Was the U.S. National Institutes of Health conflicted during the COVID-19 pandemic period?

Jon Cohen at Science has an interesting and informative article titled, “Accusers’ bad math: NIH researchers didn’t pocket $710 million inroyalties during pandemic,” published on June 5.  The article addresses allegations that government scientists made $710 million in royalties on COVID-19-related technologies.  Those allegations raise an interesting conflict of interest issue. 

The article is definitely worth a read to provide some clarity to the controversy.  The article does note that government researchers did receive around almost $37 million in royalties during a three-year period that were mostly related to COVID-19-related technologies.  The article also states that there is a significant limit on the amount of royalties an NIH researcher can receive a year: $150,000.  I guess the math adds up to around a maximum of $450,000 over a three period for an individual researcher.  How long will they receive those royalties?  Do we have an issue with this or is this type of system which provides an incentive for government researchers to try to invent useful and valuable inventions for the public a very good thing?  Does the yearly limit effectively eliminate the conflict of interest issue? 

U.S. GAO Report on Tracking U.S. Government Funding to Foreign Entities

The U.S. Government Accountability Office released a report on January 11, 2024, which studies federal funding provided to foreign entities for research and development.  The Report states:

According to the National Science Foundation, federal agencies obligated about $1.4 billion for R&D with foreign entities in fiscal year 2020 (the most recent data available). However, some foreign entities may try to exploit U.S. openness in sharing R&D for nefarious purposes.

The Research and Development, Competition, and Innovation Act includes a provision for GAO to review research funding provided to foreign entities of concern. The act's definition of such entities includes foreign terrorist organizations and foreign entities subject to the control, ownership, and jurisdiction of Russia, China, North Korea, and Iran.

This report examines challenges in identifying R&D funds awarded to foreign entities of concern and requirements for awarding and monitoring such funding.

The Report also states, in part:

GAO found that determining whether federal research and development (R&D) funds were provided to a foreign entity of concern is challenging. Such entities include foreign terrorist organizations and specially designated nationals, among others. Awarding agencies are generally prohibited from doing business with foreign terrorist organizations and specially designated nationals.

GAO found that government-wide databases which report on some of these entities lack common identifying information such as a unique identifier or personally identifiable information. For example, a physical address, date of birth, or other identifying information for entities on the foreign terrorist organization list is often unavailable as entities often try to conceal their identity or location, according to the Treasury Department. When personally identifiable information such as date of birth is available, similar information is not available in the public federal funding data source, USAspending.gov. Specifically, although awarding agencies collect other identifying information, such as phone numbers of entities seeking an award, not all such information is reported in USAspending.gov. Together, these challenges limit the ability to match foreign entities on certain lists with those receiving government-wide funding.

The full Report is available, here. 

U.S. Government Accountability Office Report on Unwanted University Tech Transfer Risk

The U.S. Government Accountability Office has released a report titled, “CHINA Efforts Underway to Address Technology Transfer Risk at U.S. Universities, but ICE Could Improve Related Data,” concerning recommendations to better track visiting scholars, students and researchers from outside the United States.  The published report is incomplete because some of it has been deemed too sensitive to disclose.  Notably, the published report points to a failure of law enforcement agencies, including Immigration, Customs and Enforcement (ICE), to track certain relevant data concerning the risk that unlawful technology transfer may occur involving federally funded university research.  The report is available, here, and states, in part:

According to federal internal control standards, management should use quality information that is, among other things, complete and accurate to achieve the entity’s objectives, and process relevant data into quality information within the entity’s information system. The U.S. government has identified research in sensitive fields, facilities and locations of expected work, and employment and employment history as potential risk factors for the transfer of technology. Improving the completeness of employer information in SEVIS could enhance ICE’s management of the OPT program and provide the U.S. government with more information on who is employing foreign students and, therefore, whether certain individuals may have access to technology.

Since 2016, oversight bodies at the five U.S. grant-making agencies in our review—NIH, NSF, NASA, DOD, and DOE—have investigated an increased number of researchers for potential violations related to the security of federally funded research at U.S. universities, according to agency data. These include grant fraud and compliance violations related to failures to disclose potential sources of foreign influence on researchers, such as other support for individual research endeavors, significant financial interests, or other conflicts of interest. These investigations have often involved undisclosed affiliations with the PRC, such as receiving PRC research funding. However, agency officials emphasized that decisions made to initiate an investigation or during the course of an investigation are not based on individual characteristics such as nationality or visa status, which is information that none of the five agencies in our review consistently collect. Agency data indicate that investigations have resulted in agency and university actions to address research security risks related to foreign influence. However, little information is available about civil and criminal cases related to potential transfer of university research because DOJ does not systematically track all cases specific to U.S. universities or federal grant funding. Further, officials from grant-making and law enforcement agencies we spoke with noted that it is challenging to assess the more general extent and negative impact of technology transfers to foreign countries. Amid agency efforts to address this type of national security threat, university faculty, officials from university and Asian and Asian-American associations, and others have highlighted the importance of balancing protection of federally funded research against potential adverse effects of these efforts. . . .

As a result of investigations initiated from 2016 through 2021, grantmaking agencies—particularly NIH, which accounted for about 73 percent of the individuals under investigation in our review—addressed a number of violations that could threaten the integrity of university research. As of October 2021, 94 percent of NIH investigations into researchers of concern had uncovered at least one compliance violation that NIH deemed serious, such as a failure to disclose foreign conflicts of interest (e.g., foreign affiliations, grant funding, or talent recruitment program participation), according to NIH data. As a result, NIH reported that at least 76 percent of individuals under investigation were no longer associated with grant-funded research or other grant-related responsibilities, primarily through resignation or actions taken by grant recipient institutions, including termination or exclusion from grant-funded research. In addition, NIH officials noted that because many of their investigations remained ongoing, they expected the number of actions taken in response to violations to rise. . . .

In this context, U.S. agencies and others have identified factors that indicate the types of foreign students or scholars who may pose a greater risk of transferring technology from U.S. universities. ICE already maintains information in its SEVIS database related to several of these factors, including country of citizenship and level of education. However, ICE has not completed a required assessment to understand whether it needs to update SEVIS to better capture information related to students and scholars who may pose a greater risk for technology transfer. Furthermore, data related to other risk factors already required in SEVIS, such as employer information, are incomplete. More complete data, and a better understanding of the information needed to identify students who present the highest risk for the potential transfer of university research, could strengthen U.S. government efforts to identify and assess risks to U.S. research and development.

Balancing Security Concerning University Research and Anti-Asian Sentiment in the United States: U.S. Senate Hearings

On April 22, 2021, the U.S. Senate Committee on Health, Education, Labor and Pensions held hearings on “Protecting U.S. Biomedical Research:  Efforts to Prevent Undue Foreign Influence.”  The Committee heard testimony from representatives from various governmental entities, including the National Institutes of Health [NIH] and the Government Accounting Office.  In written testimony, Dr. Michael Lauer, Deputy Director for Extramural Research at the NIH, explored the tension between balancing security and very serious anti-Asian sentiment in the United States.  The context involves the attempts by governments to take advantage of the open collaboration amongst international researchers in attempting to address biomedical crises.  Notably, Dr. Lauer pointed to three issues confronted by the NIH concerning security and biomedical research:

1) failure by some researchers at NIH‐funded institutions to disclose substantial contributions of resources from other organizations, including foreign governments and businesses, which threatens to distort decisions about the appropriate use of NIH funds and accurate evaluation of commitment of effort to US‐supported research; 2) diversion of proprietary information included in grant applications or produced by NIH‐ supported biomedical research to other entities, including other countries; and 3) failure by some peer reviewers to keep information in grant applications confidential; including, in some instances, disclosure to foreign entities or other attempts to influence funding decisions.

Dr. Lauer raises attempts by the NIH to address these issues, including cybersecurity measures.  Importantly, he states that the NIH has contacted over 90 awardee institutions and over 900 scientists raising potential serious concerns.  Dr. Lauer also raised potential actions that can be taken by the NIH:

Terminations or suspensions of scientists who have engaged in egregious violations of NIH grant terms and conditions and institutional policies. · Interventions to address previously un‐reported affiliations with foreign institutions. · Relinquishment or refund of NIH funds.· Prohibition of certain individuals from serving as investigators on NIH grants. · Outreach to FBI for assistance. · Discovery (through acquisition of certain foreign grants and contracts) of overlapping or duplicative work, or conflicts in stating committed effort to research projects. This discovery has led to NIH suspensions of active grants as appropriate. · Efforts to raise awareness among institutional faculty about government and institutional policies dealing with foreign affiliations and relationships (see, for example, the Penn State web site).

In addressing concerns with anti-Asian violence in the United States, Dr. Lauer states, in part:

We must ensure that our responses to this issue do not create a hostile environment for colleagues who are deeply dedicated to advancing human health through scientific inquiry. We cannot afford to reject brilliant minds working honestly and collaboratively to provide hope and healing to millions around the world.

Dr. Lauer’s testimony can be found, here.  The difficulty, of course, is maintaining security while at the same time fostering an open and collaborative environment wherein research can continue to flourish.  It will be interesting to see how this develops.  The COVID-19 global pandemic has decreased human movement throughout the world likely increasing the transfer of information through digital networks and resulting in even greater importance of the security of networks.  At the same time, as COVID-19 eases eventually (and hopefully), how will the United States ensure that foreign researchers and entrepreneurs, particularly from China, will feel welcome attending university and working in the United States.  Notably, the U.S. Senate recently passed legislation, almost unanimously (94-1 – only Senator Josh Hawley voting against it), addressing anti-Asian hate crimes. 

Improving the Allocation of Resources: Artificial Intelligence to Predict Future Clinical Success of Basic Research

In a new paper published on October 10, 2019 titled, “Predicting Translational Progress in Biomedical Research,” authors B. Ian Hutchins, Matthew T. Davis, Rebecca A. Meseroll, and George M. Santangelo describe a new way to use artificial intelligence to measure and predict which basic research type findings are likely to be translated into clinical advances.  The abstract states: 

Fundamental scientific advances can take decades to translate into improvements in human health. Shortening this interval would increase the rate at which scientific discoveries lead to successful treatment of human disease. One way to accomplish this would be to identify which advances in knowledge are most likely to translate into clinical research. Toward that end, we built a machine learning system that detects whether a paper is likely to be cited by a future clinical trial or guideline. Despite the noisiness of citation dynamics, as little as 2 years of postpublication data yield accurate predictions about a paper’s eventual citation by a clinical article (accuracy = 84%, F1 score = 0.56; compared to 19% accuracy by chance). We found that distinct knowledge flow trajectories are linked to papers that either succeed or fail to influence clinical research. Translational progress in biomedicine can therefore be assessed and predicted in real time based on information conveyed by the scientific community’s early reaction to a paper.

The full paper is available, here.  This appears to have the promise of mitigating some significant investment risk.