Research support offices an overview
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Research Support Offices An Overview. New Faculty Orientation September 21, 2010. Wesley G. Byerly, Pharm.D. Associate Dean for Research Support Services. Animal Research.

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Research support offices an overview

Research Support OfficesAn Overview

New Faculty Orientation

September 21, 2010

Wesley G. Byerly, Pharm.D.

Associate Dean for Research Support Services


Animal research

Animal Research

  • You need to use live, vertebrate animals in RESEARCH, TEACHING, or TESTING (even if conducted at another institution) regardless of funding source

  • You are the PI of a grant or contract where Duke is the prime awardee and animal research will be conducted at another institution (subcontract) as part of the grant


Animal research what do you need to do

Animal Research – What Do You Need to Do

  • Prepare an animal use application

    • Offices involved: OAWA; IACUC

  • Assure the health and safety issues are addressed

    • Complete necessary approvals by the Occupational Health and Safety Program

    • Complete the on-line form "Health Review for Animal Handlers"

    • Offices involved: OESO; OAWA

  • Obtain hazards materials use approvals

    • Offices involved: OESO; IBC; Radiation Safety


Animal research what do you need to do1

Animal Research – What Do You Need to Do

  • Complete the necessary training requirements

    • On-line training managed through the Occupational and Environmental Safety Office (OESO) web site

    • Offices involved: OESO; OAWA

  • Discuss your animal need and secure housing space

    • Offices involved: DLAR

  • Apply for and secure facility access to the designated animal facility

    • Offices involved: DLAR

  • Order for animals

    • Animals are available for use after an appropriate acclimatization period

    • Offices involved: DLAR


Office of animal welfare assurance oawa

Office of Animal Welfare Assurance (OAWA)

  • Serves a central and supporting role for the institution's animal facilitated research program. 

    • Website: http://vetmed.duhs.duke.edu

    • Phone: 919-668-6720

    • Location: 6th floor, Hock Building

    • Director: Ron Banks, DVM

  • Major Functions

    • Administrative support for the IACUC

    • Protocol pre-review

    • Compliance Monitoring

    • Training for Research Community

    • Regulatory & funding agency interaction


  • Institutional animal care use committee iacuc

    Institutional Animal Care & Use Committee (IACUC)

    • Ensures that all animals in experimental research are used appropriately and are treated in accordance with the highest standards of humane care

      • Website: [email protected]

      • Phone: 919-668-6720

      • Location: 6th floor, Hock Building

      • Chair: Laura Hale, Ph.D


    Institutional animal care use committee iacuc1

    Institutional Animal Care & Use Committee (IACUC)

    • Major Functions

      • Review and approve, require changes, withhold approval of all new proposed research activities using animals and all modifications to existing protocols

      • Review all continuing protocols annual to ensure that no significant deviations from established and approved procedures have occurred

      • Semi-annual review of institutional animal care program

      • Semi-annual review of animal facilities (any area in which animal work is performed)

      • Report results of reviews to Institutional Official including noted deficiencies and recommendations

      • Review, and if warranted, investigate concerns involving care and use of animals

      • Authorized to suspend activities involving animals


    Division of laboratory animal resources dlar

    Division of Laboratory Animal Resources (DLAR)

    • Serves as centralized provider of veterinary medical and husbandry care as well as research animal support.

      • Website: http://labanimal.duke.edu

      • Phone: 919-684-2797

      • Location: 103 Research Drive

      • Director and University Veterinarian: John Norton, DVM, PhD

      • Veterinary Emergencies: 970-9410

      • On-Call Facility Manager/Supervisor: 970-7272


    Division of laboratory animal resources dlar1

    Division of Laboratory Animal Resources (DLAR)

    Major Services

    • Breeding Core and Assisted Colony Production

    • Rederivation

    • Genotyping

    • Cryopreservation

    • Protocol Consultation

    • Animal Model Development

    • Investigator Training

    • Dosing, Injections & Blood Collection

    • Antibody Production

    • Cytology

    • Faxitron & Digital Radiography

    • Embryo Transfer

    • Cannulations

    • Ovariectomy, Vasectomy and Castration

    • Osmotic Minipump Implants

    • Perfusions

    • Other Rodent Surgical Models

    • Anesthetic Induction & Monitoring

    • Post-procedural Care and Treatment

    • Other Services Upon Request


    Reporting animal concerns

    Reporting Animal Concerns

    • Contact the Duke Office of Animal Welfare Assurance (OAWA) Animal Welfare Hotline at 684-3535 [email protected]

    • Contact the Director of the Office of Animal Welfare Assurance, Dr. Ron Banks

    • Contact the Chair of the Duke Institutional Animal Care at Use Committee, Dr. Laura Hale

    • Contact the Director of Duke's Division of Laboratory Animal Resources, Dr. John Norton

    • Contact the Duke School of Medicine Compliance Office

      • 1-800-826-8109 (Anonymous Reporting)

      • 919-684-2144


    Research involving human subjects

    Research Involving Human Subjects

    • You are collecting information about humans by intervention, interaction or observation

    • You are analyzing or studying specimens, data, or information from humans

    • Conducting any research that will presented to FDA for regulatory purposes


    Research involving human subjects what do you need to do

    Research Involving Human SubjectsWhat Do You Need to Do

    • Prepare an IRB application

      • Offices involved: IRB

    • Complete the necessary training requirements

      • On-line training managed through CITI

      • Offices involved: CRSO, IRB

    • Obtain approvals from ancillary groups

      • CPC (Cancer Protocol Review Committee) – protocols involving oncology patients

      • Affiliate Sites – protocols involving Durham Regional or Duke Raleigh

      • IBC - Gene therapy/transfer

      • Radiation Safety - using radioactive materials/sources

    • Complete Billing Grid

      • For studies with “billing risk”

      • Offices involved: CRSO


    Research involving human subjects institutional review board irb

    Research Involving Human SubjectsInstitutional Review Board (IRB)

    Functions of the IRB

    • To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by DUHS

    • To suspend or terminate approval of research not being conducted in accordance with the IRS's requirements or that has been associated with unanticipated risk to participants

    • To observe, or have a third party observe, the consent process

    • To conduct continuing review of research annually or more often when appropriate

      • Website: IRB.MC.Duke.edu

      • Phone: 919-668-5111

      • Location: 4th Floor Hock Plaza

      • Director: Jody Power, MBA

      • Senior Chair: John Falletta, MD


    Clinical research support office crso

    Clinical Research Support Office (CRSO)

    • Provides administrative and financial infrastructures to support the integration of patient care, education, and research while respecting the needs of the human subject

    • Support of Clinical Research at Duke by:

      • Reviewing charge assignment grids to assure cost responsibility is accurate

      • Maintaining a subject billing registry designed to capture specific subject information for those studies in which billing compliance is a concern

      • Establishing training and continuing education opportunities for members of the research community

      • Communicating pertinent information and policy changes to the research community via a monthly e-newsletter

      • Creating and implementing tools and systems to aid the research community


    Biosafety

    BioSafety

    You are conducting experiments or studies that involves

    • Biological hazards

    • Recombinant DNA

    • Viral Vectors

    • Plasmids

    • Select Agents (defined by the Centers for Disease Control and Prevention)

    • Biosafety Level 3 containment

    • Human gene transfer

    • Transgenic or cloned animals

    • Genetic engineering

    • Transfer of human materials into animals


    Biosafety what do you need to do

    BioSafety – What Do You Need To Do?

    • Complete and submit the applicable IBC documentation

      • Required Documents to Register rDNA Protocols with the Duke IBC

      • Recombinant DNA Survey

      • Recombinant DNA Registration Form

      • Viral Vector Registration Form

      • Plasmid\Vector Table

      • SOP for BSL2/ABSL2 Labs


    Ibc institutional biosafety committee

    IBC – Institutional BioSafety Committee

    • Ensures that all recombinant DNA research conducted at the institution or sponsored by the institution is conducted in compliance with the National Institutes of Health Recombinant DNA Guidelines

    • Ensures that all research protocols involving Select Agents (defined by 42 CFR 73) are reviewed and found to comply with all national, state, and local requirements

    • Ensures that all laboratory work conducted at Biosafety Level 3 containment or Animal Biosafety Level 3 is reviewed and found to comply with all national, state, and local requirements

    • Responds to requests from other institutional entities (e.g., Employee Occupational Health and Wellness, Division of Laboratory Animal Resources) or individuals for other types of biosafety review


    Ibc institutional biosafety committee1

    IBC – Institutional BioSafety Committee

    • Responsible for research throughout the entire Duke University enterprise

    • Authorized to:

      • Inspect research facilities

      • Approve research practices and procedures

      • Take actions in the event of an unsafe workplace situation (e.g. cessation of laboratory or clinical research activities)

    • Contacts:

      • Richard Frothingham, MD; Co- Chair

      • 919-684-5455

      • Wayne R. Thomann, DrPH; Co-Chair

      • 919-684-6320


    Research support offices an overview

    Research Misconduct

    • Fabrication – making up data or results and recording or reporting them

    • Falsification – manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record

    • Plagiarism – appropriation of another person’s ideas, processes, results or word without giving appropriate credit

    • Does NOT include honest error or differences of opinion

    • Report Research Misconduct

      • Research Integrity Officer – Donna Cookmeyer, PhD – 919-6685115

      • Associate Dean, Research Support Services – Wesley G. Byerly, Pharm.D. – 919-668-2579

      • Through the IntegrityLine – 1-800-826-8109


    Research support offices an overview

    Conflict of Interest

    • A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain) NEJM 1993

    • Require Investigator Disclosure

    • Institutional Disclosure

      • Annually

      • Upon any material change

      • PRIOR to submitting an application

    • Sponsor – Funding Source Disclosure

      • Prior to the award – PHS

      • At market application submission – FDA

    • Informed Consent

    • Publications

    • Presentations


    Research support offices an overview

    Conflict of Interest

    • FDA Regulations (21 CFR 54)

    • Applies to investigators and sponsors – requires Sponsor to disclose or certify no COI for participating investigators

    • PHS Regulations (42 CFR 50 and 45 CFR 94)

    • Applies to grantee institutions and contractors

    • Investigator

    • Anyone involved in the independent design, conduct or reporting of research

    • Spouse or dependent children


    Occupational and environmental safety office oeso

    Occupational and Environmental Safety Office (OESO)

    Your research involves:

    • Bloodborne pathogens

    • Waste disposal

    • TB and other airborne pathogens

    • Shipment of biological material

    • Laser use

    • Radiation safety


    Occupational and environmental safety office oeso1

    Occupational and Environmental Safety Office (OESO)

    • Promotes a safe environment for the Duke Community.

      • Website: http://www.safety.duke.edu/

      • Phone: 919-684-2794

      • Location: 131 Research Drive, Environmental Safety Building

      • Director: Wayne Thomann, Dr.PH


    Clinical trials quality assurance ctqa

    Clinical Trials Quality Assurance (CTQA)

    • Conducts compliance reviews related to Human Subjects Research, Clinical Trials Billing, Research Financial Compliance and other regulatory risk areas identified as part of the institutional risk assessment

    • Assists in responding to external audit or regulatory findings or determinations

      • Website: http://medschool.duke.edu/compliance

      • Phone: 919-684-2144

      • Location: 1131C Davison Building, Duke South

      • Director: Tina Tyson, JD


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