title: [Unresolved issues in the evaluation of research projects involving induced pluripotent stem cells (iPS)].
abstract: This paper identifies problems and analyzes those conflicts posed by the evaluation of research projects involving the collection and use of human induced pluripotent stem cells (iPS) in Spain. Current legislation is causing problems of interpretation, circular and unnecessary referrals, legal uncertainty and undue delays. Actually, this situation may cause a lack of control and monitoring, and even some paralysis in regenerative medicine and cell therapy research, that is a priority nowadays. The analysis of the current legislation and its bioethical implications, led us to conclude that the review of iPS research projects cannot be assimilated to the evaluation of research projects that involve human embryonic stem cell (hESC). In this context, our proposal is based on the review by the Research Ethics Committees and the checkout by the Spanish Comission of Guarantees for Donation and Use of Human Cells and Tissues (CGDUCTH) of human iPS cells research projects. Moreover, this article claims for a more transparent research system, by effectively articulating the Registry on Research Projects. Finally, a model of verification protocol (checklist) for checking out biomedical research projects involving human iPS cells is suggested.
authors.forename: María
authors.initials: M
authors.lastname: Casado
authors.forename: Itziar
authors.initials: I
authors.lastname: de Lecuona
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards*; D057189:Checklist; D005069:Evaluation Studies as Topic; D006801:Humans; D057026:Induced Pluripotent Stem Cells; D013030:Spain