The Health Sciences Spotlight

Getting in the Way of Good Research

  

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The amount of time and energy that goes into preparing to do research is astounding.  Beyond the usual headaches of building a research team, filling out the correct forms with the correct information, waiting for committee approval, and waiting for lab safety inspections, biomedical and clinical researchers around the world are dealing with an increasing amount of red tape.

Global Issues

In an opinion article, Chalmers states that “overregulation [in Britain] is preventing vital clinical trials to investigate the effectiveness of treatments.” Chalmers continues to illustrate how doctors in Britain are at the mercy of the pharmaceutical and research institutions who decide which research is a priority and that basic research is valued more by those parties in more innovative clinical research.  In fact, he feels that “laws and regulations affecting clinical practice and research should discriminate in favor of” basic research. Chalmers finishes with a call to action to British health sciences professionals to “insist on the results of all reliable research being made publicly available, including research that is too often swept under the carpet because the results are disappointing” in an effort to avoid allowing patients to “unwittingly receive harmful treatments while being denied effective ones” because of research ignorance (Chalmers, 2010).

Also in Britain, Adams identifies red tape as the culprit for “seriously delaying trials of drugs which could cut the number of people having heart attacks and strokes.” He notes that researchers for the “£2 million British Heart Foundation-sponsored study had been forced to wait two years to get started,” but “before such R&D committees were set up, under the EU's Clinical Trials Directive 2004, the normal wait was about three months.”  Adams reports that researchers feel money is being wasted on protective measures that result in diminished research quality.  Worse, delays resulting from the R&D committees mean “more people having heart attacks or strokes which could have otherwise have been avoided” (Adams, 2010)

Wong reports that leading cancer geneticists, Copeland and Jenkins have left Singapore’s Institute of Molecular and Cell Biology due to frustrations with the time spent on red tape and “increased pressure to focus on economic outcomes to get funding” instead of research (Wong, 2011).  Copeland and Jenkins’ frustration mounted as one-third of Singapore’s total research budget was slated to "be abruptly shifted to competitive 'industrial alignment funds'” and “access to that funding [would] now depend on researchers' abilities to show that their work has industrial applications” (Nature, 2010)

Researchers in Britain and Singapore are certainly not alone in having to cut through red tape to conduct their research. The US has been operating using the HHS' regulations from decades ago that have lost relevance.  Fortunately, HHS is taking great strides to update their regulations.

Progress in the US

In the first major change since human subjects regulations were created in 1981, HHS has proposed new regulations that should “speed up the process of approving and monitoring federally funded clinical trials." These changes are in response to the changing health sciences research industry, which has gone from primarily university-based for clinical trials to multi-locational, each location with its own IRB. HHS has chosen to move to a central IRB, which would simplify and streamline approval and oversight and make "trials less costly to conduct and less headache-inducing for physicians."  Further, HHS has revised informed consent policies to "limit the acceptable length of informed-consent documents, prescribe how information is presented, allow certain types of information to be included in addenda, slash legal boilerplate terms and make available standardized consent form templates" (AMA, 2011).Though HHS' changes are a big step in the right direction for the US, what governing bodies and administration often don't realize is that there are multiple forces on a researcher that prevent him from easily moving forward and beginning his work. Yes, there should be a stringent review process to ensure that funds are spent wisely, that the research is worthwhile, and that the researcher and her team will be safe, but each one of the speed bumps in the process delays results, public health, and the ability to continue on to do more good research.