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Human Subject Research Office



Intro

The Human Subject Research Office (HSRO) provides administrative support for the University of Miami Institutional Review Boards. An Institutional Review Board is a group of individuals comprised of faculty, staff and community members charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with applicable federal regulations, state law and institutional policy that govern human subject research.

Recent Updates:            December 5, 2013

The new eProst system was launched on 12/05/2013. Studies that were closed prior to 12/05/2013 will not be migrated to the new system and will remain housed on this site (eprostarchive.med.miami.edu/eprost). Studies that were active as of 12/05/2013 will be migrated to the new system, once all related amendments, continuing reports, and reportable events submitted within the old system (eprostarchive.med.miami.edu/eprost) have been approved/acknowledged by the IRB.

For instructions in using the new eProst system, please go to the new eProst site and look for the eProst user guides on the home page. 
 

 



Recent Updates

INVESTIGATOR INSTRUCTIONS FOR NCI CIRB STUDIES

October 16, 2013

NCI CIRB completed the University of Miami’s transition from facilitated protocol review model to the independent protocol review model.  Unlike the previous facilitated review process in which IRB oversight was shared by the NCI CIRB and the UM IRB, the NCI CIRB will now serve as the single IRB of record for eligible, approved studies.
 

Even though NCI CIRB is now the IRB of record for the CIRB studies, UM remains responsible for monitoring institutional compliance as described in the CIRB's Division of Responsibilities document and the Annual Signatory Institution Worksheet.

Transition from the Facilitated Review Model to the Independent Model

Authorizing Access to NCI CIRB Online Tools

Under the independent model, study teams will use the NCI CIRB’s online submission system, IRB Manager (https://irbmanager.becirb.com/).   The NCI CIRB will distribute usernames and passwords to all UM Principal Investigators and study personnel identified as requiring access to these tools.  Once contacted by CIRB, submit and receive CIRB approval of the Annual Principal Investigator Worksheet about Local Context. This is required for every Principal Investigator who currently has one or more studies open with the CIRB under the facilitated review model. 

Annual Principal Investigator Worksheet About Local Context

To provide adequate oversight of study conduct at local sites, the NCI CIRB must collect information about the institution and study team, such as resources, staff, recruitment methods, consent procedures. The NCI CIRB will now require each PI conducting research under NCI CIRB oversight to provide this “local context” information on an annual basis using the NCI CIRB’s IRB Manager system. PIs must submit an Annual Principal Investigator Worksheet About Local Context which must be deemed acceptable by the NCI CIRB before they can continue ongoing NCI CIRB studies or open any new studies under the NCI CIRB’s oversight.

A: Access the Annual Principal Investigator Worksheet about Local Context
Follow the directions in the NCI CIRB Instruction Manual for Worksheet Completion in IRB Manager (available at www.ncicirb.org) to log in to IRB Manager and open a new Annual Principal Investigator Worksheet about Local Context. Note that a study team member may enter information in the Worksheet on the PI’s behalf, but only the PI can submit the completed form.

B: Incorporate recommended language
Answers for many of the questions in the Annual PI Worksheet will be specific to each PI.  Note that recruitment practices, informed consent process, use of legally authorized representatives, and inclusion of vulnerable subject populations must be consistent with UM policies and guidance. 

C: Follow the NCI CIRB Instruction Manual for Worksheet Completion in IRB Manager to submit the Worksheet to the NCI CIRB.  (www.ncicirb.org).
When investigators submit the Annual Principal Investigator Worksheet About Local Context to the CIRB, it is reviewed in detail by the NCI CIRB’s Local Context Subcommittee. This subcommittee determines if the Worksheet is acceptable and the PI is eligible to conduct studies under the NCI CIRB’s oversight.

D:  Once the Worksheet has been submitted to the NCI CIRB, notify Evelyne Bital, Associate Director for
Privacy and Regulatory Affairs via email at ebital@med.miami.edu so that the HSRO may ensure all documents have been appropriately received by CIRB.

E: Receive NCI CIRB confirmation of approval for the Annual Principal Investigator Worksheet.

One-time Rollover of Current NCI CIRB Studies to the Independent Model

The Human Subject Research Office is responsible for transitioning ongoing studies approved via the facilitated review model to the new independent review model.

Once the HSRO receives an approval letter confirming the transition to the independent model is complete, the CIRB is considered the IRB of Record for all studies that were rolled over to the independent model.  The Principal Investigator(s) is copied on the approval letter to inform him/her that s/he is able to open new studies by submitting the Study Specific Worksheet About Local Context.

The transition is now complete.

Open Eligible New Studies using CIRB Oversight

The HSRO requires investigators to submit any new NCI cooperative group study studies via eProst.  This will ensure the ancillary review process takes place.

Which Studies are NOT Eligible for Deferral to an NCI CIRB?

  • Studies not on the NCI CIRBs menu of approved trials (see www.ncicirb.org)
  • Studies involving prisoners.  If a subject becomes incarcerated, he/she will not remain on the study.
  • Studies involving VA subjects, VA facilities, or conducted as part of a VA appointment
  • Studies requiring a waiver (partial or full) of HIPAA Authorization. NCI CIRB is not a Privacy Board.
  • Studies for which UM study personnel have a conflict of interest.

Submit New NCI CIRB study application through eProst

Although the NCI CIRB submission process has changed, investigators must continue to submit new studies via eProst as customary until the switch to the new IRB system occurs.

Ongoing studies approved under the facilitated review model have transitioned to the independent review model

Although the new NCI CIRB submission process have changed, investigators must continue to submit Continuing reports, Amendments, Reportable events and Final reports in eProst as customary until the switch to the new IRB system occurs.

For additional questions, contact Evelyne Bital via email at ebital@med.miami.edu or at 305-243-9977.



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Links of Interest:

      


Announcements

Effective immediately, applicable protocol submissions will not be processed without a valid University account number indicated in the HSRO/IRB fee processing section. This account number will be used by the Finance Team to process payment and an IDR is not required. For applicable UM studies that are at WIRB, all submissions must be routed through the HSRO accompanied by an IDR. Please see the University Fees page for further information.

In addition, any PI-Initiated studies receiving funding from a pharmaceutical/device company will be subject to the HSRO Processing and Research Compliance Fees. Please contact the HSRO Finance Team with any questions.

 



FDA Notice of the Intent (Letter of Certification) to Use Electronic Signatures


FDA Regulations related to electronic records and electronic signatures are described in 21 CFR Part 11.  The University of Miami’s notification to the FDA of the intent to use electronic signatures is available here to assist principal investigators and study teams in responding to inquiries from sponsors and CROs.
 

This letter of certification and other statements of compliance are available on the Information for Sponsors page



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