In accordance with its statutory obligations, the KL-EC ensures compliance with ethical standards in the conduct of research involving human subjects, human material and data at the KL and its affiliated university hospitals. The number of submissions highlights the need for institutional ECs and the large proportion of student theses illustrates that beyond its formal remit, the KL-EC, like other university review boards, also has an important educational and quality assurance task. We observed that only few applications pass the initial formal assessment without any queries, thus contributing to prolonged review periods. A reason for this might be that in a young university many submissions come from less experienced applicants and from medical students requiring support in the preparation of complete and assessable applications. Once formally approved, however, most projects receive provisionally positive votes, as only minor corrections or additions are required, which upon revision and resubmission by the authors, can be re-evaluated by the chairman and office alone, without the need to involve the whole committee.

Our analysis shows that corresponding to the KL’s curricula and the broad clinical scope of our affiliated hospitals, submissions cover a broad spectrum of topics. Due to the legal limitations of the commission described in the introduction, the distribution of study types is narrow and confined mainly to retrospective analyses and questionnaire studies.

In the following we provide an overview about specific challenges and issues faced by ECs. Some of these generally apply to all types of medical ethics committees and boards, others are specific for voluntary commissions, like the KL-EC.

As there is no regulation in Austria requiring special training for EC members, they are usually appointed according to their individual expertise and professional background as stipulated by law or in the statutes of the institution by the respective authorities (rectorates, governments). Thus, expertise in medical ethics varies, (particularly between institutional not legally regulated ECs) often resulting in divergent decisions on identical multicentric protocols when submitted to more than one EC. Currently, the standards of the ECs are so different that it usually must be decided on a case by case basis whether the vote of another EC is recognized or not [7]. National standardized mandatory and voluntary training programs would be useful to improve this problem [8, 9]. Once a common standard is established, a national agreement on mutual recognition of votes should follow, with the aim that common study protocols are maintained for national multicentric research projects, and only informed consent forms (ICF), other patient-related material and advertisements are site-specific. This does not apply to clinical trials according to AMG and MPG, where protocol integrity is already regulated by national and international stipulations.

Similarly, not only the expertise of ECs and individual EC members can vary but (as the results of our analysis show) also even more so the expertise of applicants, investigators and institutions. As the detrimental effects of this problem on medical progress, institutional performance, and individual careers are evident, it is the responsibility of ECs and their members to offer and participate in targeted training programs for current and future investigators. To this end, the KL not only offers relevant courses for students, but also training opportunities for scientific staff as part of its science skills services. These programs include courses on topics such as the ethical and legal framework of medical research, the basics of scientific methodology and statistics.

While the approval and conduct of clinical trials investigating medical products and devices is subject to strict regulations in Europe and worldwide, the ethical evaluation of other medical research is, at least in Austria, not or only insufficiently regulated. The § 19e (3a) of the NÖ-KAG for example states: “Vor der Durchführung angewandter medizinischer Forschung und von Pflegeforschungsprojekten und der Anwendung neuer Pflege- und Behandlungskonzepte und neuer Pflege- und Behandlungsmethoden kann die Ethikkommission befasst werden” (The ethics committee may be consulted before conducting applied medical research and nursing research projects and before applying new nursing and treatment concepts and new nursing and treatment methods). This appears to be in contrast with the Declaration of Helsinki that requests that medical research protocols “involving human subjects, including research on identifiable human material and data” must be submitted to “the research ethics committee concerned”. This ambiguity sometimes leaves researchers and ECs also in the dark about their obligation to submit and evaluate. It goes without saying that in cases of doubt and in the interest of participating patients and their material and data, the principles of the Declaration of Helsinki are paramount, and editors of scientific journals rightly require accompanying documentation of ethical approval along with the submission of manuscripts containing results of research in humans.

A frequent criticism on the need to apply for EC approval in medical research is that it is cumbersome and may delay research. Although it is obvious (and confirmed here also for the KL-EC) that approval may take time, this complaint disregards the fact that, similar to the peer-review process in scientific publishing, project review by a qualified EC leads to improvement of submitted protocols, thus preserving not only patient safety but at the same time increasing the scientific value of the proposed investigations. Formal enquiries often relate to the incorrect or incomplete completion of the online application form used by all ECs in Austria, which is designed as a standardized document for all types of studies. This makes the form appear complicated and confusing, especially to the inexperienced applicant. It is therefore the responsibility of all Austrian ECs to continuously develop this indispensable document in order to make it more convenient for the applicant and at the same time adapt it to a constantly evolving scientific landscape. In addition, while the document is primarily aimed at physicians conducting clinical trials, other disciplines conducting research on humans (e.g., psychology, nursing) often require EC approval for their projects. Both quantitative and qualitative research has to be evaluated. Therefore, mutual agreement to adapt the submission procedure and documents for these research areas and scientific methodologies is required as well. The question of whether separate or joint review committees and review procedures are preferable remains open [10].

While we tried to demonstrate and discuss issues relevant to EC submission and approval in Austria, our analysis is limited by the fact that it is primarily based on the experience, performance, and activities of a single institutional EC at a private university and thus might not be representative. Furthermore, a major part of clinical research, namely clinical trials of medical products and devices, could not be considered in our analysis and discussion as it is not within the remit of the KL-EC. Even if the allocation of applications to the individual medical specialties may be imprecise due to the limited options, the overall impression of the importance of the various medical specialties is well conveyed. A further aspect missing from our investigation is the costs associated with setting up and maintaining a qualified review board. Although the KL-EC members contribute voluntarily, office staff and premises, maintenance of software and servers and fees for external reviewers must be taken into account.