Glossary

2 A B C D E F G H I K M N O P R S T U X

OHRP

Office for Human Research Protections - HHS office overseeing human subject protection for HHS-supported research.

D

Data and Safety Monitoring Plan

Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

O

OHRP

Office for Human Research Protections - HHS office overseeing human subject protection for HHS-supported research.