Table 2 Overview of answers to open question Q15 “What do you consider to be the biggest problems in the functioning of your ethics committee?”
Number | Answer(s) |
|---|---|
Q15-A01 | A. Unduly administration. B. Necessity to archive documentation and lack of storage space. C. Ambiguous, possibly changing interpretation of certain laws (e.g., definition of intervention). |
Q15-A02 | A. Absence of self-assessment using a “checklist” for simple projects with only minimal risk. B. Ambiguity in communication with the Czech Science Foundation (GAČR) or other funding agencies about the need for approval from the REC before submitting a project to a specific call. C. Overloading by applications in some time periods: we have to deal with the ethical aspects of almost all projects we work on with partner institutions within our own REC, which increases the number of assessments (as it is still not common for research institutions to have their own REC). |
Q15-A03 | A. Unclear rules for research ethics assessment in Czechia (except for clinical trials), especially for SSH projects. B. Lack of legal framework for research ethics review in Czechia (except for clinical trials). C. Inconsistent approach of funding agencies to research ethics assessment, in particular requiring final approval of the project at the time of submission to a specific call (scientific quality of the project cannot be taken into account, most projects for a specific call are assessed by REC vainly). |
Q15-A04 | A. Insufficient time for assessment of research project proposals, resulting in time-critical evaluation). B. Inadequate work capacity dedicated to the REC (in terms of individual members), resulting in the inability of the REC to act. C. Inadequate financial, administrative and personnel support of the REC (lack of adequate budget, lack of technological support which should be in line with 21st century capabilities, lack of fair remuneration of REC members for the work done, which is now only a symbolic reward). D. Systematic education and training of existing and new EC members – completely absent in our conditions; the work of the REC is largely amateurish. |
Q15-A05 | Time overload, the necessity to study project documentation outside of the working hours. |
Q15-A06 | The activities of the REC do not receive sufficient professional and social recognition, which results in low level of interest among experts to serve as REC members. |
Q15-A07 | A. Before submitting the project proposals to the funding agency, there is no time for a detailed discussion of them in the REC (researchers usually submit them for ethical assessment on the last day for their submission, or 2 or 3 days prior to the deadline). B. Researchers and investigators do not even know the Czech (let alone international) standards on research with human subjects. C. Researchers belonging to the medical profession (hospital employees) or non-professional contractors often submit their projects for ethical review in an extremely poor state, when their repeated revisions are necessary. |
Q15-A08 | A. Missing laws. B. Incompetent lawyers, e.g. on issues of informed consent. C. Dysfunctional ethics committees and dysfunctional codes of conducts. |
Q15-A09 | The legislation is very extensive in this regard. |
Q15-A10 | A. Increase in the amount of documentation, e.g. very long questionnaires filled out by the contractor, which the REC does not really need. B. Instead of a real information document for the research participants, informed consent becomes a “safety measure” for lawyers. |
Q15-A11 | In cases of suspected scientific misconduct, we considered the main problem to be the unwillingness of those involved to communicate and cooperate with the REC in a meaningful way. |
Q15-A12 | Unclear legal conditions for the evaluation of projects other than clinical trials of medicinal products (e.g. documentation requirements, archiving periods). |
Q15-A13 | Inconsistent instructions for evaluating project proposals (forms not available, etc.). |
Q15-A14 | A. Incomplete documentation and repeated errors in documentation submitted to REC. B. Repeated unnecessary questions from the contractors or monitors. C. Inconsistent requirements of multicentric RECs regarding the maximum length of the ICF document (maximum 10 pages). D. Further new EU regulations, too much bureaucracy. |
Q15-A15 | Because this answer indirectly identified the respondent, it has been omitted from this overview for privacy reasons. |
Q15-A16 | Excessive administration, especially in clinical trials of medicinal products. Nowadays, however, due to Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014, the number of ethical assessments of these trials is expected to decrease significantly, as it will be possible to assess such clinical trials by the REC of the State Institute for Drug Control (SÚKL). |
Q15-A17 | The range and frequency of ethics assessments required. |
Q15-A18 | Currently*, only teleconferences and online meetings are possible. Outside of the pandemic period, REC works without problems. *) December 2021 – January 2022 |
Q15-A19 | Low attendance of REC members. |
Q15-A20 | A. Limited archive storage capacity. B. Unwillingness to serve as a REC member and especially as a chairperson. |
Q15-A21 | Closer collaboration with clinical departments and units to clarify research objectives and necessary ethical and legal measures. |