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 45267-0567513.558.5034Melissa.colbert@uc.eduResearch.compliance@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 (susan.groh@uc.edu)  Medical IRBs:Medical IRBs:New Protocols & Pre-approval, Katie Krier: 558-5136 (

Katie.Krier@uc.edu) Progress Reports: Lela Hinds-Peterson, 558-0479 (

Lela.Hinds-Peterson@uc.edu)Modifications: Martina Harmon, 558-1881 (

Martina.Harmon@uc.edu)Adverse Event Reports: Denise Washington, 558-7324 (

Denise.Washington@uc.edu)  Social-Behavioral IRB:Social-Behavioral IRB: Claudia Norman, 558-5784 (Claudia.Norman@uc.edu)Carolyn West, 558-7580 (Carolyn.West@uc.edu)

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: daniel.woo@uc.edu

Joanne A. Lindwall, DirectorPhone: 513.558.3576 Fax: 513.558.4498 ML HPB 0661email: joanne.lindwall@uc.edu

Angela Braggs-BrownPhone:513.558.3005Fax: 513.558.4498 ML HPB 0661Email: broag@uc.edu

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 Rob.Anderson@uc.edu• 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

• IACUC@ucmail.uc.edu

• 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: inbiocom@ucmail.uc.edu

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!