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Outstanding teacher, Andrea Gielen, Injury Prevention: Behavioral Science Theories and Applications
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Human Subjects Research Regulatory Affairs

Our team is here to assist researchers with any regulatory guidance that they may need in order to carry out their research activities. The following links provide guidance to researchers on record retention, recordkeeping, and FDA-regulated research. Guidance topics do not represent JHSPH policy and procedures. For institutional policies and procedures on human subjects research, please see the JHSPH IRB website located at www.jhsph.edu/IRB. 

Researchers can request additional guidance topics by contacting the Research Regulations Specialist at 410-502-0433 or the Research Quality Assurance Specialist at 410-502-7781.

Guidance Document on Research Records

FDA Guidance

Guidance for FDA Inspections

Guidance on Retention of Research Records by Investigators

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