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TEXAS SOUTHERN UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE PROGRAM WORKSHOP. OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR RESEARCH ENHANCEMENT AND REGULATORY SERVICES October 4, 2012. RESEARCH ENHANCEMENT AND REGULATORY SERVICES MISSION.
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TEXAS SOUTHERN UNIVERSITYINSTITUTIONAL ANIMAL CARE AND USE PROGRAM WORKSHOP OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR RESEARCH ENHANCEMENT AND REGULATORY SERVICES October 4, 2012
RESEARCH ENHANCEMENT AND REGULATORY SERVICESMISSION • To ensure research compliance with internal policies and federal governing agency regulations and to provide an environment that supports research advancements for the research community of Texas Southern University
PROTOCOL SUBMISSION AND REVIEW PROCESSES
PI must obtain password from project coordinator for submission via TOPAZ (electronic protocol management system). • PI should submit protocol 1 month in advance of any rigid deadlines. (Committee requires 1 month lead time) • Cursory review by Project Coordinator to ensure that the application is complete. • Prior to review, each IACUC member is provided with a list of proposed research projects to be reviewed. • Any member of the IACUC may obtain, upon request, full committee review of the research projects. Protocol Submission and Review Processes
Protocol Submission and Review Processes cont’ • If a full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review the project and has the authority to approve, require modifications (to secure approval) or request, full committee review for the research projects. • If a full committee review is requested the Project Coordinator disseminates protocol to each IACUC member via TOPAZ. • IACUC submits comments and/ makes recommendations for protocol modifications.
Modifications are forwarded via TOPAZ to PI and a courtesy phone call is made to notify PI that protocol modifications need to be made in the TOPAZ system. • PI makes modifications. • IACUC meets to vote on protocol. Approval of those research protocol may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of the majority of the quorum present. Protocol Submission and Review Processes cont’
Protocol Submission and Review Processes cont’ • The IACUC shall notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or modifications required to secure IACUC approval. • If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. • The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by the policy at appropriate intervals as determined by the IACUC (at least every three years) • IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the animal welfare act, the Guide, or the institution’s assurance.
TSU Guidelines and Procedures • Manuals Can be Found on Department of Research Enhancement and Regulatory Services (DRERS) Website http://www.tsu.edu/research
OCCUPATIONAL HEALTH AND SAFETY IN ANIMAL RESEARCH
Occupational Health and Safety in Animal Research Collaborative effort between the Office of Research, the Department of Environmental Health and Safety (DEHS and the Risk Management Specialist. Registration in the Occupational Health and Safety Program via The submission of Medical History and Risk Assessment Documents to the Risk Management Specialist prior to beginning Research with animals. (Forms found on OR website) Consultation with Risk Management Specialist if necessary. Proper use of personal protective equipment (ppe) In the event of injury, the submission of an accident incident report form to the Risk Management Specialist.
Reporting Injuries • Complete Accident/ Incident Report • (Available on DEHS website) • Submit report to Risk Management • Specialist in DEHS (Mellany Patrong) • @ patrongmw@tsu.edu • 713-313-6859 or 713-313-7675
CONTACT INFORMATION Linda M. Gardiner Director 713-313-7208 Gardiner_lm@tsu.edu Tequerio Banks Project Coordinator 713-313-4301 Larkins_ts@tsu.edu Randolph Hamid Interim Sr. Animal Care Technician 713-313- Hamidrj@tsu.edu