The California state legislature is currently considering a bill known as the Genetic Information Privacy Act. The bill includes very specific requirements for informed consent to[…]
A clinical investigator in Florida suggests that clinical trial simulators could someday replace trials with real participants – at least to some extent. In an[…]
FDA recently published a final rule amending 21 CFR 16, 312, 511 and 812. Under the new rule, which will become effective on May 30,[…]
The availability of large-scale human genomic data sets raises questions regarding their proper collection, use and governance. The Presidential Commission for the Study of Bioethical Issues is currently[…]
NIH is proposing updates to the estimated reporting burdens associated with various types of submissions to ClinicalTrials.gov. The revised estimates are as follows: Applying for[…]