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Strategies for Preventing Research Misconduct

It’s the type of scenario that can sully an institution’s reputation in an instant: A star researcher fabricates the results of experiments funded by grants. The data is published, the truth is discovered — and the institution is forced to repay millions of dollars.

Since 1992, more than 284 people have been sanctioned [1] by the US Office of Research Integrity (ORI) for research misconduct, defined [2] as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” According to the ORI:

  • Fabrication occurs when researchers make up the data used to support their findings or the sources of information used.
  • Falsification involves “manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.”
  • Plagiarism occurs when researchers use the ideas, information, processes, or results produced by others but do not provide appropriate credit.

To qualify as research misconduct, the acts must be committed intentionally.

The field of scientific research attracts enormously talented individuals in both academia and clinical practice. Public and private institutions regularly sponsor and promote their research endeavors, and our federal government invests hundreds of millions of dollars each year on these pursuits.

But the pressures of academic and clinical research settings are high, and researchers and research assistants may be tempted to cut corners, putting research integrity at risk. To protect their institutions, leaders must put in place best practices for recognizing and responding to allegations of research misconduct — and ensure these processes are followed.

Why Research Misconduct Occurs

Most professionals who devote their passion and knowledge to the pursuit of clinical and academic research are dedicated to the prudent and responsible use of funds that support their work. A sad truth, however, is that some researchers seek their own recognition and reward over the common good.

For example, research assistants may feel pushed to produce results that will gain the attention of their institution’s leading researchers, which can generate opportunities to work on higher-profile projects. Meanwhile, well-established researchers may buckle under the pressure to win high-profile grants for their institutions, which can be emotionally draining [3], limiting time spent with their families.

Traditionally, factors such as age, gender, peer pressure, and the absence of policies to govern researchers’ behavior have been thought to impact research integrity. Such factors can influence whether a researcher or research assistant succumbs to temptation to falsify or fabricate work or plagiarize the ideas and approaches of other scientists.

However, one recent study [4] suggests the best defense against research misconduct may be to take a hard look at the culture of the research environment. Is mutual criticism among colleagues encouraged? How strong is the mentoring program for young research assistants? How are team members held accountable for the quality of their work? When the institution’s culture affirms its commitment to transparent, ethical research practices, opportunities for misconduct decrease — protecting not only the institution’s reputation, but also its bottom line.

Strategies to Support Research Integrity

How can institutional leaders help to prevent issues of academic research misconduct before they occur? Our experience points to six best practices.

  1. Ensure policies governing academic research not only are in place, but are followed. Make sure everyone in the research environment — from the lab assistant to the housekeeping professional who cleans the lab to the most well-respected researcher in the division — knows they have a role in protecting research integrity. Posters that alert staff to the phone number they may call to anonymously report concerns should be prominently featured throughout the space. Additionally, discussions around research misconduct — what it is and how to prevent it — should take place at every level, from students to professors to board members.Institutional leaders also should take care to assure students and staff that no individual will face retaliation for reporting concerns regarding misconduct and that their comments will be taken seriously. When people trust that their concerns will be heard and acted upon, they are more likely to share their feedback internally for investigation rather than with outside agencies.
  2. Set standards for supervision of all testing.  It is critical that leadership set expectations for every member of the research team regarding the need for transparency among team members in the research setting. When tests are conducted by assistants, ensure that a more experienced member of the team is always available for consultation. The institution can determine the best form that supervision may take, depending on experience levels and facilities necessary to conduct the research.Look at the quality of the mentoring program your institution provides for research and lab assistants who are new to the field, and work to strengthen relationships between mentors and mentees. Doing so will foster a collaborative environment and establish the basis for communication and trust from the start of the working relationship.
  3. Enforce expectations for process rigor. Lack of process rigor is another defining element in academic research cases gone wrong. Provide checklists of steps that must be followed in conducting specific tests, and hold researchers and research assistants accountable for their completion and adherence.Researchers and assistants also should keep detailed notes describing the type of testing conducted and the results achieved. Make sure each researcher and assistant understands the level of detail needed, and provide examples of sample notebook entries for them to view. Checklists and notebooks should become part of the historical record for the study and should be maintained pursuant to research study and institutional document retention policies.
  4. Communicate expectations for accurate accounting of time spent on research activities. Provide education to team members — during onboarding and annually, as part of compliance training — on the types of activities that should be included in research hours that are documented for grant purposes and how to document their work. Make sure team members understand the importance of documenting their time immediately after an activity has taken place, with detailed entries that reflect the type of work conducted for a specific project. Ensure all researchers understand that their timekeeping may be audited by the funders, or, in the worst case, by enforcement agents.
  5. Evaluate the strength of your grant accounting function. Researchers who conduct studies funded by federal grants must be good stewards of the federal monies provided to them. When funds spent on these studies are tracked inadequately or incorrectly — or when hours and expenses are tracked in separate systems — it is difficult to accurately account for the time and money spent if the study were ever to become the focus of federal scrutiny. It could also lead to questions from grant oversight personnel. And if team members are past grant templates and estimations for future work, it could call grant accounting into question and lead to potential accusations of accounting fraud. Institutions should invest in a single system for grant accounting, with reports shared monthly with team members for evaluation and correction, if needed. Regularly sharing these reports with each research team member, leaders, and the board also will heighten the level of transparency associated with the initiative.
  6. Establish an Office of Research Integrity. Institutions must be equipped to respond to allegations of academic research misconduct in a timely manner. An internal ORI-like team should be headed by a compliance officer who is familiar with research practices, but does not conduct research. Team members should include professionals with a legal background and a close connection to the legal department. In allegations of fraud, the ORI would interview researchers and assistants and alert the proper institutional departments to their findings. When issues are identified, a nonpartisan panel composed of professionals who have conducted research and understand the ethical and compliance considerations involved should be tasked with reviewing the team’s findings and recommending action.

Creating the Right Environment 

When researchers and assistants at every level understand their role in protecting research integrity and the standards they must follow with each study, greater levels of transparency are achieved, fostering an environment of collaboration and trust. Take the time to evaluate your institution’s research and grant accounting processes based on these best practices, and work quickly to close any gaps. This preparation will help protect the quality of the research conducted, the reputation of the institution and its researchers, and your ultimate financial health.

Would you like to learn more about our Healthcare Disputes Practice?

Check out our Healthcare Disputes page. 

1 Alison McCook, “U.S. researchers guilty of misconduct later won more than $100 million in NIH grants, study finds,” Science Magazine, February 24, 2017.
2 Office of Research Integrity, Definition of Research Integrity.
3 Adrian Barnett and Danielle Herbert, “The personal cost of applying for research grants,” The Guardian, April 7, 2014.
4 Danielle Fanelli, Rodrigo Costas, and Vincent Lariviere, “Misconduct Policies, Academic Culture and Career Stage, Not Gender or Pressures to Publish, Affect Scientific Integrity,” PloS One Journal, June 17, 2015.

© Copyright 2018. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC., its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.


healthcare & life sciences, healthcare disputes, disputes, f-distress, memo, healthcare compliance, compliance, f-risk

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