Table 4 Overview of answers to open question Q17 “What do you consider important for improving the functioning of ethics committees in Czechia?”

Q17-A01

A. RECs should be established routinely in larger numbers.

B. Ethical standards and rules for assessment should be established in a way that is as understandable as possible to researchers, REC members, and research participants.

C. Framing by international conventions and general legal norms is necessary, but the submission and assessment of research projects and the writing informed consents should not become a formal and legal issue (e.g. the text of the informed consent would – in an extreme caricature – resemble an energy purchase contract).

Q17-A02

If possible, a quick and smooth transition to the new assessment system for clinical trials within the EU.

Q17-A03

Common knowledge about RECs – many people do research and have no idea that they need to get approval from RECs, they have no idea that their institution has a REC.

Q17-A04

Biomedical research precedes REC’s possibilities and knowledge. It is therefore important to understand the potential risks associated with the application of new biomedical technologies and their impact.

Q17-A05

A centralized consulting service in the field of research ethics.

Q17-A06

A. A well-functioning training system for prospective and current REC members (not just formal training, but real quality training/education).

B. Streamlining the RECs’ activity: assessment only of funded projects (not all proposals submitted to a specific call), as it works within the European Research Area.

C. Ensuring administrative, personnel, and financial support to the REC.

Q17-A07

Because this answer indirectly identified the respondent, it has been omitted from this overview for privacy reasons.

Q17-A08

In the field of clinical trials, a total change is coming, with centralization, a different setting within the entire EU. Now we have a transition period, in which there will be important clear and timely information on the requirements for the functioning of existing RECs and the procedure for transition to a new practice.

Q17-A09

Coordination of cooperation among RECs.

Q17-A10

REC independence from the employer (founding institution).

Q17-A11

For the founding institutions of multicenter RECs, the not inconsiderable income from the clinical trials will now decrease. At present, we have been happy to be able to give members of the REC a quarterly reward. Its amount depends on the presence and activity of individual REC members. For the University Hospital as the REC founding institution, part of this income was thus “dissolved”. However, this situation will disappear with the entry into force of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.

Q17-A12

Uniform rules for research other than clinical trials of medicinal products.

Q17-A13

A. Setting of rules or introduction of minimum standards for assessment of research ethics in projects in Czechia (except clinical trials).

B. Preparing educational materials for researchers and RECs.

Q17-A14

Establishing rules for the financial remuneration of the work of REC members, as the founding institution has no generally defined obligations in this area.

Q17-A15

We will appreciate:

A. Unification in the method of payment for compensation to clinical trial participants.

B. Unification in the maximum length of the ICF (10 pages maximum).

C. Better cooperation on controversial issues.

Q17-A16

A. We all believe it is necessary to maintain the local RECs, including their decision-making powers, because only local RECs are able to assess the level of local workplaces and investigators.

B. We have very good long-term cooperation with the multicentric REC in cases of dispute. The meetings of the Forum of Ethics Committees with the participation of experts from the State Institute for Drug Control, (SÚKL) are also very important.

Q17-A17

Improving legislation and defining legal standards for research on human gametes, especially eggs, which are not included in current legislation.