|
PI |
DEPT
ADMIN |
DEPT
CHAIR |
DEAN
OFF |
OSP |
G&C |
ORCE |
ORSP/
IRB/
IACUC |
DAR |
VP
RES |
VIP
FIN |
TECH
TRANS |
IBC |
COIC |
ASSUR
SVCS |
Others
with Roles * |
| Human and Animal Subjects |
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| Review sponsor rules and regulations as well as applicable contract terms and conditions relative to University policies and procedures to ensure they are properly reflected in protocol materials |
P |
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S |
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| Provide proposal forms and protocol application materials and help in completing the forms |
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P |
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| Complete the protocol application and submit the application to the appropriate office |
P |
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| Request waiver of HIPAA authorization (if appropriate) |
P |
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| Approve waiver of HIPAA authorization (if appropriate) |
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P |
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| Confirm that protocol application is complete and includes all required information |
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P |
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| Ensure that appropriate research personnel have attended required training courses (including HIPAA) |
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P |
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| Determine the status of reviews performed by other compliance committees |
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S |
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| Conduct preliminary review and triage of protocol in preparation for Committee review |
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P |
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| Ensure that all inter-institutional agreements related to 's federal-wide assurance are complete |
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P |
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| Ensure appropriate composition of the Committee membership |
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P |
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| Perform required review (expedited or full-board) and communicate approval decisions to investigators and sponsors |
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P |
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| Review and incorporate Committee required modifications into protocol materials |
P |
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| Evaluate and reconcile other compliance committee recommendations into protocol materials |
P |
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| Ensure that appropriate compliance committees review revised protocols prior to final approval and incorporation into research proposals or award activities |
P |
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| Ensure that sponsor terms and conditions are consistent with final protocol terms and materials |
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P |
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| Ensure that research activities are performed in accordance with reviewed and approved protocol materials |
P |
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| Ensure that research data involving human subjects is not shared unless it is de-identified |
P |
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| If research data can't be de-identified completely, ensure that it is not shared without third party signing data use agreement |
P |
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| Obtain additional compliance committee approvals as necessary to accommodate potential changes in protocol activities |
P |
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| Evaluate adverse events relative to severity, relatedness and the extent to which the adverse event was anticipated as defined in the investigator brochure and informed consent documents |
P |
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| Conduct investigations relative to adverse events to evaluate the extent to which the adverse event should be communicated to stakeholders such as enrollees in the research protocol, research sponsors, federal oversight agencies, etc |
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P |
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| Report adverse events to the Committee, sponsor and federal oversight agencies as appropriate |
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P |
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| Suspend or revise research activity as necessary to respond to serious, unanticipated adverse events |
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P |
P |
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| Maintain appropriate, current approvals from all compliance committees during the life of the research activity |
P |
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| Maintain appropriate records and documentation to demonstrate informed consent, appropriate protocol review, participant and protocol status, and other relevant administrative activities |
P |
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| Report to OHRP, FDA and other appropriate oversight organizations significant lapses in compliance procedures that may have exposed research participants to unnecessary risks |
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P |
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| Provide access and information for research participants to withdraw from research protocols |
P |
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| Receive and evaluate reports of serious adverse events resulting from Committee investigations or PI reports to external oversight agencies |
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P |
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| Prepare and implement responses to issues raised in investigative reports |
P |
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| Notify Committee when protocol activity has ended |
P |
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| Prepare reports of protocols nearing approval expirations |
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P |
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| Notify Investigator that a protocol's approval will soon expire and direct Investigator to apply for renewal of the approval |
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P |
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| Prepare reports of expired protocols |
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P |
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| Communicate protocol's expired status to Investigator and require Investigator to stop all protocol activity |
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P |
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| Communicate closeout status to close financial accounts related to the expired protocol |
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S |
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| Close all financial accounts related to expired protocols |
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| Prepare and submit renewal application for Committee approval |
P |
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| |
PI |
DEPT
ADMIN |
DEPT
CHAIR |
DEAN
OFF |
OSP |
G&C |
ORCE |
ORSP/
IRB/
IACUC |
DAR |
VP
RES |
VIP
FIN |
TECH
TRANS |
IBC |
COIC |
ASSUR
SVCS |
Others
with Roles * |
| Animals Only |
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P |
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| Place order for animals |
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P |
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| Confirm that an approved protocol exists |
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P |
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| Verify that protocol is linked to account number |
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P |
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| Confirm availability of funds |
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P |
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| Enter order into system and send to vendor |
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P |
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| Receive order confirmation from vendor and enter information into system |
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P |
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| Receive order, enter information into system, generate cage cards and notify census takers |
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P |
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| Produce bills to charge against account # |
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P |
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| |
PI |
DEPT
ADMIN |
DEPT
CHAIR |
DEAN
OFF |
OSP |
G&C |
ORCE |
ORSP/
IRB/
IACUC |
DAR |
VP
RES |
VIP
FIN |
TECH
TRANS |
IBC |
COIC |
ASSUR
SVCS |
Others
with Roles * |
| Conflicts of Interest |
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| Identify conflicts of interest in financial arrangements related to research, prepare COI disclosures for review by the COI committee, and propose management plans |
P |
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| Review proposals to determine whether the potential COI may reasonably be thought to directly and significantly affect the design, conduct, or reporting of the sponsored research or educational activities |
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P |
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| Determine what conditions or restrictions, if any, should be imposed to manage, reduce, or eliminate the conflict of interest |
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P |
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| Prepare and obtain approval of COI management plan |
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P |
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| Inform the PI, Dept Chair, and Dean of decisions related to conflicts |
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P |
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| Monitor compliance with approved COI management plan |
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P |
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| |
PI |
DEPT
ADMIN |
DEPT
CHAIR |
DEAN
OFF |
OSP |
G&C |
ORCE |
ORSP/
IRB/
IACUC |
DAR |
VP
RES |
VIP
FIN |
TECH
TRANS |
IBC |
COIC |
ASSUR
SVCS |
Others
with Roles * |
| Safety |
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| Provide appropriate materials for review by Committee for protocols involving recombinant DNA, hazardous chemicals or biological materials, or sources of ionizing or nonionizing radiation. |
P |
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| Develop program to meet new biosafety and biosecurity regulations |
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P |
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| Complete and submit biosafety security risk assessments to DOJ |
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P |
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| Maintain records of biohazardous materials |
P |
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| Develop safety, security, and emergency plans for biohazardous materials for the lab |
P |
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| Develop safety, security, and emergency plans for biohazardous materials for each School/College |
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P |
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| Develop safety, security, and emergency plans for biohazardous materials for VCU |
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P |
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