Information for Researchers

Online Resources

  • Does My Project Need Review by the IRB

    Click below to determine if your project must be submitted to the IRB

    Not Human Subjects Research Self Certification Tool


  • Miscellaneous HSRO Forms

    The following are the forms to be used for the submission of information for IRB review.

    Emergency Use Forms

    Emergency Use Report (Subsequent to Use)
    Emergency Use Request (Prior to Use)

  • Translations

    The HSRO does not recommend any particular translator, rather the list below represents translators and translation services that have been set up as vendors with the University of Miami. Alternatively, any certified translator may be used when certified translations are required.

    TransPerfect Translations Services
    Shaun Walker
    Account Manager
    200 S. Biscayne Blvd., Suite 850
    Miami, FL 33131
    Telephone: 305-347-3344
    Fax: 305-347-3222
    Morella Diaz 
    Telephone: 305-525-0625
    Dalia Brown, Pres.
    ATA-certified English-Spanish
    Telephone: 786-390-1046
    Confluent Translations
    Charlene Nagi
    Telephone: 412-539-1410
    The Language Corner
    Soledad H. Judge
    Telephone: 305-788-3167
    Pro Translating
    Julie Gonzalez
    Telephone: 305-371-7887
    Interpreters Unlimited (IU) 
    dba Accessible Communications for the Deaf 
    Sayed Ali
    Telephone: 800-726-9891

  • 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

  • Educational Activities Archive

    Information presented here was accurate at the time of publication and may be subject to change.

    2016 OHRP Research Community Forum: 21st Century Research

    April 6th and 7th, 2016 – For information about the 2016 Research Community Forum, please contact Kenia Viamonte at 305-243-9672 or at

    2015 HSR CommUnity Conference: Charting the Course for Quality

    September 10th and 11th, 2015 – For information about the 2015 HSR CommUnity Conference, please contact Kenia Viamonte at 305-243-9672 or at

    2014 HSR CommUnity Conference

    September 11th and 12th, 2014 – For information about the 2014 HSR CommUnity Conference, please contact Kenia Viamonte at 305-243-9672 or at

    IRB Grand Rounds

    IRB7 System Updates & RNI
    July 14, 2015 – Presented by Raquel Alfonso & Amanda Coltes-Rojas
    Office of Research Information Management & Human Subject Research Office

    Unlocking Information From PHI to RHI
    June 9, 2015 – Presented by Helenemarie Mirle Blake, Esq. and Evelyne Bital, MA, CIP
    Office of HIPAA & Privacy Security and Human Subject Research Office

    Education and Training with Respect to Human Subject Protections, Good Clinical Practice, and Clinical Research Coordinators
    May12, 2015 – Presented by Margaret Rankovic, M.Ed., CIP
    Collaborative Institutional Training Initiative (CITI)

    How the Miami CTSI Helps Advance Human Protections and Quality in Clinical Research
    March 10, 2015 – Presented by Jonelle E. Wright, PhD, DPNAP
    Miami CTSI

    State of the HSRO
    January 13, 2015 – Presented by Dushyantha Jayaweera, MD, MRCOG (UK), FACP, CIP
    Human Subject Research Office

    Consenting Study Participants in the 21st Century
    December 9, 2014 – Presented by Guillermo (“Willy”) Prado, PhD
    Division of Prevention Science and Community Health, Department of Public Health Sciences

    IRB7 Library and Policies: What You Need to Know
    October 14, 2014 – Presented by Amanda Coltes-Rojas, MPH, CIP, CHRC
    August 12, 2014 – Presented by Amanda Coltes-Rojas, MPH, CIP, CHRC
    Human Subject Research Office

    Research Compliance and Quality Assurance – Why, What & How?
    July 8, 2014 – Presented by Johanna Stamates, RN, MA, CCRC, CHRC
    Research Compliance and Quality Assurance

    Conflicts of Interest in Research and Scholarly Activities: Review of Investigator Interests at the University of Miami
    May 13, 2014 – Presented by Lory Hayes
    Office of Research Compliance (ORC)

    University Compliance Services
    April 8, 2014 – Presented by Rudolph (Rudy) Green
    Vice President and Chief Compliance Officer

    What Makes Minorities Participate In Clinical Research
    March 11, 2014 – Presented by Leonardo Tamariz, MD, MPH
    Miami VA Healthcare System

    Social and Behavioral Research: Need To Know
    February 11, 2014 – Presented by Vivienne Carrasco, MPH, CIP
    Human Subject Research Office

    Not My Study… Challenges of Clinical Trial Disclosure at an Academic Medical Center
    January 14, 2014 – Presented by Yolanda P. Davis
    Research Compliance and Quality Assurance

    Ethics, Translational Science & the IRB: The Future is (Still) Not What It Used to Be
    December 10, 2013 – Presented by Kenneth W. Goodman, PhD, FACMI
    University of Miami Ethics Programs

    Reportable New Information
    November 12, 2013 – Presented by Amanda Coltes-Rojas, MPH, CIP
    Human Subject Research Office

    Trusted Governance and Biobank Research
    October 8, 2013 – Presented by Robin N. Fiore, PhD
    University of Miami Ethics Programs

    Applying the Approval Criteria and the Inner Workings of an IRB
    September 10, 2013 – Presented by Dushyantha Jayaweera, MD, MRCOG (UK), FACP, CIP
    Professor of Medicine and Associate Vice Provost for Human Subject Research

    IRB 7.2 User Training
    August 13, 2013 – Presented by Jose (Joey) Casanova, BBA, CIP
    Human Subject Research Office

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