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Office of Research Compliance and Regulatory Affairs ORCRA


... Compliance at UC. December 7/14, 2007. Melissa Colbert, PhD ... Melissa Colbert, PhD. Director, Office of Research Compliance and Regulatory Affairs (ORCRA) ... – PowerPoint PPT presentation

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Title: Office of Research Compliance and Regulatory Affairs ORCRA

Office of Research Compliance and Regulatory
Research Orientation
  • What you need to know about Research Compliance
    at UC
  • December 7/14, 2007
  • Melissa Colbert, PhD
  • Director, ORCRA
  • Research Compliance Officer

Mission Statement
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-013,
ML0567 Cincinnati, OH 45267-0567 513.558.503
4 Research.compliance
What is ORCRA?
  • The Office of Research Compliance and Regulatory
    Affairs covers
  • Human subject protection IRB
  • Post IRB approval monitoring
  • Animal welfare protection IACUC
  • Biohazard use IBC IBCOf
  • Radiation safety RSOf RSC
  • FDA Assistance

ORCRAs Website
ORCRA Newsletter
  • October 2007
  • We appreciate the enthusiastic response we
    received after the first Compliance Matters hit
    inboxes. The second issue of Compliance Matters
    is coming to you with an added section under IRB
    News. Our recent accreditation by the Association
    for the Accreditation of Human Research
    Protection Programs (AAHRPP) reminded us of the
    importance of communicating updates to policies
    and procedures to the entire research community.
    Each issue wiII include a listing of any updates
    weve made, along with links to the full policy
    and procedure revisions.
  • Read on to learn more about exciting new
    initiatives and educational opportunities, and
    dont hesitate to let us know if were missing
    anything. You can contact us at For archived editions
    of Compliance Matters, additional information on
    ORCRA or to download related documents, visit
  • Melissa Colbert, PhD
  • Director, Office of Research Compliance and
    Regulatory Affairs (ORCRA)
  • Research Compliance Officer
  • Spotlight on The Transgenic Database
  • ORCRA News
  • IACUC News
  • IBC News
  • IRB News/New or Updated HRP Policies and
  • Quality Improvement Tips for Investigators
  • Radiation Safety News
  • Research Compliance Events and Training

IRB Reviews Approves 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
  • 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

Human Subject Research is Federally Regulated
  • DHHS Office of Human Research Protection(45 CFR
  • FDA (21 CFR 50 Human Subjects 21 CFR 56 IRBs)
  • Association for Accreditation of Human Research
    Protection Programs, AAHRPP

UC is Fully Accredited
  • UCs IRB has been accredited by AAHRPP
  • There are established policies and procedures
    governing all aspects of research involving human
  • These are available on http//researchcompliance.u

Documentation of Training is Required
  • 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
  • Additional individualized or group training to
    help with IRB submission is available through

Sponsored by the Office of Research Contact Dawn
ONeill for arrangements 558-6565
Forms for IRB Review are Available on the ORCRA
  • http//
  • Determining Human Research Activities
  • Policy
  • Form 
  • Medical Submission Packet
  • Social/Behavioral Submission Packet
  • IRB is moving toward electronic submission.
    eMODs will be the first piece and will be rolled
    out through Researchers Gateway in Jan 2008!

IRB Office Contact Information
  • Location G-08 Wherry Hall,
  • ML 0567
  • Telephone (513) 558-5259
  • Fax (513) 558-4111
  • Mailing Address   
  • Institutional Review Board Office                 
  • G-08 Wherry Hall, ML 0567                         
  • University of Cincinnati Medical
  • PO Box 670567                             
  • Cincinnati, OH 45267-0567

IRB Office Staff Contacts
ORCRA Provides 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 provides the investigators an opportunity
    to ask questions and receive information about
    regulations and issues regarding the protection
    of human subjects.

Criteria for Study Selection
  • All studies, including exempt research, are
    subject to quality monitoring
  • Emphasis on
  • Moderate to High Risk
  • Investigator initiated studies
  • Sponsor-investigator IND/IDE
  • Studies involving vulnerable populations
  • Potential conflict of interest
  • Those without external monitoring

Monitoring 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

No Formal Training is Required, But.
  • While not mandatory, training in Good Clinical
    Practices (GCP) is strongly suggested.
  • Templates for SOPs for GCP are available at the
    FDA Assistance site of research compliance.

Contact Information
  • Post Approval Monitoring Program
  • Daniel Woo, MD
  • Medical Director
  • Phone 513.558.2705
  • Fax 513. 558.5478 ML MSB 0525
  • email
  • Joanne A. Lindwall, Director
  • Phone 513.558.3576
  • Fax 513.558.4498 ML HPB 0661
  • email
  • Angela Braggs-Brown
  • Phone513.558.3005
  • Fax 513.558.4498 ML HPB 0661
  • Email

Animal ResearchIACUC LAMS
  • Protocol Prep Review
  • Personnel Training
  • Compliance Monitoring
  • Laboratory Animal Medicine Services
  • Animal Ordering
  • Housing Space Needs
  • Veterinary Health Issues

  • 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.

Regulatory Bodies for Animal Research
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.
IACUC Responsibilities
  • Review the institutions program for animal care
    and use at least biannually
  • Inspect all the institutions animal facilities,
    including animal study areas and satellite
  • 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

To submit an Animal Use Protocol
  • Download the protocol template from the IACUC
    website http//
  • 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
  • Schedule a Preliminary Review Meeting

Training is Mandated
  • 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
  • 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
  • Reduction, Replacement, Refinement
  • 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.

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.
To report concerns of animal misuse or abuse
  • IACUC Office 559-5187
  • Toll-Free Anonymous Compliance Hotline
  • LAMS Veterinary Staff 558-5171

Contact Information
  • IACUC Contacts
  • Rob Anderson, Director IACUC
  • George Babcock, Chair IACUC
  • Kareemah Mills, Protocol Program Manager
  • David Custer, Training Program Manager
  • Phone 558-5187
  • LAMS Contacts
  • Douglas Stone, DVM Director LAMS
  • Mark Kurtzman DVM, Assoc. Director Veterinary
  • Dale Goss, Assoc. Director Husbandry
  • Vicki Shaw, Business Administrator
  • Phone 558-5171

Biological Safety
  • 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.

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
Institutional Biosafety Committee
  • The IBC 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
  • Gary Dean, PhD
  • IBC Chairman
  • 513-556-3670

IBC Oversight
  • The IBC reviews all research protocols
  • 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

Federal Regulations on Use of Biohazards
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
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
Use of Select Agents Toxins
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.
Biosafety Office Staff
Gary E. Dean, PhD Biological Safety
Officer 513-558-0065
Erin L. Dunn Biological Safety Specialist IBC
Administrator 513-558-5210
Rob Anderson Managing Director 513- 558-5187
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 558-4110 Fax 558-9905
  • Radiation Safety Committee
  • The RSC is a committee of the Office of the
  • 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.
  • 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.

Radiation Safety Training
RAM Radiation Worker Training Schedule(for
individuals who may handle radioactive materials
in a research or clinical setting) BasicAdvanced
RetrainingBy Month for 2007/2008 Contact
Radiation Safety at 558-4110 to schedule a
training session.
Radiation Safety 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

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

ORCRA will Assist with FDA Regulated Studies
Why ORCRA Review?
  • Between September of 2006 and January of 2007,
    the University of Cincinnati received 3 warning
    letters from the FDA regarding objectionable
    conditions and non-compliance with Federal
    Regulations 21 CFR 812.
  • A root cause of these difficulties was and is a
    lack of attention to and education of our
    investigators who hold INDs and IDEs
  • As part of the Corrective Action Plan required by
    the FDA, ORCRA is undertaking pre-review of ALL
    protocols submitted to the IRB that involve an
    IND or IDE held by sponsor-investigators

Review Policy
  • It is the policy of the University of Cincinnati
    that SponsorInvestigator studies be reviewed and
    approved in accordance with Federal Regulations.
    In order for an investigational drug, agent,
    biologic or device to be used in clinical
    research, an Investigational New Drug (IND) or
    Investigational Device Exemption (IDE) must be on
    file with the FDA and an IND/IDE number granted
    when required by Federal Regulations.
  • All University of Cincinnati faculty members who
    sponsor (takes responsibility for and initiates a
    clinical investigation) an IND/IDE must be
    qualified to do so and have a knowledge of all
    applicable federal, state, and local regulations
    prior to submitting the IND/IDE to the FDA. As
    mandated by 21 CFR 312.50 (IND) and by 21 CFR
    812 (IDE), sponsors are responsible for selecting
    qualified investigators (when applicable)
  • Ongoing educational support and oversight will be
    performed at the discretion and direction of
    Office of Research Compliance and Regulatory
    Affairs (ORCRA) and the Institutional Review
    Board (IRB).

Review Process
  • The following items must be submitted for review
    and evaluation by the Research Compliance Officer
    (RCO) or FDA Regulatory Specialist out of ORCRA
  • Study Protocol (FDA application) to include a
    description of statistical analysis, benefit
    analysis, risk analysis and all study procedures.
  • The initial submission packet to the FDA
    including Forms 1571 and 1572.
  • FDA letter of IND Exemption, no rejection, or
    Clinical Hold release.
  • The investigative site's SOPs for documenting and
    reporting anticipated and unanticipated adverse
    events and/or IND Safety reports to the IRB and
    sponsor and the Sponsor's SOPs for reporting to
    the FDA as required.
  • Clinical monitoring procedures, including name,
    address and qualifications of monitors. This
    function may be outsourced to a qualified
    individual or CRO.
  • Documents should be submitted to ORCRA, ML 0567,
  • Electronic documents should be sent to

  • If, in the opinion of the RCO or FDA Regulatory
    Specialist a faculty member requires additional
    training to fulfill their obligations of sponsor
    and/or investigator, supplemental educational
    materials or specialized consultation services
    will be provided to help the sponsor-investigators
    fulfill their obligations. The RCO or FDA
    Regulatory Specialist must be satisfied as to the
    qualifications of the faculty member to serve as
  • Once ORCRA has reviewed the documents a letter
    is sent to the IRB office staff requesting that
    the protocol submission be processed according to
    IRB procedures. A copy of this letter is kept in
    the IRB protocol file as well as the ORCRA file.
  • If the investigator has no arrangements for
    study monitoring, the RCO may release the
    protocol for processing and IRB review. The IRB
    will be advised that adequate resources for the
    study are currently unavailable and request that
    release of final IRB approval be held by the IRB
    office until such time as the PI has provided
    sufficient documentation that monitoring has been

Required by the IRB Office
  • The IRB Office staff will confirm that all
    required documents have
  • been submitted by the Investigator as required
    for new protocol
  • submission and ensure they are valid
  • Sponsor Statement FDA form 1571 if investigator
  • Investigator Statement FDA form1572 and/or
  • Any supplemental information regarding the
    investigational drug, agent, or biologic supplied
    by the Sponsor (i.e., Investigator Brochure).
  • Documentation from the Sponsor or FDA that the
    IND or IDE number is valid (i.e., sponsor
    protocol or letter verifying the number). 
  • For Sponsor-Investigator studies, a letter from
    the FDA is required.  (The Investigators
    brochure is NOT an acceptable mechanism for

ORCRAs Website has Links to Useful Documents
  • IRB Policies Procedures
  • A set of SOPs for GCP and Data Monitoring
  • Information on FDA Reporting
  • Some FAQs regarding DSMB
  • Links to FDA websites and other assistance

Additional Materials
Links to Compliance Training
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
  • News and Announcements     
  • New Policy Demonstrating Knowledge of Human
    Research Protection by Researchers, December
  • 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
  • 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

Information on Drug Licenses
  • Ohio law requires investigators to hold a DEA
    license for any and all drugs used in all basic
  • 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

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.