Download Document

Download Report

Transcript Download Document

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
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
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 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.
Protocol Submission and Review Processes cont’
• 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’
•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)
@ [email protected]
713-313-6859 or 713-313-7675
CONTACT INFORMATION
Linda M. Gardiner
Director
713-313-7208
[email protected]
Tequerio Banks
Project Coordinator
713-313-4301
[email protected]
Randolph Hamid
Interim Sr. Animal Care Technician
[email protected]
Any Questions?