A Well-Implemented Ethics and Data Integrity Program Improves Data Quality and Trust

Does your laboratory have “ethical muscle”? Do you feel your employees are flexing this muscle? Ethics and data integrity should be an integral part of your laboratory’s quality program. Just as peanut butter, jelly and bread go together, so do ethics, data integrity, and quality. However, it is a concept that is too often overlooked in the field of science.

Let’s consider the meaning of ethics alone and then apply it to the concept of data integrity in laboratories. What does the term “ethics” mean in our world today? According to Mirriam-Webster, it is “the principles of conduct governing an individual or group.” But its simpler meaning is to do what’s right and not do what’s wrong, with the assumption that all individuals know the right thing to do.

Now let’s consider ethics as it applies to the workplace. You often hear the words “work ethic.” Is it something we either have or don’t have? Is a good work ethic a learned behavior as a person matures in their career and their life or is it already developed by the time they begin working? The answer to that is up for debate, but it’s a critical question. One of the first questions I ask during the interview process when bringing on a new employee to be part of our laboratory team is the following: “How would you describe your work ethic?”

Having a good work ethic means being responsible, reliable, and always willing to go above and beyond, and generally involves putting forth your best efforts to get the work done. Let’s take this thought further. What other traits can be considered to be part of someone’s good work ethic? I would argue it also means being honest and forthright in the workplace. It doesn’t matter what your job actually entails. What matters is that you have a sense of right and wrong as it applies to your job. If something doesn’t seem right, do you question it? Do you report it to the appropriate person? Maybe you run across a situation with your own work that causes you to question whether it’s acceptable to do it this way or that way. Do you ask the question when you’re unsure or do you let it go, thinking that no one will care or notice?

Let’s take this idea to the next level. Consider how ethics relates to data integrity for laboratories. Having an appropriate work ethic leads to making sound ethical decisions in the laboratory. This leads to data produced in laboratories being of good quality. Good quality data is critical. It is critical to the customers, and it is critical to the environment and the community when the data specifies contaminant levels in drinking water, for instance. Good quality data is also critical for trust…trust from the laboratories’ customers, regulatory agencies, and your fellow coworkers and management team.

This begs the question, “How can I create a solid ethics and data integrity program for my laboratory?” I will address this question as it pertains to each member of the laboratory team as well as those in charge of quality for the laboratory.

The goal of a solid ethics and data integrity program— one that your laboratory can be fully committed to—is to train and sustain. First you need to train. Then you need to know how to sustain. Employees must have the moral compass, especially when dealing with data, to understand how to do the right thing. If there is a question about the procedure they are performing, they need to ask. If something doesn’t make sense to them, they need to ask. Especially critical is that they practice the true corrective action if their data does not pass the assigned quality-control criteria. It may mean troubleshooting the procedure and checking for errors in analysis. It may also mean starting over from square one. There may be tremendous pressure involved in finishing the analysis and getting the data out the door to the customers. Maybe there is a deadline that must be met for a research project or your boss is counting on you to finish the project in order to obtain funding for their next research endeavor. These possible situations as well as countless others make it tempting to cut corners to get the job done. Employees need to know it is never the right decision to cut corners or otherwise alter data to make it acceptable.

First, employees in the laboratory need to be trained in how to correctly produce and review their data. Second, they need to be trained in how to recognize data that is of questionable quality. Third, they need to be encouraged to bring forward possible issues with their data and have enough integrity where their work is concerned to not alter their data in any way that is unacceptable. Training is the key to producing quality data. Also key is for employees to have their moral compass in alignment.

Train your employees not only on the importance of ethics and data integrity, but also how to be aware of flexing their ethical muscles in the laboratory. Inform them and empower them to make the right choices. Then sustain this effort by making ethics and data integrity a crucial part of your quality system.

Let’s first consider how to train the employees. Teach them about the ways that data can be compromised. A few examples include improper manual integration, time travel, dry labbing, and unwarranted manipulation of computer software. Once they understand the acceptable ways of dealing with their data, they can then apply their own moral compass to ensure data integrity. An excellent way to accomplish training is to have a formal training session about ethics and data integrity as part of the new hire orientation. A formal policy regarding ethics and data integrity is also a good idea. In addition, conduct a yearly refresher on this subject for all members of your team. Document the training in an effort to hold them accountable for any infractions.

Next, sustain this effort by always following your lab’s ethics and data integrity policy. For the quality assurance managers out there, an excellent way of achieving this is to perform periodic monitoring of data integrity. This could consist of many things, including spot checking data for inconsistencies or errors, checking for completion of documentation, and examining data involving manual integrations when dealing with chromatograms. You may also sustain data integrity by performing internal audits of your laboratory. This may mean an audit of the entire quality systems program in your laboratory or perhaps an audit focusing on a particular area of concern. It is always good practice to document all findings and determine corrective action if needed. If corrective actions are required, sustain this effort by always following up to ensure the corrective action is being carried out.

At the other end of the spectrum, managers have the moral duty to uphold their end of the bargain. Managers are not necessarily immune to the pressures of getting work done at any cost. Assuming they are ethical employees themselves, how can they demonstrate the importance of ethics and data integrity to their team? In addition, how do they train and sustain? It doesn’t have to be a complex process if you don’t want it to be. It can be very simple.

I like to regard data integrity as the scientists’ golden rule. When determining if data is of good quality, think of it in these terms: Ensure the work was performed, can be authenticated, can be reconstructed, and is traceable. In addition…document, document, document. Document everything. Further, don’t release data until you are confident of its quality. This applies to those producing the data as well as those reviewing the data. We are all in this together.

If I sound like I’m preaching, well…I am! As a fellow scientist, I am passionate about ethics and data integrity. It is our moral (and sometimes legal) responsibility to ensure quality data. I don’t claim to have all the answers, but I seek those answers when needed. Just as it takes a village to raise a child, it takes the entire laboratory team to ensure a superior ethics and data integrity program.

Training and sustaining a good ethical program in your laboratory will ensure your customers’ trust as well as the essential trust between each member of your laboratory team. The bottom line? If you are a manager, encourage your team to flex their ethical muscles. If you are a member of the team, challenge yourself to flex your own ethical muscles by fully participating in your laboratory’s ethics and data integrity program. Accept nothing less than the best from yourself and others. It’s that simple.