Revisions to the “RECORDS” IRB policy
Tuesday, November 17, 2009 (23 reads)
The IRB policy "Records" has been revised to reflect the following administrative clarifications: - Additional information added about what is retained in the IRB Administrative Office files for protocols that receive full Board review, expedited review or exempt status);
- How information is currently maintained in the internal IRB Administrative Office clerical database;
- How information related to non-compliance allegations is maintained and;
- Clarification that investigators must maintain copies of all study records.
In addition, there were several non-substantial editorial revisions to the policy text.
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July 1, 2009: Revisions to the “ACTIVITY DETERMINATION FORM (DET)”
Thursday, July 09, 2009 (273 reads)
The “Activity Determination Form” (DET) has been revised to clarify the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) definition of “research” and to remove the stipulation that information gathered from the non-research activity may not be published (to take into account information presented and published from quality improvement projects and case reports, per UHCMC policy). In addition, clarifications were made to the form’s instructions to state that an investigator must select applicability from all three categories on the form: DHHS (Section A and/or B), Food and Drug Administration (FDA, section C) and HIPAA (Section D) in order for the Center for Clinical Research and Technology to make a determination as to the applicability of the federal regulations pertaining to human subject research.
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July 1, 2009: FDA Requirements Regarding IRB Registration
Thursday, July 09, 2009 (757 reads)
In January, 2009, the Food and Drug Administration (FDA) posted a final rule (effective July 14, 2009) that will require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). This registration system is the same system utilized by the HHS Office of Human Research Protections (OHRP) to maintain a list of IRBs which review federally funded research. Any IRBs reviewing clinical investigations regulated by the FDA must be registered in this system by September 14, 2009. Please note that UHCMC IRB has two IRB committees, both of which are registered in this system. Anyone who requires documentation of this registration may search the OHRP website to confirm current registration status. The IRB registrations numbers (IRB00000684 and IRB00001691), as well as the HHS Federal Wide Assurance of Compliance number (FWA00003937) can be found on the IRB FAQ webpage, the IRB Statement of Compliance letter, the IRB rosters and the IRB protocol approval letter.
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June 15, 2009: Revisions to the “CHECKLIST FOR NEW PROJECT INVOLVING HUMAN SUBJECTS (N)”
Wednesday, June 24, 2009 (267 reads)
The following administrative revisions have been made to the New Protocol Checklist (N): - Question 28b has been revised to request additional information about whether the research will involve the National Institutes of Health (NIH) Genome Wide Association Studies (GWAS) Program.
- Questions 29 regarding use of investigational drug has been revised to confirm if UHCMC Investigational Drug Services (IDS) is to be utilized as part of the study and to request a copy of the IDS Exemption Request Form.
- Question 29 has also been revised to request a copy of the IND/IDE correspondence affirming IND/IDE status from either the FDA or the Study Sponsor.
- Question 35 has been revised to correct the name of the Dahms Clinical research Unit (DCRU).
Please utilize the most current version of the New Protocol Checklist when submitting a new protocol. Failure to utilize the most current version will result in delays in approval process.
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