Institutional Review Board Human Subject Protections Workshop
The Institutional Review Board will be hosting a training seminar for Investigators, Research Coordinators, Ressearch Staff, and and IRB Committee members on Wednesday April 25, 2007 at 9:00 to 12:00. The seminar will be held on the 4th Floor Auditorium of the Student Faculty Center. For more information including topics that will be covered Click here.
A Multidisciplinary Conference and Workshop at Temple University Health Sciences Center. Each conference will focus on a specific research theme and discuss relative current research at Temple. The goal of the conference is to stimulate additional clinical and translational multidisciplinary research at Temple. The Conference is open to all faculty and staff at Temple University. Please join us for this exciting initiative.
Winter 2006/2007
Office of Clinical Trials Fall Lecture Series
The Fall Lecture Series is complete and all of the lecture's are on the web-site for those that could not attend Click here. A special thanks to all the presenters who volunteered their time to make the course a great success. Please check back to the OCT web-site for furture training sessions.
Institutional Review Board Updates IRB Submission Documents for Medical Intervention Protocols
The Institutional Review Board updated its IRB Decision Tree for Protocol Review on Monday December 11, 2006. The change is to the Initial Review Submission Form. The Initial Review Submission form has been revised for all Medical Intervention Protocol submissions to the Temple IRB and the Western IRB for review. The TIRB and WIRB will not accept the old form after January 1, 2007. If you have a submission prior to January 1, 2007 you may use the old form, but if the submission is not received by WIRB prior to January 1, 2007 it will not be accepted. Please begin using the revised form ASAP.
The IRB has also added a Guidance Document for the IRB Submission Process which can be found on the IRB Decision Tree located on Forms Page of the IRB Website.
Sponsored Projects A-Z: Handling Your Grant from Cradle to Grave: Slide Show Presentation from the October 17 and October 18, 2006 Seminar Series. Procedures and Processes Guide to help you through the Lifecycle of the grant and contract process at Temple. This powerpoint includes presentations from the sponsored projects office, grant accounting, HR, payroll and purchasing and contact information for the relevant directors. For Click Here for Slide Show Presentation
Fall 2006
Grants.Gov Training/Workshop: Click here for Full announcement. Are you ready for NIH electronic submissions? Don’t wait until the last minute to learn the necessary steps to submitting your grants electronically. Plan to attend one of the Grants.gov training sessions. Faculty members, department administrators and all others who will be assisting in submitting NIH electronic submissions are encouraged to attend.
Hazardous Shipping Update from US Department of Transportation: On September 20, 2006, Temple University's Environmental Health and Radiation Safety announced an important update to the Hazardous Shipping Regulations that will impact all personnel responsible for the shipping of Diagnositic Specimens out of the University. Effective October 1, 2006 the U.S. Department of Transportation (DOT) will switch to a 2-tiered system to identify a Class 6.2 infectious material. For more information click here.
January 2006
IRB establishes requirements for protocol submission to the Institutional Review Board
The IRB has established requirements for protocol submission to the Institutional Review Board in the form of a Guidance Memorandum. The guidance details these requirements including: IRB education, access net id, Temple email address, selection of appropriate IRB application forms and declaration of Biohazards and Medical Radiation required reviews. Incomplete applications will not be scheduled for review. Click here for the full memorandum.
The on-line education program, or Research Compliance Courseware, includes the following modules:
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Use of Human Subjects in Research - this module provides the ethical basis and regulatory framework for compliance in the protection of human subjects used in research, and is required of all individuals for IRB Certification prior to performing research involving human subjects.
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Conflict of Interest and Scientific Misconduct - this module reviews the regulatory framework for identifying and managing conflicts of interest and for handling scientific misconduct, and is required of all key research personnel.
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Grants and Contracts - this module gives a general overview of the pre- and post-award process and is recommended for all individuals involved with research grants and contracts.
Important Announcement and Information concerning all IRB submission for Committee A - Medical Intervention Research
Please Note: All submission processes and forms have changed. Please review carefully. Visit the IRB home page frequently for updates on IRB processes.
Memo to Principal Investigators, Study Coordinators, Research Administrators and the Temple University Research Community. Click here
OVPR Announces Just In Time Certifications for Regulatory Certifications on Health Sciences Campus
Effective January 1, 2006, Sponsored Projects Administration at the Health Sciences Center (SPA/HSC) will no longer require Principal Investigators to submit regulatory certifications and/or assurances along with their grant application. This means that after January 1, 2006, PIs will not be required to complete and get signed or approved at the time of submission the following forms: Investigator Significant Financial Interest (SFI) Disclosure Form (for COI review), Biosafety Registration (BR) Form (for IBC review), and Assurance on Hazardous Procedures (for EHRS review). Submission of these and other regulatory compliance forms will follow the same “just-in-time” procedure now used for IRB and IACUC review and approval. more...
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