Minimizing Your Institution's Administrative Burdens Imprint. Susan Wyatt Sedwick Courtney Frazier Swaney Christopher Jenkins

Transcription

1 Minimizing Your Institution's Administrative Burdens Imprint Susan Wyatt Sedwick Courtney Frazier Swaney Christopher Jenkins

2 Panelists SUSAN WYATT SEDWICK, PhD, CRA Consulting Associate COURTNEY FRAZIER SWANEY, MPA, CRA Assoc. Director Office of Sponsored Projects CHRIS JENKINS, PhD, MPH, RBP, CHMM Director, Office of Research Support

3 Learning Objectives Gain awareness of the findings and recommendations from these studies on administrative burdens Identify actions that are recommended at the Federal and institutional levels to reduce this drain on science. Utilize good practices in the lessons learned from what other institutions are doing to reduce the administrative burdens on their principal investigators

4 FDP 2012 Faculty Workload Survey Federally funded researchers report spending less than 60% of their research time actually engaged in research. The rest is devoted to meeting administrative requirements. Post-award Admin, 13.6% Pre-award Proposal Prep, 15.4% Report Prep, 7.6% Active Research,

5 FDP 2012 Faculty Workload Survey Most Common and Intense Areas of Workload Common Finances Administrative Workload Personnel Profiles Summary Effort Reporting Targeted Animal Subject/IACUC Human Subjects/IRB Heavy Clinical Trials Subcontracts Cross-Agency Issues 33% 42% 25% Common Targeted Heavy

6 Financial management Animal use and care Effort reporting NSB TOP REPORTED BURDENS Grant proposals and submission Progress and other reports Human subjects protections

7 FASEB Report Emerging Themes 7

8 Cross-Cutting Themes Legislative and Regulatory Burden Need for Greater Harmonization Burden Due to Audit and Oversight Variable Institutional Support

9 Congressional Testimony Joint hearing before the House Committee on Science, Space and Technology Subcommittee on Oversight and Subcommittee on Research and Technology on Reducing the Administrative Workload for Federally Funded Research, June 12, 2014 Dr. Arthur Bienenstock, National Science Board Dr. Gina Lee-Glauser, VPR, Syracuse University Hon. Allison Lerner, Inspector General, NSF Dr. Susan Wyatt Sedwick, Chair, FDP Resulted in HR 5056

10 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 Interim report issued September 21, Final report issued June 29, 2016

11 Recommendations for Institutions Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements Assess processes to determine where compliance requirements can be streamlined to ensure effective use of indirect research recovery costs Honor just-in-time flexibility Sanction those who are not compliant Academic research institutions must take timely and appropriate action against members of their communities who violate the values of trust and integrity to which community standards and federal funding of research, as well as academic responsibilities, require strict adherence. 11

12 COGR Activities Actions to Reduce Administrative Burdens Checklist Data Collection mechanism that includes suggestions for institutions to think about reducing their own administrative burden Dr. Lisa Nichols - lnichols@cogr.edu Deadline has passed though results still trickling in Look for results in early 2017

13 Lipinski Bill HR 5583 University Regulations Streamlining and Harmonization Act of 2016 Follow up on recommendations from the National Academy of Sciences report Establishes a Research Policy Board to advise the Office of Management and Budget on proposed research regulations and recommend ways to improve existing regulation Allow for the review of research regulations by a panel of experts from the research & university community Eliminate requires for duplicative auditing of research grants (safe harbor) Streamline the procurement process for purchasing research equipment and help universities make sensible arrangements to save money by buying in bulk Simplify the application process across multiple funding agencies Assist scientists in filling out grant applications by setting up an online database for researcher information that can automatically input certain parts of applications 13

14 Lipinski Bill HR 5583 University Regulations Streamlining and Harmonization Act of 2016 Bill has been referred to the House Science, Space, and Technology committee and the Oversight and Government Reform committee Check with your federal relations representative about support from legislative officials for your congressional districts Write your congressman!! 14

15 University of Texas at Austin The University of Texas at Austin is currently engaged in an initiative to modernize business processes, data management, and information systems to facilitate effective and efficient pursuit of the University s mission of teaching, research, and service.

16 University of Texas at Austin Office of Sponsored Projects As part of the modernization project OSP must replacing the current pre-award system Research Management System (RMS) Background on RMS Homegrown system RMS went live in 1998 Stitched together By 2021 RMS will no longer be supported by the current mainframe

17 University of Texas at Austin Office of Sponsored Projects In anticipation of new electronic systems Reduced IT updates within current pre-award system One final improvement, PI workgroup surveyed to create a non-existent feature Created a better budget review vs. a tracking feature Create a game plan for possible Federal mandates Ex. ARRA, FFATA Informal internal review of needs and wants within a new system

18 University of Texas at Austin Office of Sponsored Projects Mitigating the black hole during a time of change and transition Black holes are perpetrated by poor communication and creates an additional burden on faculty by not knowing what is needed or where something is in the process. Review of current processes to help relieve administrative burden Implemented a triage system Administrative staff notifies PIs of awards faster than before and streamlines the process by requesting documentation earlier in the process Creating internal e-share system RMS unable to provide needed functionality for internal electronic document management currently needed by OSP Reduces redundant requests to the PIs Speeds up the process for award negotiation, award processing, and issuance of subawards/subcontracts Conversation for identifying items that are low-risk during the proposal stage

19 University of Texas at Austin Office of Sponsored Projects Planned elimination of Effort Reporting Revision of subrecipient processing/monitoring Identify and eliminating redundancy Realization of requesting the same pieces of information at each step Combing efforts with SPAA and the department Ex. Reduce PIs burden by receiving invoices centrally Developing a Financial Health Review Program Constantly reviewing for other inefficacies between the various stages of a sponsored project until a system is chosen and implemented

20 A Lesson in Mission Creep Biological Materials Oversight with Institutional Biosafety Committees *Jenkins, CL, (2014). Trends in United States Biological Materials Oversight and Institutional Biosafety Committees. Journal of Research Administration 45:

21 Fundamental Questions What is the regulatory extent of biological materials oversight in the United States for life sciences research entities? What insights can a cross-sectional survey provide into the current state of local biological materials oversight at life sciences research entities through IBCs reveal?

22 Survey Methodology Cross-Sectional Survey of NIH-OBA Registered Institutional Biosafety Committees FOIA #40395 (August, 2012), 857 FOIA #41293 (May, 2013), 866 Survey Design - 22 Questions Focus on Biological Materials Reviewed Recombinant DNA Whole microorganisms Biological toxins Human materials Select Agents Dual Use Research of Concerns (DURC)

23 NIH-OBA Registered IBCs Year ( ) : 12 IBCs added per year : 43 IBCs added per year 857 in in 2016

24 Full List of Survey Questions 1. Institution Type (small, medium large University, research institute, private industry, government, nonprofit, other) 2. Type of Biological Materials Research Reviewed by the IBC (rdna, non-rdna whole microorganisms, BBP, toxins, Select Agents, Dual Use) 3. Is your IBC administered internally (support staff on location) or externally (third-party) 4. Number of protocols reviewed over IBC active date range (1976 to 2012) at BSL-1, BSL-2, BSL-3, and BSL-4) 5. Estimated Time for Review per Protocol (from receipt, processing, inspection, IBC meeting, and follow-up items, approval) (0 hours to indefinite) 6. What type of renewal strategy is employed upon approval? 7. Number of Investigators with Approved Protocols 8. By year from the inception of the IBC, how many initial protocols are approved each year (1976 to 2012) 9. If yes to Recombinant DNA Research, what categories of rdna research have been reviewed? How often are IBC meetings held? 10. How many Full-Time Employees support the Institutional Biosafety Committee (0 to indefinite) 11. How much financial support does the IBC receive from the Office of Research ($0 to indefinite)? 12. If yes, is the IBC Chair Compensated for time spent (Yes/No/N/A) 13. If yes, are other Committee members compensated for time spent serving on the IBC? 14. How much financial support does the IRB receive from the Office of Research ($0 to indefinite) 15. How much financial support does the IACUC receive from the Office of Research ($0 to indefinite) 16. Committee Composition (NIH Roster and Function Support) 17. Number of scientific members 18. Number of biological safety professionals 19. Number of external (public) members 20. Number of administrative staff 21. Other members (include title and number) 22. If known, the number of NIH reported laboratory accidents involving recombinant DNA at the entity from *Jenkins, CL, (2014). Trends in United States Biological Materials Oversight and Institutional Biosafety Committees. Journal of Research Administration 45:

25 Response Rates and Institutional Demographics 181/817 Responses in Main Survey (21.2%) Institution Type Number Small University 19 Medium University 35 Large University 60 Research Institute 18 Private Industry 11 Government 9 Non-Profit 14 Other 11 Total Institutional Demographics

26 Institution Type by Biological Materials Research Small U. Medium U. Large U. Research I. Private I. Government Non-Profit Other Total rdna Microorgs OSHA BBP Bio. Toxins Select Agents DURC Other Total # Resp X 2 : Df: 28 p-value: 0.00

27 Type of Recombinant DNA Research Reviewed by the IBC Institution Type Number Laboratory Benchtop 156/172 Animal Research 124/172 Plant Research 67/172 Gene Therapy 54/172 Other 10/ Type of Recombinant DNA Research Reviewed by the IBC Laboratory Benchtop Animal Research Plant Research Gene Therapy Other

28 Institution Type by Recombinant DNA Research Reviewed by the IBC Small U. Medium U. Large U. Research I. Private I. Government Non-Profit Other Total Lab Benchtop Animal Plant Gene Therapy Other Total X 2 : Df: 28 p-value: 0.00

29 Additional Findings Range of Research Investigators at an Institution 1 to 800 (172 responses) Protocol Review Process Average time spent preparing protocol for IBC review 5.2 hours, with a range from 1 hour to 40 hours (110 responses) Average time from PI submission to IBC approval ~29 days, with a range from 7-90 days (62 responses)

30 IBC Approved Protocols By Year (aggregated) 2000 Total IBC Protocols by Year from 22 Institutions Y1976 Y1977 Y1978 Y1979 Y1980 Y1981 Y1982 Y1983 Y1984 Y1985 Y1986 Y1987 Y1988 Y1989 Y1990 Y1991 Y1992 Y1993 Y1994 Y1995 Y1996 Y1997 Y1998 Y1999 Y2000 Y2001 Y2002 Y2003 Y2004 Y2005 Y2006 Y2007 Y2008 Y2009 Y2010

31 Institutional Case Study

32 Survey Response Comments IBCs under-supported compared to peer Research Compliance Committees (IRB and IACUC) Low institutional interest except for Select Agents or exposure incidents Recombinant DNA viewed as less risky than wild-type and blood borne pathogens research Review of IBC protocols differs by Biosafety Level (BSL) and type of research Quantitative data on trends remains an ongoing need

33 Observed Trends in Biological Materials Oversight and IBCs Research involving biological materials has increased over time Protocol review data Expansion of IBC review beyond NIH Guidelines and Select Agent requirements Y1976 Y1978 Total IBC Protocols by Year from 22 Institutions Y1980 Y1982 Y1984 Y1986 Y1988 Y1990 Y1992 Y1994 Y1996 Y1998 Y2000 Y2002 Y2004 Y2006 Y2008 Y2010

34 Observed Trends in Biological Materials Oversight and IBCs Institutions registering multiple IBCs to handle different aspects of review Inconsistent or irregular data on laboratory incidents with biological materials 172/173 reviewed recombinant DNA, as required by NIH funding Others

35 Limitations of the Study Institutions lacked the ability to accurately report prior reviews of biological materials Responses skewed towards academic institutions Limited inferences with cross-sectional survey Lack of data on true number of accidents with biological materials Well documented for lab accidents to be under reported; Lack of willingness from institutions to disclose nonrecombinant accidents with biological materials. Summary: A cross-sectional survey was able to provide a snapshot of the regulatory burden previously unknown

36 Harvard University Goal: Simplification, streamlining, and consistency of policies and procedures across the university to minimize burdens while maintaining the highest quality of regulatory compliance and stewardship of research funds. The Sponsored Administration Leadership Committee (SALC) consists of members from the Office of Vice Provost for Research and the leadership of School Sponsored Administration and University Office of Sponsored Research to discuss shared issues, concerns and matters of oversight and grants management. Slide courtesy of Dr. Ara Tahmassian, Chief Research Compliance Officer

37 Harvard University Administrative Burdens SALC established working groups during the implementation of the Uniform Guidance The process streamlined many of the policies and procedures to eliminate requirements that were above and beyond regulatory requirements Ensures policies and procedures are developed with interdependencies recognized and addressed Outcome was elimination of duplications/ redundancies Slide courtesy of Dr. Ara Tahmassian, Chief Research Compliance Officer

38 Harvard University Ad-Hoc Task Force on Clinical Research/Clinical Trials: Review guidelines and develop new procedures New criteria streamline the process based on risk Human Subjects Protection: during the upgrading of the electronic system many of the IRB processes were unified and streamlined Efforts are ongoing New Advisory Committee on Research Administrative Burden Reduction is being formed for a broader review of all research administrative procedures. Slide courtesy of Dr. Ara Tahmassian, Chief Research Compliance Officer

39 Harvard University Ad-Hoc Committee on Animal Care and Use Issues A working group of faculty, veterinarians and IACUC administrators Charged with identifying redundant, unnecessary or burdensome requirements To-date, has identified and addressed some 22 burdensome issues Outcome: Great satisfaction by faculty, Focus on more important issues Improved animal welfare Reduced Committee meeting time Slide courtesy of Dr. Ara Tahmassian, Chief Research Compliance Officer

40 University of Michigan The University of Michigan is committed to continual improvement of its administrative processes and to utilizing the maximum amount of flexibility allowed under the current regulations. Since 2005 the UM has been a pioneer in piloting processing for streamlining review processes, particularly for human research, animal care and use, and conflict of interest. Currently, engaged in a major initiative to better integrate information management systems. Slide courtesy of Dr. Lois Brako, AVPR Regulatory Compliance and Oversight,

41 The RA Dashboard is a data visualization layer to provide PIs with easy access to info

42 University of Michigan HRPP Streamlining Initiative Using the major themes of frustrations with IRB review from the FDP Faculty Workload Survey: 1. Unnecessary workload for minimal risk research, 2. Review delays that disrupt research progress, 3. Redundancies and complications with multiple IRBs, 4. Issues related to reviewers (e.g. inconsistencies, wordsmithing) 5. Problems related to training requirements, 6. Difficulties with changing requirements Slide courtesy of Dr. Lois Brako, AVPR Regulatory Compliance and Oversight,

43 Resources See for information about streamlining practices at other institutions for non-fed sponsored research Granting two- or three-year approval periods (-M, MSU, Minnesota, USC, UCSF) Using expedited review for all minimal risk projects (categories not listed as eligible for expedited review) (Minnesota) Expanded exemption categories (U-M, Penn State, USC) See: The Seven Habits of Highly Effective IRBs IRBs_JeffCooper.pdf Slide courtesy of Dr. Lois Brako, AVPR Regulatory Compliance and Oversight, University of Michigan

44 Questions SUSAN WYATT SEDWICK, PhD, CRA COURTNEY FRAZIER SWANEY, MPA, CRA CHRIS JENKINS, PhD, MPH, RBP, CHMM