Common Rule News Today

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document entitled, Key Information and Facilitating Understanding in Informed Consent. The draft guidance is...

This study describes the reported US cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following vaccination with Ad26.COV2.S, the

This cross-sectional study compares all-cause and cause-specific mortality trends and rates among youth from different races and ethnicities between 1999

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH...

In December 2022, Julie Kaneshiro—then deputy director of the HHS Office for Human Research Protections (OHRP)—disclosed that the agency had 32 positions but that only 20 were filled,...

On April 12, 2024, the Nebraska Legislature passed the Data Privacy Act (NEDPA), sending the bill to Governor Jim Pillen’s desk for signature. NEDPA adds to the patchwork...

For scientists who perform medical research on the recently deceased, there are few regulatory or ethical guardrails.

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding...

Earlier this month, the U.S. Food and Drug Administration ("FDA") issued a draft guidance, "Key Information and Facilitating Understanding in Informed Consent"...

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research...