Hello Ampersand readers! This is my first year serving as a member of the Blog Squad. I look forward to creating helpful and interesting posts for you as PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) progresses.
Trained as a basic scientist, I received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed a Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research. I am currently a co-chair at Pearl IRB.
My fascination with ethics started when I took a class in the subject in graduate school. That class reminded me that meaningful regulatory oversight helps to prevent the complacency that often leads to tragedies in research. From the Nazi war crime trials, to the Tuskegee syphilis experiment, human subject protections have sometimes lapsed throughout history. With the explosion of exciting scientific discoveries, human subject protections activities are now as important than ever.
I have considerable experience assessing and updating IRB policies and procedures to comply with AAHRPP requirements and the revised Common Rule. As such, I am eager to attend the sessions addressing these upcoming changes. I have also recently hired a prisoner representative to serve on our board and would love to network with individuals who have previous experience reviewing studies involving prisoners.
This will be my first AER conference and I look forward to meeting a diverse group of people with varying responsibilities and approaches to the protection of persons involved in research. I am excited to connect with you at AER18, and if you see me, please introduce yourself!
Gretchen Parker, PhD, RAC, CIP, serves as co-chair for Pearl IRB and provides regulatory and clinical research support services for clients. Throughout her career, she has been deeply involved in regulatory affairs, clinical research, and medical writing for the pharmaceutical and medical device industries. She led the AAHRPP accreditation efforts at Pearl IRB and has assisted FDA inspectors on site. She is currently leading the efforts to update Pearl IRB institutional policies and procedures to comply with the revised Common Rule.
Dr. Parker began her career as a Regulatory and Compliance Analyst at a consulting firm, where she worked with clients, ranging from biotech start-ups to Fortune 500 companies, to plan and implement regulatory strategies, submissions, and research protocols. Her duties engaged her with several US governmental agencies, including FDA, USDA and EPA.
Dr. Parker received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed her Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research. She has authored and published dozens of scientific articles in major peer-reviewed journals, holds a patent for a diagnostic assay, and is a member of PRIM&R. She is Regulatory Affairs Certified (RAC) and a Certified IRB Professional (CIP).
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
PRIM&R’s 2018 Advancing Ethical Research Conference takes place November 14-17 in San Diego, CA. Explore the agenda and register on our website.