1. ©2015 Attain, LLC April 22,2015 Sponsored Projects Roulette Spinning the Wheel Each Day Susan Wyatt Sedwick, Ph.D., C.R.A. Consulting Associate, Higher Education and Academic Medical Centers Attain, LLC

2. ©2015 Attain, LLC Revising policies, procedures and systems DS-2 Revisions Procurement Provisions After-the-fact certifications Sub-award risk assessment and monitoring Charging administrative costs and computing devices Uniform Guidance Implementation

3. ©2015 Attain, LLC Balancing Compliance with Administrative Burden Multiple studies with good intentions/recommendations Universities must take an introspective look at their own policies and procedures Advocate for change by responding to requests for information (e.g. FDP procurement burdens survey)

4. ©2015 Attain, LLC H.R. 5056 Requires Director of OSTP to establish a working group under the authority of the NSTC that includes the OMB Working group would be responsible for reviewing federal regulations affecting research universities and making recommendations to harmonize, streamline and eliminate with input from non-federal stakeholders Introduced 7/10/2014, passed house unanimously without amendment 7/14/2014, and referred to Senate Committee on Commerce, Science and Transportation

5. ©2015 Attain, LLC HR 4186 FIRST Act Frontiers in Innovation, Research, Science, and Technology Act of 2014 introduced 5/28/2014 Directs OSTP to convene a working group to harmonize, streamline and eliminate duplicative regulations; minimize burden while maintaining accountability Requires Director of NSF to study the use of NSF-funded scientific computing resources at IHE

6. ©2015 Attain, LLC National Research Council Study Received $1 million from the US Department of Education under the Consolidated Appropriations Act of 2014 to study the time and costs to institutions required to comply with the regulations and reporting requirements. NRC Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities for the 21 st Century http://sites.nationalacademies.org/PGA/stl/ResearchRe gs/index.htm http://sites.nationalacademies.org/PGA/stl/ResearchRe gs/index.htm Report anticipated in early 2016

7. ©2015 Attain, LLC Yale/AAU/COGR/APLU Survey Effort Reporting FCOI Subrecipient monitoring Human Subjects Financial reporting and grants management Animal research

8. ©2015 Attain, LLC FASEB Study on Administrative Burdens Federation of American Societies For Experimental Biology (FASEB) 2013 survey on administrative burdens 2014 roundtable discussions with key stakeholders Final report now available http://www.faseb.org/Portals/2/PDFs/opa/2014 /6.7.13%20FASEB%20NSB%20Survey%20findin gs.pdf?pdf=6.7.13%20FASEB%20NSB%20Surve y%20findings http://www.faseb.org/Portals/2/PDFs/opa/2014 /6.7.13%20FASEB%20NSB%20Survey%20findin gs.pdf?pdf=6.7.13%20FASEB%20NSB%20Surve y%20findings

9. ©2015 Attain, LLC FASEB Survey Analysis Most burdensome ­ Grant preparation and ongoing management ­ Animal care regulations ­ Training requirements ­ Clinical and human subjects compliance Emerging themes ­ Improved agency communication and cooperation ­ Need for evidence-based assessment of existing regs ­ Need for metrics taking into account institutional characteristics

10. ©2015 Attain, LLC Created: December 2012 Charge: To examine the administrative burden imposed on federally supported researchers at U.S. colleges, universities, and non-profit institutions and offer recommendations where appropriateon relieving the administrative workload. Reports from FDP and Faculty Workload Survey, Research Business Models Working Group, IRB/IACUC Accreditors Request for Information (RFI) March 2013 NIH, NSF, OSTP, USDA APHIS, NIH OLAW, COGR, AAU, APLU Roundtable discussions April-May 2013 Report published March, 2014 http://www.nsf.gov/pubs/2014/nsb1418/nsb1418.pdf National Science Board (NSB) Task Force on Administrative Burdens

11. ©2015 Attain, LLC Financial management Grant proposals and submission Progress reports and other reports Human subjects research and IRBs Effort reporting Animal subjects research and IACUCs NSB Top Reported Burdens

12. ©2015 Attain, LLC Legislative and regulatory burden Need for greater harmonization Burden due to audit and oversight Variable institutional support NSB Cross-cutting Themes

13. ©2015 Attain, LLC Participants: 13453+ PIs on Federal Grants/Contracts (26% response rate)99 of 119 FDP non-federal member organizations (83%) Purposes: Assess changes in burdens since FWS1 in 2005 Obtain more detailed information about specific burdens Provide information to FDP and others to facilitate targeted reduction of administrative burden FDP 2012 Faculty Workload Survey

14. ©2015 Attain, LLC DATA Act Digital Accountability and Transparency Act (Data Act) of 2014 Oversight provided by the Recovery Accountability and Transparency Board but expands on the FFATA reporting requirements Specified role for agency IGs Three Year implementation plan with a two-year pilot Purposes: ­ Make Federal expenditures data more easily accessible and transparent expanding the information provided through USASpending ­ Simplify reporting by streamlining reporting requirements

15. ©2015 Attain, LLC Dual Use Research of Concern (DURC) Requires ongoing monitoring of life sciences research that can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misapplied to pose national security risk. Oversight by the National Science Advisory Board for Biosecurity (NSABB) Scope limited to specified toxins/agents and categories of experiments Code of Conduct Toolkit http://osp.od.nih.gov/office-biotechnology- activities/biosecurity/dual-use-research-concern http://osp.od.nih.gov/office-biotechnology- activities/biosecurity/dual-use-research-concern

16. ©2015 Attain, LLC Conflicts of Interests Confusion caused by Uniform Guidance PHS compliance Lack of harmonization Oversight ­ Investigator Disclosure Process ­ Overlap with Conflicts of Commitment/Outside Employment ­ Reviewing Disclosed FCOI ­ Mitigating FCOI ­ Management Plans ­ Monitoring and annual Updates

17. ©2015 Attain, LLC Perils & Pitfalls of Startups Conflict of Commitment Hiring Students Employing University Faculty & Administrators Corporate Role vs Project PI Company vs University Proposal Submission Facilities Use

18. ©2015 Attain, LLC Crowd Funding Research or Gift? If gift, lack of oversight Signatory authority Fees (program income?) Intellectual property/confidentiality

19. ©2015 Attain, LLC Data Issues Data sharing Protection of sensitive data ­ Confidential Information Protection and Statistical Efficiency Act (CIPSEA) ­ Federal Information Security Management Act (FISMA)  NIST Special Publication 800-53  NIST Special Publication 800-171 ­ Health Insurance Portability & Accountability Act (HIPAA) ­ DFARS Safeguarding of Unclassified Controlled Technical Information (Nov 2013)

20. ©2015 Attain, LLC Export Controls NASA China Rule Russia Rule ­ DFARS Safeguarding of Unclassified Controlled Technical Information (Nov 2013)

21. ©2015 Attain, LLC Operating at the intersection of experience and innovation. Susan Wyatt Sedwick, Ph.D., C.R.A Consulting Associate, Attain, LLC Phone: 703.857.2200 ssedwick@attain.com Attain, LLC Higher Education and Academic Medical Centers 1600 Tysons Boulevard, Suite 1400 McLean, VA 22102 703.857.2200 education@attain.com www.attain.com Contact Information 21