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Brief report
RESEARCH ETHICS
Evaluation of the work of hospital districts’ research ethics committees in Finland Ritva Halila Correspondence to Dr Ritva Halila, National Advisory Board on Health Care Ethics (ETENE), Ministry of Social Affairs and Health, P.O. Box 33, FI-00023 Government, Finland; ritva.halila@stm.fi Received 31 December 2012 Revised 13 November 2013 Accepted 14 August 2014 Published Online First 22 September 2014
ABSTRACT The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area.
INTRODUCTION
To cite: Halila R. J Med Ethics 2014;40:866–868. 866
Ethical evaluation is an essential part of medical research involving human beings. Since the Helsinki Declaration, research ethics committees (RECs) have been established all around the world.1 Rapid developments in medicine and incidents attracting wide public attention have raised concerns about the role and responsibility of RECs.2 3 Initially, RECs usually consisted of a small group of voluntary and enthusiastic medical professionals. The work of RECs has since then become increasingly regulated both internationally and by national legislation.4 5 In Finland, the Medical Research Act (488/1999) regulates the role, size, composition and duties of ethics committees. Their task in evaluating clinical trials was further defined by the European Union Clinical Trials Directive.6 7 While demands have grown significantly, the range of expertise among members of RECs has widened and the size of committees has increased. Although differences have been reported in the work of RECs, not much has been published about the quality of their work. In countries where RECs can be established freely, such as the USA, the UK
and the Netherlands, there is a growing interest in assessing the quality of their work.8–10 This study was conducted in Finland to evaluate the work of hospital districts’ ethics committees.
MATERIALS AND METHODS A questionnaire was sent to all hospital districts’ ethics committees (RECs) in March 2009. It contained questions about their size and composition, workload, working methods, facilities, resources and training. Only initial assessments concerning a national opinion were recorded; amendments or studies that had already received a national opinion in another REC were not recorded. The responses were analysed in two separate groups: nine university (uRECs) and 15 nonuniversity hospital district ethics committees (non-uRECs). Due to the small size of the sample, only means and SDs were used when the groups were analysed.
RESULTS Structural differences Responses were received from all of the RECs of mainland Finland that evaluate medical research. Significant differences were found. uRECs had a mean of 13.4 members (SD 2.7) compared with 9.3 (SD 1.9) for non-uRECs and 10.2 (SD 4.1) substitute members compared with 4.7 (SD 3.3). At the uRECs, 61% of members were medical doctors (37.4% at the non-uRECs). Medical doctors represented 9.7 different specialties per uREC compared with 4.7 for the non-uRECs (table 1). All of the uRECs had at least one full-time secretary (mean 1.5 person-years). Only one non-uREC secretary worked full time, and part of the job included research coordination in the hospital district. The other non-uREC secretaries worked part time, working mainly in hospital administration. The frequency of REC meetings also reflected the workload: uRECs held meetings at least once a month—two of them every 3 weeks. Eight out of the 15 non-uRECs held meetings once a month, the others less frequently.
The workload of RECs There was a significant difference in terms of the number of original research studies evaluated annually: 75–200 for the uRECs (mean 110, SD 40) and 0–31 for the non-uRECs (mean 6.8, SD 8.2). One of the non-uRECs accounted for one-third of the research studies evaluated by the non-uRECs as a whole.
Halila R. J Med Ethics 2014;40:866–868. doi:10.1136/medethics-2012-101313
Downloaded from http://jme.bmj.com/ on June 22, 2015 - Published by group.bmj.com
Brief report Table 1
Structure and function of hospital districts’ research ethics committees in Finland All ethics committees mean (SD)
uRECs mean (SD)
Non-uRECs mean (SD)
Members Substitute members Medical doctors Per cent Medical specialties Other healthcare professionals Percentage of other healthcare professionals Lay members Percentage of lay members New proposals/year Variation Secretary
10.9 (3.0) 6.8 (4.5) 8.9 (5.8) 50.4% 6.5 (3.8) 3.5 (1.5) 19.9% 5.25 (2.3) 29.6% 45 (56)
13.4 (2.7) 10.2 (4.1) 15 (3.8) 61% 9.7 (3.7) 2.9 (1.1) 12.2% 4.9 (2.1) 24.4% 109 (40) 75–200 1.5 person-years
Education, chair (days/year) Education, secretary (days/year) Education, members (days/year)
2.1 (1.4) 2.4 (1.5) 1.63 (1.3)
3.3 (1.3) 3.6 (1.3) 2.8 (1.4)
9.3 (1.9) 4.7 (3.3) 5.2 (2.8) 37.4% 4.7 (2.4) 3.9 (1.7) 27.6% 5.8 (2.7) 35.2% 6.8 (8.2) 0.5–31 1/15 full time 14/15 part time 1.3 (0.8) 1.5 (0.8) 0–1*
*An estimate. Most university research ethics committees (uRECs) do not record training of members and substitutes.
Ethics education uREC chairpersons and secretaries participated in educational events more often than their counterparts on non-uRECs (3.3 and 3.6 days vs 1.3 and 1.5 days, respectively), and some uREC chairpersons and secretaries also attended international meetings. The non-uRECs did not usually record the amount of training given to members or substitutes.
Other resources of RECs All of the uRECs and nine out of the 15 non-uRECs had their own website for informing researchers about the documents required, dates of meetings and so on. Eight out of nine uRECs had standard operating procedures (SOP) in use, and the ninth uREC was finishing its SOP at the time of the study. Four out of 15 non-uRECs had a SOP in use. Contact information for all of the RECs that evaluate medical research can be found in the websites of the hospital district concerned and the Sub-Committee on Medical Research Ethics (TUKIJA, http:// www.tukija.fi), later the National Committee on Medical Research ethics. uRECs had office space, equipment and separate archives for their exclusive use provided by the hospital district. Non-uRECs used mainly the resources of the hospital district administration at no extra cost.
DISCUSSION Although independent review of research by ethics committees should protect the rights of research participants, this task has become more challenging, formal and bureaucratic as research projects have become more complex. Meanwhile, demands to speed up the evaluation of clinical trials are increasing.11 Requirements for ethical assessment of clinical trials have also influenced the evaluation of other types of research, although in many countries only medical research involving humans is required by law to undergo ethical evaluation. Ethics committees should have an ‘appropriate range of expertise and experience adequately reflecting professional and lay views’.5 This study showed significant structural and functional differences between ethics committees. RECs that were established in university hospital districts had more members Halila R. J Med Ethics 2014;40:866–868. doi:10.1136/medethics-2012-101313
and especially more medical doctors from a wider spectrum of specialties than did non-uRECs. This may reflect the type of research they evaluate: uRECs evaluate mainly large, multicentre clinical projects, while non-uRECs evaluate smaller more local studies as well as studies outside the medical field. The wider range of medical expertise and the multidisciplinarity of uRECs certainly facilitate them in their examination of the challenging ethical issues of medical research. Differences in other activities in the RECs work (web pages, SOPs, days of training) reflect better resources of the uRECs. Estimates of what constitutes the optimal workload of an ethics committee vary greatly. The number of studies evaluated by an ethics committee has an impact on its expertise. In this study, uRECs evaluated around 110 research studies a year, which seems to be comparable with the workload of RECs internationally. Fourteen out of the 15 non-uRECs evaluated less than six initial studies each year. Czarkowski and Rozanowski12 have evaluated the function of ethics committees in Poland and reported an increase in the number of ethics committees that evaluate
Brief report
RESEARCH ETHICS
Evaluation of the work of hospital districts’ research ethics committees in Finland Ritva Halila Correspondence to Dr Ritva Halila, National Advisory Board on Health Care Ethics (ETENE), Ministry of Social Affairs and Health, P.O. Box 33, FI-00023 Government, Finland; ritva.halila@stm.fi Received 31 December 2012 Revised 13 November 2013 Accepted 14 August 2014 Published Online First 22 September 2014
ABSTRACT The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area.
INTRODUCTION
To cite: Halila R. J Med Ethics 2014;40:866–868. 866
Ethical evaluation is an essential part of medical research involving human beings. Since the Helsinki Declaration, research ethics committees (RECs) have been established all around the world.1 Rapid developments in medicine and incidents attracting wide public attention have raised concerns about the role and responsibility of RECs.2 3 Initially, RECs usually consisted of a small group of voluntary and enthusiastic medical professionals. The work of RECs has since then become increasingly regulated both internationally and by national legislation.4 5 In Finland, the Medical Research Act (488/1999) regulates the role, size, composition and duties of ethics committees. Their task in evaluating clinical trials was further defined by the European Union Clinical Trials Directive.6 7 While demands have grown significantly, the range of expertise among members of RECs has widened and the size of committees has increased. Although differences have been reported in the work of RECs, not much has been published about the quality of their work. In countries where RECs can be established freely, such as the USA, the UK
and the Netherlands, there is a growing interest in assessing the quality of their work.8–10 This study was conducted in Finland to evaluate the work of hospital districts’ ethics committees.
MATERIALS AND METHODS A questionnaire was sent to all hospital districts’ ethics committees (RECs) in March 2009. It contained questions about their size and composition, workload, working methods, facilities, resources and training. Only initial assessments concerning a national opinion were recorded; amendments or studies that had already received a national opinion in another REC were not recorded. The responses were analysed in two separate groups: nine university (uRECs) and 15 nonuniversity hospital district ethics committees (non-uRECs). Due to the small size of the sample, only means and SDs were used when the groups were analysed.
RESULTS Structural differences Responses were received from all of the RECs of mainland Finland that evaluate medical research. Significant differences were found. uRECs had a mean of 13.4 members (SD 2.7) compared with 9.3 (SD 1.9) for non-uRECs and 10.2 (SD 4.1) substitute members compared with 4.7 (SD 3.3). At the uRECs, 61% of members were medical doctors (37.4% at the non-uRECs). Medical doctors represented 9.7 different specialties per uREC compared with 4.7 for the non-uRECs (table 1). All of the uRECs had at least one full-time secretary (mean 1.5 person-years). Only one non-uREC secretary worked full time, and part of the job included research coordination in the hospital district. The other non-uREC secretaries worked part time, working mainly in hospital administration. The frequency of REC meetings also reflected the workload: uRECs held meetings at least once a month—two of them every 3 weeks. Eight out of the 15 non-uRECs held meetings once a month, the others less frequently.
The workload of RECs There was a significant difference in terms of the number of original research studies evaluated annually: 75–200 for the uRECs (mean 110, SD 40) and 0–31 for the non-uRECs (mean 6.8, SD 8.2). One of the non-uRECs accounted for one-third of the research studies evaluated by the non-uRECs as a whole.
Halila R. J Med Ethics 2014;40:866–868. doi:10.1136/medethics-2012-101313
Downloaded from http://jme.bmj.com/ on June 22, 2015 - Published by group.bmj.com
Brief report Table 1
Structure and function of hospital districts’ research ethics committees in Finland All ethics committees mean (SD)
uRECs mean (SD)
Non-uRECs mean (SD)
Members Substitute members Medical doctors Per cent Medical specialties Other healthcare professionals Percentage of other healthcare professionals Lay members Percentage of lay members New proposals/year Variation Secretary
10.9 (3.0) 6.8 (4.5) 8.9 (5.8) 50.4% 6.5 (3.8) 3.5 (1.5) 19.9% 5.25 (2.3) 29.6% 45 (56)
13.4 (2.7) 10.2 (4.1) 15 (3.8) 61% 9.7 (3.7) 2.9 (1.1) 12.2% 4.9 (2.1) 24.4% 109 (40) 75–200 1.5 person-years
Education, chair (days/year) Education, secretary (days/year) Education, members (days/year)
2.1 (1.4) 2.4 (1.5) 1.63 (1.3)
3.3 (1.3) 3.6 (1.3) 2.8 (1.4)
9.3 (1.9) 4.7 (3.3) 5.2 (2.8) 37.4% 4.7 (2.4) 3.9 (1.7) 27.6% 5.8 (2.7) 35.2% 6.8 (8.2) 0.5–31 1/15 full time 14/15 part time 1.3 (0.8) 1.5 (0.8) 0–1*
*An estimate. Most university research ethics committees (uRECs) do not record training of members and substitutes.
Ethics education uREC chairpersons and secretaries participated in educational events more often than their counterparts on non-uRECs (3.3 and 3.6 days vs 1.3 and 1.5 days, respectively), and some uREC chairpersons and secretaries also attended international meetings. The non-uRECs did not usually record the amount of training given to members or substitutes.
Other resources of RECs All of the uRECs and nine out of the 15 non-uRECs had their own website for informing researchers about the documents required, dates of meetings and so on. Eight out of nine uRECs had standard operating procedures (SOP) in use, and the ninth uREC was finishing its SOP at the time of the study. Four out of 15 non-uRECs had a SOP in use. Contact information for all of the RECs that evaluate medical research can be found in the websites of the hospital district concerned and the Sub-Committee on Medical Research Ethics (TUKIJA, http:// www.tukija.fi), later the National Committee on Medical Research ethics. uRECs had office space, equipment and separate archives for their exclusive use provided by the hospital district. Non-uRECs used mainly the resources of the hospital district administration at no extra cost.
DISCUSSION Although independent review of research by ethics committees should protect the rights of research participants, this task has become more challenging, formal and bureaucratic as research projects have become more complex. Meanwhile, demands to speed up the evaluation of clinical trials are increasing.11 Requirements for ethical assessment of clinical trials have also influenced the evaluation of other types of research, although in many countries only medical research involving humans is required by law to undergo ethical evaluation. Ethics committees should have an ‘appropriate range of expertise and experience adequately reflecting professional and lay views’.5 This study showed significant structural and functional differences between ethics committees. RECs that were established in university hospital districts had more members Halila R. J Med Ethics 2014;40:866–868. doi:10.1136/medethics-2012-101313
and especially more medical doctors from a wider spectrum of specialties than did non-uRECs. This may reflect the type of research they evaluate: uRECs evaluate mainly large, multicentre clinical projects, while non-uRECs evaluate smaller more local studies as well as studies outside the medical field. The wider range of medical expertise and the multidisciplinarity of uRECs certainly facilitate them in their examination of the challenging ethical issues of medical research. Differences in other activities in the RECs work (web pages, SOPs, days of training) reflect better resources of the uRECs. Estimates of what constitutes the optimal workload of an ethics committee vary greatly. The number of studies evaluated by an ethics committee has an impact on its expertise. In this study, uRECs evaluated around 110 research studies a year, which seems to be comparable with the workload of RECs internationally. Fourteen out of the 15 non-uRECs evaluated less than six initial studies each year. Czarkowski and Rozanowski12 have evaluated the function of ethics committees in Poland and reported an increase in the number of ethics committees that evaluate
