©2015 Attain, LLC

April 22,2015

Sponsored Projects RouletteSpinning the Wheel Each Day

Susan Wyatt Sedwick, Ph.D., C.R.A.Consulting Associate, Higher Education and Academic Medical Centers Attain, LLC

©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

©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)

©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

©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

©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 21st Century

• http://sites.nationalacademies.org/PGA/stl/ResearchRegs/index.htm

• Report anticipated in early 2016

©2015 Attain, LLC

Yale/AAU/COGR/APLU Survey• Effort Reporting• FCOI• Subrecipient monitoring• Human Subjects• Financial reporting and grants

management• Animal research

©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%20findings.pdf?pdf=6.7.13%20FASEB%20NSB%20Survey%20findings

©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

©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 appropriate on 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

©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

©2015 Attain, LLC

• Legislative and regulatory burden• Need for greater harmonization• Burden due to audit and oversight• Variable institutional support

NSB Cross-cutting Themes

©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

©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

©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

©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

©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

©2015 Attain, LLC

Crowd Funding

• Research or Gift?• If gift, lack of oversight• Signatory authority• Fees (program income?)• Intellectual property/confidentiality

©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)

©2015 Attain, LLC

Export Controls

• NASA China Rule

• Russia Rule

­DFARS Safeguarding of Unclassified Controlled Technical Information (Nov 2013)

©2015 Attain, LLC21

Operating at the intersection of experience and innovation.

Susan Wyatt Sedwick, Ph.D., C.R.AConsulting Associate, Attain, LLCPhone: 703.857.2200ssedwick@attain.com

Attain, LLCHigher Education and Academic Medical Centers1600 Tysons Boulevard, Suite 1400McLean, VA 22102703.857.2200education@attain.comwww.attain.com

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