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Activities of the Ethics Committees for Research 2014

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Activities of the Ethics Committees for Research 2014 Activities of the Ethics Committees for Research 2014 Summary Report of the Coordination Office for Human Research (kofam) 1 Introduction The Federal Act on Research involving Human Beings The Coordination Office for Human Research (Human Research Act, HRA) and the related imple- (kofam) was founded by the FOPH at the same time menting legislation took effect on 1 January 2014. The as the HRA took effect, and is responsible for primary objective of the HRA is protection of the indi- informing the public on the activities of the ethics vidual with regard to his dignity, psychological integ- committees. To this end, kofam prepares a sum- rity and health. Secondary objectives of the HRA are mary of the annual reports of the ethics commit- to provide favourable conditions for research and to tees. This report is the current summary. ensure the quality and transparency of research involving human subjects. In the preparation of the summary report, national statistics on the type and number of research pro- The HRA specifies the ethical, scientific and legal jects that were peer-reviewed and approved as well requirements that apply to research projects relating as the time taken for processing were omitted, since to human diseases and to the structure and function the basis for calculation was different in each case. of the human body. A central role in this context is The parameters that the ethics committees provided played by the cantonal ethics committees for to kofam in addition to the annual report were not research, referred to in the following simply as ethics complete or in a comparable format for all commit- committees. These committees review every tees. research project covered by the Act prior to its con- duct, in order to ensure that it meets the require- The factsheet ”The Human Research Act and the ments of the Act and can therefore be approved. ethics committees for human research“ that precedes this Report provides an introduction to two According to the statutory provisions of the Act, the central aspects of human research in Switzerland ethics committees report annually to the Federal and the relevant statutory regulation, namely the Office of Public Health (FOPH) on their activities, in HRA and the duties of the ethics committees for particular on the type and number of research pro- research. The basic information and the summary jects they have assessed and the times taken to annual report are available on kofam’s website www. process them. kofam.ch 2 Table of Contents Introduction 2 1 Structure and organisation of the ethics committees 4 2 Type, number and processing times for assessed research projects 7 3 Procedures of the ethics committees 9 4 Prospects 14 5 Summary 15 3 1 Structure and organisation of the ethics committees List of the cantonal ethics committees Aargau and Solothurn, which have been part of the in 2014 Northwest and Central Switzerland Ethics Commit- tee since 2014, and the cantonal Ethics Committee In 2014 there were nine (supra)cantonal ethics com- of Freiburg, whose responsibilities were taken over mittees in Switzerland. One year earlier, in 2013, four by the cantonal Ethics Committee of Vaud at the more (supra)cantonal ethics committees were listed beginning of the year 2014. – but these had been abolished or merged with other ethics committees by 1 January 2014. These were The ethics committees in 2014 in are listed in the the ethics committees of Central Switzerland, following table. Ethics Committee Regions covered Website (cantons) CCER: Cantonal Ethics Commit- Geneva www.ge.ch/ccer tee for Research, Geneva (formerly www.hug-ge.ch/ ethique) CCVEM: Valais Cantonal Valais No website Committee of Medical Ethics CE-TI: Cantonal Ethics Ticino www.ti.ch/ce Committee (Ticino) CER-VD: Cantonal Ethics Fribourg, Neuchâtel, Vaud www.cer-vd.ch Committee (VD) for Research on Human Beings EKNZ: Ethics Committee Aargau, Basel-Stadt, Basel-Land, www.eknz.ch of Northwest and Central Jura, Lucerne, Nidwalden, Switzerland Obwalden, Schwyz, Solothurn, Uri, Zug KEK-BE: Cantonal Ethics Bern www.kek-bern.ch Committee of Bern EK-SG: Ethics Committee Appenzell Ausserrhoden, www.sg.ch/home/gesundheit/ of St Gallen Appenzell Innerrhoden, St Gallen ethikkommission.html KEK-TG: Cantonal Ethics Thurgau http://www.gesundheit.tg.ch/ Committee of Thurgau xml_61/internet/de/application/ d13592/d17209/f13594.cfm KEK-ZH: Cantonal Ethics Zurich, Glarus, Graubünden, www.kek.zh.ch/internet/ Committee of Zurich Schaffhausen; as well as gesundheitsdirektion/kek/de/ Liechtenstein home.html 4 Number and areas of expertise of the area of expertise for the highest percentage of members members (mean = 41.5 %). Medicine is followed by nursing (10.6 %), ethics (10.2 %) and law (8.9 %). According to the data for the various ethics commit- With the exception of biostatistics, epidemiology tees that kofam requested from the ethics commit- and pharmacy as well as pharmaceutical medicine tees in addition to their annual reports, they have an (7.7 % each), the representation of other areas of average of 26 members. The Cantonal Ethics Com- expertise is relatively small. There are patient repre- mittee of Thurgau is the smallest committee with sentatives in the cantonal ethics committees of St eight members and the Cantonal Ethics Committee Gallen, Vaud and Zurich. of Zurich is the largest with 48 members. Medicine is Distribution of expertise of members 41.5 % 10.6 % 10.2 % 8.9 % 7.7 % 7.7 % 5.7 % 5.3 % 1.6 % 0.8 % Law Ethics Others Biology Nursing Medicine Pharmacy/ Psychology Patient representatives Patient pharmaceutical medicine Biostatistics/epidemiology N = Number of designated expertises; 246 (100 %) 5 Finances The cantonal Ethics Committee of Geneva had a defi- cit of about CHF 170,000 for 2014. The revenue from The cantons provide financial support for the Ethics fees did not cover costs, especially staff costs. Committees. The committees can therefore charge The cantonal Ethics Committee of Vaud recorded a fees that are payable by the applicants for each deficit for 2014, despite subsidies from the Health research project submitted. In 2013 and 2014, the Department. board of swissethics (the umbrella organisation of the cantonal ethics committees) prepared a recom- Information on the Internet mendation for the fee ordinance in the context of harmonisation processes 1. This recommendation An important source of public information about the allows for a graded structure for the fee ordinance individual ethics committees is their websites (see depending on the type of researcher or sponsor (for previous section «List of the cantonal ethics commit- example a pharmaceutical company, a public institu- tees in 2014»). All ethics committees have their own tion such as a hospital, a Master’s student etc.). website, with the exception of the cantonal Ethics According to their reports, the fee ordinance was Committee of Valais. Further relevant information can adopted by most of the ethics committee, some of be found on the website of swissethics 2, which has a which made a few amendments. higher level of information and documents for ethics committees and researchers, and is accessible via the Some ethics committees provide further informa- websites of the various ethics committees. tion on their finances in their reports. For example, the Ethics Committee of Northwest and Central Some ethics committees publish the titles of Switzerland mentions in its report that budgeting for research projects that they have approved on their 2014 proved to be difficult, since the financial results websites, for example the cantonal ethics commit- of previous years were of little or no use. Overtime in tees of Geneva and Thurgau, as well as the Ethics the administrative and scientific secretariat and the Committee of Northwest and Central Switzerland. co-financed BASEC project for electronic submis- The Ethics Committee of Ticino mentions the can- sion and processing of research proposals resulted in tonal registry of volunteers on its website; this data- additional unforeseen expenditure. With regard to base records all healthy subjects participating in revenue, the number of grant applications was less clinical trials in the Canton of Ticino. than in previous years, but this was offset by a rela- tively large number of Lead Ethics Committee deci- The vested interests of committee members of all sions. This enabled the Ethics Committee of North- except two ethics committees are disclosed on their west and Central Switzerland to end the year with a websites. Most of the ethics committees also list marginally positive annual balance. their current Rules of Procedure on their websites. 1 http://www.swissethics.ch/doc/ab2014/Gebuehrenreglement_d.pdf 2 http://swissethics.ch 6 2 Type, number and processing times for assessed research projects Type and number of research projects gau and Ticino also reported a slight decrease in the number of applications compared to the previ- Kofam requested that each ethics committee provide ous year. data on the type and number of applications received and their processing times in addition to its activity Research projects often last for several years, so that report for 2014. However, for various reasons a sum- the total number of research projects for which a mary of national statistics based on these data was committee is responsible can be very high. For not possible in this annual report. example, the cantonal Ethics Committee of Bern reports that it was responsible for approximately One problem was that the ethics committees provided 3,500 research projects in 2014. the total numbers of all research proposals submitted, regardless of whether the proposals were assessed by An increased number of research proposals would a lead ethics committee or a local ethics committee. If be expected simply as a result of the broader range of these numbers were combined to provide national sta- research projects that require assessment, in par- tistics, the result would be erroneous due to double ticular projects with health-related data.
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