The 2018 Advancing Ethical Research Conference (AER18) was my second PRIM&R conference, and this year I came armed with questions for specific organizations and agencies. At the top of my list was a question regarding the 2015 NIH Genomic Data Sharing (GDS) Policy: When children’s data is submitted to a national genomic data sharing repository, such as the database of Genotypes and Phenotypes (dbGaP), what are the consent expectations when those subjects reach the age of majority? Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to [...] Read more
