HRPP eNews Archive

4th Quarter 2017

  • Changes to the Common Rule
  • AAHRPP Reaccreditation Update
  • Clinical Trials Protocol Template for Investigator-Initiated NIH-FDA Phase 2 and 3 IND
  • IDE Clinical Trials
  • Contacting Potential Research Participant/Clinical Trial Recruitment and HIPAA
  • HRPP Training Partnership
  • RCQA Educational Program
  • eProst Mentoring
  • For Single IRB/Central IRB Help
  • Did you Know…? (Clinical Trial Disclosure)
  • FDA Mock Audits
  • Upcoming RCQA Classes
  • HSRO Staff News
  • UM Has Joined Smart IRB
  • UM Central IRB Open House

3rd Quarter 2016

  • University Requirements for Good Clinical Practice (GCP) Training for Researchers Involved in NIH-funded Clinical Trials
  • University of Miami HRPP Leadership Issues Guidance for Research Teams on the Florida Right to Try Act
  • UM Hosts FDA Clinical Trials Symposium on Improving Clinical Research in the Age of Precision Medicine
  • HSRO Staffing Updates
  • eProst Mentoring
  • RCQA Educational Offerings

2nd Quarter 2016

  • University of Miami Celebrates 1 Year Anniversary of AAHRPP Accreditation
  • Updates from RCQA (Research Compliance and Quality Assurance
  • To Track Changes or Not To Track?
  • Reporting Audit Findings to the IRB
  • eProst Mentoring
  • Human Subject Research Office Launches Central IRB Review (UM CIRB)
  • HSRO Staffing Updates

1st Quarter 2016

  • HSRO Issues Guidance Documents on Informed Consent
  • eProst Mentoring
  • HSRO Staffing Updates
  • What are Waivers and When Do I Need Them?
  • RCQA Educational Programs

3rd Quarter 2015

  • HHS Releases Notice of Proposed Rulemaking
  • CITI Research Ethics and Compliance Education Guidebooks
  • Good News from RCQA (Research Compliance and Quality Assurance)
  • eProst Mentoring
  • 2015 HSR Community Conference – Charting the Course for Quality
  • Prize Drawings to Incentivize Participation in Research Studies

2nd Quarter 2015

  • University of Miami Awarded Full AAHRPP Accreditation
  • Save the Date: Human Subject Research Community Conference 2015
  • Did You Notice The Newsletter’s New Name?
  • Upcoming Educational Opportunities
  • The Secret to Quick IRB Reviews
  • Featured Principal Investigator and Research Team for Audits Conducted in 2014
  • Improving Informed Consent
  • eProst/IRB7 Tip: Understanding My Inbox

1st Quarter 2015

  • The SNCC: Determination of Serious and/or Continuing Noncompliance in Human Subject Research Studies at the University of Miami
  • Important Information from your Resource
  • FDA Issues Guidance on the Use of Electronic Consent in Clinical Investigations
  • Do I Need IRB Review and Approval for My Project?
  • My Modification Requires Revision to the Informed Consent Form(s) – What’s Next??
  • IRB Grand Rounds
  • University of Miami’s Human Research Protection Program Progresses to Next Phase of AAHRPP Accreditation: Site Visitors will be at UM April 1-3,2015
  • External Audits
  • eProst Mentoring Lunch and Learn Sessions
  • Upcoming Classes from RCQA

Winter 2014

  • Incidental Findings
  • AAHRPP Accreditation Steps 1 & 2 Complete
  • Continuing Review: What Does the IRB Need?
  • Revising and Attaching Documents in eProst/IRB7
  • eProst Mentoring Lunch and Learn Sessions
  • We’ve Moved
  • IRB Grand Rounds
  • Modification of HIPAA Authorization Form (Form B)
  • Updates to IRB7 “Toolkit”
  • Updates to the HSRO Website
  • Media Coverage for Ongoing Human Studies
  • 2014 HSR Community Conference Recap

March 2014

  • IRB7: Lessons Learned
  • COI Training Notification
  • eProst Archive: Lapsed Studies and Pending Submissions
  • Office News: New Hires at the HSRO
  • IRB Grand Rounds
  • IRB7: Problems with ICF Migration
  • 2014 FDA Seminar in South Florida
  • Research Compliance Tip from the Office of Research Compliance and Quality Assurance (RCQA)
  • Revised Administrative Policy: Submission of Executed Contracts for IRB Review
  • Revised IRB Policy: Submission of External SAEs/IND Safety Reports for IRB Review
  • Call for Letters

January 2014

  • HSRO Transitions to IRB7 and Launches New Website
  • CIRB Now Conducting Independent Reviews
  • University of Miami to Pursue AAHRPP Accreditation
  • Office News: New Staff Member and New CIP and CHRC certifications
  • Updated IRS Language
  • Updated Language for Studies Involving Category B Devices
  • Which CITI Course Should I Complete
  • Call For Letters

NOTE: Older issues may be found on the “eProst Archive” site available at