Background
International epidemiological studies encounter unexpected obstacles and delays due to national non-harmonized laws. For instance, in France, some epidemiological studies are reviewed by independent bodies responsible for scientific merit and personal data protection, yet different from standard Research Ethics Committees (RECs)/IRBs. This kind of examination is not considered to be a proper ethical review by international journals. Further, some researchers conducting multicenter international epidemiological studies encounter unexpected obstacles across the European Union regarding the administrative process of reviewing. Unfortunately, the new European Regulation (EU) NR 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, is not applicable to non-interventional studies. It seems then that the unclear legal and ethical status of epidemiological studies will continue and it will be difficult to introduce a common international standard.
Given these circumstances, a thorough re-examination of ethical guidelines for epidemiological studies is urgently needed. The aims of the review presented here are: (a) to determine, systematically and transparently, all aspects of ethical review described in various epidemiological guidelines, and (b) to compare these guidelines in search for similarities and discrepancies between them. In order to achieve this goal, systematic review in PubMed, Google Scholar, and Google was conducted and qualitative text analysis of the retrieved guidelines was applied.
Methods
First, a search methodology to get a sample of guidelines was developed. They were identified through a systematic search in PubMed, as well as searches in Google Scholar and Google. As a result, eight documents were retrieved for further analysis. Neither general guidelines regarding all kinds of research involving humans, nor guidelines for condition specific epidemiological research (for instance on HIV/AIDS) were included in the study.
Qualitative Analysis
After passages concerning ethical review were extracted, a constant comparative method was applied to retrieve full range of ethical categories used in these passages. Thus, five main categories were obtained. Three of them cover main responsibilities of IRBs/RECs (information for subjects, protecting subjects, guards for research integrity), one refers to IRBs/RECs functioning (formal and operational requirements), and one defines the scope of the review (inclusion and exclusion criteria for review of epidemiological study). The results show that most guidelines fail to address at least some of the five crucial issues regarding ethical review. Some of these documents definitely should be updated by regulatory bodies.