Onsite inspections required of NIH award recipients

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

404O.

Onsite inspections of award recipients

(a)

Scope

(1)

In general

This section applies with respect to any financial assistance from the National Institutes of Health to any non-Federal entity for research-related activities, whether the assistance is made available directly or indirectly, including through the award of a subgrant or other subaward.(2)

Special rule

This section applies even where an entity described in paragraph (1) is located or operates at—(A)a site that is in a foreign country whose government—(i)prevents inspectors from reaching the site;(ii)impedes or impairs inspection; or(B)a site that restricts or delays the entry of the inspectors for any reason.(b)

Condition on receipt

As a condition on receipt of any financial assistance described in subsection (a), an entity shall agree to undergo an annual in-person inspection pursuant to this section.(c)

Inspection requirements

The Director of NIH shall conduct an annual inspection of each entity receiving financial assistance described in subsection (a) in accordance with the following:(1)The inspection shall be unannounced.(2)The timing of the inspection shall vary each year.(3)The inspection shall take place at all the sites at which activities are being funded through the financial assistance.(4)The inspection shall examine—(A)whether the funded research is consistent with the description and assurances in the relevant proposal;(B)whether each site at which the research is conducted, and the research itself, is in compliance with all applicable standards and requirements of the National Institutes of Health; and(C)whether each entity receiving the financial assistance keeps detailed and updated records of the research conducted.(5)The inspection shall include—(A)the facility at the research site;(B)the materials used to conduct the research;(C)any electronic or hard-copy materials relevant to the research; and(D)photographic and video evidence of the inspection.(6)Each team of inspectors shall consist of at least three individuals, each of whom shall have no affiliation with any of the entities receiving the financial assistance.(7)Each team of inspectors shall certify in writing that they have no financial conflict of interest with respect to the operations, researchers, or potential findings involved.(8)Each inspector upon arrival at the site to be inspected shall present officials of the entity to be inspected with credentials confirming the inspector’s identity and authority to inspect the entity.(d)

Penalties

(1)

In general

If an entity fails an inspection under this section—(A)the entities receiving the financial assistance involved shall, collectively, return the full amount of such assistance to the Treasury; and(B)each entity receiving the financial assistance involved, including each entity that receives the assistance directly from the National Institutes of Health and each entity that receives the assistance indirectly, shall be ineligible to receive financial assistance from the National Institutes of Health for a period of—(i)not less than 5 years; and(ii)in the case of an entity that is determined by the Director of NIH to have failed the inspection for a violation described in paragraph (2), not less than 15 years. (2)

Violations described

A violation referred to in paragraph (1)(B)(ii) is—(A)without regard to whether the conduct is knowing or not—(i)denial of entry by the entity to inspectors;(ii)maintaining incomplete or falsified research records;(iii)damaging or destroying research records;(iv)withholding research records from inspectors; or(v)relocating research materials to alternate sites to avoid inspection; or(B)any action taken knowingly to prevent a full and complete inspection.(3)

Relation to other penalties

The penalties specified in this subsection are in addition to any other penalties applicable to an act or omission causing an entity to fail an inspection under this section.(e)

Annual report to Congress

(1)

In general

Not later than October 1, 2024, and annually thereafter, The Director of NIH shall submit an annual report on the implementation of this section to the following congressional committees:(A)The Committee on Homeland Security and Governmental Affairs of the Senate.(B)The Committee on Finance of the Senate.(C)The Select Committee on Intelligence of the Senate.(D)The Committee on Oversight and Reform of the House of Representatives.(E)The Committee on Energy and Commerce of the House of Representatives.(F)The Permanent Select Committee on Intelligence of the House of Representatives.(2)

Contents

Each report under paragraph (1) shall, with respect to the period covered by the report, include—(A)the full text of each proposal receiving financial assistance from the National Institutes of Health;(B)data regarding whether research conducted using financial assistance from the National Institutes of Health is consistent with the substance of the corresponding proposal;(C)data regarding whether each site at which research is conducted using financial assistance from the National Institutes of Health, and the research itself, is in compliance with all applicable standards and requirements of the National Institutes of Health;(D)data regarding whether each entity receiving financial assistance from the National Institutes of Health keeps detailed and updated records of the research conducted;(E)a final assessment of whether each entity receiving financial assistance from the National Institutes of Health remains eligible to continue receiving such assistance; and(F)a plan for the National Institutes of Health to enforce the penalties under subsection (d) with respect to each entity fails an inspection under this section.(3)

Publication

The Director of NIH shall post each report under paragraph (1) in its entirety on the public website of the National Institutes of Health.(f)

Applicability

This section applies beginning on October 1, 2023, irrespective of whether the financial assistance involved is awarded before or after such date.