The following are the forms to be used for the submission of protocol information for IRB review.Not Human Subject Research
Not Human Subjects Research Self-certification Tool
External IRB Reliance
HRP-216 – FORM – External IRB Reliance Application
The HSRO recommends the use of the NIH IRB Authorization Agreement template for reliance on external IRBs.
Recommended items for Continuing Reports
Checklist of Information to Attach for Continuing Review
Emergency Use Forms
Emergency Use Report (Subsequent to Use)
Emergency Use Request (Prior to Use)
Optional Summary Logs for Reportable Events Submitted at Continuing Review
Form HSR-4A – Internal Non-Serious Adverse Event Log Sheet
Form HSR-4C – IND Log Sheet
NOTE: Investigators may use sponsor-provided ICFs. However, these must be submitted to the IRB as a Microsoft Word document and must incorporate the JHSFooter Template or UHealth Footer Template if the study will take place at clinical care facilities that are part of either of these systems. The following standalone consent forms may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions. The following standalone consent forms may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions. For more information concerning genetics consent and guidelines, please visit the UM Ethics Programs web site. The following standalone consent forms may be used or pertinent language may be included in the main Informed Consent Form(s). If the standalone form is used, study teams must ensure that the appropriate footer(s), signature lines, etc. are incorporated into the final versions. NOTE: Use of “Short Form” Written Consent Forms in a study for oral translation of English consent forms must be approved by the IRB on a case-by-case basis. An English version of the Short Form Written Consent Form is available for your reference by clicking here. The certificate of Translation for these documents is available here.Recording or Photographing Subjects
Audio/Video/Photo Consent
Audio/Video/Photo Consent (Spanish)
Genetics Consent Templates & Guidelines
Genetics Consent (Linked, No Recontact)
Genetics Consent (Linked, Recontact)
Genetics Consent (Unlinked)
HIV Testing as part of Screening Procedures
MSC HIV Consent
MSC HIV Consent (WIRB)
Observation of Pregnant Partners of Subjects for Outcome Data
Pregnant Partner Consent
Social and Behavioral Sciences (SBS)
Release of Student Records for Research
“Short Form” Written Consent Forms
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
Email: shwalker@transperfect.com
Morella Diaz
Telephone: 305-525-0625
Email: morediaz@aol.com
DREAMS INNOVATORS, INC.
Dalia Brown, Pres.
ATA-certified English-Spanish
Telephone: 786-390-1046
E-mail: dreams.innovators@hotmail.com
Confluent Translations
Charlene Nagi
Telephone: 412-539-1410
E-mail: cnagy@confluenttranslations.com
The Language Corner
Soledad H. Judge
Telephone: 305-788-3167
E-mail: soledad@thelanguagecorner.com
Pro Translating
Julie Gonzalez
Telephone: 305-371-7887
E-mail: jgonzalez@protranslating.com
Interpreters Unlimited (IU)
dba Accessible Communications for the Deaf
Sayed Ali
Telephone: 800-726-9891
E-mail: sayed.ali@iugroup.com
Health Information is among the most sensitive types of personal information. The Health Insurance Portability and Accountability Act of 1996 (also known as HIPAA) protects the privacy and security of patient health information. Protected Health Information (PHI) under HIPAA includes oral, written or electronic information that relates to an individual’s physical or mental health, or the provision of health care to an individual or payment for health care. The Certificate of Translation for the above forms may be downloaded by clicking this linkHIPAA Compliance Procedures
HIPAA Research Authorization Templates
Authorization to Use and Disclose Health Information
Form B (English)
Form B (Creole)
Form B (Portuguese)
Form B (Spanish)
Referral Release of Individually Identifiable Health Information for Research
JMH Research Authorization
JMH Research Authorization (Creole)
JMH Research Authorization (Spanish)
UM Research Authorization
UM Research Authorization (Creole)
UM Research Authorization (Spanish)
Other HIPAA Forms
4th Quarter 2017
3rd Quarter 2016
2nd Quarter 2016
1st Quarter 2016
3rd Quarter 2015
2nd Quarter 2015
1st Quarter 2015
Winter 2014
March 2014
January 2014
NOTE: Older issues may be found on the “eProst Archive” site available at http://eprostarchive.med.miami.edu
September 11th and 12th, 2014 – For information about the 2014 HSR CommUnity Conference, please contact Kenia Viamonte at 305-243-9672 or at kviamonte@med.miami.edu. IRB7 System Updates & RNI
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 kviamonte@med.miami.edu.
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 kviamonte@med.miami.edu.
2014 HSR CommUnity Conference
IRB Grand Rounds
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 http://eprostarchive.med.miami.edu