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Human Subject Research Office



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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

Re-deployment of eProst Smartforms and Workflow

On March 15th, 2008 the HSRO completed the redeployment of the electronic workflow with the eProst system for all departments. All submissions to the HSRO for review by the University of Miami IRB's will now be submitted electronically. The electronic workflow in eProst offers many benefits to our researchers including faster turnaround time, easier tracking of studies through the review process, incorporated audit trails and the opportunity for improved interaction between study teams, departmental approvers, ancillary committee reviewers, the HSRO staff and IRB members.

All IRB determinations will now be communicated to study teams via system-generated emails and IRB-approved, watermarked documents will be available online through eProst. All members of the study team must now log in individually to complete their Conflict of Interest Disclosure and Principal Investigators must now log in to eProst to submit their study protocols, continuing reports, amendments or reportable events.

PDF versions of the new forms are available on the HSRO Forms page for your reference.

Updated Policies & Procedures

The HSRO is continually reviewing and revising its written Policies and Procedures. The main Standard Operating Procedures [SOP]  (*.pdf) document on the HSRO website was updated on 08/03/09. Updates include:

Section 16: Compliance Audits

  • 16.2 Reporting Audit Findings and Outcomes (March 27, 2009)  

Section 17: Data and Safety Monitoring Boards (August 3, 2009)

Please check our Policies and Procedures page for additional information



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.

 







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Human Subjects Research Office

1500 NW 12th Avenue, Ste. 1002, Miami, FL 33136
Tel. 305-243-3195
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