University of Miami

HSRO Mission

Protecting the safety, rights, and welfare of human research participants through:

Collaboration and Regulatory Compliance

Collaborating with Investigators, key study personnel, and other supporting institutional bodies toward a common goal of protecting human research participants.

HSRO Strategic GoalsRedeployment of the Eprost online

protocol submission system – COMPLETED

AAHRPP accreditation – initial application expected to be submitted by December 2008

WIRB reacquisition – currently less than 400 studies at WIRB – ongoing

IRB Goal and ObjectiveTo protect the rights and welfare of those individuals who contribute

to the research process by participating as subjects.

In protecting the research subject, the IRB also protects the institution and the researcher from the potential harmful consequences of an inadequate consent process or the exposure of the subject to excessive risk.

To review each research plan and consent process in order to safeguard the rights and welfare of human subjects.

To determine that each study conforms to ethical standards including: a reasonable balance of risks and anticipated benefits; adequate provisions for informed consent; and equitable selection of subjects

HSRO Operational GoalDeliver High Quality Service

Guiding and Supporting the development of research based on sound research design and strong ethical principles that contribute to scientific and scholarly advances in biomedical, behavioral, social and other sciences.

Developing and Implementing human research protections training programs on the application of IRB policies and procedures, and Federal regulations and guidelines.

Consulting with Investigators and key study personnel in the development of research programs to facilitate compliance with regulations, and assuring adherence to FDA and other regulatory guidelines, ethical considerations, and institutional policies related to human research protections.

Continual Learning of Investigators and key study personnel resulting in an up-to-date and knowledgeable research community in human research protections

Organizational StructureMoved from functional structure (pre-/post-

board, etc.) to a Board-focused ModelRegulatory Staff are assigned to specific

Boards Turnaround time is averaging 20 days for

new full board submissions, 12 days for new expedited, 6 days for new exempt

Daily triage of incoming submissions with expectations to conduct initial regulatory review within 5 working days

Operational Model for the Human Subject Research Office

Finance / Office Management

Finance Manager

Jeanette Laschower

Vice Provost

Myron Rosenthal, PHDHuman Subjects Research Protection Program

UM

Executive Director

Kelly Insignares PHD, MBA, CIP

OCT 2008

Director for Regulatory Affairs and Educational Initiatives

Amanda Coltes-Rojas CIP

Assistant Provost

for IRB Affairs

Dr. Stephen Richman

Marisel Valdes

Mireya Diaz De ArceYaslaime Fraga

Educational Initiatives

Associate Director Marisabel Davalos CIP

Privacy & Regulatory Affairs

Associate Director Evelyne Bital CIP

Information Technology

Senior Systems AdministratorStella Uyeno

IRB Chairs

Dr. Ofelia Alvarez

Dr. Charles Carver

Dr. D. Jayaweera

Dr. Thomas Sick

Office Of Research Compliance

Office of Research Training & Education

HSCOIC

Ethics Program,

Privacy Office,

Ancillary Committees

Leandro Guzman

Programmer – TBA

Education SpecialistJoey Casanova

Daniel Auguste

Medical IRB ASimonnette Thompson, CIP

Cecilia Grano De OroRebekah Barreth

Medical IRB BYoko Young Sang (Co-RA)

Jada Rauls (Co-RA)April Cohen

Medical IRB CNatalie Francis, CIP

Michael PaezJessica Duque

Social Behavioral Sciences Board

Vivienne Carrasco, CIPAdriana Robledo

Meghan Stein, CIPSonya Hadrigan CIP

Alexis ClascaLiza Gordillo

Compliance IRB Affairs

Compliance Manager

Kenia Viamonte

Regulatory Operations

Sr. ManagerDawn Stoutt

Accountant Amanda Dufau

Eprost SystemEnhancementsRevisiting current smart formsUpdating content, questions and system

branchingModifying IRB determination letters Users group will also have an opportunity to

propose recommended changes to the formsNew form redeployment expected June 2009System Security and Authentication

Innovative Practices—IP3RInnovative Practices for the Protection of

Participants in ResearchAny study that meets the criteria will be approved

for 3 years rather than the 1 year stipulated in the regulations1. No more than minimal risk2. Not federally-funded (DHHS, FDA)3. Not subject to state or other regulations related to the

ethical standards of human subject research4. Not involving Certificates of Confidentiality issued by

the NIH5. Not under federal obligations or contractual restrictions

Innovative PracticesFor studies that require IRB review within a 2-

week minimum time-frame to secure fundingMust meet criteria for regulatory completenessResearch support personnel must be trained and qualified

to participate by the HSRO. They must exhibit high attention to detail and be able to immediately respond to requests for changes

Guarantees IRB review not approval within a 2-week window with attention paid to the meeting dates and deadlines for IRB submission

More details to follow as the process is finalizedImplementation goal: January 2009

Innovative Practices-EfficiencyFinding ways to make the review of HSR

studies more efficient…1. Enables better protection for human research

participants2. Fosters partnership among HRPP stake

holders3. Helps everyone meet their respective

obligations

UM/HSRO Policies and ProceduresIt is the expectation that all research

personnel are familiar with the policies and procedures posted on the HSRO website to ensure:culture of compliance with all applicable

regulationsethical conduct of human subject researcha knowledgeable research community is fostered

HSRO website should be checked periodically for updated policies and forms

Updated Policies—FDA ProductsPolicies on investigational drugs, biologics and

devices currently under revisionEmergency Use reporting forms available on

HSRO websiteEnsure all applicable

documentation/information related to investigational products is available to IRB at time of reviewIND/IDE approval letter from FDAIND/IDE exemption justifications and/or sponsor

letter

Updated Policies Section 3: Authorities and Responsibilities

3.1 IRB Authority (August 8, 2008) 3.4 Responsibilities of the Principal

Investigator (July 8, 2008) Section 22: Participant Recruitment

Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements22.1 General Principles (August 6, 2008) 22.2 IRB Approval and HHS (August 6, 2008)

Section 23: Vulnerable Populations23.1 General Principles (July 6, 2008)

Updated PoliciesSection 24: Privacy, Security, Confidentiality and

HIPAA24.1 Which Policies Must Be Followed (August 6,

2008) 24.2 Definitions (August 6, 2008) 24.3 General Principles of IRB Review of Privacy,

Security and Confidentiality (August 6, 2008) 24.4 Privacy (as applicable to ALL studies) (August

6, 2008) 24.5 HIPAA-related Privacy Policies (applicable to

studies involving PHI and HIPAA) (August 6, 2008) 24.6 Security (August 6, 2008) 24.7 Confidentiality (August 6, 2008)

Updated PoliciesSection 27: Emergency Use

27.1 General Principles (August 24, 2008) 27.2 Emergency Use of Unapproved

Medical Devices (August 24, 2008) 27.3 IRB Requirements (August 24, 2008) 27.4 Emergency Use and Informed

Consent (August 24, 2008)

Updated PoliciesSection 28: Retention of Study Records

and Documents28.1 General Principles (September 15,

2008) 28.2 Record/Document Retention

Requirements (September 15, 2008) 28.3 Record/Document Storage and

Deletion (September 15, 2008)

HSRO CommunicationThe HSRO disseminates information via

several means1. HSRO eNewsletter—monthly2. eProst listserv—as needed3. Educational presentations (Departmental, etc.)4. Expert seminars (IRB 250, FDA)

We rely on your feedback! What are we doing well? What could we be doing better?