The Progressive War on Science: Obama Admin. Regulations Crushing Research
President Barack Obama spoke the following during his 2009 inaugural address:
We will build the roads and bridges, the electric grids and digital lines that feed our commerce and bind us together. We will restore science to its rightful place and wield technology's wonders to raise health care's quality and lower its costs. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age.
How has Obama performed on these promises: “restoring science to its rightful place” and "transforming our schools and colleges and universities to meet the demands of a new age"? PJ Media spoke with a scientist at a major university for his take on the Obama administration’s effect on his profession. (He requested anonymity, based on his opinion that the revelation of his political conservatism could damage his livelihood.)
Our source told PJ Media that less of his time is spent on actual science, and more is spent dealing with regulations and administrative work. This has become worse over the last four years, and more intrusive as well:
It used to be the case that faculty were appointed to 80 percent research and 20 percent teaching and administration. The intent was to spend no more than 1-2 percent on administration unless you were … an administrator. The teaching effort is also supposed to include the time we spend writing papers and grant applications. With tightening budgets, the institutions want researchers to bring in more of their salaries, up to 95 percent on research. Yet the regulatory effort increases each year -- again, a net of about 10 percent of total time, but in many cases the institutions are paying less of our administrative effort, and not more.
This actually causes a conflict of interest -- one of the regulations is to accurately report effort to NIH (and DoD) each year. We are not supposed to charge effort to NIH grants that we don't actually spend doing research on those grants -- yet we are expected to perform all of our regulatory compliance effort on grant-paid time. We spend at least 10 percent of our time on average dealing with regulations, with brief spurts up to 50 percent of our time.
Moreover, while he spends only 3-4 hours a week on regulations which directly affect his research, there's tons more time spent dealing with, of all things, the IRS:
Several times a year I have to work on reports to USDA and our internal Animal Care and Use committee that will take several entire days to complete.
I also spend a lot of time dealing with budget tracking, quarterly reports to the DoD, and yearly reports to NIH for each grant we hold -- I would say that we spend a net of about 4-5 hours a week on regulatory issues (as faculty, with technicians handling the daily records). This doesn't even take into account the number of times I am interrupted by email or phone with a paperwork request whose sole purpose is to satisfy the CYA (“cover your ass”) attitude with respect to IRS reports. Last month alone I had to fill out 100 percent additional burden of paperwork that was placed on the investigators simply because of the threat of IRS audit.
But that's just the paperwork, according to him. The experimental effects are far worse, because time spent on regulation and new restrictions on care of animals slows down the work:
In terms of animal care and handling, we must adhere to regulations regarding cage size, food intake, water intake, "environmental enrichment" (activities other than just sitting in the cage), temperature and humidity measurements and control. We have daily veterinarian health checks for primates, weekly for rodents. Our facilities are inspected at least weekly. We have to train all new personnel (about 15-20 hours each) on regulations with refreshers each year (about five hours each).
A Ph.D., he must attend several classes to ensure he knows how to fill out the paperwork and understands the workplace security regulations -- activities which have nothing to do with the practice of science:
In August alone, I spent six hours on annual compliance training in "financial conflict of interest," "workplace security," "patient abuse" (required since I spend a small amount of time on the hospital campus), "chemical safety," "hazardous waste," "Herpes B virus" (primates can carry this and transfer to humans via bites, scratches, or bodily fluids) -- and two hours on a triennial human study informed consent and ethics course.
Additionally, under Obama a system which has worked relatively well for many years has been tightened and made more restrictive:
Before about a year ago, most federal oversight agencies exercised what they termed the "age of education." When USDA (given regulatory power over lab animals by the "Animal Welfare Act" in the 90s) inspected animal facilities, if they found a shortcoming the institution and investigator were informed, a report was written, and they filed it until the next inspection. Only severe infractions or repeated failure to correct them would result in a fine. Now the agencies are in the "age of enforcement." Infractions are immediately met with fines and penalties. My institution recently had an incident in animal care that was the first of its kind in 25 years. We have a better record than most federal or academic facilities of that type -- but the institution was immediately hit with a $25,000 fine.
Not only that, but more and more drugs are being "scheduled" or restricted by the Centers for Disease Control and the Drug Enforcement Administration, which requires -- you guessed it -- more paperwork:
Use of these chemicals requires licensing, training, facility certification, usage protocols, facility inspections, identification of disposal plans and more paperwork.
Additionally, the NIH book Guide for the Care and Use of Laboratory Animals, which contains the regulations they are supposed to adhere to, was to have been in effect until 2015 with a transition window until 2018 to produce a new edition. In 2009, work on the eighth edition was begun. Debate occured in 2009 and 2010, with public and researcher-only hearings to determine the extent of rules and when they would be applied. According to our source, by 2011 the Guide was in press, and in late 2011 he was informed that the Guide took effect on January 1, with a one-year window to comply.
He said this has had a profound effect on the way he does his job:
[There is] more time spent on compliance, and much more limitation on what we can do with individual animals. The cage-space requirement limits my facility to half the animals it was designed to house. Unless I can justify the need -- typically with more grant awards (which are also much harder to get -- NIH now funds about seven percent of applications received, down from 12 percent four years ago, down from 24 percent in 2003) -- the institutions do not want to give an investigator more space or renovate the space we have. Thus we have to do more with less.
The issues of more work with less capacity and decreased NIH funding have likely dropped productivity by anywhere from 10 to 20 percent. Unfortunately, we are also seeing researchers leave academic settings -- over the last four years we've lost three faculty to early retirement and not replaced them.
I know of at least six colleagues who have left academic research in the last four years, after more than 20 years in research, and not anywhere near retirement age. From an animal welfare and workplace safety point of view, the regulations are helpful, but the increased regulatory burden is largely tied to merely incremental improvements. Frankly, I don't see much benefit to most of the new regulations beyond satisfying bureaucratic egos.
According to our source, fear is what drives most of the regulations:
The fear of lawsuit and audit is driving so much of our regulations. A nearby hospital had an incident where a family member entered a room and assaulted a patient. The hospital was sued, fined by several government agencies, audited, and held responsible by Medicare/Social Security -- with the result that until repeated audits showed that the entire medical center had been educated in patient protection, they could not receive Medicare reimbursement. A disturbed family member -- not at all connected with the hospital -- brought health care to a halt.
Likewise, fear of IRS audit and animal rights activism drives much of the regulation and compliance that we deal with daily.
Second -- the only defense is education. Scientists make poor publicists, but we must make it clear to the public what we do and stop hiding behind jargon in obscure scientific journals. Schools are culpable, too, but it also means we must educate the teachers (and journalists). If the public understood that research was valuable for understanding the brain, and might mean a cure for X (even if 20 years down the line); if they understood that some research ends up in dead ends; if they were informed as to why research must be repeatable, what constitutes a good model or hypothesis, then they'd be less likely to be swayed when an activist mouths off about "useless research" or "senseless repetition."
With a less gullible populace and a defense against frivolous lawsuits and audits, much of the regulatory and compliance burden could go away, leaving us the ability to do more and better research.
On top of this burden our source said funding has been essentially flat since 2004 and yet the number of applications for grant funding has increased tenfold. About the only thing which has grown on research campuses is the research and compliance offices -- at his campus, there has been an expansion from two employees to six.
Obama’s promises -- "restoring science to its rightful place" and “[meeting] the demands of a new age” -- have in fact led to policies that put science under the government’s thumb, impotent to defend against threats from attorneys.