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Working Together to Protect the Integrity of NIH-funded Research

When research findings are made up from thin air, misrepresented in some way, or blatantly and without credit copied from others, we risk eroding the public’s trust, damaging institutional reputation, harming careers, incurring skepticism, misleading future research, and, arguably most importantly, hurting patients.

NIH takes research misconduct seriously.

We are being proactive. A recently published Notice reminds the community about our expectations that NIH-supported institutions address misconduct allegations when they occur (see NOT-OD-19-020). When a recipient institution finds, learns of, or suspects research misconduct that impacts or may impact an NIH-supported project, the recipient must work with NIH to assess the effect on the integrity of the project.

We are being vigilant. When research misconduct concerns are identified and relayed to the NIH, we work with the recipient institution to protect human participants or vertebrate animals and to protect the integrity of the research and research funding. We also work with our colleagues at the Office of Research Integrity (ORI) within the U.S. Department of Health and Human Services, as ORI has the authority to oversee investigations into allegations of research misconduct involving Public Health Service (PHS) funds.

We are strengthening partnerships. A collegial relationship between recipient institutions, NIH, and ORI is paramount for this process to work. NIH awardees certify, through an assurance with ORI, that they will address allegations of research misconduct that may arise when performing the approved research activity. As part of this, they commit to maintaining confidentiality for all identifiable respondents, complainants, and research subjects involved. In addition, recipient institutions seeking an approved assurance with ORI must have written policies and procedures for addressing research misconduct that include appropriate interim institutional actions and notice of any facts that may be relevant to protect public health, Federal funds and equipment, as well as the integrity of the PHS supported research process. Such actions and notices may involve working with the NIH to protect the project’s scientific integrity, including the safety of any human research participants, laboratory animals, and the environment. ORI has also clarified this reporting responsibility for institutions.

We are taking action. If concerns are identified, NIH addresses them. This may include actions such as imposing specific award conditions (e.g. requiring additional supervision of the research).  If an institution fails to comply with the terms and conditions of award, NIH may take further actions that may include disallowance of costs, withholding further support, or suspension or termination of the grant. When researchers who have or may have committed misconduct transfer or plan to transfer institutions, NIH may work with the former institution(s) and/or the new institution(s) to address concerns.

We appreciate that you are vigilant too. If a research misconduct allegation involving NIH-funded research moves to an investigation, recipient institutions must inform ORI and other relevant Public Health Service agencies of any special circumstances that may exist. Special circumstances may include risks to the health or safety of the public, immediate needs to protect human participants or laboratory animal subjects, threats to federal resources, or need to suspend research activities. We will work with you to determine if the project can continue as originally approved, if a change in the scope or senior/key personnel is needed, or some other action is warranted depending on the situation. Together, we can help mitigate effects of fabricated, falsified, or plagiarized information on the integrity of the NIH-supported research project.

The steps we take with our federal partners and recipient institutions are meant to promote the highest levels of scientific integrity, public accountability, and social responsibility in the conduct of science. When we adhere to the principles of accountability, fairness, openness, and stewardship, our research endeavors will have the best chance to achieve the NIH mission, advance knowledge, and importantly, improve public health.

Want to know more? We invite you to watch this video on our actions to address research misconduct in NIH-supported research.

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5 thoughts on “Working Together to Protect the Integrity of NIH-funded Research

  1. Is NIH going to introduce rules similar to The Sainsbury Laboratory?

    “Post-publication peer review is becoming increasingly popular, but authors need more incentive to self-correct and amend the scientific record (see D. B. Allison et al. Nature 530, 27–29; 2016). We propose that failure by authors to correct their mistakes should be classified as scientific misconduct. This policy has already been implemented by our institute, and we encourage research institutions and funding bodies to follow suit.

    The responsibility to correct errors lies mainly with the criticized authors. Snubbing criticism by not addressing it promptly runs counter to our fundamental ethos as scientists, and threatens to erode society’s trust in the scientific community.”

  2. The Integrity of NIH review process also has to be reexamined. The Program officers play god. The vigor and reproducibility should also apply to NIH reviewers and reviews. NIH needs to explain how a review could get 15% on round one and get streamlined in the subsequent review. It just doesn’t make sense. NIH grants have become a chance game rather than scientific pursuit. The reviewers are poorly informed, play favorites, and often don’t face any consequences for bad reviews.
    Machine readable format for grant application and reviews must be in place.

  3. I am retired now, but I was the RIO at the University of Connecticut Health Center for 32 years, and the Associate VP for Research Administration for most of that time. I believe that this notice is ambiguous, and will make it difficult for grantees to comply with NIH’s expectations regarding reporting of research misconduct.

    The language I am bringing to your attention is the following:

    “When a recipient institution finds, learns, or suspects that falsified, fabricated, or plagiarized information has affected the integrity of NIH-supported research, including but not limited to, applications for funding and progress reports, or published research or research products supported by NIH funds, NIH has a need to know this information, and the institution must immediately provide information on the affected research to the NIH Office of Extramural Research – Research Integrity (OER-RI),”

    NIH grants are a main source of property interests to investigators, and any action by an employer which may affect those interests is one that could have serious legal consequences for grantees. Hence, without a formal regulatory requirement to do so, reporting alleged or suspected research misconduct before a grantee has completed a research misconduct investigation could be construed as negatively affecting a respondent’s property rights. A research misconduct investigation is a complex, and often drawn out procedure. Allegations need to be properly vetted through an inquiry phase, which is never confirmatory; and respondents have significant rights to defend themselves throughout the entire process. The problem, in my opinion, is the requirement to report “suspected” research misconduct. An allegation of such immediately creates a suspicion, but the investigation process is designed to determine if research misconduct has occurred, while protecting the rights of the respondent.

    Thus, absent a clear regulatory requirement to report allegations of research misconduct, grantees could be placed in jeopardy of affecting a respondent’s property rights by reporting “suspected” research misconduct before the respondent has had an opportunity to defend himself. Conversely, if a grantee decides not to report alleged (“suspected”) research misconduct until the investigation has been completed, it risks running afoul of NIH’s requirement as outlined in the current notice.

    Another factor to consider is that in my experience, the majority of allegations of research misconduct which I handled, and which I suspect is the case at most research institutions, were resolved during the inquiry phase of an investigation with no findings of misconduct.

    Having been down this road several times in my career, I know just how difficult it is to prevent running afoul of a respondent’s perception of his employer running roughshod over his rights, and dealing with respondents’ attorneys who are eager to file lawsuits and restraining orders.

    It is not clear to me what NIH’s concern is in promulgating this notice. If NIH needs to know that an allegation of research misconduct has been received by a grantee, i.e., that someone has raised the “suspicion” of research misconduct, then the notice should so state, unambiguously, and give grantees a reasonable amount of time to comply with the notification requirement. However, this should be done with the clear understanding that most allegations do not lead to formal investigations.

    If NIH feels it needs to be informed of the initiation of a formal investigation phase of the process, then it should require grantees to report after the inquiry has been completed, at the same time as they are required to report to ORI. However, this should be done with the understanding that even at this stage of the process respondents are not considered guilty

    If NIH is concerned about the appropriate execution of grant funded research once research misconduct has been determined, then the notice should drop the inclusion of the term “suspected”, and require grantees to report once the investigation process has been concluded.

    I encourage NIH to review the language of this notice to make it clear to grantees when they are required to report such matters.

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