Office of Research Compliance
and Regulatory Affairs
*ORCRA*
What you need to know about
Research Compliance at UC
Decembe...
What is ORCRA?
The Office of Research Compliance and
Regulatory Affairs is responsible for:
• Human subject protection – I...
What is the Mission of
ORCRA?
The mission of ORCRA is one of service, to both the University of
Cincinnati and to the facu...
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 information
from...
What are the criteria for
human research?
What is the IRB?
Institutional Review Board
UC has 2 medical boards
And 1 social/behavioral board
The University of Cincin...
How do I submit a protocol for
IRB review?
http://researchcompliance.uc.edu/irb/default.html
IRB Procedures:
• The IRBs en...
IRB Protocol Review
IRB Workflow
IRB Office
Individual
Committee
Reviews
1 2
3
IRB Approval Meeting
4
6 1 New Protocols (1...
Do I need training?
• The Federal Government (DHHS 45 CFR 46) and The
University of Cincinnati require that you demonstrat...
How do I contact the IRB Office?
Location: G-08 Wherry Hall,
ML 0567
Telephone: (513) 558-5259
Fax: (513) 558-4111
Mailing...
IRB Office Staff Contacts
General InquiriesGeneral Inquiries: Susan Groh, 558-5259
(susan.groh@uc.edu)
Medical IRBs:Medica...
IRB Office Staff
What is post approval
monitoring?
The Human Subjects Research Post-Approval Monitoring
Program administers quality assuran...
What do we monitor?
• Education of investigators
• Investigator initiated studies
• Sponsor-investigator IND/IDE
• Informe...
What is the Process?
There are two processes:
1. Off-site review (self assessment)
• complete questionnaire
2. On-site rev...
Do I need training?
• While not mandatory, training in Good
Clinical Practices (GCP) is strongly
suggested.
• Recommendati...
Some Frequently Asked Questions
associated with monitoring:
Q:  Why does the University have a monitoring program?
A: The ...
Contact Information
Post Approval Monitoring Program
Daniel Woo, MD
Medical Director
Phone: 513.558.2705
Fax: 513. 558.547...
Post Approval Monitors
Animal Research:
Who do I call IACUC or LAMS?
IACUC
• Protocol Submissions
• Personnel Training
• Compliance Concerns
LAMS...
What is the IACUC?
Institutional Animal Care and Use Committee
Both federal Animal Welfare Act Regulations 
(AWARs) and th...
What are the regulatory charges
the IACUC?
• Review the institution’s program for animal care and use at least 
biannually...
Where do these regulatory
mandates come from?
PHS Office of Laboratory Animal Welfare (OLAW) is
charged with implementing ...
How do I submit an Animal Use
Protocol?
• Download the protocol template from the 
IACUC website 
http://researchcomplianc...
What is the IACUC Protocol
Review Process?
1) PI Submits Protocol Template to IACUC Office
Pre-Review: IACUC Office Staff ...
Do I need training?
Both OLAW and the USDA require proper training of all personnel who will work with vertebrate animals....
What are Laboratory Animal
Medicine Services?
The primary mission of Laboratory Animal Medical Services is to provide 
an ...
How do I order animals?
• REQUISITIONS-Animal SOP
Information for the Researcher:
• Complete the Animal Requisition Form t...
How can I report concerns of
animal misuse or abuse?
• IACUC Office 559-5187
• IACUC@ucmail.uc.edu
• Toll-Free Anonymous C...
Contact Information
IACUC Contacts:
Rob Anderson, Director IACUC
George Babcock, Chair IACUC
Kareemah Mills, Protocol Prog...
IACUC Office Staff
What is the Biosafety
Department?
The University of Cincinnati Biosafety
Department has two functional
components:
• The B...
What is the role of the
Biosafety Office?
The Biosafety Office is charged with ensuring compliance with
institutional requ...
What is the role of the IBC?
The Institutional Biosafety Committee is charged by the Senior
Vice President and Provost for...
What agents does the
IBC regulate?
The IBC reviews all research protocols
involving:
• Recombinant DNA (rDNA)
• Agents inf...
What are risk groups?
Basis for the Classification of Biohazardous Agents by
Risk Group (RG)
Risk Group 1 (RG1) Agents tha...
What is meant by containment
level?
Relationship of Risk Groups to Biosafety Levels
Risk Group Biosafety
Level
Laboratory ...
What are select agents?
On June 12, 2002 President Bush signed the
"Public Health Security and Bioterrorism Preparedness a...
What do I need to do to work
with select agents?
To begin the process for approval:
• Contact the BSO.
• Submit to a secur...
Why do I need IBC approval?
The NIH and the University of Cincinnati require research involving biohazards to be
reviewed ...
Biosafety Office Staff
E-mail: inbiocom@ucmail.uc.edu
Gary E. Dean, PhD
Biological Safety Officer
513-558-0065
Erin L. Dun...
IBC Office Staff
Radiation Safety
The mission of the University of Cincinnati Radiation Safety Office is
to provide the means necessary for...
What is meant by
Radiation Safety?
The Radiation Control and Safety Program
(RCSP) is overseen by:
• The Radiation Safety ...
What are the duties of the
Radiation Safety Committee?
• The RSC is a committee of the Office of the President.
• The RSC ...
What are the duties of the
Radiation Safety Officer?
• The RSO is responsible for implementing the RCSP
and ensuring for U...
Do I need Training in
Radiation Safety?
RAM Radiation Worker Training Schedule
(for individuals who may handle radioactive...
Frequently Asked Questions
I took radiation safety training at another institution. Do I have to take training at the
Univ...
What other information is
on the RSOf website?
• FAQ
• Manuals, QMP & Policies
• Forms
• Newsletters
• Isotope Fact Sheets...
RSOf Staff
ADMINISTRATIVE STAFF
Business Manager
Carolyn Hurt
Program Coordinator
Debbie Kirkpatrick
Administrative Secret...
What is the Office of Research
Compliance Training?
The office of Research Compliance Training is responsible for
developi...
What kinds of training
are offered?
Educational Programs
• Hot Topics Schedule
• Investigator 101
• IRB Seminar
• Orientat...
Why do I need information on
drug licenses?
Ohio law requires investigators to hold a DEA license for any
and all drugs us...
To Report Concerns:
Toll-free Anonymous Compliance Hotline 1-800-889-1547Anonymous Compliance Hotline 1-800-889-1547
Any c...
Thank You!
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Office of Research Compliance and Regulatory Affairs ORCRA

  1. 1. Office of Research Compliance and Regulatory Affairs *ORCRA* What you need to know about Research Compliance at UC December 1, 2006 Melissa Colbert, PhD Director, ORCRA Research Compliance Officer Research OrientationResearch Orientation
  2. 2. 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
  3. 3. What is the Mission of ORCRA? The mission of ORCRA is one of service, to both the University of Cincinnati and to the faculty and staff. Our main focus is to ensure the safety of research involving human and animal subjects, the safe use of hazardous biologicals and radioactivity and to maintain University compliance with all Federal, State and Local regulations. We are here to help and promise to work with you, to be proactive in ensuring that all researchers are appropriately following existing guidelines, and to do so in the least burdensome way possible. Research Compliance Officer: Melissa C. Colbert, PhD Director ORCRA 3223 Eden Avenue Room G-08, ML0567 Cincinnati, OH 45267-0567 513.558.5034 Melissa.colbert@uc.edu Research.compliance@uc/org
  4. 4. http://Researchcompliance.uc.edu Where do I go to find information about ORCRA?
  5. 5. What is Human Subjects Research? Human subjects research means any activity intended to obtain and record information from or about individuals for research purposes. Any undertaking in which students, faculty, or staff investigate and/or collect data on human subjects or use existing data or specimens collected from living human subjects for research purposes, requires review by the Institutional Review Board prior to initiation of the project. This includes both funded and non-funded research, including dissertations, masters theses, pilot studies, class projects, and non-funded, faculty-directed research if the following conditions are met: • the research is sponsored by the University, or • the research is conducted by or under the direction of any University employee or agent of this institution in connection with his/her institutional responsibilities, or • the research is conducted by or under the direction of any University employee or agent of this institution using any University property or facility, or • the research involves the use of the University's non-public information to identify or contact human research subjects or prospective subjects
  6. 6. What are the criteria for human research?
  7. 7. What is the IRB? Institutional Review Board UC has 2 medical boards And 1 social/behavioral board The University of Cincinnati has established three Institutional Review Board (“IRB”) panels to review all proposed research involving human subjects to ensure that the rights and welfare of participants in research are adequately protected. The University of Cincinnati IRB serves as the IRB of record for the University of Cincinnati, University Hospital, Inc., The Shriners’ Institute for Burned Children, The Cincinnati Veterans Affairs Medical Center, and The Drake Center. The IRBs are composed primarily of faculty members from disciplines in which research involving human subjects is integral to that discipline's work, as well as several members from the community whose primary interest is in non-scientific areas. The Board(s) membership, policies, and procedures are governed by an Assurance agreement with the Federal government.
  8. 8. How do I submit a protocol for IRB review? http://researchcompliance.uc.edu/irb/default.html IRB Procedures: • The IRBs encourage submmission as soon as the application is complete • Incomplete applications will be returned • If your study meets the Federal criteria for Expedited review, submissions go directly to the chair • If the study requires Full-Board review, the following scheme illustrates the process Schedules: Medical IRBs, every Wednesday Social/Behavioral, the third Thursday each month
  9. 9. IRB Protocol Review IRB Workflow IRB Office Individual Committee 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 Committee 3 Reviewers Comments 4 IRB Meeting Approval Process 5 IRB Office Processing 6 IRB Office Approval Notification 7 Adverse Events (7) 7 5
  10. 10. 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.
  11. 11. How do I contact the IRB Office? 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 Center PO Box 670567 Cincinnati, OH 45267-0567
  12. 12. 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)
  13. 13. IRB Office Staff
  14. 14. 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 ofThe program is also designed to improve the quality of research by detecting errors and/or omissions that mightresearch 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.
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. 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”).
  19. 19. Contact Information Post Approval Monitoring Program Daniel Woo, MD Medical Director Phone: 513.558.2705 Fax: 513. 558.5478 ML: MSB 0525 email: daniel.woo@uc.edu Joanne A. Lindwall, Director Phone: 513.558.3576 Fax: 513.558.4498 ML HPB 0661 email: joanne.lindwall@uc.edu Angela Braggs-Brown Phone:513.558.3005 Fax: 513.558.4498 ML HPB 0661 Email: broag@uc.edu
  20. 20. Post Approval Monitors
  21. 21. 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
  22. 22. 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. 
  23. 23. 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.
  24. 24. 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. 
  25. 25. How do I submit an Animal Use Protocol? • Download the protocol template from the  IACUC website  http://researchcompliance.uc.edu/iacuc/ProtocolSub missions.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
  26. 26. What is the IACUC Protocol Review Process? 1) PI Submits Protocol Template to IACUC Office Pre-Review: IACUC Office Staff + Veterinarian meet with the PI to Pre-Reviews the protocol prior to submission to the IACUC 2) IACUC Office routes protocol to IACUC & Safety Offices Designated Review: 2 Members + Veterinarian (no meeting approval required) Full Review: All members (meeting approval required) 3) Reviewers return comments to IACUC Office 4) IACUC Reviewer Comments Routed to PI 5) PI response to Reviewer comments routed to reviewing IACUC members 6) IACUC Full Review at Convened Meeting 7) Committee Decision Routed by IACUC Office 8) Protocol Approval Notification Designated Review Approval: 2 Members + Veterinarian may approve Full Review Approval: Requires majority vote at convened meeting for approval Safety Approval: IACUC approval is contingent upon safety approval IACUC Office IACUC Reviewers 1 2, 5 3 IACUC Approval Meeting (FULL REVIEW PROTOCOLS ONLY) 6 4, 8 7 Safety Review Principal Investigator (PI) IACUC Workflow
  27. 27. 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.
  28. 28. 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.
  29. 29. How do I order animals? • REQUISITIONS-Animal SOP Information 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 order Late 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
  30. 30. 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
  31. 31. 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 Care Mike Metze, Assoc. Director – Husbandry Vicki Shaw, Business Administrator Phone: 558-5171
  32. 32. IACUC Office Staff
  33. 33. What is the Biosafety Department? The University of Cincinnati Biosafety Department has two functional components: • The Biosafety Office • The Institutional Biosafety Committee (IBC). They work closely to ensure the safety and health of research staff and compliance with applicable laws.
  34. 34. What is the role of the Biosafety Office? The Biosafety Office is charged with ensuring compliance with institutional requirements and federal, state and local regulations pertaining to the possession, use, transfer and disposal of biohazardous agents. The Biosafety Officer (BSO) is responsible for performing risk assessments to identify hazards and to guide Principal Investigators and staff in implementing practices and procedures that will minimize or eliminate risks associated with research involving biohazardous materials. Biosafety Office:Biosafety Office: 3255 Eden Ave3255 Eden Ave HPB G34HPB G34 MLC0767MLC0767 558-5210
  35. 35. What is the role of the IBC? The Institutional Biosafety Committee is charged by the Senior Vice President and Provost for Health Affairs to review and approve all University research activities involving the use of biohazardous agents and recombinant DNA molecules, as described in the National Institutes for Health “Guidelines for Research Involving the Use of Recombinant DNA Molecules” (NIH Guidelines) and the current edition of the Centers for Disease Control and Prevention’s “Biohazards in Microbiological and Biomedical Laboratories” (the “BMBL” or CDC Guidelines). Daniel B. Oerther, PhD IBC Chairman 513-556-3670
  36. 36. What agents does the IBC regulate? The IBC reviews all research protocols involving: • Recombinant DNA (rDNA) • Agents infectious to humans, animals or plants • Other genetically altered organisms & agents • Select agents & toxins To use any of these agents, you must complete a biosafety protocol and have it reviewed and approved by the IBC. In order to begin the process, contact Erin Dunn in the Biosafety Office for password approval
  37. 37. What are risk groups? Basis for the Classification of Biohazardous Agents by Risk Group (RG) Risk Group 1 (RG1) Agents that are not associated with disease in healthy adult humans Risk Group 2 (RG2) Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)
  38. 38. 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 with RG4 agents Is not allowed At UC
  39. 39. What are select agents? On June 12, 2002 President Bush signed the "Public Health Security and Bioterrorism Preparedness and Response Ac (Public Law 107-188). The Law's purpose is to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. The Law requires that all persons possessing select biological agents or toxins deemed a threat to public health, animal or plant health, or animal or plant products register with the appropriate federal agency. On March 18, 2005, final rules were published in the Federal Register by the Departments of Health and Human Services (HHS) and Agriculture (USDA) governing facilities that possess, use or transfer select biological agents or toxins. These rules became effective on April 18, 2005.
  40. 40. What do I need to do to work with select agents? To begin the process for approval: • Contact the BSO. • Submit to a security risk assessment (SRA) by the United States Department of Justice, Federal Bureau of Investigations, Criminal Justice Information Services. • The individual PI and laboratory personnel must: • Have fingerprints taken and submitted to the FBI, CJIS by an authorized officer in the University of Cincinnati Department of Public Safety • Complete sections II and III of form FD-961 • Be added to the University of Cincinnati entity registration. Please note the following: • Individuals may not self register. • Approval of individual registrations may take from 3-6 months. • Approval for the possession, use and transfer of select agents cannot be transferred from one entity to another
  41. 41. Why do I need IBC approval? The NIH and the University of Cincinnati require research involving biohazards to be reviewed and approval by the Institutional Biosafety Committee (IBC). Section IV-B-2-b-(1-6) The institution shall establish an Institutional Biosafety Committee, whose responsibilities need not be restricted to recombinant DNA and is responsible for reviewing recombinant DNA research ..in compliance with the NIH Guidelines. The unapproved use of biohazardous agents is in violations of NIH Guidelines and places not only individual funding, but all research funding at UC in jeopardy. Section I-D-1. All NIH-funded projects involving recombinant DNA techniques must comply with the NIH Guidelines. Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and the NIH funds for other recombinant DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution”
  42. 42. Biosafety Office Staff E-mail: inbiocom@ucmail.uc.edu Gary E. Dean, PhD Biological Safety Officer 513-558-0065 Erin L. Dunn Biological Safety Specialist & IBC Administrator 513-558-5210 Neal D. Wolfe, MS BL3 Facility Director 513-558-3486
  43. 43. IBC Office Staff
  44. 44. Radiation Safety The mission of the University of Cincinnati Radiation Safety Office is to provide the means necessary for personnel to protect themselves, their coworkers, the general public, and the environment from detrimental effects of radioactive materials and radiation producing devices used under the University's Radiation Control and Safety Program. Its mission is also to provide day-to- day oversite and services to meet the goals of the Radiation Control and Safety Program 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 Cincinnati Radiation Safety Office 170 Panceza Way PO Box 670591 Cincinnati, OH 45267-0591 Phone: 558-4110 Fax: 558-9905
  45. 45. What is meant by Radiation Safety? The Radiation Control and Safety Program (RCSP) is overseen by: • The Radiation Safety Committee (RSC) • The Radiation Safety Officer (RSO) The RSC and RSO work in tandem to ensure the health and safety of personnel, along with ensuring compliance with applicable rules, regulations and license conditions.
  46. 46. What are the duties of the Radiation Safety Committee? • The RSC is a committee of the Office of the President. • The RSC is responsible for generating, defining, implementing and monitoring a RCSP that complies with rules, regulations and license conditions. • The RSC grants and withdraws authorized user (AU) status and restricts radiation source usage as needed for safety and compliance.
  47. 47. What are the duties of the Radiation Safety Officer? • The RSO is responsible for implementing the RCSP and ensuring for UC that radiation safety activities are in accordance with rules, regulations and license conditions. • The RSO, with the assistance of Radiation Safety Office (RSOf) staff, is responsible for managing the day-to-day operations of the RCSP.
  48. 48. Do I need Training in Radiation Safety? RAM Radiation Worker Training Schedule (for individuals who may handle radioactive materials in a research or clinical setting) Basic Advanced Retraining By Month for 2005/2006 Contact Radiation Safety at 558-4110 to schedule a training session.
  49. 49. Frequently Asked Questions I took radiation safety training at another institution. Do I have to take training at the University of Cincinnati before I can begin to use radioactive materials (RAM)? Yes. Even if you attended training or have experience using radioactive materials (RAM) at another institution you are still required to attend site-specific training at the University of Cincinnati before you may handle radioactive materials under the University of Cincinnati Radiation Control and Safety Program (RCSP). What training must I complete before handling radioactive materials? Before handling radioactive material under the University of Cincinnati Radiation Control and Safety Program (RCSP) individuals must complete site specific training provided by the Radiation Safety Office (RSOf). Also, the individual must complete lab-specific training provided by the authorized user(s). Site-specific training provided by the RSOf consists of two courses called “Basic” and “Advanced”. Experienced users of radioactive material may pass out of the “Basic” course by taking the “Challenge Test” After completing or passing out of the “Basic” course, all individuals must attend the “Advanced” course. The “Advanced” course covers policies and procedures under the RCSP. A schedule of courses is available on the RSOf website at www.uc.edu/radsafety
  50. 50. What other information is on the RSOf website? • FAQ • Manuals, QMP & Policies • Forms • Newsletters • Isotope Fact Sheets • Isotope vendors • Training schedule • Chart of nuclides and decay calculator • Request special survey or waste pickup
  51. 51. RSOf Staff ADMINISTRATIVE STAFF Business Manager Carolyn Hurt Program Coordinator Debbie Kirkpatrick Administrative Secretary I Robin Davis Records Management Officer Tammy McCall Radiation Safety Officer Victoria Morris, MS, CHP TECHNICAL STAFF Assistant Radiation Safety Officer Mike Burba, BS Radiation Safety Specialists Kevin Imes, MS Ken Egan, BS Ed Case, BS John Zometsky, MS Michelle (Mickey) Croyle, MS Senior Health Physics Technicians Dave Root, BA Mark Powers, BS Staff Health Physics Technicians Dick Henderer Dave Kobza Janine Sumrall Bill Hutzel Adam Hutzel
  52. 52. What is the Office of Research Compliance Training? The office of Research Compliance Training is responsible for developing and delivering workshops and training classes, as well as designing computer-based training courses on research regulatory compliance issues. In addition to delivering training that meets the needs of the research investigators, courses are developed in response to changing regulatory and accreditation requirements, e.g., HIPAA. Many programs are eligible for continuing education credits 3223 Eden Avenue Wherry Hall G01 Cincinnati, Ohio 45267-0567 Mail Location: 0567 Director: Dawn O’Neill 513-558-6565
  53. 53. 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 C o u n c e m e n t s • New Policy : Demonstrating Knowledge of Human Research Protection by Researchers, December 2005 • T r a i n i n g I n s t r u c t i o n s F A Q s • Frequently asked questions O f f i cC o u n c e m e n t s • New Policy : Demonstrating Knowledge of Human Research Protection by Researchers, December 2005 • T r a i n i n g I n s t r u c t i o n s F A Q s • Frequently asked questions O f f i c 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.
  54. 54. Why do I need information on drug licenses? Ohio law requires investigators to hold a DEA license for any and all drugs used in all basic research. For the Ohio State Board of Pharmacy application, there is a different fee associated with each “Schedule” of drug you are using. This fee should accompany your OSBP application to 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
  55. 55. To Report Concerns: Toll-free Anonymous Compliance Hotline 1-800-889-1547Anonymous 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 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.
  56. 56. Thank You!

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