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Principal investigator reviews experiment data with researcher
iStock, Kobus Louw

How Principal Investigators Can Help Ensure Accurate Research

Actionable steps that PIs can take to minimize research misconduct and ensure high-quality results from their labs

by Paul S. Thaler, Esq.,Paul E. Simon, Esq.
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Until recent years, the scientists found responsible for research misconduct were generally those directly responsible for the experiments, figures, or text at issue. More recently, there has been a rise in research misconduct allegations against principal investigators (PIs), even though they typically rely on lab members to conduct the experiments, generate the figures, and draft the text. Allegations that a PI engaged in research misconduct are generally not based on what the PI did but instead what they purportedly did not do: detect the problematic image or data before it was reported. In other words, PIs are often held responsible for inaccurately reported data generated by lab members. PIs have the ultimate responsibility for everything published out of their lab. However, this responsibility does not necessarily equate to responsibility for research misconduct.

It is unreasonable to expect that PIs routinely should, or could, subject the data in every manuscript, grant application, or other presentation to the level of scrutiny that is usually necessary to reveal errors (be they the result of an honest mistake or a lab member’s research misconduct)—especially in the absence of red flags suggesting that additional scrutiny is warranted. PIs must protect the lab’s research integrity, effectively minimizing the risk of research misconduct allegations, as well as helping lab members engage in responsible research. By adhering to the following steps, PIs can accomplish this and be positioned to refute any allegations by doing so:

Develop SOPs to minimize errors

PIs must ensure that all lab members are aware of their responsibility to research integrity. Ensuring that standard operating procedures (SOPs) are written and disseminated to lab members in an easily accessible, written format demonstrates both the existence and breadth of a PI’s lab practices. Written SOPs can help a PI avoid research misconduct allegations before an investigation is found warranted in two ways: (1) fostering a lab environment in which lab members are encouraged to spot errors and engage in responsible research and (2) acting as safeguards to minimize the risk of errors and research misconduct. 

Implement effective data management procedures

Data maintenance practices should be consistent with the requirements of any funding source and the institution itself. PIs should also be aware that research misconduct allegations often involve data older than the baseline of three years for which original data must generally be retained and, frequently, beyond the soft “limitations” period set forth in the federal regulations. PIs’ lab practices should ensure that research records are retained for a longer period and are backed up and stored electronically and accessibly. PIs should also ensure lab members are knowledgeable about recording and storing data. Lab members should organize their lab notebooks to be usable even if they leave the institution before research questions arise. Readily locating, identifying, and providing the original raw data can often address any questions or concerns before they become allegations.

PIs must ensure that all lab members are aware of their responsibility to research integrity.

Manage the lab with a human touch

An important part of strong leadership fostering research integrity is building and nurturing relationships with all lab members. This can be accomplished in many ways. Some possibilities include: making time for regularly scheduled one-on-one meetings with each lab member (in addition to any full lab meetings); inviting and listening to lab members’ concerns and suggestions with an open mind; having open office hours; walking the lab for spontaneous discussion, brainstorming, and problem-solving with lab members while they work; communicating with all lab members respectfully at all times; encouraging collaboration and mutual support; and scheduling occasional social activities outside the lab for further team development. Adopting any of these ideas (or similar ones) should foster a healthy, transparent, collaborative lab culture that inspires integrity.

Teach lab members how to be ethical researchers

Mentoring trainees and other lab members on how to be effective, ethical researchers is a critical responsibility. A PI must provide technical and equipment training, and also ensure that lab members know how to engage in the responsible conduct of research. Particularly with very junior lab members, PIs serve as important role models who can promote ethical research practices both by serving as exemplars and by passing down specific advice to the next generation of researchers. PIs should encourage lab members to focus on what is truly important in research—i.e., the truth, as reflected by the data—rather than on extraneous pressures such as publishing rate. By being accepting and tolerant of what the data show, even in the event a promising hypothesis is proven wrong, and using those results to discuss alternative options, a PI places importance on ethical research instead of creating an atmosphere that may tempt lab members to seek shortcuts.

Establish standards for addressing concerns

Often, determining whether a concern should be viewed as a research misconduct allegation comes down to whether there was a proper exclusion of outlying data, a legitimate disagreement, an authorship dispute, or something more. By addressing these topics in written lab practices, PIs may be able to prevent some concerns from being raised by setting expectations for all lab members and providing standards to resolve these issues. By ensuring authorship standards are set, PIs can more easily identify which lab members performed which parts of the research and drafting, even years later. This can help a research misconduct review hone in on which authors should be considered respondents rather than casting a wide net over everyone involved in the project in any manner whatsoever.

Review before submitting 

While PIs cannot reasonably be expected to scrutinize every piece of data in every figure, they should take some steps to confirm that figures and descriptions match the original raw data. This review does not need to be overly time-consuming or demanding, nor does it need to engage in the forms of image manipulation that a forensic analysis would. However, PIs should ensure that the original raw data exists and appears as represented in the figure. Lab members, especially coauthors, should also be encouraged to conduct some level of review, perhaps in even greater detail than the PI, to catch any mistakes before submission. 

PIs should consider engaging in spot checks, subjecting at least some amount of the data to a higher level of scrutiny. Including spot checks in established lab practices could discourage lab members’ research misconduct. These steps could help PIs avoid even the allegation that they were complicit in or responsible for research misconduct if a concern later arises.

Make a record 

In addition to documenting all lab practices, PIs should create records not only of the research their lab generates but of steps taken to meet lab practices and instructions given to lab members. While verbal communications may be swifter, creating a record at or near the time of instructions or advice can be crucial in demonstrating events that may have occurred years earlier.

Mentoring trainees and other lab members on how to be effective, ethical researchers is a critical responsibility.

Adhere to accepted research community practices

There are many resources available to PIs to consider in creating good lab practices. In 2017, the National Academies of Sciences, Engineering, and Medicine published a Consensus Study Report, “Fostering Integrity in Research,” which includes recommendations for best practices to identify and promote research integrity. While some recommendations may be above those necessary to meet the research community’s standards, they are, at a minimum, worth considering in shaping a PI’s lab practices. These recommendations include (but are not limited to):

  • Understanding “the definitions of, and policies to address, research misconduct” applicable to their institutions and funding sources and being cognizant of their own biases in reviewing or expressing concerns;
  • Remaining “close to the primary data even if [a PI] lack[s] the technical skills to generate those data themselves” to assist in ensuring data are maintained and managed appropriately;
  • “Ensuring that trainees understand and follow best practices in research,” including by checking lab members’ work before submission and engaging in “[c]onstructive skepticism” of results provided by lab members; and
  • Taking reasonable steps “to prevent competitiveness in the lab from reaching the point where it becomes harmful.”

Similarly, the federal Office of Research Integrity (ORI) hosts voluminous Responsible Conduct of Research resources on its website. Demonstrating that a PI’s lab practices follow ORI-endorsed guidance could be a significant tool in avoiding a research misconduct allegation or, should one arise, showing that the PI lacked reckless intent to engage in research misconduct.

Ultimately, research misconduct allegations cannot be entirely prevented. Allegations can be made by anyone, anonymously or otherwise, for any reason, and must inherently be taken seriously. While most researchers strive for excellence, mistakes and other errors are unavoidable. At times, allegations are based on honest errors. Other times, lab members may take shortcuts that result in deliberate research misconduct, which they then try to conceal. By following the advice discussed above to foster responsible research, a PI can reduce the risk of allegations and minimize the likelihood of a research misconduct finding against the PI.