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.
|Title of host publication||Regulating Biobanks in Humans: The Use of Adult and Children Biomaterials for Clinical and Research Purposes|
|Publisher||Nova Science Publishers, Inc.|
|Number of pages||16|
|ISBN (Print)||9781631176166, 9781631176050|
|Publication status||Published - Apr 1 2014|
ASJC Scopus subject areas
- Materials Science(all)