1 Nov

ORIC Newsline - Fall 2011 (Text)

Jonathan | November 1st, 2011

The West Virginia University Office of Research Integrity & Compliance (ORIC)

ORIC is committed to helping faculty, staff, and students comply with all applicable federal, state, and institutional requirements and policies. Research integrity and compliance areas covered by this office include human research protections, animal welfare, biosafety, conflict of interest in research, export control and the responsible conduct of research. The ORIC Newsline online newsletter has the goal of keeping the WVU research community informed and up-to-date on policies and procedures, guidelines, educational programs, regulatory changes, and monitoring and accountability in these areas.

Human Research Protections

Kuali Coeus (KC)

Having difficulty completing IRB protocols? Want to avoid BRAAN freeze? We do too. Coming soon you will be able to use Kuali Coeus (KC).

The KC project is using the latest web technology, in combination with an MIT product known as Coeus, to build a comprehensive system to manage the complexities of research administration. The WVU Research Office and OIT are working together to replace the current electronic system known as BRAAN with a new KC IRB module. This new system will be put into place January 2012. Investigators will continue to be able to create and manage IRB protocols; however, the KC IRB will be a stable and user friendly system. The KC IRB system will operate in parallel with BRAAN for one year as protocols are manually transferred by the investigators to the new system through the new protocol and renewal application process. BRAAN will eventually become an archive system for historical data only.

The WVU community is encouraged to follow the status of this project and provide feedback. Please ‘Like’ us on Facebook at WVU Kuali Coeus (KC) for weekly updates. Also we encourage the WVU IRB investigators to sign up for the WVU Office of Research Integrity and Compliance (ORIC) IRB listserv on the ORIC website at http://oric.research.wvu.edu/ . For further information please contact us at ResearchIT@mail.wvu.edu or 3-5967 in the Research Office. Information Technology department.

Responsible Conduct of Research

Please remember that both NIH and NSF now have Responsible Conduct of Research (RCR) training requirements. Monitoring for compliance with these RCR training requirements has now been fully implemented by ORIC..

Our office monitors each NSF or NIH award, when applicable, for compliance with RCR regulations. In the event an award is not in compliance with federal and WVU RCR standards, both the PI and relevant others will be notified that immediate follow-up is required to bring the grant into compliance.

Note that failure to comply with federal and University regulations may result in the suspension of research funding for that particular project.

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

ACUC Announces Changes!

There have been some important changes that animal users need to know!

• The due date for amendments and protocols is the 15th of the month.
• There is a new animal care and use protocol form.
o Are you renewing a protocol or submitting a new protocol? Go to http://oric.research.wvu.edu/animal/protocolsub for instructions as well as the new form and appendices to the new form
o Are you amending a protocol that is currently approved in the old form?
 Make changes in this old form.
 Highlight these changes.
 Include a summary addressing the reason for the amendment and brief synopsis of the changes.
o Save a tree?we don’t require hard copies of your protocol! Submit your protocol via email to ACUC@mail.wvu.edu or mhollander@mail.wvu.edu.
o Signed signature pages should be mailed to Robin Anderson, PO Box 6845.
• Veterinary pre-reviews will be done before your protocol goes to the committee. Protocols WILL NOT be submitted to the committee until the veterinary review is addressed.
• New IACUC polices, standard operating procedures and guidelines are being posted every month! Find all of them at http://oric.research.wvu.edu/animal/guidlines
• Dr. Michael Perone, a Professor in the Department of Psychology, is now serving as the Chairperson for the IACUC.

Biosafety

OLAR ABSL2 Biosafety SOPs have been finalized and are being posted at the ORIC website under the title ‘Animal Biosafety’.

A memorandum of Understanding of the Authority & Scope of the Institutional Biosafety Committee has been drafted pending review by the Vice President for Research, Dr. Curt Peterson.

WVU’s Exposure Control Plan for Non Healthcare Personnel is being developed as a part of the OSHA Bloodborne Pathogen Training.

The list of WVU Biosafety CITI Training modules has been finalized, and the
ORIC Export Control & Biosafety websites are being updated.

Please visit http://oric.research.wvu.edu/biosafety for more information.

Export Control

On September 21, 2011, a meeting was held for an update on the WVU Export control program. Dr. Smitha Moter presented the current structure of the WVU Export control program.

Many principal investigators, graduate students or research fellows, and even undergraduates travel internationally to attend various academic projects. The academic traveler’s failure to comply with U.S. export control laws can have grave consequences. WVU personnel scheduled for international travel for an academic purpose must fill out the Academic Travel Forms posted at the ORIC website.

Guidelines regarding encryption software as related to academic travel and U.S Export control regulations have been posted at the ORIC website.

For more information, please visit http://oric.research.wvu.edu/export_control.

Conflict of Interest in Research

New Federal regulations regarding the disclosures made on the WVU Disclosure of Interest in Research (DOIR) Form and the WVU Supplemental Disclosure Form will go into effect in July 2012. Currently, amounts over $10,000 earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities need to be disclosed. With the new regulations, amounts earned over $5,000 for payments for services and/or equity interests earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities will need to be disclosed on the DOIR and Supplemental Forms. An equity interest of 5% or more will still need to be disclosed for interests in publicly traded entities. With the new regulations, any equity interest in non-publicly traded entities will also need to be disclosed.
If there are any questions regarding who needs to complete and submit a DOIR Form, whether or not a DOIR is currently on file, or any other questions regarding the WVU Policy, please feel free to contact Devin Goudy (304-293-5475) or Dr. Daniel Vasgird, ORIC Director (304-293-6094).

For more information, please visit http://oric.research.wvu.edu/conint.