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ORI - Guidelines and Policies


Standard Operating Procedures/Policies Relating to the Office for Research Integrity (IRB).
Requesting/Obtaining Parental Permission and Child Assent for Clinical Research
Education-Human Subjects Research.doc 
Emergency Use of Investigational Drug or Biologic

Expedite-Exempt.doc

Human Subject Regulations Decision Chart.doc 
(IND) Investigator Initiated Investigational New Drug Applications
NIH Policy Change on IACUC Review 
NIH Release Notice: NOT-OD-02-044

Guidelines for Blood Sampling Related to Research

FDA Guidance for Industry-Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects 

For all CMH Researchers: FYI - New Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles.
Of note are the comments regarding retention of personal identifiers on research samples and the effect on the need for IRB review. Please review at your convenience. Notice: NOT-OD-02-044

Kathy Johnson, RN, CCRC
Manager, Office for Research Integrity

CMH Employees