Colleges and universities are important centers for research and scholarship, as many new discoveries are made by faculty or graduate students working under the auspices of an educational institution. Any institution that wants to develop legitimate, credible research has standards in place that safeguard research integrity. Colleges and universities must also adhere to standards and protocols set by the federal Office of Research Integrity (ORI) if they want to gain federal funding for research projects related to biomedical sciences and public health.
When a student, research assistant, or professor is placed under scrutiny for potential research misconduct, most universities consider it a very serious matter. A full-fledged investigation usually follows such an allegation, and the consequences for the accused, should the allegations be proven true, are severe. For this reason, hiring an experienced education attorney to advise and represent you as you go through a research misconduct investigation is essential.
What Is the Office of Research Integrity?
ORI is a government agency within the Department of Health and Human Services (HHS). It oversees accountability for all research activities within the scope of Public Health Services (PHS). ORI's reach extends to federal agencies as well as colleges, universities, medical schools, research institutes, and any entity receiving PHS research funding. PHS provides nearly $38 billion for health research and development, primarily in biomedical and behavioral sciences.
ORI sets standards for what is considered research misconduct and establishes the scope of the federal government's interest in reliable and accurate research activities. Its policies also act as a uniform code for integrity in research that all agencies and institutions can refer to.
The Purpose of ORI
ORI exists to ensure that research findings are accurate and honest. If a protocol is breached or data is reported dishonestly, it corrupts the research. Tainted results can have dire consequences for public health, so researchers are held to strict standards. It's the job of ORI to ensure that research corruption doesn't happen and if there are reported instances of it, to handle it so that it's less likely to happen again.
ORI has several responsibilities related to upholding research integrity, including:
- Developing policies and regulations that help detect, investigate, and prevent research misconduct
- Reviewing and monitoring research misconduct investigations
- Sending research misconduct findings to the Assistant Secretary for Health after completing an investigation
- Providing technical assistance to institutions handling allegations of research misconduct
- Promoting responsible research conduct and integrity through various activities and programs
- Conducting policy analyses and evaluations to build the knowledge base on research misconduct
What Is Research Misconduct?
Since research misconduct can lead to such serious consequences, it's important to know what ORI considers research misconduct. According to ORI, research misconduct is “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” Each of these terms is also defined.
- Fabrication: Making up data or results and recording or reporting them.
- Falsification: Manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented.
- Plagiarism: Appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
The Difference Between Honest Error and Intentional Error
The above actions must be committed knowingly to be considered research misconduct. Honest error or difference of opinion does not constitute misconduct. The lines between an intentional and unintentional mistake can sometimes be blurred, however, and you may not know how it applies in your situation.
For example, if you used an inappropriate statistical model without realizing it, and none of your peer reviewers caught it, it would be considered an honest error. If your peer reviewers did notice, however, and warn you that this model would materially misrepresent your data, and you used it anyway, that would be an intentional error that could qualify as research misconduct.
The crux of the issue is a substantial deviation from standard practices. This matter was debated over heavily when ORI was first established and remains a key component of demonstrating honest or international errors. If it can be shown that your deviation from accepted conventions in your field was intentional, then you may be found responsible for research misconduct.
Correcting an Honest Error in Research
If it's discovered you made an honest error in your research, there are a few ways to correct the scientific record. Publications can offer retractions, corrections, or expressions of concern:
- Retraction: The entire paper gets retracted due to research errors or an unethical study. It's wholly removed from the field and is the most drastic option for correcting an honest error.
- Correction: A paper is republished with a correction stating the research error and offering a remedy, such as using a more appropriate statistical model.
- Expression of concern: For more minor issues of data collection and representation, a journal can republish the paper with an expression of concern. It points out a potential issue without removing the underlying study from the body of research.
Keep in mind that fixing an error after a study has been published is entirely up to the journal that published it. The editorial board may have other ways of dealing with it, but you can recommend one of the above options as a solution when you learn that your research contains an honest error.
University Policies for Research Conduct
Most colleges and universities have their own office of research integrity, or similar entity to uphold standards amongst their own researchers. Policies of university ORIs usually adhere to those of the federal ORI, to ensure consistency. University-level research integrity boards also deal with claims of misconduct before they get elevated to the federal ORI.
ORIs within universities usually also have the responsibility of overseeing a research misconduct policy. The University of Southern California, Columbia University, and the University of Maryland are all examples of higher education institutions that have extensive research misconduct policies. These policies typically define research misconduct (most use the same definition as the federal ORI), state processes for reporting suspected misconduct, and describe how to handle alleged misconduct.
The University of Maryland and Columbia University both appoint a Research Integrity Officer (RIO), whose job is to oversee inquiries and investigations of faculty research misconduct. Inquires into research misconduct at the university level can be lengthy, including filing a report, assessing the allegations, investigating, making a determination, and appeals. If the university's RIO determines it's necessary, the matter may also be reported to relevant federal agencies or sponsors. It's usually at this point that the federal ORI gets involved in a suspected research integrity case.
The ORI Misconduct Claims Process
ORI has a standardized process for dealing with research misconduct. Although many cases end up getting reported by institutions, they can also be reported directly by claimants, or whistleblowers. When ORI receives a report, the case must go through a series of steps for ORI to review it.
Preliminary Assessment
The institution looks into the matter to determine if it's within PHS jurisdiction. The criteria are:
- The research and facility in question receive PHS funding or have applied for PHS funding.
- The allegation meets the definition of research misconduct.
- The allegation contains enough information to move forward with the inquiry.
Inquiry
The inquiry evaluates all the existing information and evidence surrounding the allegation, to decide if there should be a full investigation. At this point, faculty or researchers who are the subject of the allegation can be notified and asked for testimony.
Institutional Decision
After the investigation is complete, the institution's RIO makes a decision. If the matter falls under PHS jurisdiction, the RIO will forward the case to ORI for review.
ORI Oversight Review
ORI reviews the case received from the institution to see if it's thorough, competent, objective, and timely. If these criteria are met and the evidence supports the conclusions of the report, ORI forms a recommendation to make to the PHS/HHS concerning which administrative actions (sanctions) are appropriate.
PHS/HHS Decision
The final determination on which actions should be taken for the research misconduct committed is by the Assistant Secretary for Health. The findings and recommended administrative actions are compiled in a report, which the Assistant Secretary sends to the accused.
Appeal
If you want to appeal a decision and recommended sanction in the ORI report, you have 30 days to respond and request a hearing before an Administrative Law Judge (ALJ). You are allowed to have legal counsel present with you at this hearing. The ALJ will make a recommendation to the Assistant Secretary for Health after the hearing. The Assistant Secretary can then affirm, reverse, or modify the decision. If debarment or suspension is recommended, however, the HHS Debarring Official must make the final decision.
Faculty Penalties for Research Misconduct
Penalties for research misconduct can come from a faculty member's educational institution or PHS. These penalties are referred to as “administrative actions” and may include oral reprimand, termination of employment, or something much more serious.
At the University of Minnesota, faculty who are responsible for committing research misconduct may face one of the following actions:
- Oral reprimand with no permanent record
- Written reprimand that goes in the permanent record
- Heightened monitoring of future research projects
- Removal from the research project in question
- Probation
- Suspension
- Salary reduction
- Rank reduction
- Termination of employment
The above list merely includes examples that a faculty member could face; the actions the university takes are subject to employment rules and appropriate labor agreements.
The administrative actions that HHS could take may include:
- Correction of the research record
- Letter of reprimand
- Suspension or termination of PHS funding
- Restriction on activities involving PHS funding
- Special review of all future PHS funding requests
- Prohibition on participating in federally funded research for a set period (debarment)
- Recovery of PHS funds that were sent to support activities involving the research misconduct
- Prohibition serving in an advisory capacity to PHS
- Retraction or correction in the journal where the research is published, if it's already been published
In addition to taking administrative action against individuals, HHS can also take action against institutions. If an institution does not follow ORI's requirements, it could also receive a letter of reprimand, be placed on special review status, be forced to take corrective actions, or even be debarred.
Can ORI Send You to Prison for Research Misconduct?
No, ORI does not have the authority to charge you with a crime and cannot send you to prison. It is possible, however, that an ORI investigation uncovers other misdeeds or allegations of criminal activity. In this situation, ORI refers these matters to the appropriate channels for further action.
Are ORI Investigations Public?
ORI cannot disclose information about individuals without their written consent first. However, HHS can disclose the findings of an investigation after it's completed to third-party agencies such as professional journals and the news media. Your case may be published in the Federal Register, the NIH Guide to Grants and Contracts, and on the ORI website. The disclosure can detail the ORI's findings about your research misconduct and the administrative actions taken against you.
How Does HHS Decide on Administrative Actions?
The action that HHS takes once someone is found responsible for research misconduct is based on the circumstances and the severity of the misconduct. Aggravating and mitigating factors are taken into account as well. Some of the factors that HHS considers when deciding include:
- Whether the misconduct was an isolated event or a regular pattern of behavior
- The impact the misconduct has on public health
- Whether the accused accepted responsibility for their actions
- Whether the accused retaliated against the people who assessed the misconduct
- Whether HHS found the accused responsible to conduct PHS-funded research
Voluntary Agreement
If ORI determines that you have committed research misconduct, you may have the option to enter into a voluntary agreement to show good faith and avoid administrative actions. By choosing a voluntary agreement, you neither admit nor deny ORI's findings and agree to conclude the matter without further expenditure of time, finances, or other resources.
Generally, when you enter into a Voluntary Agreement with ORI, you agree to have your research supervised for a period of one year or more. In more serious cases of research misconduct, the supervision period could last for several years. You may also have other requirements, including:
- Submitting a supervision plan to ORI before applying for PHS support for a PHS-funded project
- A committee of two or three senior faculty members at your institution (excluding your supervisor or collaborators) familiar with your field to provide oversight and guidance, do quarterly audits, and submit progress reports to ORI
- Ensuring that your institution certifies to ORI that your research is accurate and legitimate
A voluntary agreement can be a way to avoid stricter administrative sanctions, but you can end up having supervised research for many years afterward. You may be able to appeal the determination instead and avoid both sanctions and a voluntary agreement. If you hire a research misconduct attorney to advise you, they can let you know what the best option is in your situation.
Other Research Issues That May Lead to Professional Discipline
Understanding ORI's requirements is crucial to secure PHS funding, but you should stay aware of your institution's specific research policies as well. Research based on human subjects or personal identifying information tends to have stricter policies that, if violated, could land you in significant trouble with your university.
How an Attorney Can Help for Research Misconduct Cases
Research misconduct is not illegal and you most likely won't end up with criminal charges, but it's still a serious matter. It can have major repercussions for you as a faculty member, possibly ending with the termination of your employment. If you lose your position over research misconduct, it may be difficult to get another educational institution to hire you.
An experienced research misconduct attorney will know how the process works at your institution and with ORI. They'll be able to help you stand up for your rights and guide you on how to handle the inquiry, investigation, and any meetings you have with university officials. If you decide to have a hearing for your appeal, a lawyer can also gather evidence and represent you. They'll have the negotiation skills to work toward a more favorable outcome for you. Involving an attorney with your research integrity allegation could be the factor that saves your career.
Attorney Joseph D. Lento has handled many misconduct cases involving educational institutions, including those with ORI. If you've been accused of research misconduct, contact the Lento Law Firm Team by calling 888-535-3686 to see how we can help.
