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IRB Consulting Services: 08 - 09 Academic Year

NEWS & ANNOUNCEMENTS

4    4/2/2008: New Social and Behavioral Research IRB RRSF (Research Review Submission Form) Available

4   4/1/2008: IRB Goes Electronic

4    08/02/2007: New Medical IRB RRSF (Research Review Submission Form) Available

4    07/20/2007: Notice: IRB Review Fee Increasing September 1, 2007



UC IRBs

4      IRB Contacts

4      Federal Wide Assurance

4      Medical IRBs

§ Membership Rosters

§ Meeting Schedules

4      Social/Behavioral IRB

§ Membership Rosters

§ Meeting Schedule

  

SUBMITTING NEW PROTOCOLS

4      Determining Human Research Activities

§ Policy

§ Form

4      Medical Submission Packet

4      Social/Behavioral Submission Packet 


REPORTING TO THE IRB

4      Adverse Events

§ Internal Medical Form

§ External Medical Form and Policy

§ Social/Behavioral Form

4      Unanticipated Problems

§ Medical Directions & Form

§ Social/Behavioral Form

4      Deviation Report

4      Investigator Brochure Information Sheet



CONTINUING REVIEW

4      Progress Report Packet

§ Medical

§ Social/Behavioral

4      Expired Protocols

§ Medical

§ Social/Behavioral



 		  

MODIFICATION REQUEST

4      Medical ( Valid for use through April 30, 2008. Electronic submission required as of May 1, 2008.)

4      Social/Behavioral (Valid for use through April 30, 2008. Electronic submission required as of May 1, 2008.)


ELECTRONIC MODIFICATION REQUEST

4   Researchers Gateway ( Available for use April 1, 2008. Must be used as of May 1, 2008.)

4 Electronic Modifications Instructions




POLICIES and PROCEDURES

4      Human Research Protection Policies

4      IRB Procedures

4      Investigator SOPs

4  Sponsor – Investigator SOPs

4      Outside Activity Reports


PROTECTING HUMAN SUBJECTS

4      Conflict of Interest Form & Instructions

§ Social/Behavioral

4      Informed Consent

§ Medical

§ Genetics Consent Template

§ Social/Behavioral

§ Waiver of Consent Form

§ Waiver of Consent Process

4      HIPAA

4      Training & Education

4      Post-approval Monitoring Program

4     

External Resources for Human Subjects
Researchers

ESPECIALLY FOR

4      IRB Members

4      VA Researchers

4      CCHMC Researchers

4      Education Researchers

4      Student Researchers

4      Clinical Trials Participants