Marylana Saadeh Helou, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, was quoted in STAT News, in “NIH Specifies How Grant Reviewers Should Ensure Alignment with Trump Priorities,” by Anil Oza. (Read the full version – subscription required.)

Following is an excerpt:

Signaling a move toward the next phase of change, leaders at the National Institutes of Health have sent new guidance to its staff on how to further move its $39 billion portfolio in alignment with the Trump administration's priorities.

The seven-page guidance, sent on Friday and titled "Reviewing Grants for Priority Alignment," provides details to program officers, who manage grants within a subject area, on how to determine whether grants fall into the administration's priorities - and if not, how to appropriately terminate them. The guidance, which follows a public memo from NIH Director Jay Bhattacharya, is another step in the administration's unprecedented campaign to bend the focus of biomedical research in the country to its will. …

Since the administration began terminating awards it deemed out of step with its agenda, it has faced legal pushback. Following those challenges, the Department of Health and Human Services outlined ways that the administration could continue to terminate grants in a fashion that could withstand legal scrutiny. Part of that guidance, from HHS' Office of General Counsel, recommended that the NIH make its priorities public.

In August, Bhattacharya did that, stating that his tenure would focus on 12 key priorities, including replication, artificial intelligence, nutrition, and moving away from animal models, among others.

The main challenge to NIH grant terminations argued that the terminations were "arbitrary and capricious," and did not put enough consideration into each termination.

The new guidance focuses on tailoring terminations to specific grants, and ensuring there is a discussion of a grant's alignment with the administration's priorities.

"The door has been opened, I think, for more dialogue with the [NIH's institutes, centers and offices]," said  Marylana Saadeh Helou, a partner at the law firm Epstein Becker & Green who has helped researchers appeal grant terminations.

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