Non-research determination

Human Research Protection Program
Office of Research Integrity
Office of the Vice President for Research
Brown University

January 2, 2018
Stefan Gravenstein, M.D.
Department of Health Services, Policy and Practice
School of Public Health
Brown University
Box G-S121-6
Providence, RI 02912

RE: CORE ELEMENTS OF ANTIMICROBIAL STEWARDSHIP IN NURSING HOMES
(protocol #1612001659)
Dear Dr. Gravenstein,
Based on the information provided, Phase 2 of your study (program improvement with key
informants) does not constitute human subjects research.
Therefore, Phase 2 as described to the Human Research Protection Program in December 2017, does
not meet the definition of human subjects research as defined in Title 45 CFR 46.102(f).
The IRB will not need to review Phase 2 activities at this time, but an amendment should be
submitted when you are ready to begin work with secondary data.
Please do not hesitate to contact our office should you have any questions regarding this matter.
Sincerely,

Ita Irizarry, MA, CIP
Senior IRB Manager
Human Research Protection Program
Office of Research Integrity
Brown University
Box 1986, Providence, RI 02912
Phone: (401) 863-3050

Brown University 350 Eddy Street Box 1986 Providence, RI 02912 TEL: 401 863-3050