Focused Topics are one to one-and-a-half hour sessions on a specific topic. Topics have been chosen based on requests from departments, areas of risk or a new policy or procedure. For all Focused Topic sessions: Please register on the OFS/iSite/Training Sign up page.
When: Tuesday, Sep. 22, 2015, 2-3 p.m.
Where: Kresge 502
Presenter: Judy Lo, Manager of Cost Accounting
Description: Come to this session to review the eCrt certification requirements for annual certification, including the use of Proxy for 6030 employees. Also we will review the new job aids for the FY16 payroll journal process for payrolls that cross fiscal quarters. Ruth Lacroix will be here to answer any other questions you may have, including statements re-opened due to payroll journals, negative effort values, and other recertification scenarios.
Audience: SPH financial administrators responsible effort certification.
New! Understanding the IRB Review and Approval Process
When: Tuesday, Sep. 29, 2015, 2-3 p.m.
Where: Kresge 201
Presenters: Alyssa Speier, Assistant Director of Regulatory Affair & Research Compliance, and Leslie Howes, Director-Office of Human Research Administration (OHRA)
Description: This presentation introduces the Office of Human Research Administration. Presenters provide examples of what constitutes Human Subjects Research and when such activities are exempt from certain IRB requirements. In addition, the two modes of IRB approval will be discussed, namely Expedited and Full Board. We will also review NIH’s new Genomic Data Sharing policy and how it impacts JIT and IRB submissions. Available resources will be highlighted, and there will be plenty time for questions!
Audience: Grant managers interested in learning more about the human subject review process
De-mystifying the Biohazard/rDNA GMAS Approval – for GMs, ADFs & SRAs
When: Wednesday, Oct. 7, 2-3 p.m.
Presenter: Dana Burns, Laboratory Health & Safety Officer
Description: A business process for biohazard approvals was recently implemented to ensure projects involving biohazards/rDNA are appropriately reviewed prior to the start of work. However, reviewing the research strategy can be daunting, and there may be uncertainty in determining the nature of a project and whether or not it requires biohazard approval. Proper identification of projects requiring biohazard approval will ensure awards are properly set up to avoid interruptions and delays.
Audience: This session is geared towards GMs, ADFs & SRAs and will provide an overview of biohazard and rDNA research and how to identify projects involving these materials when preparing and reviewing proposals and setting up awards.
New! The Uniform Guidance and Prior Approvals (and why we like NIH so much!)
When: Wednesday, Oct. 14, 2-3 p.m.
Presenters: Elaine Kiley, Associate Director of Sponsored Programs Administration, and Eileen Nielsen, Director of Research Administration Education
Description: This session will focus on the Prior Approval requirements in 2 CFR 200 (the Uniform Guidance). What are the requirements? Are federal granting agencies allowed to deviate from the requirements? Are the Prior Approval requirements contained in 45 CFR 75 (the HHS implementation of the UG) the same? When and in what format should prior approval requests be submitted? ? What makes NIH special?
Audience: Anyone involved in requesting prior approvals. (GMs, ADFs, Program Managers)