ORIC Newsline - May 2011 (Text)
- PDF version available at
http://oric.research.wvu.edu/r/download/90225
- Human Research Protections (HRP): Please remember that any upcoming audits of a protocol, conducted either by your sponsor or the FDA must be reported to the ORIC and the Internal Audit Office. A representative from these offices will need to attend the exit interview held by the auditing team.
Consider Summer IRB Submission
For any researcher that is planning to conduct a research project that will involve human research subjects, the summer season is an excellent time to submit your project for IRB review.
The fall semester is always the busiest semester with new students and faculty arriving at the University. With this in mind, we encourage you to call our office at (304) 293-7073 if you need any guidance for your study or call (304) 293-1119 to begin the process of creating your protocol for approval for any future study.
- Responsible Conduct of Research (RCR): Complete monitoring for compliance with the Responsible Conduct of Research (RCR) training requirements has now been fully implemented.
Our office is now monitoring each NSF or NIH award, when applicable, for non-compliance. In the event an award is not in compliance with federal and WVU standards, the person who is listed as principle investigator on the award will receive an e-mail informing them of the specific requirements applicable to their study and who on that study is non-compliant. Each researcher who is non-compliant will also receive a letter of notice. Moreover, when a new researcher is added to a grant and falls under the purview of the RCR regulations, that researcher must also remain in compliance.
Remaining in a non-compliant state may result in the suspension of funding for that grant.
In order to facilitate understanding of the specific requirements for each applicable award and whether the award does indeed fall into a category for compliance monitoring, our office has posted the Responsible Conduct of Research Requirements Sheet online.
For questions, concerns, and inquiries please contact Jonathan Young by e-mail at Jonathan.Young@mail.wvu.edu or by phone at
(304) 293-1119. - Animal Care and Use (ACU): Post Approval Monitoring for Animal Protocols:
Post Approval Monitoring (PAM) is a new program that will begin in June or July. The purpose of this new program is to fulfill the federal requirement to assure that the actual animal activities being conducted are consistent with the approved protocol. This will be a scheduled visit and an opportunity to ask questions regarding the Animal Care Program at WVU. The visits will be conducted by various people involved with the Animal Care Program and are designed to ensure that the quality of animal research and care at WVU remains at the highest level.
We encourage all PIs with an Animal Care and Use Protocol to review their protocols and ensure that what is being done in practice matches what has been approved by the Animal Care and Use Committee. If discrepancies are found, we highly suggest that you amend your protocol accordingly. We now have a great way to track amendments so please do not hesitate to submit as many amendments as are needed. We are always available to answer questions and assist you, so please feel free to contact the Animal Compliance Officer at any time.
- Conflict of Interest in Research (COIR): Any University investigator/key personnel engaged in a research study, regardless of the source of funding, who wishes to be eligible to engage in a particular research program shall have an ongoing duty to complete and file annually (by June 30th of each year) the WVU Disclosure of Interest in Research (DOIR) Form. This form was previously entitled “Conflict of Interest in Research Certification Form.”
Federal regulations require the University to manage any potential conflicts of interest through an appropriate management process which is initiated and generally resolved through disclosure. If any questions arise as to who must complete and file a DOIR, or whether the DOIR is up to date please contact our office at (304) 293-5475.
- Biosafety: The Instituitional Biosafety meeting is scheduled on the second Monday of every month. The Principal Investigators have been requested to submit their IBC Protocol Registration Document to the ORIC on the Last Monday of each month to aid in the Protocol review process.
Lab Inspections & the completion of necessary Training will become mandatory prior to the approval of IBC Protocols. Biosafety Guidelines for WVU will be implemented. Other upcoming changes would be the IBC Protocol approval duration & the content of IBC registration documents. If needed the Biosafety training topics will be added on to the existing Biosafety training modules. - Export Control: Deemed Export Control Policy awareness will be created by circulating the Policy to the Principal Investigators all over the West Virginia University campus. The implementation of the Export Control Training and auditing will follow.
The Export Control Officer, Dr. Rayadurg is responsible for assessing and communicating the requirements of U.S. export controls on WVU research activities. She serves as the primary point of contact on export control issues, both internally and with outside government agencies.