For information on IBC please visit: http://www.miami.edu/rdna
HSRO Standard Operating Procedure: Assuring IBC Review and Approval for Human Subjects Protocols Involving rDNA or Gene Transfer
Effective Date: February 2005
Author: Cheryl A. Savini, Director, Human Subjects Research Office
Description of change: Policy on IBC Reviews
- Purpose: To implement a process by which the Human Subjects Research Office (HSRO) can identify each human subjects protocol that may require Institutional Biosafety Committee (IBC) review and approval prior to Institutional Review Board (IRB) approval whether or not the principal investigator has indicated on the protocol submission that IBC review is needed.
|HSRO: Human Subjects Research Office (Administrative support office for the IRB)
|IRB: Institutional Review Board
|IBC: Institutional Biosafety Committee
|rDNA: Recombinant Deoxyribose Nucleic Acid
|Reviewers: Reviewers are generally scientists who have expertise in the pertinent area of study, but depending on the review process, full or expedited, could include community representatives/laypersons
|IRB: Review of Reseach protocols that involve human subjects
|IBC: Review of research protocols that involve the generation or use of rDNA/rDNA technologies in human subjects prior to IRB approval.
|Reviewer: Person(s) who will thoroughly scrutinize research protocols according to federal, state and institutional policies/guidelines during the review process. The review may be conducted under either the expedited or full review process, whichever appropriate under the federal guidelines.
- Procedure: The IRB administrative review which is performed prior to the actual IRB review by an IRB Coordinator, will include the use of a checklist that will assist in identifying whether or not IBC review and approval is needed, regardless of whether the principal investigator has checked the appropriate box on the human subjects protocol form. The IRB coordinator will review the human subjects protocol to see if the research study involves rDNA or gene transfer.
If the IRB coordinator is not clear whether or not the protocol involves rDNA or gene transfer, the protocol is referred to the IRB Chair or IRB member with the scientific background appropriate to determine if the protocol involves rDNA or gene transfer.
If the human subjects protocol involves rDNA or gene transfer, the IRB Coordinator will review the human subjects protocol submission to check for written documentation of IBC review and approval, to assure that appropriate IBC review and approval has occurred. If the principal investigator has not checked the appropriate box, and no written documentation is found, the protocol is referred back to the principal investigator to obtain IBC approval before the protocol is considered by the IRB. In certain instances where the appropriate written documentation is included and the principal investigator has not checked the appropriate box on the human subjects protocol form, the IRB Coordinator will notify the principal investigator by email or phone that he/she is updating the protocol form to check the appropriate box. This action will be documented in the protocol file.
Documentation of IRB review and approval will be forwarded to the principal investigator only after the IRB has written documentation that the IBC has reviewed and approved the protocol, and the IRB has given final approval of the research study.
- Documentation: Review checklists are retained in the HSRO office
- HSRO protocol submission form
- UMiami Human Subjects Website