Regulatory Burden in Research

David W. Robinson, Ph.D. Executive Vice Provost

Oregon Health & Science University

CASRAI October 2016

2

The Problem

“Concerns have been raised repeatedly that federal laws, regulations, rules, policies, guidances, and reporting requirements, while essential to a well-functioning, responsible system of research, have led over time to an environment wherein a significant percentage of an investigator’s time is spent complying with regulations, taking valuable time away from research, education, and scholarship.”

Report Summary, “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century”, 2015

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Cumulative Number of New Federal Regulations or Modifications

0

10

20

30

40

50

60

70

80

90

100Cu

mul

ativ

e N

umbe

r of N

ew F

eder

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odifi

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Data from COGR and FASEB

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However…..

“Effective regulation is essential to the overall health of the research enterprise, protecting both national investment and the various parties in the partnership (research participants, investigators, universities, and agencies).

Report Summary, “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century”, 2015

Regulatory Burden

Faculty workload surveys

In order to assess the administrative burden placed on federally funded faculty by increases in regulations, especially with respect to reporting, compliance, safety and security, the Federal Demonstration Partnership (FDP) has conducted two large scale surveys of its members. The original survey was conducted in 2006 and collected data from 6,295 principal investigators who had received federal funding in 2005 The current follow-up survey was conducted last year based on data collected from 13,452 principal investigators who had received federal funding in 2012 The 2014 Faculty Workload Survey can be downloaded from:

http://sites.nationalacademies.org/pga/fdp/index.htm

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Cumulative Number of New Federal Regulations or Modifications

0

10

20

30

40

50

60

70

80

90

100Cu

mul

ativ

e N

umbe

r of N

ew F

eder

al R

egul

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or M

odifi

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Exi

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gula

tions

Data from COGR and FASEB

Workload on federally-funded projects

Active Research,

57.7%

Pre-Award

Activities, 22.6%

Post-Award

Activities, 19.7%

2005

Workload on federally-funded projects

Active Research,

57.7% Pre-Award Activities,

22.6%

Post-Award Activities,

19.7%

2005

Active Research,

57.7% Pre-Award Activities,

21.1%

Post-Award Activities,

21.2%

2012

• Researchers still report spending less than 60% of their research time actually engaged in research! • 42% of their federally-funded research time is still spent completing pre- and post-award requirements!

Workload on federally-funded projects

Active Research,

57.7% Pre-Award Activities,

22.6%

Post-Award Activities,

19.7%

2005

Active Research,

57.7% Proposal

Prep, 15.4%

Pre-award Admin, 5.7%

Post-award Admin, 13.6%

Report Prep, 7.6% 2012

On average, 23% of researchers’ federal research time is spent writing proposals and progress reports; almost 20% is spent on other administrative requirements.

Faculty burden rating in 2005

2

2.5

3

3.5

Mea

n Ti

me

Away

Rat

ing

(2-li

ttle

to

5-m

uch)

Administrative Workload Type

Faculty burden rating in 2005 vs 2012

2

2.5

3

3.5

Mea

n Ti

me

Away

Rat

ing

(2-li

ttle

to 5

-muc

h)

Administrative Workload Type

2005 2012

Time for Action

There is no question that when effective and well coordinated, federal regulation protects the government, universities, investigators and the public and helps prevent fraud, waste and abuse. However, there is a growing concern that the unintended cumulative effect of federal regulation is undermining research productivity and diminishing the return on federal investment in research. As a result, Congress called upon the National Academy of Sciences to examine the regulations and policies of federal agencies that support the research enterprise. In turn the National Academy of Sciences formed an ad hoc “Committee on Federal Research Regulations and Reporting Requirements: A New Framework for the 21st Century”

Summary of Recommendations The activities of the Committee were recently published and can be obtained from https://www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory The Committee documented 9 overarching findings and made 4 broad recommendations to help address regulatory burden that included 44 specific recommendations directed towards the President, Congress, Inspectors General, Office of Management and Budget, Research and other Federal Agencies and Research Institutions Since Part I of the report was published last year, a number legislative proposals have been introduced to 114th US Congress by Democrats and Republicans alike to address the toll federal research regulations take on investigators. There has also been a lot of activity at the Federal Agency level to try to address some of the issues raised. However, only if Legislators, Federal Agencies and the Research Institutions work together will the issues related to regulatory burden be effectively addressed.