Winter 2018 Continued
Issue 52
¶¶Òõ̽̽Connect
A note from the Executive Director for the Office of Research Support & Integrity, Brian Prindle:
In November 2017, I announced through that the ¶¶Òõ̽̽ Board of Trustees had approved purchase of Huron’s Research Suite of software solutions (known as Click) for managing research. In follow-up to this news, I would like to introduce ¶¶Òõ̽̽Connect, our future electronic portal where investigators and staff connect to accomplish the business of research administration and compliance.
¶¶Òõ̽̽Connect will transform the way our investigators and administrators manage the lifecycle of IRB Protocols, IBC Protocols, IACUC Protocols, Conflict of Interest Disclosures, and Grants Management, Proposal Submissions through Award set-up with direct integration of award data to PeopleSoft financials.
·&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è; ¶¶Òõ̽̽Connect: Project Start: February 1, 2018
·&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è; ¶¶Òõ̽̽Connect: Module Release Order: IRB, IBC, COI, Grants, IACUC
·&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è;&²Ô²ú²õ±è; ¶¶Òõ̽̽Connect: Project Manager, Lynn Tracy
Soon we will announce the launch our ¶¶Òõ̽̽Connect website, where the latest project information, timelines, and updates will be posted.
¶¶Òõ̽̽Connect is made possible with support from the Office of the Provost, Office of the Vice President for Research, Larner College of Medicine and ¶¶Òõ̽̽ Medical Center. The Office of Research Support and Integrity, reporting to the Vice President for Research, has been tasked with taking the lead and coordinating the implementation of ¶¶Òõ̽̽Connect.
Single IRB for NIH Proposed Research – Western IRB Site Visit
As of January 25, 2018, NIH policy requires that all NIH multi-site protocols use a single IRB of record. ¶¶Òõ̽̽ has entered into an agreement with Western IRB for single IRB services where ¶¶Òõ̽̽ researchers wish to be the lead single IRB for their NIH proposals. Proposals in development should include the use of WIRB as the IRB of record for the multi-site research activities and budgets must be developed to include the expense for the use of Western IRB (opens in a new window).
In preparation for this requirement, a Western IRB representative will be at ¶¶Òõ̽̽ on Tuesday, March 27, 2018 from 2:30 to 4:00 pm in Davis Center 419 (Mildred Livak Room). They will present their NIH budget calculator and address any questions you may have in regards to their services.
New IRB Policies and Procedures
As previously announced, RPO has been working on a new and improved version of the research manual. This new document is a merger of the existing internal Committee Operating Procedures document and the Researcher Manual. The new document will now be referred to as the IRB Policies and Procedures (opens in a new window). During this task, we identified and updated areas that needed clarification, as well as reorganized the information so that the flow is improved. The IRB Policies and Procedures document will always be a work in progress as regulatory changes or new guidance is provided. If you have suggestions or questions about any of the content, please do not hesitate to contact the RPO Office.
Note: The IRB Policies and Procedures contain content that is specific to the revised 2018 Common Rule which will not go into effect, presumably, until July 19, 2018. These updates are clearly indicated throughout the manual and should be disregarded until further notice. These changes have been retained to ease the transition as the new compliance date approaches. Notifications and further instructions pertaining to the Common Rule update will be shared as information is received.