Office of Research Compliance and Regulatory Affairs ORCRA

1
Office of Research Compliance and Regulatory
AffairsORCRA
Research Orientation

• What you need to know about Research Compliance
  at UC
• December 1, 2006
• Melissa Colbert, PhD
• Director, ORCRA
• Research Compliance Officer

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What is 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 IBCOf
• Radiation safety RSOf RSC
• Compliance training

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What is the 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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Where do I go to find information about ORCRA?
http//Researchcompliance.uc.edu
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What is Human Subjects Research?

• 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 if the following conditions are met
• the research is sponsored by the University, or
• the research is conducted by or under the
  direction of any University employee or
• agent of this institution in connection with
  his/her institutional responsibilities, or
• the research is conducted by or under the
  direction of any University employee or
• agent of this institution using any University
  property or facility, or
• the research involves the use of the
  University's non-public information to
• identify or contact human research subjects or
  prospective subjects

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What are the criteria for human research?
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What is the IRB?

• Institutional Review Board
• UC has 2 medical boards
• And 1 social/behavioral board
• The University of Cincinnati has established
  three Institutional Review Board (IRB) panels
  to 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.
• The 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.

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How do I submit a protocol for IRB review?

• http//researchcompliance.uc.edu/irb/default.html
  
• IRB Procedures
• The IRBs encourage submmission as soon as the
  application is complete
• Incomplete applications will be returned
• If your study meets the Federal criteria for
  Expedited review, submissions go directly to the
  chair
• If the study requires Full-Board review, the
  following scheme illustrates the process
• Schedules Medical IRBs, every Wednesday
• Social/Behavioral, the third Thursday each
  month

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IRB Protocol Review
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Do I need training?

• 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)
• Training HRP Instructions
• 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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How do I contact the IRB Office?

• Location G-08 Wherry Hall,
• ML 0567
• Telephone [phone]
• Fax [phone]
• Mailing Address   
• Institutional Review Board Office                 
              
• G-08 Wherry Hall, ML 0567                         
      
• University of Cincinnati Medical
  Center                             
• PO Box 670567                             
• Cincinnati, OH 45267-0567

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IRB Office Staff Contacts

• General Inquiries Susan Groh, 558-5259
• (susan.groh_at_uc.edu) 
•  
• Medical IRBs
• New Protocols Pre-approval, Katie Krier
  558-5136 (Katie.Krier_at_uc.edu)
• Progress Reports Lela Hinds-Peterson, 558-0479
  (Lela.Hinds-Peterson_at_uc.edu)
• Modifications Martina Harmon, 558-1881
  (Martina.Harmon_at_uc.edu)
• Adverse Event Reports Denise Washington,
  558-7324 (Denise.Washington_at_uc.edu) 
•  
• Social-Behavioral IRB
• Claudia Norman, 558-5784 (Claudia.Norman_at_uc.edu)
• Carolyn West, 558-7580 (Carolyn.West_at_uc.edu)

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IRB Office Staff
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What is post approval monitoring?

• 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 do we monitor?

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

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What is the Process?

• There are two processes
• 1. Off-site review (self assessment)
• complete questionnaire
• 2. On-site review
• Formal visit by Program Director
• 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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Do I need training?

• 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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Some Frequently Asked Questions associated with
monitoring


Q  Why does the University have a monitoring
program?A  The Post-Approval Monitoring Program
serves five functions 1) to assist investigators
to improve their research processes by sharing
best practices among researchers 2) to protect
the integrity of research by identifying and
correcting significant deficiencies in approved
research protocols 3) to promote human subject
protection through the ethical conduct of
research 4) to improve the processes of the IRB
and 5) to identify topics for research education.
Q Am I in trouble because I was selected for
monitoring? A  The majority of studies that are
monitored are selected at random. Receiving
notification that a study has been selected for a
monitoring visit does NOT imply that wrong doing
is suspected in the conduct of the study. Q
What research protocols are subject to
review?A  Research studies for which the
Post-Approval Monitoring Program will conduct
reviews will be chosen mostly from among studies
not monitored by other institutions or by
sponsors of the research, and which Present
greater than minimal risk to participants are
investigator-initiated protocols have vulnerable
populations, including UC employees and students,
decisionally-impaired participants, pregnant
women/fetuses/neonates, prisoners, and children
present a potential for conflict of interest are
requested by the IRB to be reviewed
(IRB-requested monitoring).
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Contact Information

• Post Approval Monitoring Program
• Daniel Woo, MD
• Medical Director
• Phone [phone]
• Fax [phone] ML MSB 0525
• email daniel.woo_at_uc.edu
• Joanne A. Lindwall, Director
• Phone [phone]
• Fax [phone] ML HPB 0661
• email joanne.lindwall_at_uc.edu
• Angela Braggs-Brown
• Phone[phone]
• Fax [phone] ML HPB 0661
• Email broag_at_uc.edu

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Post Approval Monitors
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Animal ResearchWho do I call IACUC or LAMS?

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

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What is the IACUC?

• Institutional Animal Care and Use Committee
• Both federal Animal Welfare Act Regulations
  (AWARs) and the Public Health Service Policy on
  Humane Care and Use of Laboratory Animals (PHS
  policy) require that the Chief Executive Officer
  or his/her designee appoint an Institutional
  Animal Care and Use Committee (IACUC).
• Essentially, the IACUC serve 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.

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What are the regulatory charges the IACUC?

• Review the institutions program for animal care
  and use at least biannually
• Inspect all the institutions animal facilities,
  including animal study areas and satellite
  facilities
• Report to the Institutional Official on the above
  inspections and reviews and make recommendations
  for corrections
• Investigate concerns involving the care and use
  of animals at the institution resulting from
  complaints from personnel at the institution or
  the public
• Review proposed activities related to the care
  and use of animals including modifications to
  previously approved activities (protocol review).
  
• Suspend an activity involving animals if it does
  not comply with PHS policy, AWRs, the Guide, or
  the University of Cincinnatis Animal Welfare
  Assurance.

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Where do these regulatory mandates come from?
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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How do I submit an Animal Use Protocol?

• Download the protocol template from the IACUC
  website http//researchcompliance.uc.edu/iacuc/Pro
  tocolSubmissions.html
• Review hints and tips on the download page
• If questions arise while completing the template,
  please call
• Rob Anderson at 558-5187
• Email a draft to Rob.Anderson_at_uc.edu
• Schedule a Preliminary Review Meeting

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What is the IACUC Protocol Review Process?
1) PI Submits Protocol Template to IACUC
Office Pre-Review IACUC Office Staff
Veterinarian meet with the PI to Pre-Reviews the
protocol prior to submission to the IACUC 2)
IACUC Office routes protocol to IACUC Safety
Offices Designated Review 2 Members
Veterinarian (no meeting approval required) Full
Review All members (meeting approval
required) 3) Reviewers return comments to IACUC
Office 4) IACUC Reviewer Comments Routed to
PI 5) PI response to Reviewer comments routed to
reviewing IACUC members 6) IACUC Full Review at
Convened Meeting 7) Committee Decision Routed by
IACUC Office 8) Protocol Approval
Notification Designated Review Approval 2
Members Veterinarian may approve Full Review
Approval Requires majority vote at convened
meeting for approval Safety Approval IACUC
approval is contingent upon safety approval
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Do I need 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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What are Laboratory Animal Medicine Services?
The primary mission of Laboratory Animal Medical
Services is to provide an animal care and use
program for the University of Cincinnati research
and teaching community. This program provides for
the health, husbandry and veterinary medical care
of animals under the University of Cincinnati's
stewardship. The department delivers such in a
compassionate, humane and respectful manner, as
well as maintaining the highest standards of
quality and strives to achieve accreditation and
compliance excellence. Laboratory Animal Medical
Services serves as a resource to the medical
research community through the provision of
education, training and consultative services and
provides leadership and direction in response to
scientific advancements.
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How do I order animals?

• REQUISITIONS-Animal SOPInformation for the
  Researcher
• Complete the Animal Requisition Form thoroughly
• Make sure you have completely filled out the form
  and that your Business Manager has signed the
  form or it will be returned unprocessed
• There is a 42.98 fee per orderLate Fees are
  15.00 each
• Animal Requisitions must be submitted by NOON on
  Wednesday
• Late Fees will incur if forms are submitted after
  NOON on Wednesdays through NOON on Thursdays
• http//medcenter.uc.edu/lams/lamspp.htmlareq

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How can I report concerns of animal misuse or
abuse?

• IACUC Office 559-5187
• IACUC_at_ucmail.uc.edu
• Toll-Free Anonymous Compliance Hotline
  1-800-889-1547
• LAMS Veterinary Staff 558-5171

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Contact Information

• IACUC Contacts
• Rob Anderson, Director IACUC
• George Babcock, Chair IACUC
• Kareemah Mills, Protocol Program Manager
• David Custer, Training Program Manager
• Phone [phone]
• LAMS Contacts
• Douglas Stone, DVM Director LAMS
• Mark Kurtzman DVM, Assoc. Director Veterinary
  Care
• Mike Metze, Assoc. Director Husbandry
• Vicki Shaw, Business Administrator
• Phone [phone]

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IACUC Office Staff
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What is the Biosafety Department?

• The University of Cincinnati Biosafety
  Department has two functional components
• The Biosafety Office
• The Institutional Biosafety Committee (IBC).
• They work closely to ensure the safety and
  health of research staff and compliance with
  applicable laws.

34
What is the role of the Biosafety Office?

• The Biosafety Office is charged with ensuring
  compliance with institutional requirements and
  federal, state and local regulations pertaining
  to the possession, use, transfer and disposal of
  biohazardous agents. 
• The Biosafety Officer (BSO) is responsible for
  performing risk assessments to identify hazards
  and to guide Principal Investigators and staff in
  implementing practices and procedures that will
  minimize or eliminate risks associated with
  research involving biohazardous materials.

Biosafety Office 3255 Eden Ave HPB
G34 MLC0767 558-5210
35
What is the role of the IBC?

• The Institutional Biosafety Committee is charged
  by the Senior Vice President and Provost for
  Health Affairs to review and approve all
  University research activities involving the use
  of biohazardous agents and recombinant DNA
  molecules, as described in the National
  Institutes for Health Guidelines for Research
  Involving the Use of Recombinant DNA Molecules
  (NIH Guidelines) and the current edition of the
  Centers for Disease Control and Preventions
  Biohazards in Microbiological and Biomedical
  Laboratories (the BMBL or CDC Guidelines).
• Daniel B. Oerther, PhD
• IBC Chairman
• 513-556-3670

36
What agents does the IBC regulate?

• 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
• To use any of these agents, you must complete a
  biosafety protocol and have it reviewed and
  approved by the IBC.
• In order to begin the process, contact Erin Dunn
  in the Biosafety Office for password approval

37
What are risk groups?
Basis for the Classification of Biohazardous
Agents by Risk Group (RG) Risk Group 1 (RG1)
Agents that are not associated with disease in
healthy adult humans Risk Group 2 (RG2) Agents
that are associated with human disease which is
rarely serious and for which preventive or
therapeutic interventions are often
available Risk Group 3 (RG3) Agents that are
associated with serious or lethal human disease
for which preventive or therapeutic interventions
may be available (high individual risk but low
community risk) Risk Group 4 (RG4) Agents that
are likely to cause serious or lethal human
disease for which preventive or therapeutic
interventions are not usually available (high
individual risk and high community risk)
38
What is meant by containment level?
Work with RG4 agents Is not allowed At UC
GMT Good microbiological technique,  BSC
Biological Safety Cabinet
39
What are select agents?
On June 12, 2002 President Bush signed the
"Public Health Security and Bioterrorism
Preparedness and Response Act of 2002" (Public
Law 107-188). The Law's purpose is to improve the
ability of the United States to prevent, prepare
for, and respond to bioterrorism and other public
health emergencies. The Law requires that all
persons possessing select biological agents or
toxins deemed a threat to public health, animal
or plant health, or animal or plant products
register with the appropriate federal agency.
On March 18, 2005, final rules were published
in the Federal Register by the Departments of
Health and Human Services (HHS) and Agriculture
(USDA) governing facilities that possess, use or
transfer select biological agents or toxins.
These rules became effective on April 18, 2005.
40
What do I need to do to work with select agents?

• To begin the process for approval
• Contact the BSO. 
• Submit to a security risk assessment (SRA) by the
  United States Department of Justice, Federal
  Bureau of Investigations, Criminal Justice
  Information Services. 
• The individual PI and laboratory personnel must
• Have fingerprints taken and submitted to the FBI,
  CJIS by an authorized officer in the University
  of Cincinnati Department of Public Safety
• Complete sections II and III of form FD-961
• Be added to the University of Cincinnati entity
  registration.
• Please note the following
• Individuals may not self register.
• Approval of individual registrations may take
  from 3-6 months.
• Approval for the possession, use and transfer of
  select agents cannot be transferred from one
  entity to another

41
Why do I need IBC approval?
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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Biosafety Office Staff
E-mail inbiocom_at_ucmail.uc.edu
Gary E. Dean, PhD Biological Safety
Officer 513-558-0065
Neal D. Wolfe, MS BL3 Facility Director 513-558-34
86
Erin L. Dunn Biological Safety Specialist IBC
Administrator 513-558-5210
43
IBC Office Staff
44
Radiation Safety

• The mission of the University of Cincinnati
  Radiation Safety Office is to provide the means
  necessary for personnel to protect themselves,
  their coworkers, the general public, and the
  environment from detrimental effects of
  radioactive materials and radiation producing
  devices used under the University's Radiation
  Control and Safety Program. Its mission is also
  to provide day-to-day oversite and services to
  meet the goals of the Radiation Control and
  Safety Program

Mailing address University of
CincinnatiRadiation Safety Office 170 Panceza
Way PO Box 670591Cincinnati, OH
45267-0591 Phone [phone] Fax [phone]
45
What is meant by 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.
46
What are the duties of the Radiation Safety
Committee?

• The RSC is a committee of the Office of the
  President.
• The RSC is responsible for generating, defining,
  implementing and monitoring a RCSP that complies
  with rules, regulations and license conditions.
• The RSC grants and withdraws authorized user (AU)
  status and restricts radiation source usage as
  needed for safety and compliance.

47
What are the duties of the Radiation Safety
Officer?

• The RSO is responsible for implementing the RCSP
  and ensuring for UC that radiation safety
  activities are in accordance with rules,
  regulations and license conditions.
• The RSO, with the assistance of Radiation Safety
  Office (RSOf) staff, is responsible for managing
  the day-to-day operations of the RCSP.

48
Do I need Training in Radiation Safety?
RAM Radiation Worker Training Schedule(for
individuals who may handle radioactive materials
in a research or clinical setting) BasicAdvanced
RetrainingBy Month for 2005/2006 Contact
Radiation Safety at 558-4110 to schedule a
training session.
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Frequently Asked Questions
I took radiation safety training at another
institution. Do I have to take training at the
University of Cincinnati before I can begin to
use radioactive materials (RAM)? Yes. Even if you
attended training or have experience using
radioactive materials (RAM) at another
institution you are still required to attend
site-specific training at the University of
Cincinnati before you may handle radioactive
materials under the University of Cincinnati
Radiation Control and Safety Program
(RCSP). What training must I complete before
handling radioactive materials? Before handling
radioactive material under the University of
Cincinnati Radiation Control and Safety Program
(RCSP) individuals must complete site specific
training provided by the Radiation Safety Office
(RSOf). Also, the individual must complete
lab-specific training provided by the authorized
user(s). Site-specific training provided by the
RSOf consists of two courses called Basic and
Advanced. Experienced users of radioactive
material may pass out of the Basic course by
taking the Challenge Test After completing or
passing out of the Basic course, all
individuals must attend the Advanced course.
The Advanced course covers policies and
procedures under the RCSP. A schedule of courses
is available on the RSOf website at
www.uc.edu/radsafety
50
What other information is on the RSOf website?

• FAQ
• Manuals, QMP Policies
• Forms
• Newsletters
• Isotope Fact Sheets
• Isotope vendors
• Training schedule
• Chart of nuclides and decay calculator
• Request special survey or waste pickup

51
RSOf Staff
Radiation Safety Officer Victoria Morris, MS, CHP

• ADMINISTRATIVE STAFF
• Business ManagerCarolyn HurtProgram
  CoordinatorDebbie Kirkpatrick
• Administrative Secretary IRobin DavisRecords
  Management OfficerTammy McCall

TECHNICAL STAFF Assistant Radiation Safety
OfficerMike Burba, BSRadiation Safety
SpecialistsKevin Imes, MSKen Egan, BSEd Case,
BSJohn Zometsky, MSMichelle (Mickey) Croyle,
MSSenior Health Physics TechniciansDave Root,
BA Mark Powers, BSStaff Health Physics
TechniciansDick Henderer Dave KobzaJanine
Sumrall Bill HutzelAdam Hutzel

52
What is the 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

Director Dawn ONeill 513-558-6565
3223 Eden Avenue Wherry Hall G01 Cincinnati, Ohio
45267-0567 Mail Location 0567
53
What kinds of training are offered?
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

54
Why do I need information on drug licenses?

• Ohio law requires investigators to hold a DEA
  license for any and all drugs used in all basic
  research.
• For the Ohio State Board of Pharmacy
  application, there is a different fee associated
  with each Schedule of drug you are using. This
  fee should accompany your OSBP application to
  ColumbusInformation Regarding Fees and
  ExemptionFor the DEA application, there is a
  section that requests PERSON CERTIFYING
  EXEMPTION. Since UC is a state agency, the fee
  is waived for the DEA license. In this section,
  insert Fred Hamilton, Assoc General Counsel as
  this person. Insert his phone number as (513)
  558-7748 also.United States Drug Enforcement
  Agency Frequently Asked QuestionsDrug
  Enforcement Agency Ohio State Board of Pharmacy
  SlideshowOhio State Board of Pharmacy Rules
  Regarding LaboratoriesUsage and Inventory Log

55
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.
56
Thank You!