1. Paula Peyrani, MD Division of Infectious Diseases University of Louisville p0peyr01@louisville.edu The IRB Process What do I need to know? The IRB Process What do I need to know?

2. LEVELS OF REVIEW Full Expedited Exempt IRB makes the final decision Full board review unless meeting criteria for expedited or exempt

3. LEVELS OF REVIEW FULL BOARD REVIEW Research involving more than minimal risk Collection of sensitive data (e.g. substance abuse) Use of investigational drug or device Invasive research procedures

4. LEVELS OF REVIEW EXPEDITED REVIEW Protocol, amendments, or continuing reviews Submitted materials are reviewed by Chair or Vice-Chair Examples:  Blood collection – within limits  Collection of other biological specimens  Collection of data through non invasive procedures  Research on existing data, specimens, materials collected for NON research purpose  Medical records (retrospective chart review)  Surveys, questionnaires.

5. LEVELS OF REVIEW EXEMPT REVIEW Committee review is not required IRB has to review the study to determine criteria are met WILL NOT be exempt:  Prisoners, sensitive surveys  Surveys/interviews or observation of public behavior of children  Test article regulated by the FDA

6. LEVELS OF REVIEW EXEMPT REVIEW Data, documents, records, specimens that are publicly available Information recorded by the investigator in a manner that the subjects cannot be identified

7. Coded private information or specimens (no subjects) Level of review depends on whether these information or samples are identifiable to research staff Determination is made by the IRB, not the investigator LEVELS OF REVIEW NO HUMAN SUBJECTS INVOLVED

8. SUBMITTING A PROTOCOL TO THE IRB Application CV investigator and key personnel COI Scientific merit review MIRA Protocol Informed Consent Survey/interview questions (if applicable) Data collection sheet HIPAA form Recruitment ad (if applicable)

9. References 1. Woodin K. The CRC’s Guide to Coordinating Clinical Research. Thompson Centerwatch. 2004 2. University of Louisville. Investigator’s Guide for Human Research. Version November 29, 2010.