Research support offices an overview
Download
1 / 24

Research Support Offices An Overview - PowerPoint PPT Presentation


  • 78 Views
  • Uploaded on
  • Presentation posted in: General

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha

Download Presentation

Research Support Offices An Overview

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Research Support OfficesAn Overview

New Faculty Orientation

September 21, 2010

Wesley G. Byerly, Pharm.D.

Associate Dean for Research Support Services


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

  • 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 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)

  • 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)

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

      • Website: IACUC@DUKE.EDU

      • Phone: 919-668-6720

      • Location: 6th floor, Hock Building

      • Chair: Laura Hale, Ph.D


    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)

    • 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 (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

    • Contact the Duke Office of Animal Welfare Assurance (OAWA) Animal Welfare Hotline at 684-3535 or IACUC@duke.edu 

    • 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

    • 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 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 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)

    • 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

    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?

    • 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

    • 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 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 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


    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


    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)

    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 (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)

    • 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


    ad
  • Login