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, leaving 12 vacant or “on hold,” due to...more
Report on Research Compliance Volume 20, no. 10 (October, 2023) The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more
Report on Research Compliance 18, no. 12 (December, 2021) - A month after rumors circulated that President Biden planned to tap former Food and Drug Administration (FDA) Commissioner Robert Califf to serve again, the...more