By SHANNON O. WELLS

 

In its first meeting of the 2026-27 academic year, the Senate Research Committee discussed a wide range of new federal requests, regulations and proposals likely to affect most grant-based research at Pitt and other universities. 

 

The Sept. 16 meeting outlined these pending and potential changes in presentations from Rob Rutenbar, senior vice chancellor for research, who provided an overview of a busy summer spent responding to federal requests for information (RFIs) from the Office of Management and Budget (OMB), and other agencies. 

 

Bill Yates, vice chancellor for research protections, focused on new Department of Energy conflict-of-interest rules, including changes in “refresher” training, along with regulations and restrictions related to four “countries of concern,” restricted-party lists, gain-of-function research and new biosafety requirements.

 

The federal government, through the CHIPS and Science Act, determined that research interaction with four countries of concern — China, Russia, Iran and North Korea — will be under additional scrutiny and regulation. 

 

“Effectively, the only one of these countries where we have a lot of collaborations now is China,” Yates said, noting the element of ‘restricted party lists.’ “The government maintains lists of entities that we need their permission to do business with. There's actually several of these lists out there by different departments of the government — Commerce, Treasury, State and Defense — and these lists are continually updated. 

 

“All the agency has to do is publish something in the Federal Register saying we've added these entities to our list, and we don't get any pre-warning when that happens,” Yates explained. “If you're added to a list and you don't like it, there's a way of actually appealing it, but we have to basically address anybody that's added to one of these lists.”

 

That includes the Department of Defense 1260 H list, part of its “Project Clear: Contractor Lobbying Evaluation for Adversarial Relationships” implementation. “If you have Department of Defense money, you can't deal with, at all, people from those institutions.”

 

Moving on to addressing DOE conflict-of-interest rules issued on July 16, Yates noted that research administrators had “a whole month” to implement them. 

 

“They were very gracious,” he joked … “Everyone came back with the same comment: ‘Please don't have the Department of Energy deviate from all the federal funding agencies. It creates compliance problems and confusion.’ What did they do? They deviated from everybody else.”

 

As opposed to Public Health Service (PHS) rules that other funding agencies follow, DOE now requires reporting new engagements within 15 days, a reduction from the previous 30-day time frame. 

Another recent “big one,” Yates noted of federal mandates, relates to conflict-of-interest (COI) refresher training that’s currently required every four years. 

 

“Unless you have DOE funding, you now have to do it every two years, which we have to track,” he said, adding that research security training must include COI training. “So, we're having to deal with that as well.”

 

The “biggest one,” however, applies to those receiving new grant awards. The Senate Research COI Office looks at the grant and disclosures to see if a conflict needs to be managed.

 

“All those awards that come in … have a conflict-of-interest review at the time of award, and this makes sense,” he noted. “Why do a conflict-of-interest award review for a grant that's not going to be awarded?” 

 

However, “DOE doesn't feel that way.” Now a review is required even before a proposal is submitted. 

 

“If there are conflicts to be managed, (or) unmanageable conflicts, we have to disclose them in the application themselves, as well as all foreign government-linked conflicts,” Yates said. 

 

While Pitt doesn’t have a “huge number” of DOE grants, the rule “just adds a lot of work, because we're doing this review for proposals that won't get funded. 

 

“We had to update with the new rules our conflict-of-interest policy, and they gave us 30 days. We've done that,” he said, with a DOE-specific appendix added to the policy. “We’re updating our research security training … adding a little bit more of conflict of interest there.”

 

Because training is now required for all key personnel, the COI module will be eliminated. “You're going to be doing COI training at exactly the same time, and that every-four-years COI training requirement will go away,” he said. “We hope that's going to eliminate some burden for investigators.” 

Based on the Defense Authorization Act signed into law last year, the OMB was required to formulate a “biotechnology companies of concern” list by the end of 2026, Yates noted. Any biotech company on some of the restricted-party lists will automatically be added. Implementation is required once the list is released. 

 

“Probably by sometime late in 2027, if you're on this list, federal funding cannot be used to transact with the company,” he said. “Any company that was added to restricted party lists this summer, eventually we can't have any transactions with them. 

 

“Unfortunately, some companies that we deal with a lot were added to the DoD 1260 H list,” including Novogene, often used for sequencing, and WuXI AppTec, used for synthesis of small molecules. The latter’s addition is now on pause “because they're suing the federal government,” Yates noted. 

 

Other companies on the list eventually will be off limits for federal procurement, and anyone using DoD money “absolutely can't purchase anything from a company on their restricted-party lists … If you want to go to Novogene, for example, and you have a DoD grant, you can't, because the DoD rules prohibit it. 

 

National Science Foundation (NSF) transactions will go the same way next year, “and we know that because they put out a ‘Dear colleague’ letter this summer saying they're going to implement similar requirements, restricting collaborations with entities on the restricted-party lists,” Yates explained. “The government is putting out more prohibitions now.”

 

New changes in biosafety and biosecurity include a U.S. government policy issued this summer for stopping high-risk life sciences research. In response, life sciences agencies or government agencies that fund life sciences research have to give researchers guidance by Nov. 17 before the changes are implemented by Jan. 16.

 

“We're going to have all of 60 days to implement the guidance after it comes out,” he said. “And this applies to all institutions that receive federal funding.”

 

The policy prohibits: 

 

1) Dangerous gain-of-function research through federal funding, defined as any research that enhances harm or transmissibility of an agent that makes it more evasive to immunization, provides therapeutic resistance to an infectious agent or alters its host range or host susceptibility. 

 

“Or if you're trying to eradicate or basically reconstitute an eradicated agent, any of these things are now prohibited.”

 

2) International research of concern, pertaining to the four countries of concern. 

 

“Life sciences research funded by the federal government can't go on there anymore,” and a new list is coming of entities of concern with whom life-science research can’t collaborate. “We also cannot conduct U.S.-funded life-sciences research at any site that can't comply with U.S. standards,” Yates noted. 

 

Based on a “very broad definition,” when the policy goes into effect in January, use of companies in countries of concern for life-science research will be “strongly curtailed.”

 

In response, the University must set up an institutional review entity with at least five “conflict-free members,” including a community member, and establish an institutional contact, likely Yates. This intends to certify that proposals don't have dangerous gain of function, defined by U.S. Department of Health and Human Services as experimentally altering viruses or bacteria to increase their contagiousness, deadliness or resistance to treatments, 

 

“Every PI is going to have to attest their proposal does not have dangerous gain of function, and then Pitt has to certify that that is accurate,” he said. “We also have to build dangerous gain-of-function training for all life-sciences investigators … It has to be annual, and we have to retain compliance records. 

 

“We have to report non-federally funded potential dangerous gain of function that we do annually if we get federal funding,” Yates added. “If something turns out to be dangerous gain of function, we have to stop it and notify the funding agency within 24 hours.”

 

Although Pitt’s never had “legitimate dangerous gain of function research,” he noted the potential that an experiment changing genetic characteristics of an organism could “serendipitously” turn out to be. 

 

“The government recognizes that we just have to stop it and notify,” including a statement in the My Funding system from all PIs that there are no dangerous gain-of-function projects here. “We're going to … drill down a little bit more to certify there's no dangerous gain of function in the application. It's going to be a little tricky to do.”

 

If the government suspects dangerous gain of function in an application, it will face a committee review. 

 

“That may hold up your review at the federal funding agency … If we find something that we think could be dangerous gain of function, but we're not sure, we have to flag it and send it to that committee for review.”

 

Yates emphasized there's “a lot of penalties if you fail to do this properly” in the policy, which must be implemented by January. “I know what I'm going to be doing over the winter break this year, as I'm going to figure out how to implement this new policy,” he said. 

 

An advisory group comprises senior investigators from Pitt’s Center for Vaccine Research and “a couple department chairs are actually helping us review this and come up with practices to implement this new policy.”

 

Some other new policies and developments regarding federal research guidelines include the following: 

 

Biosafety policy: A draft NIH biosafety policy released in August that replaces guidelines on recombinant DNA is out for public comment, which closes in October. 

 

“This covers all biosafety,” Yates noted. “It changes the scope entirely (of) what the IBC (Institutional Biosafety Committee) does from recombinant DNA research to any laboratory biomedical research involving biohazards — a huge increase in scope.”

 

Previously, the NIH guidelines covered recombinant molecules and cells, organisms and viruses. “In other words, if you're doing things to manipulate the genes in something, now wild-type pathogens and genetically modified entities are part of the policy,” he explained. 

 

New safety recommendations include replacing every IBC protocol every three years, based on de novo — or from the beginning — reviews. 

 

“We have to publicly post our meeting minutes on a public website. Before it was just (for) recombinant DNA,” Yates noted. “Now, all biohazardous work goes to the IBC and has to be captured in our meeting minutes. We have to notify NIH or the funding agency within 24 hours of any exposures … and post the incident reports on a public website.”

 

The draft notification form posted on a researcher’s public website “requires a lot of information” including the agent involved and the PI’s name. “It's a big security risk,” he said. “It would actually place out there a lot of information about PIs and the work that they're doing publicly.”

 

Foreign component: NIH recently defined a foreign component as a “performance of any significant scientific element or segment of a project outside of the United States. 

 

“If you do any human subject or animal research at a foreign site, it doesn't just mean a country of concern anywhere outside the United States,” Yates explained. 

 

For example, hiring a contract research organization to do research for you outside the United States is a foreign component. “If you collaborate with a foreign investigator that may produce co-authorship, that typically is a foreign component, and NIH is actively looking at progress reports. 

 

“They're starting to question this: ‘What was going on here? Why didn't we know that you were doing part of your research outside of the United States?’ This counts whether or not grant money is involved.”

 

Yates advised researchers to notify NIH before involving someone outside the U.S. in NIH-funded research. 

 

Research Security Decision Matrix: Before issuing an award, the Department of War, aka Defense, looks at a researcher’s publication history from the past five years for collaborations with individuals that work with institutions on a restricted-party list. 

 

Most that would be of relevance are in China, Yates noted. “They're not going to give you the money. You cannot do a collaboration with an individual working for a restricted institution and get DoD money to do that work.”

 

Those who have collaborated with a foreign institution on a restricted-party list in the past five years are required to submit a mitigation plan, “essentially a promise you're not going to be collaborating with them during the duration of the award.”

 

The NSF also announced in a ‘Dear colleague’ letter this summer that it will implement similar rules by sometime in 2027. 

 

“If you're collaborating with a restricted institution, then you can't do that during the course of your NSF award,” Yates said. “Foreign collaborations typically now need to be approved by your funding agency, particularly for NIH. Never start a foreign collaboration if it's going to result in co-authorship before prior approval is granted.”

Responding to a committee question about researchers visiting Pitt from countries of concern when they are named on the funding application, Yates said “while they're here, they're not a restricted entity … While they're in your lab, they're not a covered person. As soon as they go back home, however, they become a covered person again.”

 

To those who have somebody from a country of concern visiting, he recommends making it “very clear in the paper all the work was done here.”

 

It’s “completely fine” if a postdoc from China is working in a Pitt lab. However, if they go back to China “for a month for the holidays, all of a sudden you've exported that sensitive data to a country of concern and violated the rule … Even taking your data to a country of concern can violate these rules, even if you don't share it with anybody there.”

 

Regarding a question about what more frequent COI training will mean for research security, Yates said COI already is part of training modules. 

 

“We're going to add just a little bit more, and I'm going to add half a page on dangerous gain of function,” he said. “That way, everything everybody has to do is going to be covered. Dangerous gain of function doesn't apply certainly to all investigators, but it's a way of getting everybody to know about it. 

 

“Everybody's going to have to certify their grant as not having dangerous gain of function in it. Even if you do physics or chemistry research (or materials engineering) … you still have to make that certification. We (have to) train people about what that means.”

 

Shannon O. Wells is a writer for the University Times. Reach him at shannonw@pitt.edu.

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