Blog
Harmonization of FDA Regulations with the Common Rule
The 21st Century Cures Act mandated that the Department of Health and Human Services (“DHHS”) “revise the DHHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules to reduce regulatory duplication and unnecessary delays;...
Ask the Expert: How to Ensure Your Submission Package is Ready for IRB Review
This is the fourth of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Gretchen Parker, PhD, RAC, CIP, Pearl’s IRB Co-Chair, Senior Advisor, was interviewed for this piece. If you have...
Fast Tracking IRB Approval Takes Skill and Strategy
In clinical research, the purpose of institutional review board (IRB) review is to ensure the rights and welfare of human subjects are protected. Unnecessary delays in the IRB review process can prevent treatments from getting to patients and slow the improvement of...
What is a Researcher to Do? IRB Review of Applications and Proposals Lacking Final Details for Involvement of Human Subjects
This happens quite often: a researcher would like to apply to a funding agency for a grant to perform a human subjects research study before they can finalize the study methods. But, the agency needs proof of IRB approval as part of the grant application. Can a...
Indiana Life Sciences Collaboration Conference: “Impact of the New Administration: FDA, HHS, CMS, et al.”
Pearl Pathways' own Director of RA/QA Services Becki Nowatzke was honored to serve on the planning committee for this compelling event featuring an outstanding slate of keynote speakers including Jonathan Blum (Principal Deputy Administrator & COO, U.S. Centers...