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Gary L. Chadwick, Pharm.D., M.P.H.

Contact Information

Phone Numbers

Administrative: (585) 273-4127

Office: (585) 273-4631

Fax: (585) 273-1174

Research Labs

Office for Human Subject Protection (administrative office that includes institutional review boards and research education and monitoring)

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Research Network

Biography

Dr. Gary Chadwick is an Associate Provost at the University of Rochester and Professor of Clinical Community and Preventive Medicine and Medical Humanities in the School of Medicine and Dentistry. He is the Director of the Office for Human Subject Protection, which is responsible for the operation and support of the University's Institutional Review Board (IRB) system. Gary was a commissioned officer in the U.S. Public Health Service for over 26 years. He served in the FDA and in the Office for Protection from Research Risks at the NIH. He was the founding Chair of the ARENA Council for Certification of IRB Professionals. He earned his BS in Pharmacy from the Ohio State University, his PharmD from the University of Tennessee, and his MPH from the Uniformed Services University.

Professional Background

Dr. Gary Chadwick is an Associate Provost at the University of Rochester and Professor of Clinical Community and Preventive Medicine and Medical Humanities in the School of Medicine and Dentistry. He is the Director of the Office for Human Subject Protection, which is responsible for the operation and support of the University's Institutional Review Board (IRB) system. His office also operates the investigator ethics training program and a quality improvement program. He develops, teaches and implements training programs for faculty, staff and students in research ethics. He is the co-author of the widely used training manual for investigators, Protecting Study Volunteers in Research (CenterWatch, 3rd ed. 2004). Gary regularly conducts training sessions and program audits for universities, hospitals and professional societies.

Research

Dr. Gary Chadwick is an Associate Provost at the University of Rochester and Professor of Clinical Community and Preventive Medicine and Medical Humanities in the School of Medicine and Dentistry. He is the Director of the Office for Human Subject Protection, which is responsible for the operation and support of the University's Institutional Review Board (IRB) system. His office also operates the investigator ethics training program and a quality improvement program. He develops, teaches and implements training programs for faculty, staff and students in research ethics. He is the co-author of the widely used training manual for investigators, Protecting Study Volunteers in Research (CenterWatch, 3rd ed. 2004). Gary regularly conducts training sessions and program audits for universities, hospitals and professional societies.

Dr. Chadwick is a past President of Applied Research Ethics National Association (ARENA) - the national association for IRBs. Gary was the founding Chair of the Council for Certification of IRB Professionals (CCIP). He has served on National Institutes of Health study sections in research ethics and he is a subject matter expert for the HHS Office for Human Research Protection (OHRP). Gary has served as Chair of the National Committee for Quality Assurance (NCQA) Human Research Protection Advisory Council, and as a consultant to the State of New York and various federal agencies on issues of research ethics and regulation. He has been a member of two national subcommittees of the Secretary's (HHS) Advisory Committee on Human Research Protections (SACHRP). Currently, he serves on the Subpart A Subcommittee, which is evaluating the regulations for the basic protections of human research subjects' informed consent and IRB review.

Before joining the University of Rochester in 1996, Dr. Chadwick was a commissioned officer in the U.S. Public Health Service (PHS) for over 26 years. He served in many PHS agencies, including the Food and Drug Administration (FDA) where he was the Associate Director for Human Subject Protection in the Office of the Commissioner and a Senior Scientific Reviewer in the Division of Scientific Investigations of the FDA's Center for Drug Evaluation and Research, where he worked with Dr. Frances Kelsey, of Thalidomide fame. Gary has also worked for the Office for Protection from Research Risks (OPRR) when it was housed at the National Institutes of Health and run by Dr. Charles McCarthy. He earned his Bachelor of Science in Pharmacy from the Ohio State University, his Doctor of Pharmacy in clinical psychopharmacology from the University of Tennessee, and his Masters in Public Health (ethics and administration) from the Uniformed Services University.

Credentials

Faculty Appointments

Education

1974
Dphm | Univ of Tennessee
Clinical Pharmacology

1993
MPH | Uniformed Svcs U of Hl Sciences
Public Health

1969
BS | Ohio State University
Pharmacy

Awards

2005
Distinguished Service Award, Council for Certification of IRB Professionals

2003
Distinguished Service Award, Applied Research Ethics National Association

Publications

Journal Articles

8/2004
Wagner TH, Cruz AM, Chadwick GL. "Economies of scale in institutional review boards." Medical care.. 2004 Aug 0; 42(8):817-23.

6/2003
Wagner TH, Bhandari A, Chadwick GL, Nelson DK. "The cost of operating institutional review boards (IRBs)." Academic medicine : journal of the Association of American Medical Colleges.. 2003 Jun 0; 78(6):638-44.

12/2001
Chadwick GL. "Clinical trials in the 21st century: a global approach." Research in nursing & health.. 2001 Dec 0; 24(6):541-2.

Books & Chapters

2006
Chapter Title: How to Prepare for an FDA Audit
Book Title: Institutional Review Board: Management and Function 2nd Ed.
Author List: Chadwick, GL
Published By: Jones and Bartlett2006

2006
Chapter Title: International Conference on Harmonization
Book Title: Institutional Review Board: Management and Function 2nd Ed.
Author List: Forster, DJ; Chadwick, GL
Published By: Jones and Bartlett2006

2006
Chapter Title: Certification of IRB Professionals
Book Title: Institutional Review Board: Management and Function 2nd Ed.
Author List: Delano, SJ; Henry, S; Chadwick, GL
Published By: Jones and Bartlett2006

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