On 6/21/16, the National Institutes of Health (NIH) issued a final policy to streamline IRB review. Expectations are that a single IRB (sIRB) will be used for all non-exempt multi-site research at U.S. sites for research funded by NIH. There may be exceptions only if...
The Government Accountability Office (GAO) recently released a report in regard to women in clinical research. While past efforts by the National Institutes of Health (NIH) have increased the number of women involved in research, further changes are still necessary....
The National Institute of Health Advisory Committee to the Director (ACD) presented a detailed plan for building a national research cohort to expand the industry’s knowledge of precision medicine. The cohort will include over 1 million Americans that will aim to...
The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...
NIH may be the next to join Apple and Google in using technology (i.e. smartphones) to help gather information for clinical trials. This new step for the NIH came under the White House’s Precision Medicine Initiative (PMI). President Obama hopes the PMI will “bring us...
According to a recent article by Senator Amy Klobuchar, the United States has always been the world leader when it comes to biomedical research and innovation. However, many other countries are starting to rapidly catch up, and the United States may need to put more...
