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

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About Me

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 a...
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.

Faculty Appointments

Professor Emeritus - Department of Health Humanities and Bioethics (SMD)

Credentials

Residency & Fellowship

Menninger School of Psychiatry: Interdisciplinary Fellow (Psychopharmacology) 1974 - 1975

Education

MPH | Uniformed Svcs U of Hl Sciences. Public Health. 1993

Dphm | Univ of Tennessee. Clinical Pharmacology. 1974

BS | Ohio State University. Pharmacy. 1969

Awards

Distinguished Service Award, Council for Certification of IRB Professionals 2005

Distinguished Service Award, Applied Research Ethics National Association 2003

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 a...
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.

Research Lab

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

Visit Research Lab Website

Publications

Journal Articles

Economies of scale in institutional review boards.

Wagner TH, Cruz AM, Chadwick GL

Medical care.. 2004 August 42 (8):817-23. Epub 1900 01 01.

The cost of operating institutional review boards (IRBs).

Wagner TH, Bhandari A, Chadwick GL, Nelson DK

Academic medicine : journal of the Association of American Medical Colleges.. 2003 June 78 (6):638-44. Epub 1900 01 01.

Clinical trials in the 21st century: a global approach.

Chadwick GL

Research in nursing & health.. 2001 December 24 (6):541-2. Epub 1900 01 01.

Historical perspective: Nuremberg, Tuskegee, and the radiation experiments.

Chadwick GL

Journal of the International Association of Physicians in AIDS

Emergency Room Research and Informed Consent

Chadwick, GL; McCardle, P; Jacoby, I.

Trauma. 1995; .

Psychiatric pharmacy residency and services.

Chadwick GL

Military medicine.. 1976 August 141 (8):537-9. Epub 1900 01 01.

Books

Institutional Review Board: Management and Function 2nd Ed. (2006)

Chapter: How to Prepare for an FDA Audit

Authors: Chadwick, GL

Publisher: Jones and Bartlett 2006

Institutional Review Board: Management and Function 2nd Ed. (2006)

Chapter: International Conference on Harmonization

Authors: Forster, DJ; Chadwick, GL

Publisher: Jones and Bartlett 2006

Institutional Review Board: Management and Function 2nd Ed. (2006)

Chapter: Certification of IRB Professionals

Authors: Delano, SJ; Henry, S; Chadwick, GL

Publisher: Jones and Bartlett 2006

Protecting Study Volunteers in Research: A Manual for Inv Sites (2004)

Authors: Dunn, CM, Chadwick, GL

Publisher: Thompson Centerwatch, Boston 2004