Research Compliance Takes Off

A little-known area of compliance is becoming a very big deal. A massive amount of money flows into research every year. This is true even in the Era of Trump. The U.S. government awards research grants and contracts worth more than $60 billion a year, primarily to universities. Corporations in the aggregate spend far more on basic, divided between in-house and outside contractors and grantees.

Serious money doled out for research requires monitoring. Consequently, a whole new field of research compliance has emerged and evolved around this immense expenditure. Like so many compliance subspecialties, research compliance too is now trending toward specialization. Specialty areas include:

  • Research Misconduct
  • Informed Consent
  • Clinical Trials (Human Subject Safety)
  • Laboratory Animal Welfare
  • Data Integrity of Sensitive Health Information
  • Management of Controlled Substances Related to Research
  • Commercialization of Federally-Funded Research

The temptations to divert research money to other pursuits (several years ago a principal researcher at a major university used several hundred thousand dollars of federal grant money for solid gold home bathroom fixtures) and to fudge results (remember “cold fusion”?) are huge. The response from grantors and contracting parties has been slow but steady.

The area most prone to potential abuse is research misconduct, defined as fabrication, falsification and plagiarism (but not including honest error or differences of opinion).

Research compliance is typically a multi-disciplinary function that includes attorneys.

One of the biggest impetuses behind the proliferation of research compliance hiring has been the U.S. Department of Health and Human Services policy that requires every institution that receives Public Health Service (PHS) funding to have written policies and procedures addressing allegations of research misconduct. This is a big deal because the PHS is much more than a bunch of physicians and nurses. It consists of the following offices that award tens of billions of dollars in grant and contract money every year:

  • Office of Public Health and Science
  • National Institutes of Health.
  • The Centers for Disease Control and Prevention
  • The Food and Drug Administration (FDA)*
  • The Substance Abuse and Mental Health Services Administration
  • The Health Resources and Services Administration
  • The Agency for Healthcare Research and Quality.
  • The Agency for Toxic Substances and Disease Registry
  • The Indian Health Service

*FDA does not fall under PHS for research integrity purposes. Instead, FDA handles such matters through its Office of Scientific Integrity

Other selected major employers of research compliance professionals include:

U.S. Government

Universities

Research Hospitals

Boutique Law Firms

Note. I have omitted corporations from this selected list is because the bulk of the research they fund is proprietary and often (surprise, surprise) results in endorsement of their products. Consequently, corporate research integrity offices are often “paper tigers.”

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