Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.

ABSTRACT: The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents fo

SUBMITTER: Gainotti S 

PROVIDER: S-EPMC4989211 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature