Research Oversight at UC

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Research Oversight at UC
Office of Research Compliance and Regulatory
Affairs ORCRA

• March 21, 2007
• Melissa Colbert, PhD
• Director, ORCRA
• Research Compliance Officer

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Mission of ORCRA
The mission of ORCRA is one of service, to both
the University of Cincinnati and to the faculty
and staff. Our main focus is to ensure the safety
of research involving human and animal subjects,
the safe use of hazardous biologicals and
radioactivity and to maintain University
compliance with all Federal, State and Local
regulations. We are here to help and promise to
work with you, to be proactive in ensuring that
all researchers are appropriately following
existing guidelines, and to do so in the least
burdensome way possible. Research Compliance
Officer Melissa C. Colbert, PhD Director
ORCRA 3223 Eden Avenue Room G-08,
ML0567 Cincinnati, OH 45267-0567 513.558.503
4 Melissa.colbert_at_uc.edu Research.compliance
_at_uc/org
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What Constitutes ORCRA?

• The Office of Research Compliance and Regulatory
  Affairs is responsible for
• Human subject protection IRB
• Post IRB approval monitoring
• Animal welfare protection IACUC
• Biohazard use IBC IBOf
• Radiation safety RSC RSOf
• Compliance training

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Visit the ORCRA Website
http//Researchcompliance.uc.edu
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Research Involving Human Subjects

• Human subjects research means any activity
  intended to obtain and record information
• from or about individuals for research purposes.
• Any undertaking in which students, faculty, or
  staff investigate and/or collect data on human
  subjects or use existing data or specimens
  collected from living human subjects for research
  purposes, requires review by the Institutional
  Review Board prior to initiation of the project.
  This includes both funded and non-funded
  research, including dissertations, masters
  theses, pilot studies, class projects, and
  non-funded, faculty-directed research.

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Institutional Review Boards

• IRBs are composed primarily of faculty members
  from disciplines
• in which research involving human subjects is
  integral to that discipline's work, as well as
  several members from the community whose primary
  interest is in non-scientific areas. The Board
  (s) membership, policies, and procedures are
  governed by an Assurance agreement with the
  Federal government (FWA).
• UC has 2 medical IRBs
• And 1 social/behavioral IRB
• These panels review all proposed research
  involving human subjects to ensure that the
  rights and welfare of participants in research
  are adequately protected. The University of
  Cincinnati IRB serves as the IRB of record for
  the University of Cincinnati, University
  Hospital, Inc., The Shriners Institute for
  Burned Children, The Cincinnati Veterans Affairs
  Medical Center, and The Drake Center.
• A recent Memorandum of Understanding has been
  signed by UC and Childrens Hospital that allows
  for reciprocal review of protocols.

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Training Requirements

• The Federal Government (DHHS 45 CFR 46) and The
  University of Cincinnati require that you
  demonstrate your knowledge of basic ethics and
  Human Subjects Protection
• This can be fulfilled by online training
• CITI Human Research Protection Online(Meets UC's
  HRP training requirement)
• The IRB site also contains information on the IRB
  Committees, the IRB Office, and the protocol
  process.
• You will find information on HIPAA waivers,
  forms, orientation procedures, regulations, and
  FAQs.

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Federal Agencies that Require Oversight of Human
Research
List of Departments Agencies which have adopted
the Common Rule (DHHS 45 CFR 46)

•               10 CFR 745                   
  Department of Energy
• 7 CFR 1C Department of
  Agriculture
•               14 CFR 1230      
             National Aeronautics and Space
  Administration
•               15 CFR 27                     
  Department of Commerce
•               16 CFR 1028                 
  Consumer Product Safety Commission
•               22 CFR 225                   
  Agency for International Development
•               24 CFR 60                     
  Department of Housing and Urban Development
•               28 CFR 46                     
  Department of Justice
•              32 CFR 219                  
  Department of Defense
•               34 CFR 97                     
  Department of Education
•               38 CFR 16                     
  Department of Veterans Affairs
•               40 CFR 26                     
  Environmental Protection Agency
•               45 CFR 46         
         Department of Health and Human Services
•               45 CFR 46                     
  Central Intelligence Agency
•               (by Executive Order 12333)
•               45 CFR 690                   
  National Science Foundation
•               49 CFR 11                     
  Department of Transportation
• 21 CFR 56 Food
  and Drug Administration

AAHRPP
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Consequences of Non-compliance

• Non-compliance with DHHS (OHRP) or FDA
  regulations puts the entire institution at risk
• Loss of FWA means that IRB is shut down
• No clinical/human research allowed until
  deficiencies are corrected
• This has happened at top tier institutions such
  as Duke University, Johns Hopkins and Penn

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Monitoring of IRB Protocols

• The Human Subjects Research Post-Approval
  Monitoring Program administers quality
  assurance/quality improvement monitoring.
• The purpose of this program is to ensure that
  scientific, ethical and regulatory requirements
  are followed in all Institutional Review Board
  approved protocols.
• The program is also designed to improve the
  quality of research by detecting errors and/or
  omissions that might occur when performing
  research activities.
• This will also give the investigators an
  opportunity to ask questions and receive
  information about regulations and issues
  regarding the protection of human subjects.

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What we monitor

• Education of investigators
• Investigator initiated studies
• Sponsor-investigator IND/IDE
• Vulnerable population studies
• Informed consent observations
• Performance of the study
• AE communications from subjects
• Data tissue handling
• Drug device storage

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Monitoring Process

• 1. Off-site review (self assessment)
• complete questionnaire
• 2. On-site review
• Formal visit by Monitors
• Interview of personnel
• Review of SOPs, etc.
• Observation of consent process
• Medical Director will meet with PI for interview
• Final report sent to Compliance Officer, IRB
  Chair, Senior VP for Research

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Training Beyond CITI

• While not mandatory, training in Good Clinical
  Practices (GCP) is strongly suggested
• Recommendations for training materials are
  located on the Compliance Training site

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Consequences of Failure to Follow GCP

• Failed FDA Inspections
• 483 Findings
• Official Warning Letters
• Cease Desist Orders
• Loss of FWA, etc.

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IACUC

• Institutional Animal Care and Use Committee
• The IACUC serves as animal research ethics
  board committed to the welfare of animals. The
  IACUC plays an important role in ensuring that
  the animals under its purview are used and cared
  for in a humane manner.
• The Federal Government requires that the Chief
  Executive Officer or his/her designee appoint an
  Institutional Animal Care and Use Committee
  (IACUC).

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Agencies that Regulate Animal Use
PHS Office of Laboratory Animal Welfare (OLAW) is
charged with implementing the Health Research
Extension Act (HREA) of 1985, as well as any
policies/regulations established by PHS to
implement HERA
The United States Department of Agriculture
(USDA) Animal and Plant Health Inspection Service
(APHIS) is charged with implementing the Animal
Welfare Act. The USDA has done so through the
Animal Welfare Act Regulations and the Animal
Care Policy Manual.
The Association for the Assessment and
Accreditation of Laboratory Animal Care
International (AAALAC) is a non-profit
association that provides a voluntary
accreditation program to institutions wishing to
demonstrate the highest level of commitment to
responsible care and use of animals.
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Required Training

• Both OLAW and the USDA require proper training
  of all personnel who will work with vertebrate
  animals. At the University of Cincinnati and
  Shriners Hospitals for Children, all personnel
  must attend Orientation prior to working with
  animals and every 3 years thereafter. Orientation
  sessions are provided on a regular basis. As
  research staff is added to protocols, their
  experience is reviewed, and they must attend
  appropriate training before beginning work with
  animals.
• Orientation covers the following items
• Federal Regulations, including OLAW USDA
  regulatory requirements
• Institutional Policies
• AAALAC The Guide for the Care and Use of
  Laboratory Animals
• AVMA Panel on Euthanasia
• Animal Welfare
• Humane practice of animal maintenance and
  procedures
• Reduction, Replacement, Refinement
• IACUC LAMS
• Overview of the Universitys Occupational Health
  Safety Program, including zoonotic diseases
• A Certification Examination is conducted at the
  end of Orientation. All personnel must receive a
  passing score to receive credit for the
  Orientation. If a passing score is not received,
  personnel will be required to attend another
  Orientation session.
• The Principal Investigator (PI) must complete
  IACUC Orientation and other applicable training
  before the IACUC will consider approving the
  protocol.  If funds need to be transferred from
  another institution and the PI is not yet at UC,
  the protocol may be approved but animals cannot
  be ordered and animal studies may not begin until
  all training requirements have been met.  The
  approval will be valid for 60 days.

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Monitoring

• IACUC does staggered inspections of every animal
  facility semi-annually
• LAMS staff also examines animal cages daily
• Infractions can be self reported, reported to
  IACUC by LAMS, or HotLine

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Consequences

• All infractions must be reported to OLAW
• Loss of AAALAC accreditation
• For cause The Veterinarian can immediately
  suspend research IACUC will suspend research if
  they consider infractions serious. Suspensions
  can be of individuals on protocol or all research
  under protocol

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Responsibilities of IACUC vs. LAMS for Animal
Research

• IACUC
• Protocol Submissions
• Personnel Training
• Compliance Concerns
• LAMS
• Animal Ordering
• Housing Space Needs
• Veterinary Health Issues

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Biosafety Program

• The goal of the Biological Safety Program is to
  ensure compliance with all institutional
  requirements and all federal, state, and local
  regulations pertaining to the possession, use,
  storage, transfer, and disposal of biohazardous
  agents, as well as ensuring the safety of
  university employees and the surrounding
  community.
• The University of Cincinnati Biosafety Office has
  three functional components
• The Biosafety Office
• The Biosafety Officer
• The Institutional Biosafety Committee (IBC).

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Reviewing/Monitoring

• The IBC reviews all research protocols
  involving
• Recombinant DNA (rDNA)
• Agents infectious to humans, animals or plants
• Other genetically altered organisms agents
• Select Agents Toxins
• The BSO is charged by the NIH with periodic
  inspection of laboratory facilities.
  Non-compliance with the Guidelines must be
  reported to the IBC and NIH/OBA.

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Reporting Consequences
The NIH and the University of Cincinnati require
research involving biohazards to be reviewed and
approval by the Institutional Biosafety Committee
(IBC). Section IV-B-2-b-(1-6) The institution
shall establish an Institutional Biosafety
Committee, whose responsibilities need not be
restricted to recombinant DNA and is responsible
for reviewing recombinant DNA research ..in
compliance with the NIH Guidelines. The
unapproved use of biohazardous agents is in
violations of NIH Guidelines and places not only
individual funding, but all research funding at
UC in jeopardy. Section I-D-1. All NIH-funded
projects involving recombinant DNA techniques
must comply with the NIH Guidelines.
Non-compliance may result in (i) suspension,
limitation, or termination of financial
assistance for the noncompliant NIH-funded
research project and the NIH funds for other
recombinant DNA research at the institution, or
(ii) a requirement for prior NIH approval of any
or all recombinant DNA projects at the
institution
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Radiation Safety

• The Radiation Control and Safety Program (RCSP)
  is overseen by

• The Radiation Safety Committee (RSC)
• The Radiation Safety Officer (RSO)

The RSC and RSO work in tandem to ensure the
health and safety of personnel, along with
ensuring compliance with applicable rules,
regulations and license conditions.
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Training in Radiation Safety
RAM Radiation Worker Training Schedulefor
individuals who may handle radioactive materials
in a research or clinical setting BasicAdvanced
Retraining Contact Radiation Safety at 558-4110
to schedule a training session.
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Monitoring ReportingConsequences

• RS does regular unannounced inspections of all
  research laboratories
• Violations result in disciplinary action and may
  lead in suspension of the AU status
• Serious violations can lead to significant fines
  to the University and loss of license

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Office of Research Compliance Training

• The office of Research Compliance Training is
  responsible for developing and delivering
  workshops and training classes, as well as
  designing computer-based training courses on
  research regulatory compliance issues.  In
  addition to delivering training that meets the
  needs of the research investigators, courses are
  developed in response to changing regulatory and
  accreditation requirements, e.g., HIPAA.  Many
  programs are eligible for continuing education
  credits

This will be subsumed in FY 2008 By the Office of
Research Programs
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Training Available
Welcome to the Research Compliance Training Site

Welcome to the Research Compliance Training Site

Welcome to the Research Compliance Training Site

This site is your gateway to online compliance
training, online competency testing, non-online
educational programs and compliance
training-related news.

• Educational Programs      
• Hot Topics Schedule
• Investigator 101
• IRB Seminar
• Orientation Program
• Research Education AdvisoryCommittee Membership
  List
• News and Announcements     
• New Policy Demonstrating Knowledge of Human
  Research Protection by Researchers, December
  2005
• Training Instructions
• FAQs     
• Frequently asked questions

• Compliance Training      
• CITI Human Research Protection Online(Meets UC's
  HRP training requirement)
• Training HRP Instructions
• Continuous Professional Developmentonline
  compliance training
• Blood Borne Pathogens
• Biosafety
• HIPAA
• Human Research
• Radiation Safety
• Transcript
• UC Physicians
• GCP Training
• Self-Paced Training
• Competency Testing     
• Continuous Professional Development online
  compliance training
• Biomedical Research HRP Knowledge Exam
• IRB - M HRP Knowledge Exam
• IRB - S HRP Knowledge Exam

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To Report Concerns
Toll-free Anonymous Compliance Hotline
1-800-889-1547 Any concerns of University
employees concerning the human research
protection program should be shared with the
appropriate academic or administrative manager
for action. Employees who have concerns about job
security arising from reporting internally may
use the Universitys toll-free reporting hotline.
The hotline is free to the user, and anonymous. 
Callers may report noncompliance and request a
copy of the final report. Although the callers
name and mailing address may be given to the
compliance agency, no one at the University may
access this information. The caller remains 100
anonymous to all individuals at the University!
It should be noted that this hotline could be
used to report any compliance concerns at The
University of Cincinnati. The hotline is not
restricted to research concerns.
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Thank You!