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New Faculty Orientation COMPLIANCE FOR THE USE OF SUBSTANCES AND SUBJECTS IN RESEARCH

TEXAS SOUTHERN UNIVERSITY OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR DEPARTMENT OF RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES. New Faculty Orientation COMPLIANCE FOR THE USE OF SUBSTANCES AND SUBJECTS IN RESEARCH August 21, 2009.

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New Faculty Orientation COMPLIANCE FOR THE USE OF SUBSTANCES AND SUBJECTS IN RESEARCH

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  1. TEXAS SOUTHERN UNIVERSITYOFFICE OF RESEARCHLINDA M. GARDINER, Ph.D.DIRECTORDEPARTMENT OF RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES

  2. New Faculty Orientation COMPLIANCE FOR THE USE OF SUBSTANCES AND SUBJECTS IN RESEARCH August 21, 2009

  3. RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES MISSION To ensure research compliance with state and federal governing agency regulations and internal policies, guidelines and procedures, and to provide an environment that supports research advancements for the research community of Texas Southern University.

  4. What We Do • Facilitate and coordinate the research protocol submission, review, approval and management processes. • Ascertain that all state and federally required inspections, evaluations and program reviews are conducted and that all internal and external reporting is done efficiently and effectively. • Coordinate faculty development URCC workshops, seminars, and training sessions.

  5. How We Do It • Provide oversight and administrative support to the URCC’s • Along with the URCC’s screen, review and manage all research protocols • Serve as the liaison between the URCC’s, the Provost, Deans, faculty members and students • Manage animal care facility operations and coordinate animal facility inspections and animal care and use program reviews. • Conduct and/or coordinate URCC workshops and research compliance training sessions

  6. Who is Responsible for Research Compliance? • Principal Investigator (Faculty, Staff and Students) • Department of Research Enhancement and Compliance Services • University Research Compliance Committees • Federal Governing Agencies

  7. Why the Emphasis on Research Compliance? • Obligation • Penalties • Potential Exposure • Federal Sentencing Guidelines

  8. University Research Compliance Committees (URCC) • Institutional Animal Care and Use Committee (IACUC) • Committee for Protection of Human Subjects (CPHS) • Radiation Safety Committee (RSC) • Recombinant DNA Committee

  9. Federal and State Governing Agencies and Policies • Office for Human Research Protection (OHRP) • Office of Laboratory Animal Welfare (OLAW) • United States Drug Administration (USDA) • Public Health and Service (PHS) Policy • Texas Department of State Health Services (Radiation Control Program) • Occupational Safety and Health Administration • Occupational Health and Safety Policy

  10. TSU Guidelines and Procedures • Manuals Can be Found on Department of Research Enhancement and Compliance Services (DRECS) Website

  11. ROLES OF THE UNIVERSITY • RESEARCH COMPLIANCE COMMITTEES • Review Research Protocols • Develop internal research compliance policies, guidelines and • procedures • Ensure that the University’s research compliance guidelines and • procedures are in accordance with federal governing • agencies regulations • Ensure that all involved in subject or substance research • understand the seriousness of research compliance • responsibilities

  12. What Steps Should You Take For Protocol Review and Approval? • Ascertain that your protocol requires research committee approval. • Use of rDNA and radioactive isotopes is straight forward • Approval requirements for the use of humans and animals depends on how the humans are being used and animal state of being and species • If you are uncertain, contact DRECS director/ staff or committee chairperson

  13. What Steps Should You Take For Protocol Review and Approval? • In cases where it is not clear whether the study requires committee review DRECS director/staff or chairperson may require that researcher sends a hard or soft copy of the protocol for preliminary review. • In complicated cases DRECS or the respective chairperson may ask that you submit an application to determine whether the protocol is exempt from committee review and approval.

  14. What Steps Should You Take For Protocol Review and Approval? • rDNA and radiation safety application documents on DRECS website • Animal and Human Subjects applications must be submitted via TOPAZ technologies Electronic System • Must obtain password to log on to TOPAZ System • Must have Human Subjects certification before a Human Subjects protocol can be reviewed • Applications should be submitted at least 1 month in advance of rigid deadlines

  15. CONTACT INFORMATION Linda M. Gardiner Director 713-313-7208 Tequerio S. Banks Research Compliance Larkins_ts@tsu.edu 713-313-4301 Christina Pevey Science Building Animal Care Facility 713-313-4203 Ernest Hogan or Randolph Hamid Spurgeon Gray Hall Animal Care Facility 713-313-7558 or 713-313-4348

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