Academic & Scientific Research Misconduct Attorney

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Allegations of research misconduct and scientific fraud can mean serious, potentially disastrous consequences for the accused, including damage to one’s reputation, destruction of one’s career and loss of federal research grants. KJK’s Research & Scientific Misconduct Practice Group protects graduate students, professors and scientists facing such accusations. 

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Research Misconduct:

What You Should Know

An allegation of research misconduct can be personally and professionally devastating for individuals who have dedicated their lives to contributing to their respective fields. However, research misconduct allegations need not be career-ending scandals. A skilled research misconduct attorney can help you navigate this complex process. Beginning with the initial allegation of research misconduct, we can support you through every facet of the process, while making sure to protect your professional reputation in our efforts to procure a just result.

Bottom line: Navigation of a particular research misconduct case requires in-depth analysis and a ready understanding of institutional policies and procedures, as well as the legal requirements. An experienced research misconduct attorney is best equipped to help individuals accused of research misconduct to protect their professional reputations and successfully navigate the process.

What Constitutes Research Misconduct?

Research misconduct may involve a combination of issues with scientific data gathered and analyzed in published formats. Research misconduct is defined in Title 42 of the Code of Federal Regulations (“CFR”) § 93.103 as, “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” Importantly, a finding of misconduct requires proof of intentional misrepresentation or falsification.

Typically, the institution investigating an allegation of research misconduct bears the burden of proving an allegation of research misconduct by a preponderance of the evidence standard. 42 C.F.R. §§ 93.106(b)(1), 93.516(b)(1). To constitute misconduct, the researcher’s conduct must constitute a significant deviation from accepted practices in the relevant research community and the misconduct must have been committed intentionally, knowingly or recklessly. See 42 C.F.R. § 93.104.

The individual accused of research misconduct has the burden to establish by a preponderance of the evidence any affirmative defenses, including honest error or difference of opinion, and any mitigating factors relevant to administrative actions based on a finding of research misconduct.

See 42 C.F.R. §§ 93.106(b)(2), (3); 93.516(b)(2), (3). A “preponderance of the evidence” standard is an amount of evidence that, when compared to controverting evidence, leads to a finding that a fact in issue is more probably true than not. 42 C.F.R. § 93.219.

Can an Honest Error be used as an Affirmative Defense?

The required element of intent in proving research misconduct also allows for the accused to assert the affirmative defense of honest error.
Honest error and differences of opinion are specifically excluded from the regulatory definition of research misconduct. 42 C.F.R. § 93.103(d). A researcher accused of misconduct has the burden of proving, by a preponderance of the evidence, any affirmative defenses, including honest error or difference of opinion.

What are other research issues that could potentially result in professional discipline or liability?

It is important to remain informed of your institution’s research policies, including special requirements surrounding sensitive areas of research such as those involving human subjects and personal and identifying information. Institutions may establish and enforce their own policies in addition to maintaining compliance with federal regulations.

How is Human Subject Research reviewed and approved?

Typically, institutions of higher learning utilize Institutional Review Boards (IRBs) to review and approve human subject research. IRBs weigh many factors before approving proposals. Their main focus is to determine whether:

  • risks to subjects are minimized;
  • risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
  • selection of subjects is equitable;
  • informed consent will be sought from each prospective subject or the subject’s legally authorized representative;
  • informed consent will be appropriately documented;
  • when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
  • when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

See 42 C.F.R. § 46.111(a). These items of concern contribute to the potential damage caused by a case of inappropriate or incomplete IRB review and approval.

What types of research involving human subjects may be exempt from human subject requirements?

A common pitfall in human subject research is a researcher’s (possibly mistaken) belief that a study involving human subjects will be exempt from IRB approval requirements through one of the few exceptions allotted in the regulations. The following types of research involving human subjects may be exempt from human subject requirements under the regulations:

  • Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
  • Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    • Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation; or
    • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination [that an exemption is appropriate].

See 45 C.F.R. § 45.104(d) (1-2). The key consideration here is that IRB approval cannot be applied retroactively. See, e.g., 45 C.F.R. § 45.104(d)(ii-iii) (providing only for a priori IRB approval prior to data collection in human subject research).

What Activities Constitute Research?

The very definition of what activities constitute “research” may be critical in an evaluation of allegations of research misconduct. 45 CFR 46.102(l) defines “research” as follows:

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess or investigate potential public health signals, onsets of disease outbreaks or conditions of public health importance (including trends, signals, risk factors, patterns in diseases or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Collection and analysis of information, biospecimens or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions.

The very definition of “research” may be at issue in a research misconduct investigation. Certain applied data collection, for example, an in-house evaluation of quality control procedures at a big box store chain, may not qualify as “research” because the relevant activities are done for the purpose of gaining specific and applied, rather than generalizable, knowledge.

What is the difference between honest error and intentional error?

An example of honest error would be a researcher using an arguably inappropriate statistical model accidentally, and this error was not noted by relevant peer reviewers. In this scenario, the researcher did not alter any data intentionally or fraudulently in a published paper. By contrast, if a researcher was repeatedly informed that a statistical model would materially represent data by relevant peer reviewers, but the researcher chooses to publish the model anyway, there may be a finding of misconduct. As can be understood from these examples, honest error is at the heart of the issue of whether a substantial deviation from accepted practices was intentional, knowing or reckless; and not whether the underlying data or models at issue are scientifically sound. In both examples, the data was misrepresented by the relevant statistical model. However, only in one scenario was the misrepresentation intentional.

What is the difference between a confidential study and an anonymous study?

45 CFR 46.102(e)(5) defines identifiable private information as “private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.” A confidential study may allow the researcher to number or otherwise anonymize research results to avoid connections with human subjects. Confidential studies of human subjects require prior IRB approval to ensure the confidentiality of the relevant data.

An anonymous study, by contrast, may, in certain circumstances, be exempt from human subject requirements. However, anonymous data must not involve any directly or indirectly identifying information of the subjects. Another occasional pitfall in research involving human subjects is the potential that a combination of otherwise neutral and anonymous information may serve to change an anonymous data collection into non-anonymous data. For example, if a study is conducted that has only one member of a relevant demographic, for example, a study that includes only one subject of a certain profession and age group, the combination of those demographic markers could serve to reveal the identity of the subject.

What is the Data Retention policy for scientific research studies?

Compliance with federal regulations also requires retention of data underlying scientific research for a set period of time. 45 CFR 46.115(b) and 21 CFR 56.115(b) require that all IRB records be retained for at least three (3) years, and that all records relating to research be retained for at least three (3) years after completion of the research. Institutions and journals may complement federal regulations with their own policies surrounding data retention.

Can the Scientific record be corrected in cases of honest error?

Often, in cases of honest error, i.e., unintentional deviations from accepted research procedures, relevant publications can be retracted or amended to correct issues in the published article(s). Although private journals will have the final say in determining how to handle potential research issues in their publications, there are a number of options to consider in proposing a resolution.

  • Retraction: A complete and simple retraction of a scientific paper with research errors or ethical issues may be an option to remove said erroneous or potentially unethical study from the body of research in a particular field. This option is the most severe remedy to potential research issues.
  • Correction: A paper may be re-published with a correction that remedies the research error. In the example above involving an honest error in the use of an inappropriate statistical model, a correction may come in the form of a revised statistical model being used to represent the underlying data.
  • Expression of Concern: A paper involving relatively slight issues in data collection or representation, or one that may use outmoded methods, may be appropriate for republication with an expression of concern. An expression of concern may be sufficient to point out a potential issue or confounding variable without removing the entire underlying study from the relevant body of research. An expression of concern is most appropriate where the science is reliable, but there are potential issues to bring to light.

How Our Team Can Help:

Guiding you through Academic Misconduct Investigations

When individuals are accused of research misconduct in the academic setting, we navigate both the academic proceeding and the investigation conducted by the Office of Research Integrity, which is tasked with investigating and adjudicating research fraud involving government funds. This means we defend our clients in two separate processes. 

Our experience with academic and administrative proceedings, the criminal justice system and employment issues enables us to provide a comprehensive defense for those accused of research misconduct nationwide. 

Attorney helping her client

Important to KNow

Cheating & Plagiarism

Allegations of cheating and plagiarism are at an all-time high due to virtual and hybrid learning environments. If you’ve been accused of academic misconduct during this time, please don’t hesitate to contact us. 

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Who We Serve

OUR CLIENTS INCLUDE:

Professors

An academic and scientific research lawyer can help ensure that faculty receive access to fair hearings, collaborating with subject matter experts to aid in their defense. 

GRADUATE STUDENTS

We know that navigating academic misconduct investigations can be overwhelming early in your professional career. That’s why our team is here to guide you through every step of the process. 

SCIENTISTS

Once a report of misconduct is made to an institution, we work to make sure the process is handled impartially through every phase.

Our Process

How we work through your case, together

Academic and Administrative Proceedings

A local academic research attorney will stand by you to make sure that you get a fair hearing from your institution’s administration.

CRIMINAL DEFENSE

Being accused of scientific fraud can pose serious consequences not only for your academic career, but also for your criminal record. Our team has decades of criminal defense experience to help protect your reputation.

Employment

Protecting your reputation is about your present, past and future. A scientific misconduct lawyer’s goal is to make sure that academic misconduct allegations don’t impede your career growth.

What you should know:

What happens during a research misconduct investigation?

Our experience with academic and administrative proceedings, the criminal justice system and employment issues enables us to provide a comprehensive defense for those accused of research misconduct. Our team represents scientists through a multi-step process. 

Once a report of misconduct is made to an academic institution, we work to ensure that the process is handled impartially through the inquiry and investigative phases. Institutional compliance with policies is essential for fairness in the process. Collaborating with leading subject-matter experts to help unravel the substantive allegations, we are armed and ready to build a defense. 

Woman doing research with a stack of papers

Other Top Questions:

Academic & Scientific Research Misconduct
Frequently Asked Questions

I have been accused of research misconduct. How can you help me?

Sometimes you have to use all resources to defend one’s life’s work from accusations of research misconduct. We use our expertise to shepherd clients through internal investigations by academic institutions or government bodies. No two defenses are the same. Our goal is to find subject matter expertise to support our defense and to help our clients find the witnesses and evidence to clear their reputation and mount an effective defense.

Can I lose my position and/or degree because of research misconduct?

There is a lot on the line when a professor or scientist is accused of research misconduct. Institutions are apt to terminate the employment of an employee rather than face public scrutiny of not showing zero tolerance – even if the allegations prove to be unfounded. We work tirelessly to protect the careers of highly advanced professionals who have dedicated years to their career.

What is our experience representing professors and/or faculty?

Our practice is dedicated to representing students, professors and/or faculty accused of misconduct. Representing employees presents unique challenges. For examples, when a professor is accused of research misconduct, there can be several parallel proceedings that occur back to back. First, a professor will have to defend allegations of research misconduct. Second, if the professor has tenure and there is a finding of misconduct, there may be a secondary hearing on professionalism to determine if the professor should be stripped of tenure and even terminated from employment. Further, if the research is connected to the receipt of federal funds, we have had to defend that employee before the Office of Research Integrity or ORI. Understanding the interlinking proceedings is integral to mounting a proper defense in these cases.

See What Our Clients are Saying

Testimonials

I worked with The Team during one of the most emotionally trying periods of my life.

They were compassionate and professional toward me at all times. I appreciated their sincerity and straightforwardness. They were available whenever I needed their assistance, day or night and throughout the weekend, in putting my documentation together. They were diligent and thorough; they familiarized themselves with all the necessary information in an impressively short time frame given the complex nature of my case. I felt confident that I was able put my best possible case forward because I had them on my team. I highly recommend their services and I am forever grateful for the support they provided me.