We all want to believe that the results of experiments that scientists report are proven facts, backed by a wealth of statistical data and peer review. That is what research is all about, right? Unfortunately, several instances of scientific misconduct have been uncovered in recent years, highlighting another true fact: scientists are not infallible. Yet the research institutions backing these scientists can be held legally responsible or suffer reputation damage, and often human health can be put at risk.
How, therefore, can data integrity be preserved? By putting into place a permanent safeguarding mechanism that not only stops tampering, but is also easy to implement and use so that scientists are naturally encouraged to use it. An electronic laboratory notebook (ELN) is this tool.
In one well-known recent case, Baystate Medical Center anesthesiologist Scott Reuben falsified data in at least 21 of his papers regarding the benefits of COX2 inhibitors. The New York Times reported it “may be among the longest-running and widest-ranging cases of academic fraud” ever. And fraud of this type can be serious: increased risk of death has been linked with COX2 inhibitor drugs such as Pfizer’s Celebrex and Merck’s Vioxx.
False reporting can be the result of errors either intentional or mistaken, but the consequences are widespread in either case. Just in 2011 alone, multiple cases of scientific falsity were uncovered in the media limelight. Test data and results were manipulated and mishandled. Signatures were falsified. Records were stolen. Reputations of both researchers and backing institutions have endured irreparable damage. These scandals at times discouraged new scientists from entering the field and left the rest of the populous wondering what to believe.
In another high-profile example, researcher Judy Mikovits with Whittemore Peterson Institute falsified data regarding the linkage of a retrovirus called XMRV to chronic fatigue syndrome (CFS). When she left the institution, Mikovits then illegally took some of her research records with her. Quite often researchers don’t fully realize that the funding institution is the legal owner of research documentation; Mikovits served jail time for her actions. Making matters worse, certain CFS activists strongly motivated to find a physical cause of the disease (those who do not want CFS dismissed as a largely psychosomatic malady) created such a severe backlash against detractors of Mikovits’ research, including sending death threats, that people became discouraged from entering the field, possibly delaying further research on the disease.
Bad recordkeeping violates data integrity and fosters research misconduct. One article on error misreporting in scientific journals draws attention to discrepancies between published results and the actual experimental data. The article encourages data sharing to reduce instances of errors, and also states “the association between reporting errors and sharing of data after results are published may also reflect differences in the rigor with which researchers manage their data. Rigorously working researchers may simply commit fewer reporting errors because they manage and archive their data more diligently.”
In all of the above cases of misconduct, the preferred method of choice for recordkeeping was the paper laboratory notebook. Paper notebooks are flawed instruments for good recordkeeping for several reasons.
- They cannot be easily monitored to ensure compliant recordkeeping.
- They are hard to secure.
- The notebooks themselves can easily be lost, damaged or misplaced.
- Their records are vulnerable to falsification and manipulation.
- The notebooks are not searchable and not readily shared.
Clearly, another mechanism averse to these issues must be employed to ensure good and sustainable recordkeeping.
In January, researcher Dr. Dipak Das, responsible for the common “red wine is good for the heart” belief, was found to have falsified data in more than 100 instances regarding the benefits to cardiovascular health of resveratrol which is found in red wine.
Electronic notebooks are infused with all of the elements that encompass good recordkeeping:
- Each captured record has its own date/time stamp and the electronic signature of the researcher who modified it.
- Each record and its audit trail are permanently retained and preserved, ensuring its authenticity. Constant monitoring and auditing of data allows for the easy detection of fraud. Regulatory findings can be readily compared with raw data. When data issues are uncovered early, action can be taken early to minimize the cost of these data risks later in a project.
- In addition to auditing and archiving data, ELNs preserve data integrity through the mechanisms of disaster recovery, data backup, and, most importantly, role-base access controls. Important data can never be lost. Access to data access is given only to those with suitable privileges, preventing inappropriate or inadvertent disclosures of information.
- ELNs provide a venue by which collaboration among researchers is both encouraged and fostered, creating an atmosphere which leads to an even greater minimization of scientific misconduct.
Scientific misconduct is a serious risk for both safety and legal reasons. If the key to maintaining data integrity and reducing opportunities for misbehavior is good recordkeeping, electronic laboratory notebooks (ELNs) have the needed mechanisms that both digitally record actions and foster those good recordkeeping habits. When data integrity is preserved and results are more reliable, fewer mistakes are made, and legal risks are averted, researchers are freed to expend their valuable energy towards the important task of finding solutions, rather than fending off issues of scientific misconduct. Clearly, the solution to limiting scientific misconduct is an ELN.
About the Author:
Isabel Fasciano has a Bachelors Degree in Computer Science and a MBA in Technology Management. She has worked with laboratory systems for over a decade in roles such as systems analyst, systems developer, and systems administrator. Fasciano is currently the President/CEO of consulting firm Quality Systems Consultants. She is always seeking new challenges, opportunities, and learning experiences; visit her blog Thoughts on Laboratory Software at labsoftthoughts.com.
You may also be interested in these additional resources:
Harvard University said Friday that it had found a prominent researcher, Marc Hauser, “solely responsible” for eight instances of scientific misconduct.
Findings of Research Misconduct
Based on the report of an investigation conducted by Wyeth Pharmaceuticals and additional analysis conducted by ORI in its oversight review, ORI found that Boris Cheskis, PhD, former senior scientist, Discovery Research, Women’s Health, Wyeth Pharmaceuticals, engaged in misconduct in science
For those following the XMRV saga, or who simply like intrigue, the latest twist is that lead researcher Judy Mitovits, formerly of the Whittemore Peterson Institute—she was dismissed some time ago—has been arrested for theft of materials from the WPI.
Office of Research Integrity
This section contains summaries of closed inquiries and investigations. Institutions are not required to report inquiries to ORI if an investigation is not warranted unless the allegation had been forwarded to the institution by ORI.