NIH asked to replace a PI on grants after university said she violated policy

An office of the National Institutes of Health requested earlier this year that a university designate a new principal investigator (PI) for two grants after the institution found she had violated its policy in a research misconduct investigation, Retraction Watch has learned. 

The NIH’s Office of Extramural Research, which oversees funding granted to external institutions, made the request after SUNY Downstate sent the office a summary of its investigation report that found Stacy Blain, an associate professor in the departments of pediatrics and cell biology at Downstate, had committed research misconduct in 11 instances. 

As we reported in August, Blain is suing SUNY for discrimination and retaliation related to the finding of research misconduct, seeking, among other things, reinstatement on the grants. 

According to documents filed as evidence in Blain’s suit, in December 2021 an official at SUNY Downstate notified the NIH Office of Extramural Research of the investigation’s findings and requested direction on next steps for the two grants on which she was the PI. 

Officials from the NIH and SUNY Downstate met via Zoom in January of this year to discuss the grants, according to emails filed as evidence in the suit.  

As a follow-up to the meeting, Michelle Bulls, director of the Office of Policy for Extramural Research Administration in the Office of Extramural Research, sent a letter to SUNY Downstate summarizing the meeting and stating that “NIH expects that SUNY Downstate will designate a new PD [program director]/PI” for the grants on which Blain was the PI. 

The letter, which was also filed as evidence, cited NIH policies for grants and SUNY Downstate’s finding that Blain had violated its research misconduct policy by not cooperating fully with the investigation. 

Bulls quoted from a policy that said the NIH may “withdraw approval” of a PI and request that a recipient institution designate a new one:

if there is a reasonable basis to conclude that the PD/PI and other such named senior/key personnel are no longer qualified or competent to perform the research objectives. 

It is unclear how often NIH does so. C.K. Gunsalus, a longtime observer of scientific integrity policy, said that recently she’s seen the institutes put a lot more emphasis on the grants policy manual, and in several recent cases NIH “was holding an institution’s feet to the fire about the grant manual terms.”  

The NIH gave SUNY 30 days to designate a new PI for the two grants or request to terminate them. In a memo filed in court at the end of September, SUNY Downstate’s lawyers stated that the university officials were “surprised” at the ultimatum and “decided to push back formally against the NIH’s demand and send a letter expressing their reservations.” 

On February 22, SUNY Downstate’s Senior Vice President for Research, David Christini, replied to Bulls’ letter, saying that the university likely would not have sought to remove Blain as PI on the grants solely based on the policy violation, which it seemed NIH was focused on, without the findings of research misconduct.  

The NIH did not respond, so SUNY designated new PIs for the grants. 

According to NIH RePORTER, one of the grants, R01 CA249667, was funded by the National Cancer Institute for $675,099 in 2021 and $620,808 in 2022.  The other, R21 CA252585, was funded by the same institute for $438,275 in 2020. 

In SUNY’s investigation report (page 8), the committee wrote that Blain had violated the university’s research misconduct policy and procedure by declining to identify the raw data in lab notebooks corresponding to the figures with alleged tampering. 

In court filings, letters to the NIH attached to court filings, and in a statement to Retraction Watch, lawyers for Blain deny that she violated SUNY Downstate’s policy and argue that she should not have been removed from the grants. 

Commenting on behalf of Blain, two of her lawyers, Paul Thaler of Cohen Seglias Pallas Greenhall & Furman in Washington, D.C. and Jim Walden of Walden Macht & Haran in New York City, called SUNY’s finding that Blain did not cooperate with the investigation a “misrepresentation.” 

Blain was only required to cooperate in sequestering data and telling the truth during interviews, which she did, they said: 

The Investigation Committee sought to abdicate itself of its burden to conduct a full, impartial investigation by placing the burden on Dr. Blain and then claiming she was in violation of the Cooperation Policy when she refused.  

Thaler and Walden’s full statement is available here. 

We reached out to a SUNY Downstate spokesperson, who said the institution “does not comment on pending litigation.”

This summer, Walden sent two letters, later filed in court, to Michael Lauer, Deputy Director for Extramural Research at NIH, arguing on Blain’s behalf that she had indeed cooperated with the research misconduct investigation and asking that Lauer “reconsider her removal from the grants.” 

On July 18th, Lauer emailed Walden’s second letter to Christini at SUNY Downstate and asked him to respond to the following two questions within ten days: 

• Does SUNY Downstate continue to believe, as stated in its Final Investigation Report, that Dr. Blain was uncooperative with the scientific misconduct investigation and therefore violated University policy?
• Does SUNY Downstate believe that she is still being uncooperative and in violation of University policy? 

Christini’s letter, also filed in court, reiterated the university’s finding that Blain had violated its policy and responded to her lawyers’ arguments: 

The Investigation Committee’s requests were not an effort to have Dr. Blain do their work for them. To the contrary, and as the RIO testified, committee members spent countless hours combing through lab notebooks and other data. The requests were seeking Dr. Blain’s assistance to navigate through copious amounts of what can charitably be referred to as a poorly organized research record. As the lab director, a federally funded Principal Investigator, and a corresponding author on a principal paper in the proceeding, the University expects Dr. Blain to be able to support her research findings and to work with the Investigation Committee during the research misconduct proceeding, particularly here where the state of the research record was problematic.

Christini concluded with a defense against Blain’s allegations – detailed in our earlier post – that the findings of research misconduct were discriminatory and retaliatory: 

We at Downstate take very seriously our obligation to ensure the honest, ethical and meticulous conduct of scientific research. Our responsibility to assess, inquire, and investigate any allegations of research misconduct weighs heavily on us. Our dual obligation to support our hard-working scientists and protect the reputation and continued research funding of the institution as a whole requires us to spend considerable time and effort in pursuing such allegations. There is no circumstance in which it is in the University’s interest to find research misconduct where none exists. Any finding of research misconduct by a member of our community, including those pertaining to Dr. Blain, is painful and disheartening. To be accused of doing so for biased and unethical reasons is offensive – and could not be farther from the truth.

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