, there were no representatives of the people, and half of its members had a period of service of four years or less, the other 50% having more than 4 years on the committee. The fact that the CNIC is responsible for evaluating and determining research protocols from the pharmaceutical industry, multicenter projects, and studies concerning changes in institutional policy, could partly explain its composition; however, as mentioned before, the consequences of this bias in the composition of the committees may be more risky than beneficial.

Although the research ethics commission, a single entity in the IMSS, did not participate in the survey, it deserves a comment based, first, on the tasks set out in the IMSS manual for integration and operation,¹⁷ and moreover on the concept of research ethics set forth in the manual for integration and functioning of the national commission on bioethics.²⁶ The first establishes the sole function of "reviewing the risks and benefits and informed consent forms"; and the second mentions that "the inclusion of ethical issues in the protocols is a quality indicator on par with the methodological rigor of an investigation." The ethics of scientific research is not limited to risk-benefit ratio and informed consent alone; nor is it limited to methodological rigor. Certainly these are some of the factors to be taken into account during the committee's deliberations, but there are other moral principles and considerations, which together provide a framework for ethical review; for example, the use of placebos and the protection of vulnerable groups are not questions of methodological rigor, nor are they justified only because there is informed consent; rather, it is also in the ethics of subject selection, the value of research to society, and the absence of conflict of interest, etc.²⁷

Study limitations

Limitations of this study are related to courtesy bias and social desirability that may have made for a report with information that is not completely truthful about the current state of the activity and functions of committees of both groups. From this research, later investigators may then use research designs and methodologies that do not rely on self-report, to reliably know their status and to promote continuity and increase the overall effectiveness of its operation.

Conclusion

The results of this research indicate that there are still some unresolved fundamental problems related to organizational structure, composition and working committees of both groups (HBC and LHREC) to make them work effectively and efficiently. It is clear that the simple requirement of its existence is not sufficient in itself, and a comprehensive plan to boost its development is required, as well as improving their operating procedures and policies.

The results of this study also suggest that both groups of committees should be regularly assessed through audit cycles, focused on education and development of the work process of each of the committees.
Qualitative research studies are needed to understand deeper how both sets of committees are doing their work and to assess the quality of their work.

Acknowledgements

Thanks to Dr. Manuel H. Ruiz de Chávez, President of the Consejo de la CONBIOÉTICA, and to all IMSS hospital directors in the country.

References

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