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…
Research conducted at universities and academic medical centers is responsible for the development of a myriad of innovative products over the years. These innovations vary…
Most people learn reading, writing, and math in school. However, few of us learn how to productively manage the inevitable conflicts that show up in…
Hacking is a significant threat to health care data and attacks can be very costly. Recently, an orthopedic clinic serving 138,000 patients annually, paid $1,500,000…
The U.S. National Academy of Medicine, National Academy of Sciences, and the UK’s Royal Society have formed the The International Commission on the Clinical Use…
