by Stuart Buck
In the first installment of this series, I wrote about the burden of administrative compliance on federally-funded researchers. Everyone seems to agree that the burden is tremendous. Official surveys show that it is as much as 44% of researchers’ time, and worse, the “time taken from research by requirements is increasing, not decreasing.”
The next question: What has been done to address this problem?
Quite a bit. But not enough to have any meaningful effect.
Why is that so?
That’s where things get complicated and lengthy. Bear with me — it’s not easy to come up with a compelling way to write about bureaucratic requirements.
But ultimately, it’s a fascinating story about how government works–or doesn’t. The TL;DR version:
In case after case after case, major agencies write a monster-sized report, and even get stuff enacted into legislation. But in no case do the reports or legislation 1) identify the exact actors who are going to be 2) held responsible for 3) actually solving the problem 4) on a particular timeline.
Without any of that, reports and legislative recommendations often end up getting ignored, and the problem continues to get worse.
So that’s the TL;DR version. Here’s the full story.
The 1999 Report
First, let’s rewind 24 years.
In 1998, the House Committee on Appropriations had asked NIH to “streamline and rationalize duplicative and unnecessary Federal regulations which govern the conduct of extramural scientific research.”
The next year, NIH released a report written by John Mahoney (who had been NIH’s deputy director for management). The report’s title: “NIH Initiative to Reduce Regulatory Burden.” (Here’s an article in Nature at the time.) The report’s purpose was “to identify items considered to be burdensome by the research community and to begin the process of identifying potential solutions for the issues that emerged.”
To produce the report, Mahoney set up five different workgroups of about 10 experts apiece–the workgroups each had a specific item to investigate, such as conflicts of interest, research integrity, and ethical rules for research on human subjects.
The report highlighted the need for “dramatic change” in many ways — NIH needed to start focusing on “results, not process” by eliminating procedural burdens that don’t actually lead to hard results, and needed to eliminate conflicting requirements that just created confusion, and so forth.
The report then concluded that “NIH should designate an individual, or an Office . . . to coordinate this overall effort to reduce regulatory burden” across NIH, other agencies, the White House and Congress.
This is important: The 1999 report pointed out that someone had to be given the direct responsibility of making all this happen.
After all, reports are just a bunch of words, until someone is given the direct mandate to carry out the report’s recommendations.
Keep that principle in mind. It will come up again, and again, and again.
What happened next?
It’s hard to tell.
This is partly because websites from the early 2000s have vanished, even at NIH.gov.
(One might hope that major government agencies would maintain permanent URLs over time, or else figure out how to migrate/redirect if needed.)
It’s also because the people involved are hard to track down (e.g., John Mahoney had originally retired in 1996, and as far as I can tell, he is either deceased or has completely vanished from the Internet).
But here are a couple of the examples I could find.
First, in December 1999, the NIH’s Office of Extramural Research released “Guidance Regarding Reduction of Regulatory Burden in Laboratory Animal Welfare.”
Promising title, but what of the substance?
This guidance did two things: It allowed university committees that do ethical review of animal research (IACUCs, or Institutional Animal Care and Use Committees) to 1) submit annual reports on membership changes, etc., at the same time that they report to the accrediting association, and 2) do their 6-month evaluations and inspections of animal facilities with “ad hoc consultants” just as they do for reports to the accrediting association.
Second, the NIH released a “Regulatory Burden Three-Month Plan” for late 1999 (available only through the Internet Archive here). It’s hard to summarize without being tedious, but the three-month plan mostly consisted of a lot of meetings with external associations and with the FDA (in the latter case, to figure out how to reconcile the two agencies’ rules on whether to allow teleconferences for IRB meetings).
What Did I Not find?
Any instance where somebody was given the key responsibility of making sure that the report’s recommendations actually happened.
In other words, there was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
Instead, the NIH’s actions — admittedly at 20+ years’ remove — seem like making a molehill out of a mountain. Congress and the 1999 report identified huge regulatory burdens that demanded “dramatic change,” but the immediate response was to do things like coordinating a few deadlines and teleconferencing rules. In other words, the problem was monumental, but the initial response only came up with a few trivial cures.
A small wonder that when the Association of American Medical Colleges put out a short policy brief on regulatory burden, the paragraph on the NIH’s 1999 report skipped straight to a 2012 survey, with literally no information about anything in between.
Whatever happened in those years wasn’t enough for anyone to notice or care.
The 2012 Survey
So too, let’s skip ahead to that 2012 Faculty Workload Survey by Federal Demonstration Partnership.
A short note: the Federal Demonstration Partnership is a long-running partnership between the National Academies, federal agencies, and universities. As of 2012, the partnership included 10 federal agencies and 119 organizations that did federally-funded research (mostly universities).
The headline from this report/survey: federally-funded scientists said that “an average of 42% of their research time associated with federally-funded projects was spent on meeting requirements rather than conducting active research.”
The most common burdens involved “federal project finances, personnel, and effort reporting.” And for researchers who worked with human or animal subjects (as opposed to everything else, from stars to cells), the requirements from ethical review boards “were by far the most time-consuming.” Other obligations that seemed to be time-consuming “were those involving clinical trials, subcontracts, and cross-agency differences.”
The report concludes that “reducing the administrative workload associated with federally-funded projects is critical for increasing the efficiency and effectiveness of research,” and that the current burden of bureaucracy harmed “the ability of highly qualified scientists to focus on the content of their research.”
In other words, there was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
The 2014 National Science Board report
In 2012, the National Science Board (which helps govern the National Science Foundation) started up a Task Force on Administrative Burdens. They then released a report in 2014: “Reducing Investigators’ Administrative Workload for Federally Funded Research.”
The report starts out by noting that “we have lost focus on the science and introduced requirements that are not necessary for the assessment of merit and achievement, accountability, or the protection of research subjects.” “Failure to address these issues has resulted in wasted Federal research dollars. At a time of fiscal challenges and with low funding rates at many Federal agencies, it is imperative that these issues are addressed so that researchers can refocus their efforts on scientific discovery and translation.”
The National Science Board had several recommendations.
First, requirements that are “not critical” to a proposal’s initial review should be “postponed until the proposal has been positively reviewed and is being considered for funding.” Second, regulations that “are ineffective or inappropriately applied to research” should be reduced or eliminated.
Third, the report noted that despite efforts by “OMB, Federal agencies and groups such as the Research Business Models Working Group (RBM) and FDP [Federal Demonstration Partnership], a substantial lack of consistency and standardization remains within and among agencies in all aspects of grant management.”
Fourth, the report noted that universities themselves had a role to play, such as avoiding “adding unnecessary requirements to those already mandated,” and working to provide better support to researchers doing work with human or animal subjects.
In other words, there was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
Not even NSF.
The 2016 National Academies report
In 2016, the National Academies released a report prepared at Congress’ behest. Its title: “Optimizing the Nation’s Investment in Academic Research.”
An “overarching” conclusion was that “the continuing expansion of federal regulations and requirements is diminishing the effectiveness of the U.S. research enterprise and lowering the return on the federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters.”
The National Academies panel moreover concluded that “the only clear path to strengthening the U.S. research enterprise and preparing it for continued leadership in the 21st century is through the creation of a Research Policy Board as an analytical, anticipatory, and coordinating forum on research regulatory policy.”
One of the main conclusions was that the White House OSTP should create a permanent position “for the primary purpose of maintaining strong links to the research community, the Office of Management and Budget, federal research agencies, inspectors general, and the United States Congress.”
The White House OSTP could theoretically accomplish something here, but it would probably be difficult. Under Trump, OSTP’s director (Kelvin Droegemeier) prioritized the issue of reducing administrative burden, and even hired someone (Lisa Nichols) who had worked on it extensively before while at the National Science Board (see the report above, which both she and Droegemeier were involved with!). Yet it’s fair to say that OSTP wasn’t able to get much progress even under a president who bragged about reducing regulations–no one at federal funding agencies was mandated to take action, after all.
In other words, there was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
The 2016 GAO report
In response to a request from Congress, the Government Accountability Office (GAO) released a report in 2016 titled, “Federal Research Grants: Opportunities Remain for Agencies to Streamline Administrative Requirements.”
Opportunities remain. Yes, indeed.
Unfortunately, that title is timeless. Opportunities always remain to do something here, because no one is ever given a mandate and timeline to actually do anything.
What did GAO recommend, after an extensive review of the efforts to date?
Four things.
First, HHS and NSF should work with NASA, Energy, and OSTP to “identify additional areas where they can standardize requirements.”
Second, HHS and others should try to “reduce pre-award administrative workload and costs” by figuring out how to use “preliminary proposals,” or to postpone certain requirements until it looked like someone would indeed get funding.
Third, HHS should look at adjusting the conflict of interest requirements, so as to focus on areas of greatest risk while reducing the burden of reporting trivial issues.
Fourth, OMB should look at the “requirements for purchases and subrecipient monitoring” to focus on the “areas of greatest risk for improper use of research funds.”
All good ideas. But . . . yes, you guessed it:
There was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
Finally, some legislative action!
2016 was a big year for addressing research bureaucracy. There were two pieces of legislation that tried to create interagency working groups on the issue.
At long last, some progress!
Well, no. Neither piece of legislation accomplished much, in the end.
Let’s take a closer look.
The American Innovation and Competitiveness Act
2016 started out with the enactment of the American Innovation and Competitiveness Act, Public Law no. 114-329 (enacted Jan. 6, 2016). [As is customary in government, there’s a way to pronounce the abbreviation: AICA is pronounced “Ike-uh,” which at least makes more sense than how NHTSA is pronounced.]
Section 201 of that Act has its own title — the “Research and Development Efficiency Act.”
It says that Congress recognizes “researchers spend as much as 42 percent of their time complying with Federal regulations, including administrative tasks such as applying for grants or meeting reporting requirements,” and that “it is a matter of critical importance to United States competitiveness that administrative costs of federally funded research be streamlined so that a higher proportion of federal funding is applied to direct research activities.”
The Act then says that OMB and OSTP should “establish an interagency working group” for the ‘purpose of reducing administrative burdens on federally funded researchers.”
What else was that group supposed to do?
Lots of things, all of them useful (or potentially so)!
“regularly review relevant, administration-related regulations imposed on federally funded researchers”
“recommend those regulations or processes that may be eliminated, streamlined, or otherwise improved”
“recommend ways to minimize the regulatory burden on United States institutions of higher education performing federally funded research while maintaining accountability for federal funding”
“recommend ways to identify and update specific regulations to refocus on performance-based goals rather than on process”
The working group was also given several specific responsibilities, such as:
“conduct a comprehensive review of Federal science agency grant proposal documents; and develop, to the extent practicable, a simplified, uniform grant format to be used by all Federal science agencies”
“establish, to the extent practicable, a secure, centralized database for investigator biosketches, curriculum vitae, licenses, lists of publications, and other documents”
“establish a central repository for all of the assurances required for Federal research grants; and provide guidance to institutions of higher education and Federal science agencies on the use of the centralized assurances repository”
“conduct a comprehensive review of the mandated progress reports for federally funded research; and develop a strategy to simplify investigator progress reports”
The working group was supposed to work with researchers (federally funded or not), colleges, scientific societies, nonprofit research institutions, industry, and members of the public, in investigating all the above.
Notably, though, such outside folks were not actually represented on the board itself.
So, that was one research board that was supposed to have launched in 2016. There’s another!
The 21st Century Cures Act
On Dec. 13, 2016, the 21st Century Cures Act was enacted (Public Law 114-255, embodied at 42 U.S.C. section 3051 (note). This bill did several things.
One was to mandate that the HHS Secretary and/or the NIH Director should take specific actions to reduce administrative burden.
- First, within 2 years, the HHS Secretary should “lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest,” and should try to “harmonize existing policies and reduce administrative burden on researchers.”
- Second, the NIH Director should “implement measures to reduce the administrative burdens” about “monitoring of subrecipients of grants.”
- Third, the HHS Secretary and NIH Director should “evaluate financial expenditure reporting procedures” and try to “avoid duplication” and “minimize burden.”
- Fourth, the NIH Director should work with USDA and FDA to review the regulations for animal research, and “reduce administrative burden on investigators.”
- Fifth, the HHS Secretary should work with OMB to clarify how much flexibility grantees have as to “documentation of personnel expenses.”
Finally, the Act said that OMB should “establish an advisory committee” known as the Research Policy Board. The Board would include up to 10 federal members, including folks from OMB, OSTP, HHS, and NSF.
Unlike the board created in the American Innovation and Competitiveness Act, the Research Policy Board had to include 9 to 12 outsiders–i.e., folks from universities or other non-profit institutions. As Lisa Nichols and David Wynes argued in Science, this part was quite important: universities are where federal requirements get implemented, and the sponsored programs offices know the impact better than anyone.
What was the Research Policy Board supposed to do?
Make recommendations about changing and harmonizing policies so as to reduce administrative burden “to the greatest extent possible.” This could include:
(A) providing thorough and informed analysis of regulations and policies;
(B) identifying negative or adverse consequences of existing policies and making actionable recommendations regarding possible improvement of such policies;
(C) making recommendations with respect to efforts within the Federal Government to improve coordination of regulation and policy related to research;
(D) creating a forum for the discussion of research policy or regulatory gaps, challenges, clarification, or harmonization of such policies or regulation, and best practices; and
(E) conducting ongoing assessment and evaluation of regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes.
The Board was then supposed to write reports that would be submitted to OMB, OSTP, federal agencies, and Senate and House committees with “formal recommendations” on all the above.
But what happened next?
Not much.
Believe it or not, OMB never even established the Research Policy Board that was required by the 21st Century Cures Act!
Why? For that, we have to turn to the Government Accountability Office (GAO), which wrote a rather critical review of OMB’s behavior here. According to GAO, OMB claimed that “the Board would necessarily delve into issues related to compliance burden and indirect cost reimbursement.”
What do indirect costs have to do with anything, you might ask?
Good question.
The main 2017 appropriations bill (Public Law No. 115-56) affecting HHS/NIH had a provision stating that “none of the funds appropriated in this Act may be used to develop or implement a modified approach to” indirect costs.
OK, so what?
Apparently, the reasoning was that if you tinkered with the administrative burden created by federal regulations and policies, that could affect (indirectly, if you will) the indirect costs that universities spend in order to meet those administrative burdens!
Therefore, HHS and NIH wouldn’t be allowed to participate in the interagency working group, and “OMB would not be equipped to meet the statutory goals of the Board.”
If this line of reasoning seems unclear or unpersuasive to you, you’re not alone.
GAO wasn’t buying it either.
Its report noted that HHS itself “stated in written responses to us that the indirect cost provision would not prohibit NIH’s participation on the Board and that the department was not aware of any other appropriations law provision that would prohibit such participation.” Moreover, “the 21st Century Cures Act does not specifically require the Board to examine indirect cost policies, and there are several other issues that the Board could consider examining under its mandate.”
GAO therefore recommended that Congress extend the time for creating and authorizing a Research Policy Board.
So much for that.
What about the American Innovation and Competitiveness Act (AICA)?
OMB and OSTP didn’t actually set up a new working group. Instead, they just repurposed an existing “Research Business Models” group that had existed since 2006. As its short report in 2018 stated:
“OMB and OSTP chose the National Science and Technology Council’s Research Business Models (RBM) Working Group to serve as the interagency Working Group called for in the AICA, and the agency members of the RBM accepted the assignment willingly. The RBM, which has been chartered since 2006, has the appropriate membership and authorities to carry out the mandates related to administrative burdens on researchers.”
What did the rest of the 2018 report do? First, it says that the General Services Administration was going to come up with a centralized repository of assurances (i.e., any organization that applies for federal grants has to assure the government that it is in compliance with all sorts of federal laws and regulations, such as the False Claims Act or the Age Discrimination Act).
Second, the report says that creating a new database of researcher profiles (as AICA suggested) wouldn’t be practical, nor would it actually reduce the burden on researchers. Instead, pilot projects like the one NIH had with the Federal Demonstration Partnership or with ORCID might be the best path forward. As well, the National Center for Biotechnology Information at NIH had already created a tool to help researchers fill out biosketches — the Science Experts Network Curriculum Vitae, abbreviated SciENcv.
Third, as for AICA’s suggestion of a “a simplified, uniform grant format,” the report pointed to existing efforts by NIH, NSF, and others to develop common data elements for proposals, as well as efforts to create standard data elements for reporting on grants.
Fourth, as for AICA’s direction to consider “just-in-time” submission of information (e.g., budgets) rather than requiring everything up front (even when most grants aren’t approved), the report said that several agencies “have experimented with such innovations,” and that the working group would explore this issue further.
Around 2019, as far as I can tell (almost nothing about this is mentioned online), the tasks of the AICA group were reassigned to a new “Coordinating Administrative Requirements for Research” subcommittee (CARR), which was part of the Joint Committee on the Research Environment, under the National Science and Technology Council.
It put out a request for comments in Dec. 2019, on how to reduce the administrative burden of research. It’s not clear what, if anything, was done after 2019 in response to the public comments.
As of now, the task of being the interagency working group has been reassigned once again: to the JCORE Subcommittee on Research Security. It works on national security issues related to research, and recently released a report on that issue. As far as I can tell, the working group isn’t doing much, if anything, on the original idea of reducing the overall administrative burden on researchers.
In short, here’s a table that I created (this was tedious!) to figure out what the 2016 legislation required, and whether or not it occurred:
| Law | Requirement | Did It Occur? |
| 21st Century Cures Act | Establish Research Policy Board | No |
| 21st Century Cures Act | HHS Secretary should “lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest,” and should try to “harmonize existing policies and reduce administrative burden on researchers.” | No. GAO says this was not implemented |
| 21st Century Cures Act | NIH Director should “implement measures to reduce the administrative burdens” about “monitoring of subrecipients of grants.” | Yes. GAO says this was implemented |
| 21st Century Cures Act | HHS Secretary and NIH Director should “evaluate financial expenditure reporting procedures” and try to “avoid duplication” and “minimize burden.” | NA |
| 21st Century Cures Act | NIH Director should work with USDA and FDA to review the regulations for animal research, and “reduce administrative burden on investigators.” | Arguably completed. See here. |
| 21st Century Cures Act | HHS Secretary should work with OMB to clarify how much flexibility grantees have as to “documentation of personnel expenses.” | NA |
| AICA | OMB and OSTP should “establish an interagency working group” for the ‘purpose of reducing administrative burdens on federally funded researchers.” | Partially implemented |
| AICA | Working group should “conduct a comprehensive review of Federal science agency grant proposal documents; and develop, to the extent practicable, a simplified, uniform grant format to be used by all Federal science agencies,” including procedures for preliminary proposals in advance of peer review, “increased use of ‘Just-In-Time’ procedures for documentation,” “simplified initial budget proposals in advance of peer review selection” | GAO says this was not implemented |
| AICA | Working group should “establish, to the extent practicable, a secure, centralized database for investigator biosketches, curriculum vitae, licenses, lists of publications, and other documents” | Partially implemented as per 2018 Report |
| AICA | Working group should “establish a central repository for all of the assurances required for Federal research grants; and provide guidance to institutions of higher education and Federal science agencies on the use of the centralized assurances repository” | Partially implemented as per 2018 Report |
| AICA | Working group should “conduct a comprehensive review of the mandated progress reports for federally funded research; and develop a strategy to simplify investigator progress reports” | NA |
Not very encouraging.
Many legislative requirements were left unfulfilled, and even for the ones that were implemented (e.g., reducing the burden on animal researchers or the burden of monitoring subawards), it isn’t clear whether the efforts actually made any difference!
It’s infinitely easier to get immediate access to all sorts of arcane statistics on the stock market or on NBA basketball players than it is to figure out incredibly basic questions like whether federal legislation was implemented at all (as in, does a working group even exist, and what is its name, and has it actually met or done anything?).
But then, the stock market and sports are important.
The 2018 Survey
In 2018, the Federal Demonstration Partnership — which by now included 10 federal agencies and 154 grantees (i.e., universities) — released another Faculty Workload Survey.
If you recall from above, the 2012 survey found that scientists said they spent 42% of their research time on administrative requirements.
Surely, with all of the reports and legislation since 2012, the 2018 survey would show at least some improvement, eh?
Surely by 2018, scientists might say they were only spending 30% of their time on bureaucracy.
OK, maybe that’s too ambitious, but maybe 40%–a two-percentage point reduction in two years?
Ha.
The key finding:
In 2018, this value increased by 2% (or about 30 minutes per week), with PIs estimating that an average of 44.3% of their research time associated with federally-funded projects was spent on meeting requirements rather than conducting active research. Thus, the trend seems to be that time taken from research by requirements is increasing, not decreasing.
bolding from the original report
So that isn’t encouraging. After all, who could have foretold that a bunch of reports, as well as legislation creating working groups to do even more reports, would have made the problem worse rather than solving it?
In any event, you can guess what I’m going to say about the 2018 survey:
This was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
The 2019 Report on Animal Research
In 2019, the NIH, FDA, and APHIS (Animal and Plant Health Inspection Service) released a joint report on “Reducing Administrative Burden for Researchers: Animal Care and Use in Research.”
If you think anything above was tedious, you can’t even imagine. The report is full of recommendations such “consolidating all agency animal research oversight into a single agency,” a “single set of guidelines,” streamlining the reviews of animal research, and much more.
Fortunately, we have a heuristic that has been helpful thus far.
This was an ambitious report recommending all sorts of ways to reform government, but no one was given a mandate and timeline to actually carry out the recommendations.
What Else Has Been Happening?
Good question.
- The folks working on SciENcv (the unified science cv) have been making some progress (see their May 2022 report). This effort will hopefully make it more efficient for scientists to create and use profiles across different agencies. (See here).
- The Subcommittee on Research Security just issued a report in January 2022 on streamlining disclosure forms and statements on conflicts of interest, creating persistent digital identifiers, etc.
- The latest idea — embodied in Section 503 of the Cures 2.0 bill — is to resurrect the “Research Policy Board” from the original 21st Century Cures Act. Again, that’s currently found at 42 U.S.C. section 3501 (note).
I think the latter will be largely ineffective. But that’s for the next piece in the series. I’m worn out, and if you’ve read this far, you have much more patience than the average reader. So, let’s call it a day for now.