Upload
basil-hood
View
214
Download
1
Tags:
Embed Size (px)
Citation preview
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?