Information for Researchers

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.

HRP-502a - TEMPLATE: Consent Document (Biomedical Studies)

HRP-502c - TEMPLATE: Consent Document (Assent, 7-12 Years Old)

Sample Proxy Informed Consent Template

Sample Registry Informed Consent Template

Sample Repository Informed Consent Template

Sample HUD Consent Template

Sample Investigational Product Consent

Recording or Photographing Subjects

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.

Audio/Video/Photo Consent

Audio/Video/Photo Consent (Spanish)

Genetics Consent Templates & Guidelines

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.

Genetics Consent (Linked, No Recontact)

Genetics Consent (Linked, Recontact)

Genetics Consent (Unlinked)

HIV Testing as part of Screening Procedures

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.

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

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.

Short Form Written Consent - Chinese (Traditional)

Short Form Written Consent - French

Short Form Written Consent - German

Short Form Written Consent - Haitian Creole

Short Form Written Consent - Brazilian Portuguese

Short Form Written Consent - Russian

Short Form Written Consent - Spanish

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.

HIPAA Compliance Procedures

HIPAA Form B Sponsor Changes Template

UM Standard Operating Procedures for HIPAA Compliance – (For Investigators)

UM Standard Operating Procedures for HIPAA Compliance – (For the IRB)

Joint Guidance on the Application of the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) To Student Health Records

HIPAA Research Authorization Templates

Authorization to Use and Disclose Health Information

Form B (English)

Form B (Creole)

Form B (Portuguese)

Form B (Spanish)

The Certificate of Translation for the above forms may be downloaded by clicking this link

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

HIPAA Attachment 45 – Accounting for Disclosure

HIPAA Attachment 46 (English Version)

HIPAA Attachment 46 (Spanish Version)

UM Data Use Agreement for Disclosure of a Limited Data Set

Investigator’s Certification for Research with Decedents’ Information (Form D)

Investigator’s Certification for Reviews Preparatory to Research (JHS Form C-687)

Investigator’s Certification for Reviews Preparatory to Research (UM Form E)

Research Photo Authorization Form (English)

Research Photo Authorization Form (Spanish)

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 clinicaltrials.gov 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 http://eprostarchive.med.miami.edu

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 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

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.

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 http://eprostarchive.med.miami.edu