Report Urges Life Science Industry to Establish Research Standards

Life sciences research may be building its own Tower of Babel—a global, collaborative pursuit of breathtaking ambition that begins well but ultimately falls apart. Work on the original Tower of Babel was abandoned because the builders began speaking different languages and, according to Genesis, “would not return to each other.” In the life sciences, researchers may suffer a similar fate: In the absence of unifying standards, they may generate ever larger volumes of irreproducible results, wasting resources, missing opportunities, and eroding the public’s confidence in the value of research.

Such a scenario has been outlined in a report released late last year by the Global Biological Standards Institute (GBSI). The report,  “The Case for Standards in Life Science Research: Seizing Opportunities at a Time of Critical Need,” takes a hard look at the problem of irreproducibility and finds that it is experienced by roughly 75 percent of academics and about the same proportion of industry scientists. The report also concludes that irreproducibility largely is the consequence of inadequate standards. Next to the absence of standards, scientific misconduct, however lurid, is practically insignificant.

The GBSI study (dubbed The Case for short), was conducted by a third-party organization, which interviewed nearly 60 stakeholders across the life science community. The Case integrates the findings of these interviews, an extensive review of the literature, and other sources, including government agencies and the pharmaceutical industry. One of the key findings is that irreproducibility is a pervasive, systemic problem across research settings and profoundly affects the entire community, from bench scientists to patients.

“Reproducibility is the foundation of life science research and yet far too often the inability to reproduce experimental data has resulted in the invalidation of research breakthroughs, retraction of published papers, and abrupt discontinuation of studies,” said Leonard Freedman, Ph.D., president of GBSI. “The global community can no longer afford the economic and intellectual drain, reduced trust in the research enterprise, and lost opportunities to expedite discovery of cures and enhance global health.”

Stakeholders interviewed for The Case agreed there is a need for more standards in life science research and said that need has become more urgent. The reasons cited included a relative flattening of National Institutes of Health funding, a growing number of interdisciplinary projects, and an increasing emphasis on translational research.

After noting that standards are taken for granted in a range of endeavors, from ISO guidelines to WiFi protocols, The Case observes that standards in the life sciences are fairly spotty, at least in the preclinical realm. While it is true, The Case acknowledges, that standards exist for animal care and certain aspects of data reporting and cell line authentication, broadly based standards that cover all phases of research and development are still lacking.

According to The Case, “Irreproducibility is a pervasive, systemic problem that has multiple direct and systems-level causes. These causes range from individual laboratory decisions, such as lack of an appropriate control for a particular experiment; to variability in journal publication requirements; to lack of consistent research quality systems. Fundamentally, irreproducibility stems from undefined variance in reagents, practices, and assays between laboratories.”

The Case highlights two kinds of standards—materials standards and written consensus standards. Materials standards consist of well-characterized, purified biological or chemical reference materials. (These may include reference reagents, which may be used for assay validation and calibration or directly in research and development.) Written standards consist of consensus documents describing optimal practices. (These may include analytic standards, which can be used to specify assay methodology, cut-off values, and calibration reagents.)

By implementing such standards, argues the GBSI, the life sciences stand to realize a range of benefits. These include more efficient use of resources and time; protection of reputation; and more favorable public opinion of research.