Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the...
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...
Pearl IRB joins an elite group of 23 commercial-independent IRBS’s and becomes just the second AAHRPP accredited organization in the state of Indiana by demonstrating high standards of excellence for quality, ethics, and protection in all levels of research. Pearl...
Fred Upton, chairman of the House Energy and Commerce Committee, and Rep. Diana DeGette have recently launched the 21st Century Cures initiative, a bill intended to improve clinical trials and expedite the drug and device approval process. Upton and Degette plan to...
In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....
