Abstract
The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.
Highlights
Stem cells are the starting point for the development of human organism, representing the precursors of more than 200 cell types
The latest International Society for Stem Cell Research (ISSCR) guidelines about research in human embryonic cell research and clinical application of stem cells address several issues that are not included in previous versions, with the aim to encompass government regulation, Table 1: Main issues from ISSCR 2016 “Guidelines for Stem Cell Research and Clinical Translation”
A further issue considered in the discussed guidelines is represented by the communication which, according to the authors, is a crucial element because of the great deal of attention received by the stem cell research from the scientific and political world, as well as the public opinion [48]
Summary
Stem cells are the starting point for the development of human organism, representing the precursors of more than 200 cell types. About the involvement of patients in clinical studies and the increasingly common commitment of the community of patients in funding clinical trials, the guidelines stress the need for these studies to follow the international rules on clinical trials, including supervision by an independent authority which guarantees rigor and scientific validity Another interesting aspect of the guidelines is represented by the theme of proper communication and information about the results of scientific research on stem cells. The ISSCR guidelines, which are valid within the scientific community, are obviously subject to the legislation and regulations of individual nations, they may provide information on the interpretation of local laws and guidance for research practices that are not covered by the legislation These principles are to be considered as basics in all countries, and we must try to standardize the legal systems of all the different states
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