Research Support Offices An Overview

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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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