Minimizing Your Institution's Administrative Burdens Imprint · Minimizing Your...

Minimizing Your Institution's Administrative

Burdens Imprint

Susan Wyatt SedwickCourtney Frazier Swaney

Christopher Jenkins

Panelists

SUSAN WYATT SEDWICK, PhD, CRA Consulting Associate

COURTNEY FRAZIER SWANEY, MPA, CRAAssoc. Director – Office of Sponsored Projects

CHRIS JENKINS, PhD, MPH, RBP, CHMMDirector, Office of Research Support

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

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.

4

Active Research, …

Proposal Prep, 15.4%

Pre-award …

Post-award Admin, 13.6%

Report Prep, 7.6%

2012

Most Common and Intense Areas of WorkloadCommon• Finances• Personnel• Effort Reporting

Targeted• Animal Subject/IACUC• Human Subjects/IRB

Heavy• Clinical Trials• Subcontracts• Cross-Agency Issues

33%

42%

25%

Administrative Workload Profiles Summary

Common Targeted Heavy

FDP 2012 Faculty Workload Survey

Financial management

Grant proposals

and submission

Progress and other reports

Human subjects

protections

Effort reporting

Animal use and care

NSB TOP REPORTED BURDENS

FASEB Report Emerging Themes

7

Legislativeand Regulatory

Burden

Need for Greater

Harmonization

Burden Due to Audit and Oversight

Variable Institutional

Support

Cross-Cutting Themes

• 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

Congressional Testimony

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

• Interim report issued September 21, 2015.• Final report issued June 29, 2016

• 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

Recommendations for Institutions

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

Lipinski Bill – HR 5583University 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

• 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

Lipinski Bill – HR 5583University Regulations Streamlining and Harmonization

Act of 2016

University of Texas at AustinThe 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.

University of Texas at AustinOffice of Sponsored Projects

As part of the modernization project OSP mustreplacing 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

University of Texas at AustinOffice 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

University of Texas at AustinOffice 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

University of Texas at AustinOffice 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

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: 35-48.

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?

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)

0

100

200

300

400

500

600

700

800

900

Year (1976-2013)

NIH-OBA Registered IBCs

• 1976-2000: 12 IBCs added per year

• 2001-2013: 43 IBCs added per year

• 857 in 2013• 902 in 2016

1. Institution Type (small, medium large University, research institute, private industry, government, non-profit, 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 Protocols8. 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?

*Jenkins, CL, (2014). Trends in United States Biological Materials Oversight and Institutional Biosafety Committees. Journal of Research Administration 45: 35-48.

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 members18. Number of biological safety professionals19. Number of external (public) members20. Number of administrative staff21. Other members (include title and number)22. If known, the number of NIH reported laboratory

accidents involving recombinant DNA at the entity from 1976-2012.

Full List of Survey Questions

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 177

0

10

20

30

40

50

60

70

Institutional Demographics

Institution Type by Biological Materials Research

Small U. Medium U. Large U. Research I. Private I. Government Non-Profit Other Total

rDNA 18 35 59 17 11 8 13 11 172

Microorgs. 11 24 43 8 2 5 8 8 109

OSHA BBP 10 22 37 13 3 5 5 8 103

Bio. Toxins 8 18 41 9 2 6 3 7 94

Select Agents 10 20 40 7 2 5 2 7 93

DURC 2 9 30 5 0 2 3 5 56

Other 1 4 9 1 1 1 0 3 20

Total # Resp. 19 35 60 18 11 9 14 11 173

X2: 53.18 Df: 28 p-value: 0.00

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 10/172 0

20

40

60

80

100

120

140

160

180

LaboratoryBenchtop

Animal Research Plant Research Gene Therapy Other

Type of Recombinant DNA Research Reviewed by the IBC

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 18 31 60 15 7 7 10 8 156

Animal 13 26 51 14 3 3 6 8 124

Plant 7 11 42 2 2 0 2 1 67

Gene Therapy 6 12 15 3 3 3 3 9 54

Other 0 2 4 0 1 0 2 1 10

Total 18 34 60 17 11 8 13 11 172

X2: 53.18 Df: 28 p-value: 0.00

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)

IBC Approved Protocols By Year (aggregated)

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Y197

6

Y197

7

Y197

8

Y197

9

Y198

0

Y198

1

Y198

2

Y198

3

Y198

4

Y198

5

Y198

6

Y198

7

Y198

8

Y198

9

Y199

0

Y199

1

Y199

2

Y199

3

Y199

4

Y199

5

Y199

6

Y199

7

Y199

8

Y199

9

Y200

0

Y200

1

Y200

2

Y200

3

Y200

4

Y200

5

Y200

6

Y200

7

Y200

8

Y200

9

Y201

0

Total IBC Protocols by Year from 22 Institutions

Institutional Case Study

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

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

0

500

1000

1500

2000

Y197

6Y1

978

Y198

0Y1

982

Y198

4Y1

986

Y198

8Y1

990

Y199

2Y1

994

Y199

6Y1

998

Y200

0Y2

002

Y200

4Y2

006

Y200

8Y2

010

Total IBC Protocols by Year from 22 Institutions

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

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 non-

recombinant accidents with biological materials.

Summary: A cross-sectional survey was able to provide a snapshot of the regulatory burden previously unknown

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

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

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

Harvard UniversityAd-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

University of MichiganThe 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,

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

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,

Resources See http://www.usc.edu/admin/oprs/flex 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

https://oprs.usc.edu/files/2013/07/Seven-Habits-of-Highly-Effective-IRBs_JeffCooper.pdf

Slide courtesy of Dr. Lois Brako, AVPR – Regulatory Compliance and Oversight, University of Michigan

Questions

SUSAN WYATT SEDWICK, PhD, CRA Email: ssedwick@attain.com

COURTNEY FRAZIER SWANEY, MPA, CRAEmail: c_frazier@austin.utexas.edu

CHRIS JENKINS, PhD, MPH, RBP, CHMMEmail: chris.Jenkins@austin.utexas.edu