Office of Research Compliance and Regulatory Affairs
*ORCRA*
What you need to know about Research Compliance at UC
December 1, 2006Melissa Colbert, PhD
Director, ORCRAResearch Compliance Officer
Research OrientationResearch Orientation
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
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, PhDDirector ORCRA 3223 Eden Avenue
Room G-08, ML0567Cincinnati, OH [email protected]@uc/org
http://Researchcompliance.uc.edu
Where do I go to find information about ORCRA?
What is Human Subjects Research?
Human subjects research means any activity intended to obtain and record informationfrom 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 orspecimens collected from living human subjects for research purposes, requires review bythe Institutional Review Board prior to initiation of the project. This includes both fundedand non-funded research, including dissertations, masters theses, pilot studies, classprojects, 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 oragent of this institution in connection with his/her institutional responsibilities, or• the research is conducted by or under the direction of any University employee oragent of this institution using any University property or facility, or• the research involves the use of the University's non-public information toidentify or contact human research subjects or prospective subjects
What are the criteria for human research?
What is the IRB?
Institutional Review BoardUC has 2 medical boardsAnd 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.
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 WednesdaySocial/Behavioral, the third Thursday each month
IRB Protocol Review
IRB Workflow
IRB Office
IndividualCommittee
Reviews
1 2
3
IRB Approval Meeting
4
6 1 New Protocols (1-6) Modifications (1-6) Progress Reports (1, 4-5-6)2 Route to Review Committee3 Reviewers Comments4 IRB Meeting Approval Process5 IRB Office Processing6 IRB Office Approval Notification7 Adverse Events (7)
7
5
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 Subject’s 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.
How do I contact the IRB Office?
Location: G-08 Wherry Hall, ML 0567Telephone: (513) 558-5259Fax: (513) 558-4111
Mailing Address: Institutional Review Board Office G-08 Wherry Hall, ML 0567 University of Cincinnati Medical Center PO Box 670567 Cincinnati, OH 45267-0567
IRB Office Staff Contacts
General InquiriesGeneral Inquiries: Susan Groh, 558-5259 ([email protected]) Medical IRBs:Medical IRBs:New Protocols & Pre-approval, Katie Krier: 558-5136 (
[email protected]) Progress Reports: Lela Hinds-Peterson, 558-0479 (
[email protected])Modifications: Martina Harmon, 558-1881 (
[email protected])Adverse Event Reports: Denise Washington, 558-7324 (
[email protected]) Social-Behavioral IRB:Social-Behavioral IRB: Claudia Norman, 558-5784 ([email protected])Carolyn West, 558-7580 ([email protected])
IRB Office Staff
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 The program is also designed to improve the quality of research by detecting errors and/or omissions that might research by detecting errors and/or omissions that might occur when performing research activities.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.
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
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
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
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”).
Contact Information
Post Approval Monitoring ProgramDaniel Woo, MDMedical DirectorPhone: 513.558.2705 Fax: 513. 558.5478 ML: MSB 0525email: [email protected]
Joanne A. Lindwall, DirectorPhone: 513.558.3576 Fax: 513.558.4498 ML HPB 0661email: [email protected]
Angela Braggs-BrownPhone:513.558.3005Fax: 513.558.4498 ML HPB 0661Email: [email protected]
Post Approval Monitors
Animal Research:Who do I call IACUC or LAMS?
IACUC• Protocol Submissions• Personnel Training• Compliance Concerns
LAMS• Animal Ordering• Housing Space Needs• Veterinary Health Issues
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.
What are the regulatory charges the IACUC?
• Review the institution’s program for animal care and use at least biannually
• Inspect all the institution’s 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 Cincinnati’s Animal Welfare Assurance.
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.
How do I submit an Animal Use Protocol?
• Download the protocol template from the IACUC website http://researchcompliance.uc.edu/iacuc/ProtocolSubmissions.html
• Review hints and tips on the download page• If questions arise while completing the
template, please call • Rob Anderson at 558-5187Rob Anderson at 558-5187
• Email a draft to [email protected]• Schedule a Preliminary Review Meeting
What is the IACUC Protocol Review Process?
1) PI Submits Protocol Template to IACUC OfficePre-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 OfficesDesignated 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 NotificationDesignated Review Approval: 2 Members + Veterinarian may approveFull Review Approval: Requires majority vote at convened meeting for approvalSafety Approval: IACUC approval is contingent upon safety approval
IACUC Office IACUC Reviewers
1 2, 5
3
IACUC Approval Meeting(FULL REVIEW PROTOCOLS ONLY)
64, 8
7Safety Review
Principal Investigator (PI)
IACUC Workflow
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 Shriner’s 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 University’s 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.
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.
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.html#areq
How can I report concerns of animal misuse or abuse?
• IACUC Office 559-5187
• Toll-Free Anonymous Compliance Hotline 1-800-889-1547
• LAMS Veterinary Staff 558-5171
Contact Information
IACUC Contacts:Rob Anderson, Director IACUCGeorge Babcock, Chair IACUCKareemah Mills, Protocol Program ManagerDavid Custer, Training Program ManagerPhone: 558-5187
LAMS Contacts:Douglas Stone, DVM Director LAMSMark Kurtzman DVM, Assoc. Director – Veterinary CareMike Metze, Assoc. Director – HusbandryVicki Shaw, Business AdministratorPhone: 558-5171
IACUC Office Staff
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.
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:Biosafety Office:3255 Eden Ave3255 Eden Ave
HPB G34HPB G34MLC0767MLC0767558-5210
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 Prevention’s “Biohazards in Microbiological and Biomedical Laboratories” (the “BMBL” or CDC Guidelines).
Daniel B. Oerther, PhDIBC Chairman513-556-3670
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
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)
What is meant by containment level?
Relationship of Risk Groups to Biosafety Levels
Risk Group Biosafety Level
Laboratory Type Laboratory Practices
Safety Equipment
1 1 Basic Teaching, Research
GMT None; Open bench work
2 2 Primary health services,
diagnostic services, research
GMT plus personal
protective equipment,
biohazard sign
Open bench plus BSC for potential
aerosols
3 3 Special diagnostic services, research
BL2 plus special clothing,
controlled access, directional airflow
BSC and/or other primary
containment devices for all
activities
4 4 Dangerous pathogen units
BL3 plus airlock entry, shower
exit, special waste disposal
Class III BSC, positive pressure air suits, double ended autoclave,
filtered air
GMT – Good microbiological technique, BSC – Biological Safety Cabinet
Work withRG4 agentsIs not allowedAt UC
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.
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
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”
Biosafety Office Staff
E-mail: [email protected]
Gary E. Dean, PhDBiological Safety Officer
513-558-0065
Erin L. DunnBiological Safety Specialist &
IBC Administrator513-558-5210
Neal D. Wolfe, MSBL3 Facility Director
513-558-3486
IBC Office Staff
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
For emergencies outside normal working hours (7:30 am - 5:00 pm)Contact the on-call technician by digital pager at 249-6812
Mailing address: University of CincinnatiRadiation Safety Office170 Panceza WayPO Box 670591Cincinnati, OH 45267-0591Phone: 558-4110Fax: 558-9905
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.
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.
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.
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)Basic
Advanced Retraining
By Month for 2005/2006
Contact Radiation Safety at 558-4110 to schedule a training session.
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
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
RSOf Staff
ADMINISTRATIVE STAFF
Business ManagerCarolyn Hurt
Program CoordinatorDebbie Kirkpatrick
Administrative Secretary IRobin Davis
Records Management OfficerTammy McCall
Radiation Safety OfficerVictoria Morris, MS, CHP
TECHNICAL STAFF
Assistant Radiation Safety OfficerMike Burba, BS
Radiation Safety SpecialistsKevin Imes, MSKen Egan, BSEd Case, BS
John Zometsky, MSMichelle (Mickey) Croyle, MS
Senior Health Physics TechniciansDave Root, BA Mark Powers, BSStaff Health Physics Technicians
Dick Henderer Dave KobzaJanine Sumrall Bill Hutzel
Adam Hutzel
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
3223 Eden AvenueWherry Hall G01
Cincinnati, Ohio 45267-0567Mail Location: 0567
Director: Dawn O’Neill513-558-6565
What kinds of training are offered?
Educational Programs • Hot Topics Schedule • Investigator 101 • IRB Seminar • Orientation Program • Research Education Advisory
Committee Membership List
News and Announcements • New Policy : Demonstrating Knowledge
of Human Research Protection by Researchers, December 2005
Training Instructions
• FAQs • Frequently asked questions
This site is your gateway to online compliance training, online competency testing, non-online educational programs and compliance training-related news.
Compliance Training
• CITI Human Research Protection Online
(Meets UC's HRP training requirement)
• T
raining HRP Instructions
• C
ontinuous Professional Development(CPD)online compliance training
• B
lood Borne Pathogens
• B
iosafety
• H
IPAA
• H
uman Research
• R
adiation Safety
• T
ranscript
• U
C Physicians
• GCP Training
• S
elf-Paced Training
Educational Programs
• Hot Topics Schedule
• I
nvestigator 101
• I
RB Seminar
• O
rientation Program
• R
esearch Education Advisory
Committee Membership List
News and Announcements
• New Policy : Demonstrating Knowledge
of Human Research Protection
by Researchers, December 2005
• T
raining Instructions
FAQs
• Frequently asked questions
Office of Research Compliance Training
• Contact Information
Competency Testing
• Continuous Professional Development(CPD)online compliance training
• B
iomedical Research HRP
Knowledge Exam
• I
RB - M HRP Knowledge Exam
• I
RB - S HRP Knowledge Exam
• S
ocial and Behavioral HRP
Knowledge Exam
• T
ranscript
This site is your gateway to online compliance training, online competency testing, non-online educational programs and compliance training-related news.
Compliance Training
• CITI Human Research Protection Online
(Meets UC's HRP training requirement)
• T
raining HRP Instructions
• C
ontinuous Professional Development(CPD)online compliance training
• B
lood Borne Pathogens
• B
iosafety
• H
IPAA
• H
uman Research
• R
adiation Safety
• T
ranscript
• U
C Physicians
• GCP Training
• S
elf-Paced Training
Educational Programs
• Hot Topics Schedule
• I
nvestigator 101
• I
RB Seminar
• O
rientation Program
• R
esearch Education Advisory
Committee Membership List
News and Announcements
• New Policy : Demonstrating Knowledge
of Human Research Protection
by Researchers, December 2005
• T
raining Instructions
FAQs
• Frequently asked questions
Office of Research Compliance Training
• Contact Information
C
ompetency Testing
• Continuous Professional Development(CPD)online compliance training
• B
iomedical Research HRP
Knowledge Exam
• I
RB - M HRP Knowledge Exam
• I
RB - S HRP Knowledge Exam
• S
ocial and Behavioral HRP
Knowledge Exam
• T
ranscript
Compliance Training • CITI Human Research Protection Online
(Meets UC's HRP training requirement) • Training HRP Instructions • Continuous Professional Development
online 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 • Social and Behavioral HRP
Knowledge Exam • Transcript
This site is your gateway to online compliance training, online competency testing, non-online educational programs and compliance training-related news.
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 Columbus
Information Regarding Fees and Exemption:
For 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 Questions
Drug Enforcement Agency Ohio State Board of Pharmacy Slideshow
Ohio State Board of Pharmacy Rules Regarding Laboratories
Usage and Inventory Log
To Report Concerns:
Toll-free Anonymous Compliance Hotline 1-800-889-1547Anonymous Compliance Hotline 1-800-889-1547Any 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 University’s 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 caller’s 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.
Thank You!
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