Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Miscellaneous Reporting to the IRB by an Investigator

Unexpected pregnancies of subjects that might affect the safety of the mother or fetus, incarceration of subjects (a person incarcerated after consenting to be a research subject is seldom allowed to continue as a research subject) not previously incarcerated, and results of Data and Safety Monitoring Boards will be reported to the IRB as soon as the investigator is aware of the occurrence. The IRB will assess this information and provide guidance as to whether or not the subject may remain in the study or if changes will be required in the research because of new safety information from the DSMB. Senior IRB members will be available to consult with investigators about these or any unusual problems that may occur concerning research.