Sponsors and Agencies (SA)

Covers: the nature of “sponsorship”; defining roles and responsibilities between sponsors, grantors, awardees; private sector sponsors: technology, foundations; state sponsorship issues; federal agency updates; new initiatives in research; international agency relations;  working with program officer leadership; and sponsoring agency rules.

Monday, February 29, 2016

M206: The National Institutes of Health (NIH) Grant Proposal Guide: 273 Pages in 75 Minutes!
Monday, February 29, 2016 - 11:00am to 12:15pm

Content level: Basic

We will take the participants through the long and arduous grants.gov NIH proposal application process, but we promise that the workshop will NOT be long and arduous! The application can be extremely intimidating to inexperienced faculty and staff. In this workshop, we will go over and explain each section of the application including the budget and budget justification. We will also relate our experiences with walking Principal Investigators (PIs) painlessly through the process. 

Learning objectives:

  1. Be able to approach the NIH grant application with confidence. 
  2. Learn tips for working with new PIs applying to NIH.

Prerequisites: None

Speaker(s):

Stephanie Endy, Associate Vice President for Research, Case Western Reserve University

M306: National Institutes of Health (NIH) Updates (Webinar)
Monday, February 29, 2016 - 2:15pm to 3:30pm

Content level: Basic

This live webinar-session will cover the latest news from the National Institutes of Health (NIH), including information on the NIH budget, current policy topics, policy reminders and updates on NIH Electronic Research Administration (eRA) activities.

Learning objectives:

  1. Learn basic information concerning the NIH, including new, emerging initiatives as well as recurring policy reminders. 
  2. Learn basic information concerning NIH eRA activities, including eRA Commons and electronic submission of NIH grant applications, progress reports and other post-award electronic processes.

Prerequisites: None

Speaker(s):

Michelle Bulls, Director, Office of Policy for Extramural Research Administration (OPERA), National Institutes of Health (NIH)

M406: It's Your Cost of Doing Business. Take It or Leave It.
Monday, February 29, 2016 - 3:45pm to 5:00pm

Content level: Intermediate

Clinical trial budgets are always negotiable. Still, many investigators and clinical teams accept original budgets proposed by industry sponsors. The process of budgetary negotiation may seem intimidating, overwhelming, or ungrateful. In reality, negotiation allows both the sponsor and the site to arrive at a consensus which will benefit both sides. With an acceptable budget the site is more likely to fully commit to subject enrollment and site compliance by allocating proper resources and effort, which will result in producing higher quality data. Trial success can be easily compromised when budgets are negotiated poorly or accepted with no negotiation at all. Who is the right negotiator at the site level? How to muster sufficient negotiation power? When to push back and what to forgo? These and other questions will be addressed in the course of the session. The participants will discuss practical negotiation tips and techniques. Actual budget negotiation examples will be used to reveal most common stumbling blocks between sites and sponsors and the ways to circumvent them.

Learning objectives:

  1. Define the role of budget negotiation in trial success. 
  2. Utilize various budget negotiation tips and techniques.

 

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business and Financial Operations, Clinical Trials Office, University of Utah

Tuesday, March 1, 2016

T106: National Institutes of Health (NIH) Post-award Prior Approvals: When You Need to Call NIH
Tuesday, March 1, 2016 - 9:00am to 10:15am

Content level: Intermediate

We all know that grant awards never quite go according to plan and significant changes are often needed for a project to remain viable after the initial award is made. Some changes definitely require prior approval while others definitely do not, but in many cases the need for the National Institutes of Health (NIH) prior approval is a definite maybe! This session will address NIH post-award prior approval requirements for grantees and explain when you need to contact NIH staff. The presenters will discuss the specific actions that require prior approval and what materials grantees should provide for NIH to review and respond to the request.

Learning objectives:

  1. Be able to identify what actions require prior approval from NIH and where to locate NIH policy regarding prior approvals. 
  2. Know what items NIH needs to review and respond to prior approval requests and best practices for submitting these items.

 

Prerequisites: None

Speaker(s):

Jessica Moise, Senior Associate Dean for Sponsored Programs, Icahn School of Medicine, Mount Sinai; Katie Joffee, Grants Management Specialist; and Mark Langer, Grants Management Specialist/Officer, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Department of Health and Human Services, National Institutes of Health

T206: National Science Foundation (NSF) Update
Tuesday, March 1, 2016 - 10:30am to 11:45am

Content level: Basic

This session will cover new developments at the National Science Foundation (NSF) - programs, policies, people and budgets. Senior NSF staff will provide a comprehensive review of what is new and developing at NSF.

Learning objectives:

  1. Learn about the NSF Fiscal Year (FY) 2016 and 2017 budgets and administration priorities for NSF programs. 
  2. Understand how NSF has implemented recent changes to proposal and award policies and procedures.

 

Prerequisites: None

Speaker(s):

Samantha Hunter, Senior Grant and Agreement Policy Specialist, National Science Foundation (NSF)

T306: New York University Langone Medical Center (NYULMC) Superstorm Sandy Recovery Efforts: Three Years Later
Tuesday, March 1, 2016 - 1:45pm to 3:00pm

Content level: Basic

The NYULMC pre- and post-award management offices will discuss the administrative steps that were taken immediately after Super Storm Sandy through the closing out of the National Institutes of Health (NIH) Disaster Relief Appropriations Act (DRAA) funds. Discussion points will include the mobilization of staff and the proposal submission plan, the establishment of the Sandy Advisors and Recovery Assistance group, award set-up and monitoring, progress report requirements, Office of Inspector General (OIG) auditing and Improper Payment Act Monitoring.

Learning objectives:

  1. Understand the requirements and challenges of managing NIH DRAA funds. 
  2. Understand what steps can mitigate our research administrative challenges if a disaster were ever to occur to their institution.

 

Prerequisites: None

Speaker(s):

Sara Stanley, MA, CRA, Associate Director, Sponsored Programs Administration, Tony Carna, MBA, Senior Director, Sponsored Programs Administration, Mario Reyes, MBA, Senior Director, Research Finance Operations, Regulatory Reporting & Compliance, and Tracey Volz, Assistant Director, Research Finance Operations, Reporting & Portfolio Management, School of Medicine, New York University

 

T406: Spotlight on Sponsors
Tuesday, March 1, 2016 - 3:15pm to 4:30pm

Content level: Basic

If the array of sponsors and differing submission systems seems overwhelming, then this is the session for you. Let's shine a spotlight on many of the major sponsors (federal and non-federal) and cut through the confusion. We'll overview differing submission systems, special sponsor requirements and provide helpful tips.  

Learning objectives:

  1. Understand of some of the many different submission systems used in sponsored projects. 
  2. Identify some of the gaps they or their organization may have in sponsor requirements or systems.

 

Prerequisites: None

Speaker(s):

Fran Stephens, CRA, Proposal Development Specialist, University of Oklahoma

Wednesday, March 2, 2016

W106: Defense Advanced Research Projects Agency (DARPA): From Application Submission to Award Management
Wednesday, March 2, 2016 - 9:00am to 10:15am

Content level: Intermediate

"I want to apply for a DARPA award!" is a sentence that may strike fear into the most seasoned research administrator when uttered by a principal investigator (PI), especially when the PI has never worked with DARPA or the Department of Defense (DOD) before. DARPA applications are detailed and complex and the process is very different from the highly standardized application process for our typical sponsors (NIH, NSF, USDA, etc). Once your DARPA application is funded, the real project starts. Managing science in a results-driven sponsored research project is aided by excellent administrative and financial management of the award. In this session, the speakers will give an overview of the sponsor, discuss the pre-award process (where to find funding opportunities and explain how to respond to DARPA's funding announcements) and the post-award management (transitioning from a proposer to a performer, reporting and funding) of DARPA grants, cooperative agreements and contracts.

 

Learning objectives:

  1. Understand the DARPA mentality, where to find DARPA funding opportunities and how to construct an application. 
  2. Identify key compliance and award management issues, including reporting and Institutional Review Board (IRB) / Institutional Animal Care and Use Committee (IACUC) requirements.

 

Prerequisites: None

Speaker(s):

Will Helmrath, MSM, CRA, Grants and Contracts Coordinator, Institute of Agriculture, University of Tennessee; Chad Restrick, MSM, CRA, School of Medicine, Johns Hopkins University

W206: My National Center for Biotechnology Information (NCBI): Bibliographies, Biosketches and National Institutes of Health (NIH) Public Access Policy
Wednesday, March 2, 2016 - 10:30am to 11:45am

Content level: Basic

Keeping up with the changes that the National Institutes of Health (NIH) make to grant applications can be a challenge. My NCBI is an online resource that allows researchers to maintain a current bibliography, verify that all publications comply with the NIH Public Access Policy and build biographical sketches (biosketches) in proper NIH and National Science Foundation (NSF) formats. My NCBI can be linked to a researcher's electronic Research Administrator (eRA) Commons account, which allows researchers to quickly populate biosketches with NIH grants. This session will introduce attendees to the My NCBI tool and cover the new requirements for NIH-style biosketches.

Learning objectives:

  1. Learn to build a bibliography in My NCBI and determine if their publications are compliant with the NIH Public Access Policy. 
  2. Learn to build a biographical sketch in the new NIH format or the NSF format.

 

Prerequisites: None

Speaker(s):

Carson Harrod, PhD, Assistant Investigator, Baylor Research Institute