On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as…
On 22 December 2020 the U.S. Centers for Disease Control and Prevention (CDC) updated their Ensuring the Safety of COVID-19 Vaccines in the United States…
Investigators can request discretionary Certificates of Confidentiality (CoCs) from the U.S. Food and Drug Administration (FDA) for non-federally funded research that is subject to FDA…
The Department of State’s Exchange Visitor Program (BridgeUSA) has issued Guidance Directive Exchange Visitor Program – Confucius Institutes 2020-01, which provides new guidance on the relationship…
Clinical drug and biologics trials should aim to have participants represent the likely users of the approved medication. The FDA has issued guidance for sponsors…
OHRP has added an annotated comparison of the pre-2018 Common Rule with the 2018 regulations. On this page you’ll also find additional information about whether…
As we continue to work together to fight COVID-19, we are reminded of the importance of volunteers to serve in vaccine trials. But deciding to…
On November 19, 2020 and as part of the of The Hastings Center’s series, Securing Health in a Troubled Time, Dr. Anthony Fauci, Director at…
This was one of the first questions asked of us when I started teacher training college in England a number – possibly a great number…
In recognition of National Cybersecurity Awareness Month, Dr. Michael Lauer, the NIH’s Deputy Director for Extramural Research, has published some thoughts on the importance of…
Emmanuelle Charpentier and Jennifer Doudna have won the Nobel Prize in Chemistry for their contributions to genome editing. The pair partnered in 2011 and by…
We are excited to add two new modules to our Technology, Ethics, and Regulations course: “Artificial Intelligence (AI) and Ethics in Human Subjects Research” and…
