Exploring FDA Regulations  Workshop One

Kindra Cooper, JD, MPA, MA, CIP

Kindra Cooper is the IRB Director at Creighton University in Omaha, Nebraska, and an Unaffiliated Board Member with Advarra. She is responsible for oversight of Creighton University’s Human Research Protection Program and two institutional review boards (Biomedical and Social/Behavioral). Kindra is a regulatory and life sciences attorney. She earned her JD at the University of Washington School of Law. She also holds a Master of Bioethics and Health Policy from Loyola University Chicago, and a Master of Public Administration from The George Washington University. Prior to her role at Creighton, Kindra served as an IRB Chairperson for Advarra and in-house Regulatory Counsel for Quorum IRB. She is a published author on topics including eConsent and mobile medical applications. She has presented at national conferences and via online webinars on topics including IRB Myths, eConsent, and IRB review of medical device research. 

Josh Fedewa

Joshua has worked for more than 10 years in research specializing in human research participant protections. He has worked as a Clinical Research Educator, served as the Director of the IRB at the University of Texas Southwestern University, and most recently is serving as the Director of the IRBMED Office at the University of Michigan. He's managed many projects including: 

- Implementing a new electronic submission system; 

- Completing a full rewrite of an IRB Policy and Procedure Manual; and 

- Developing a quality review program. 

Josh currently serves as an AAHRPP Site Visitor and has been through multiple intiial accreditations at institutions.