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To present the experience of running workshops for members of research ethics committees (REC) in Spain from 2001-2008 by a non-profit institution.
We analyzed data from 7 sessions of the course, involving 165 health professionals. Data were taken from an opinion survey conducted at the end of each seminar and a deferred questionnaire sent after the workshops.
Opinions of 122 participants who completed the first questionnaire (84% of the 146 attendees) on these training courses were very positive (median, ≥4.5 out of 5). The second questionnaire was administered a few months after each session, and a total of 43 participants responded (36% of 118). The participants improved their knowledge, attitude, and skills (median, 4.0 out of 5) in most of the areas evaluated. Furthermore, they believed that training for REC members should be mandatory (median, 5.0 out of 5) and carried out regularly (median, 4.0 out of 5). The lack of communication between RECs and limitations in monitoring clinical trials (median, 4.5 out of 5) were the main problems according to respondents. Training was rated as a strong necessity (median, 4.0 out of 5).
The courses were well received, they contributed to the overall learning of the participants, and served to highlight some of the major problems faced by REC members. These results emphasize the importance of training.
The main function of research ethics committees (REC) is to ensure the protection of human subjects in biomedical and behavioral research and to provide an adequate public guarantee in this regard, such as was ratified in the subsequent European directive (1). RECs are commonly known in Spain as Comités Éticos de Investigación Clínica, in the US as Institutional Review Boards, and in Canada as Research Ethics Boards. In Spain, they were established in 1990 when the Spanish Medicines Act made them compulsory for clinical research, especially drug research (2).
As outlined in the current Spanish regulations (1,3,4), RECs must comprise at least 9 members, including medical and non-medical professionals, and must ensure the independence of their decisions. They must also ensure their competence and experience in the methodological, ethical, and legal aspects of the research, and in the pharmacology and clinical practice both inside and outside of the hospital. The most recent policy change that has affected RECs came as a result of the Spanish Biomedical Research Act, which changed the name of these committees and expanded their functions (5).
Although the several Spanish regulations on RECs date back more than 20 years, it was not until 2004 that training activities for members in the various ethical, methodological, and administrative aspects were considered necessary (3). The Coordinating Center of RECs (in Spanish, Centro Coordinador de Comités Éticos de Investigación Clínica, CC-CEIC) was created as part of the Department of Pharmacy and Health Products of the Spanish Ministry of Health to take over the responsibility of organizing these activities for the then 127 RECs in Spain. However, two more years passed before CC-CEIC initiated training courses.
Until the CC-CEIC began its training initiative, how were the members of the RECs trained? How did they acquire the necessary skills? Many of them had to organize their own training in order to acquire the competencies needed to carry out their duties. In those areas where they lacked experience they generally learned through their daily work in the REC and especially through personal effort, which was not always sufficiently recognized (6). Furthermore, what happened when for some reason it was necessary to replace a member of the REC? It is obvious that REC members can only fulfill their statutory function through adequate training (7,8).
It was this situation that provided the catalyst for the initiative launched by two of the authors of this paper (JEB and FB), with the support of the Esteve Foundation. With the experience gained from previous initiatives (9), a series of workshops entitled “Introduction to the Functioning of RECs” was scheduled with the aim of training REC members. These courses were designed according to an interactive format similar to previous training activities organized by the Esteve Foundation (10). After 8 years of organizing such seminars for REC members between 2001-2008 (11-17), these activities eventually ceased after CC-CEIC began its training initiative in 2006.
In this article, our aim is to identify the best practices based on experience of giving these seminars over 8 years, and also to guide future efforts to ensure the efficiency of this type of training. We analyze the workshop outcomes in the following areas: the acceptability of such courses for participants; the main problems and areas for improvement in RECs and proposed solutions; and, finally, the degree of improvement in the knowledge, skills, and attitudes of those attending the seminars.
In total, 7 sessions of the seminar “Introduction to the Functioning of RECs” were organized between 2001 and 2008 in 7 Spanish cities (Table 1). With an almost identical format and with the participation of 2 teachers in each session, these courses were also conducted in several Spanish cities in collaboration with various institutions (Table 1). With the exception of the first 2 sessions, in which Dr Inés Galende (Servicio de Regulación Sanitaria, Consejería de Sanidad, Comunidad de Madrid) also participated, all the courses were taught by two of the authors (JEB and MIL).
All courses were advertised through the Esteve Foundation mailing list, comprising mainly professionals in fields related to pharmacology, as well as through Spanish medical societies. A small fee was asked (€ 50) for every two-day seminar, and the course was also offered free to recently graduated professionals. Each course had an intensive format and ran all day on two consecutive days, with a total duration of 16 teaching hours. The themes and content of each session are detailed in Table 2. Teaching methods involved lectures, discussions of cases and an REC simulation, in which the entire group was divided into two committees to discuss a real clinical trial protocol.
During the first two workshops, discussion groups were formed to consider what participants considered the main problems affecting RECs in Spain. In addition to this list of problems, a second list of suggestions of how to improve the functioning of RECs was prepared by the attendees.
At the end of each workshop, participants were asked to complete a voluntary opinion questionnaire about the workshop. The questionnaire consisted of several questions about the course, materials, organization, teachers, and other aspects, with the aim of improving those areas that received lower scores. Each parameter was rated on a Likert-type scale from 0 “very inadequate” to 5 “very adequate.”
Between the fifth and sixth session of the seminar (January and February 2004) a questionnaire was sent to all participants of the 5 previous seminars, followed by at least 2 reminders by email if they did not respond. This means that the interval between the seminar and the deferred questionnaire ranged from 4 months to 3 years, depending on when the participant took the course. An introductory message was sent by email (or fax) with the questionnaire attached (in Word format). It analyzed whether participation in the courses had led to improved knowledge, attitudes, and skills in their daily work. Other questions were aimed at soliciting their opinion on the need for such courses. Those who were members of RECs were also asked about their perspectives on the future and their concerns. Drawing on the list of important issues elicited in the first two workshops, information was sought on what issues were considered priorities. This questionnaire used a Likert-type scale of 5 options ranging from 1 “strongly disagree” to 5 “strongly agree.” Instructions on the scale and how to complete the questionnaire were included in the file attached to the email containing the questionnaire.
Data were processed using the statistical package SAS® Enterprise Guide® (SAS Institute Inc., Cary, NC, USA). For the presentation of the results median and ranges were calculated. For comparison between means the Wilcoxon rank-sum test was used. Data were presented as a box-plot.
A total of 165 health professionals, of whom 101 (61%) were women, attended the 7 training workshops. Participants belonged to diverse disciplines: biochemistry, biology, cardiology, clinical analysis, emergency medicine, epidemiology and public health, hematology, hepatology, general practice, infectious diseases and microbiology, internal medicine, law, medical management, neurology, nursing, oncology, pharmacology, pharmacy, psychiatry, surgery, urology, and zoology.
A total of 122 (84%) of the 146 participants who attended the first 6 seminars completed the first questionnaire. As shown in Figure 1, the opinion on the workshops was very high, in particular in relation to the overall assessment, the work of the teachers, materials, and the organization of the seminars (median ≥4.5 out of a maximum of 5).
Deferred questionnaire was sent to a total of 118 participants of the first 5 sessions of the workshop. In this questionnaire, 43 participants (36%) gave their opinion on the usefulness of these courses, of which 27 (63%) were female and 16 (37%) men. The majority of respondents were medical doctors (51%). Of these participants, 21 (49%) said they were members of an REC at the time of completing the questionnaire.
According to the questionnaire responses, health professionals considered that they had achieved an improvement in their knowledge, attitudes, and skills after completion of the course (Table 3). There were no significant differences in the opinion between members and non-members of an REC on the data obtained from the deferred questionnaire (data not shown). On the other hand, there appeared to be unanimous demand for such seminars to be mandatory training for members of RECs (median 5), and for their implementation on a regular basis (median 4) (Table 4).
From the list of problems drawn up during the first 2 workshops and included in the deferred questionnaire, 26 (60%) participants (15 women and 11 men), who had at some time been involved in an REC, scored each problem from 1 (strongly disagree) to 5 (strongly agree). The list and an assessment of each problem can be found in Table 5. During the preparation of this list, participants in the first 3 workshops engaged in group discussions and proposed some solutions to those problems that interfere with the day-to-day functioning of the REC (Table 6).
Broadly speaking, it appears that these courses were well regarded. At the same time, they yielded information about the limitations and expectations of REC members at a time when no institution had the explicit responsibility of providing training for them. These training workshops were also a challenge for the organizers since there were no such previous initiatives in Spain, and they were filling an unmet need.
The success of the courses was probably due to some of the following: a) the intensive format – although it involves losing two days of work, this may prove to be more efficient than courses of a few hours repeated during consecutive weeks (7); b) splitting up into small groups of 20 people – this facilitates interaction and learning due to the personalized attention that each attendee receives; c) the combination of participatory teaching methods (discussions) and practical case studies and role play; d) delivery of the workshops by two teachers – this facilitates the exchange of views and makes the course more entertaining; and finally e) the very small registration fee and the availability of grants to attend the workshop – the course was organized by a non-profit institution and the fees were not intended to fund the workshop, therefore it was much more feasible economically for those who wished to attend. As such, this type of collaboration between public institutions (academic, health care, training, scientific societies) and private institutions (such as the Esteve Foundation) can be highly recommended.
Courses, workshops, and other training initiatives for REC members have been used as a format in Spain (18), as well as in other countries (7,9,19). The first described experience was specifically aimed at phase 1 volunteer studies (9), which is an important difference from the experience we describe. In 2003, the National Bioethics Committee for Medicine in Croatia held a workshop for members of hospital ethics committees (19). A survey of the 107 participants was performed following this workshop and it was found that members’ level of knowledge was greater after the course. It was also found, as in our study, that most respondents felt their knowledge could be improved by additional training (19).
Although the workshop format is only one type of model, there are other alternatives such as books on bioethics training and research, teaching materials, or selections of articles that RECs can provide for the training of its members (6). Online learning systems are another option (7). Furthermore, a guide for ethics committees has been recently published that includes case studies on issues related to the REC (20).
The active participation of attendees in the workshops described in this article allowed us to gather information about their concerns and proposals regarding the work of RECs. Among the problems highlighted at the time of completing the questionnaire was the lack of training for committee members, along with other issues such as lack of communication between different RECs, overwork, excessive bureaucracy, and the problem of monitoring studies. Both the lack of communication between committees and the problem of monitoring studies could be improved with information technology initiatives, such as the Spanish databases GESTO and SIC-CEIC (21). The problems of RECs unearthed through our training workshops, along with other more diverse issues, have also arisen in publications and surveys conducted in Spain (22-24), as well as in other countries (25-30). Even though we highlighted the need for consistent standards among the different Spanish RECs, this problem is even more evident at the European level (31).
We are in agreement with the recommendations proposed by participants to improve the work of RECs. We would add our own recommendations which would be to create a central database of RECs with contact information that would be kept, updated, and disseminated periodically by one centralized Spanish organization.
The deferred questionnaire conducted after the training seminars collected data on the views of participants regarding the applicability of the knowledge, attitudes, and skills acquired during the course. The data clearly demonstrated the usefulness of the courses. This questionnaire also demonstrated the unanimous demand for compulsory courses, as well as the need for their implementation on a regular basis for REC members. This finding is in accordance with other works on this subject, which show a demand for continuing medical education and training for REC members (8). It has even been proposed that the accreditation of RECs should be linked to the training of committee members and that the nomination of a new member should necessarily be preceded by a training course (7). Regarding the contents of the training courses, it is worth mentioning that a survey was conducted in 3 African countries in which REC members were questioned about their training needs (32). It was found that among their chief concerns were fundamental ethical principles, regulatory issues, and evaluation of informed consent, all of which arose in the workshops discussed in this article.
The need to communicate findings about REC training is essential for continuous quality improvement. Although CC-CEIC has organized at least 2 basic training courses for REC members, nothing was published on how these courses were run or how they were received. Consequently, an additional advantage of the workshops discussed in this article is the effort made to publish information on what they involved, which is also what this article aims to do. Outside of Spain, there are various data on the experience of running training courses for REC members (9,19).
The data presented verify that this activity proved to be a positive experience, while at the same time indicating some limitations of this study. The first questionnaire can be considered representative of the attitude of attendees as more than 80% of them responded; however, only 36% responded to the deferred questionnaire, even though at least 2 reminders were sent. It should also be noted that both the training seminars and this study were conducted between 2001 and 2008, when there were significant changes in the world of clinical research, including the European directive (1), the Spanish Data Protection Act (33), and most importantly (34), the Biomedical Research Act (5). Another limitation of this study is that it assessed participants’ self-evaluation but not their actual knowledge, skills, and attitudes after the training. That would have required a different analysis on objective measures of attendees’ performance. In addition, it would have been more rigorous to have asked about their knowledge before and after the seminar, since it is possible that some participants already had good knowledge in some areas before attending the training.
We wish to express special thanks to Inés Galende for her participation and involvement in the first two sessions of these workshops in 2001. We also thank the following collaborating institutions and their coordinators who allowed us to conduct these courses in different Spanish cities: Montserrat Clerigué at Donostia Hospital, Antonio Guerrero at La Ribera Hospital, Luis Miguel Palomo of the Cáceres District Health, María Magdalena Salom of the Balearic Islands Department of Health, and María Luisa Ugedo of the University of the Basque Country. We also thank Jesús Giraldo for his support and methodological recommendations and to Sergio Erill and Brian McCarthy for their support and help on the technical aspects and the English version of the manuscript. We are also grateful to the course participants and those who submitted the information we requested during the different phases of this research.
Conflict of interest: Two of the authors (JEB and MIL) were teachers at the seminars, for which they received salaries from the Esteve Foundation. The other two authors (ES and FB) are members of the Esteve Foundation.