Research biobanks: A unified model of informed consent to collect, store, distribute and use human biological materials and data from adults

Although the issue of informed consent for human research biobanks has been analyzed in a number of publications, revolving on speculative as well as empirical perspectives, it remains a critical matter within the ethical community globally. Considering that ethical requirements for information and consent vary widely, depending on the international, regional and national regulatory landscape, the development of a harmonized model of informed consent for research biobanks is today a huge challenge. After the analysis of the informed consent issue in pediatric biobanks, this chapter describes the variability of regulations addressing adult research biobanks on a global, regional and national level by focusing on the several consent standards reported into the literature. Afterward, this chapter proposes a template and procedure for developing unified informed consent forms for the storage and use of human specimens for research purposes, based on the experience of an inter- disciplinary group of professionals collaborating with a multispecialty biobank in the context of a public university hospital. Although local, this experience and the related consent template and procedure could serve as models suitable in similar research environments.