“Bioethics is a very, very important field. As we get more and more in the arena of understanding science and getting better opportunities, the fact that you can do things with biological sciences that have an impact on a human being means you must have ethical standards.” Those were the words of a man who is now as culturally relevant as he’s ever been, Dr. Anthony Fauci.
In a few lines, Dr. Fauci was able to articulate and underscore the gravity of adhering to scientific standards. Failing to do so can cause real damage to real people, and that is something that, once done, cannot be washed away.
The results of scientific research cannot be the only thing that matters, the safety and validity of the studies must be the primary concern. We’ve seen what can happen when scientists only cared about the results of their studies, operating with complete disregard for how they got there, and the outcome was disastrous.
Like the colorful flower sprouting up through the earth after a forest fire, this catastrophe led to growth within the scientific research community, and we’ve all benefited from it.
Industrial Bio-Test Laboratories Scandal
One of the foremost labs in the United States a number of decades ago, Industrial Bio-Test Laboratories (IBT Labs) tested products for their safety and toxicology. IBT tested several different types of products, including pharmaceuticals, chemicals, and other industrials.
During its heyday, IBT was the biggest facility of its kind, and was reportedly responsible for over one-third of toxicology testing in the United States. IBT Labs were accused and found guilty of gross and widespread scientific misconduct and fraud, which led to the indictment of its president and several chief executives in 1981, and their eventual convictions in 1983.
There were numerous horrifying revelations about how Industrial Bio-Test Laboratories operated. Here are a few of them:
- Food and Drug Administrator Adrian Gross physically inspected IBT’s labs, and during an examination of the labs’ raw safety data, found several references to the acronym TBD/TBA which he later discovered meant “too badly decomposed”
- In June of 1977, IBT Labs were found to have shredded large amounts of internal documents
- In an audit of IBT Labs’ studies, the FDA found that 618 of 867 or 71% of their studies were invalid for having “numerous discrepancies between the study conduct and data.”
- The Canadian newspaper the Regina Post-Leader reported that there was an abundance of sloppy and inadequate record keeping that invalidated test results.
- In several cases, test animals that fell ill were replaced with healthy ones, resulting in invalid test results.
- In October 1983, three former officials of the company were convicted by a US federal jury of fabricating key product safety tests used to gain government approval for marketing two popular pesticides and two commonly used drugs.
- Cornelius Garrett testified that “[no] research animals survived the entire testing period” for either Sencor or Nemacure (two companies that IBT Labs ran testing for).
- Garrett also testified that it was “common practice” to falsify subject data
- One employee testified that he was instructed to falsify data on trichloro carbanilide tests.
- In 1983, after seven years of reviewing its files, the Environmental Protection Agency reported that it had found that only 16 percent of IBT’s testing results were valid.
If all of this seems alarming, it should. But the above facts aren’t even the worst part. These fraudulent lab practices led to an immense number of products being released for public consumption that weren’t anywhere close to being proven safe.
Some of these products caused kidney or bladder problems, testicular atrophy, birth defects, or cancer. These shoddy and dishonest lab practices likely caused innocent people to suffer.
And the US government wanted to make sure that something like this did not happen again. So, they introduced the Good Laboratory Practice (GLP) regulation.
Good Laboratory Practice
Good Laboratory Practices are accepted methods used to carry out activities or operations in a laboratory. More specifically, they are principles intended to assure the quality and integrity of non-clinical laboratory studies.
These principles concern planning, performance, monitoring, recording and reporting of a study. Before we dig into all the strict requirements for GLP, let’s cover why it’s important.
Quality
The principles of GLP are designed to ensure that laboratory testing and results are of a high quality and easily traceable. Testing that has been performed using the incorrect materials, methods or equipment can conveniently be identified and discounted.
Labs that use GLP are therefore widely considered more reputable than those who fail to use GLP.
Integrity
Adhering to GLP means that analysts and managers of laboratories have to consistently keep clear and accurate records of the testing procedures and the methods that they use. The accompanying paper trail ensures the integrity of the lab and its experiments, while its accuracy minimizes the possibility of fraud.
Replicability
GLP necessitates having a written protocol to follow when performing tests and supporting documentation to ensure the procedures were followed correctly. This means that another analyst or laboratory can replicate the testing precisely, which can confirm the validity of a result.
Safety
In many cases, GLP regulations are the only thing standing between a lab like IBT and the public. GLP regulations don’t just protect the quality and integrity of the results and the public, they protect the technicians performing the experiments, management, and the company as a whole.
Requirements
The following regulations must be implemented in order for a laboratory to be compliant with Good Laboratory Practices (GLP). Note that GLP requires that a Sponsor, Study Director, and Testing Facility Manager be selected and appointed.
- Sponsor
- Must be selected and appointed and is required to notify the laboratory testing facility that the study must comply with GLP standards
- Personnel records must be open and available to confirm that all key employees possess the necessary training and experience
- Testing Facility Manager
- Must be selected and appointed to designate the Study Director, to verify the presence of a Quality Assurance Unit, and to ensure the presence of adequate personnel, resources, facilities, equipment, materials, and practices
- Study Director
- Must be selected and appointed as the contact person that ensures the following:
- All protocols are properly approved and adhered to
- That all relevant and necessary data is recorded
- That GLP standards are strictly followed
- That data, documentation, protocols, specimens, and final reports are archived
- Must be selected and appointed as the contact person that ensures the following:
- Quality Assurance Unit (QUA)
- Must be appointed to ensure that:
- Facilities, personnel, practices and records are in compliance with GLP regulations
- A master schedule sheet of studies is properly maintained
- Each non-clinical study is inspected to ensure compliance
- Findings are reported to the Study Director and to the Testing Facility Manager
- Must be appointed to ensure that:
Here are some more general regulations and requirements that have less to do with the special people appointed to specific positions for the study:
- All equipment must have standard operating procedures (SOPs) with detailed descriptions of their use, maintenance, and calibration.
- All testing methods must have standard operating procedures (SOPs).
- All test studies must have written protocols describing in detail the objectives and methods that were used for conducting the test study.
- All data must be in written form; dated and initialed by the appropriate people.
- The final report by the Quality Assurance Unit (QUA) must contain a compliance statement signed by the test applicant, the Sponsor and the Study Director describing any and all deviations from GLP standards.
Non-GLP Compliance
Now that you know all about Good Lab Practice Compliance, it’s time to look at the other side of the coin: non-GLP compliance. The main difference between GLP and non-GLP compliance is that non-GLP studies do not require the painstakingly detailed, extensive documentation and quality assurance protocols that GLP studies do.
Non-GLP studies can be conducted when the safety of a product is not being assessed. They are useful when conducting discovery, basic research, and screening, and the less stringent recording requirements provide more freedom and allow for more efficient documentation.
Conclusion
Good Lab Practices are integral to conducting valuable science accurately and safely. What happened with the Industrial Bio-Test Labs scandal was a travesty of the highest order, and while it was a dark mark on the field of science, it directly spawned GLP regulations that have made lab technicians, their test subjects, and the public at large a great deal safer. Good Lab Practices were the rainbow after the thunderstorm.
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