January 8-10, 2017
Hyatt Regency Capitol Hill
Meeting Agendas, Minutes and Presentations are available as PDFfiles for viewing and printing which requires the free Acrobat Reader.
Monday, January 9, 2017
New Attendee Orientation
FDP Project Updates
eRA Project Update
Faculty Project Update
Finance, Audit and Costing Project Update
Research Administration Project Update
Dr. Richard Buckuis, Chief Operating Officer, National Science Foundation
Recording of the presentation
TOPIC: The National Science Foundation supports basic research and education in all fields of science and engineering with 93% of its current $7.5 billion budget going to support research and educational activities, including a major emphasis on STEM education. Working collaboratively, both internally and externally, NSF has developed a number of initiatives and bold ideas for the future. Recent advances related to these efforts, community input, and proposal and award processes will be the focus of this discussion.
Faculty Lunch Forum
Dr. Mike Lauer, National Institutes of Health
TOPIC: “How Do We Measure the Value and Output of Research? Thoughts from NIH”
Committee and Task Force -- Concurrent Session 1
Single Institutional Review Board (sIRB) – Implementation and Costing Perspective Update
Speakers: Diane Dean, National Institutes of Health; Jim Luther, Duke University; Sara Bible, Stanford University
Topic: This session will start with a brief contextual update, including an overview of the requirements of implementation of the sIRB. The primary topic of discussion will be the options for direct charging the costs to clinical trials. It will be helpful if you bring anecdotal and specific concerns and questions from your institutions.
Speakers: Amanda Humphrey, Harvard University; Stephanie Scott, Columbia University; Amanda Hamaker, Purdue University
• Clarifications and guidance on the latest subaward templates.
• Half-hour discussion on guidance for authorizing carryover of funds to subrecipients.
• Updates from several subawards working groups, includes FFATA.
Open Government/eRA - DATA Act Program Management Office (DAP) Section 5 Grants Pilot: Notice of Award – Proof of Concept Test Model
Speakers: Christopher Zeleznik, Intergovernmental and Recipient Engagement Lead, HHS DATA Act Program Management Office (DAP)
Hosts: Mark Sweet, University of Wisconsin; Jason Hitchcock, U.S. Department of Agriculture; Bronda Harrison, Environmental Protection Agency; Richard Fenger, University of Washington
Topic: You will learn how the NOA – POC may help reduce recipient reporting burden for Federal grant recipients. The session will provide an overview of the DATA Act and the Section 5 Grants Pilot and execute the Notice of Award – Proof of Concept Test Model.
Faculty Working Group
Faculty Workload Survey
Committee and Task Force -- Concurrent Session 2
Clinical Trial Policy ~ Rebecca Williams
Clinical Trial Policy ~ Jodi Black
Speakers: Dr. Jodi Black, Deputy Director, Office of Extramural Research, National Institutes of Health; Rebecca J. Williams, Pharm. D., MPH, Assistant Director, ClinicalTrials.gov, National Library of Medicine
Topic: This session will focus on reporting on clinical trials in ClinicalTrials.gov and the HHS Final Rule, and the need for policy changes.
Speakers: Lynette Arias, University of Washington; Jennifer Barron, Johns Hopkins University; Pamela Webb, University of Minnesota; Julie Thatcher, Institute for Systems Biology; Chris Renner, Vanderbilt University Medical Center
Topic: Update on status of Pilot to include: Phase 1 – Excel Profile Repository: 2nd Reporting Period Data results; Phase 2 - Web based system: Demo & Training for Go-live in early 2017; plans for Cohort 3 Go-Live (3/1/2017 tentative); and Development of Financial Questionnaire for non-Single Audit entities.
Uniform Guidance: Updates on Expected Changes
Speakers: Jim Luther, Duke University; Sara Bible, Stanford University; Edwin Bemmel, University of Miami; Doug Backman, University of Central Florida
Topic: This session will cover expected updates to the Federal Register for the Uniform Guidance. The discussion will include updates on the requirements for procurement and how to implement the new requirements, and new/revised Frequently Asked Questions and other changes to the Uniform Guidance. Other regulatory updates will also be discussed including pending legislation (21st Century Cures, American Innovation and Competitiveness Act, & National Defense Authorization Act).
Open Government/eRA – DATA Act Program Management Office (DAP) Section 5 Grants Pilot: Common Data Element Repository (CDER) Library Test Model
Speakers: Christopher Zeleznik, Intergovernmental and Recipient Engagement Lead, HHS DATA Act Program Management Office (DAP), and Debbie Kramer, HHS DATA Act Program Management Office (DAP)
Hosts: Mark Sweet, University of Wisconsin; Jason Hitchcock, Dept of Agriculture; Bronda Harrison, Environmental Protection Agency; Richard Fenger, University of Washington
Topic: You will learn how the CDER Library, a Federal-wide, online repository for grants-specific data standards, definitions, and context, can help reduce recipient reporting burden. To participate, bring a laptop or tablet
Faculty Working Group
Faculty Workload Survey (continued)
Faculty Working Group
Research Pipeline Initiative
Committee and Task Force -- Concurrent Session 3
eRA – SciENcv & Administrative Burden
Speakers: Neil Thakur, National Institutes of Health; Bart Trawick, National Institutes of Health; Lori Schultz, University of Arizona
Topic: This session will feature a SciENcv update with Neil Thakur and Bart Trawick from the NIH. After the update, eRA Committee members will facilitate small group discussions to gather feedback about possible future functionality. We’ll also discuss pending legislation that may impact the profile space.
21st Century Cures Act and the Impact on Research Regulations
Recording of the presentation
Speakers: Dick Seligman, California Institute of Technology; David Robinson, Oregon Health & Sciences University
Topic: This session will present information on the recently enacted 21st Century Cures Act and its implications for the FDP in 2017 and beyond. One section of the Cures Act is devoted to “Reducing Administrative Burden for Researchers.” Details of that section will be presented and discussed. As time permits, other legislative actions impacting the reduction of administrative burden will be discussed.
Speakers: J.P. Kim, National Institutes of Health; Dina Paltoo, National Institutes of Health; Melissa Korf, Harvard University; Rick Ikeda, National Institutes of Health
Topic: In mid-November, NIH published a Request for Information (RFI) on Strategies for NIH Data Management, Sharing, and Citation. In this session, we will share information on the background context that led to the issuance of the RFI and the NIH’s NIH plans for next steps with the information obtained. We will have an opportunity for questions and answers regarding the intention behind the questions posed in the RFI. We will also have the opportunity for a discussion among the membership about how various institutions plan to respond.
Tuesday, January 10, 2017
Committee and Task Force -- Concurrent Session 4
Membership Standing Committee
Co-Chairs: Larry Sutter, Michigan Technological University; Charisse Carney-Nunes, National Science Foundation; Becky Hayes, Kent State University
Topic: Committee Business
Animal Care & Use Subcommittee
Speakers: Ara Tahmassian, Harvard University; Susan Silk, National Institutes of Health, Sally Thompson-Iritani, University of Washington; Michelle Brot, University of Washington, Aubrey Schoenleben; University of Washington
Topic: The University of Washington’s Office of Animal Welfare is proposing to set up a repository where an index of substances and procedures that are commonly used for animal care protocols can be placed and used by the broader animal welfare compliance community. This will be the initial meeting for attendees to discuss the best way to store, display, access, and update this information through some kind of electronic database. We encourage any and all interested institutions to attend and provide input.
Changes to Policies for Intergovernmental Personnel Act (IPA) Agreements for Personnel on Assignment to NSF
Session Leaders: Gerri Ratliff, Deputy Division Director, Human Resource Management Division, NSF; Anand Desai, Section Head, Evaluation and Assessment Capability, Office of Integrative Activities, NSF; Lisa Frehill, Evaluation and Assessment Capability, Office of Integrative Activities, NSF; Joanne Tornow, Chief Human Capital Office and Head, Office of Information and Resource Management, NSF
Topic: For many years, the National Science Foundation (NSF) has provided the opportunity for scientists, engineers, and educators to rotate into the Foundation on a temporary basis. Many of our rotators, who are an integral and valued part of the NSF workforce, come to the agency through the Intergovernmental Personnel Act (IPA) program. As part of the continuing effort to enhance the administration of temporary personnel at NSF under the IPA program, on October 21, 2016, NSF announced changes for all new IPA agreements. First, NSF is piloting a requirement that institutions continue to pay 10% of the IPA’s academic-year salary and benefits. Second, lost consulting payments are no longer a reimbursable cost element. In addition, NSF-funded IPA travel to the home institution under the Independent Research/Development (IR/D) program is now limited to 12 trips per year. In this session, NSF representatives will answer questions about the new policies and solicit feedback on the extent to which they may impact universities’ willingness to support staff in accepting IPA assignments at NSF.
Committee and Task Force -- Concurrent Session 5
Co-Chairs: Sandy Schneider, University of South Florida; Michele Masucci, Temple University
Topic: Reports of Faculty Liaisons to Committees, Subcommittees, and Working Groups
Data Stewardship Survey Results
Speakers: David Mayo, California Institute of Technology; Alexandra Albinak, Johns Hopkins University; Melissa Korf, Harvard University; Rick Ikeda, National Institutes of Health
Topic: FAR Implementation of the Uniform Guidance; DFARS 7012, FAR CUI and other committee business; Data Stewardship survey results
eRA – Agency Matrix Discussion
Speakers: eRA Steering Committee
Topic: Research institutions must interact with a wide variety of pre- and post-award Federal Agency systems. This session will be an open discussion on an updated version of the Federal Agency Matrix. The Matrix was originally created in 2003 and contains information on various Federal electronic systems. However, there have been many changes since the last revision. This updated Agency Matrix could have several uses: i) reference for institutions; ii) reference for the Federal Agencies to see other Federal systems; iii) documentation of administrative burden brought on by Federal systems. The eRA Steering Committee will also be looking for pre- and post-award volunteers for a small working group to complete the Matrix.
Plenary – Federal Agency Updates