June 17, 2019

Ensuring the integrity, longevity, and strength of the biomedical research enterprise

In my 10 years as the NIH Director, I have rarely seen a time where the NIH has found it necessary to tackle so many tough issues facing the biomedical research enterprise simultaneously.  For such complex challenges, I rely heavily on the advice from my Advisory Committee to the Director (ACD), which has delivered several interim and final reports at the December 12-13, 2018, and June 13-14, 2019, meetings.  The members of the working groups have expertise in the areas under examination and provide perspectives from the extramural community. The working groups have worked tirelessly to consider the issues and develop options for the ACD to consider.  In turn, the ACD has provided high level recommendations to me, and I want to share the actions that NIH is taking in several key areas. 

Artificial Intelligence (AI): This Working Group, initiated in December 2018, was charged with recommending how to best advance and take advantage of AI and related technologies to benefit biomedical research while being cognizant of the associated ethical challenges. The group delivered its interim report,  which focused on five themes: more AI-ready data, more “multilingual” researchers, ethical, legal, and social implications, important areas to apply AI, and important areas to advance AI. Their final recommendations will be presented at the December 2019 meeting.

Next Generation Researchers Initiative (NGRI): This Working Group delivered its final report in December, and the ACD made several recommendations which we have fully embraced, with most in various stages of implementation. An update was presented at the June meeting about these implementation efforts. After instituting the NGRI policy in fiscal year 2018, NIH awarded the highest number of Early Stage Investigator (ESI) grants in its history (1,287).  As part of its effort to help at-risk investigators, OER also instituted a process of flagging to NIH Institute and Center (IC) Directors meritorious, established investigators whose applications for new grants scored well but fell outside the payline, putting them at risk for losing NIH funding. The IC Directors can choose to prioritize funding of these investigators. NIH also is increasing the level of post-doctoral support by increasing the stipends for Ruth L. Kirschstein National Research Service Award recipients. Finally, NIH will be launching a new ESI award called the Stephen Ira Katz Award in memory of the longtime director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases who passed away unexpectedly in December. Still in development, this award will issue R01 grants to fund deserving ESIs who are designated on meritorious applications with no preliminary data, enabling them to propose and address highly innovative ideas that may represent entirely new research directions from the work they did as trainees.

High-Risk, High-Reward (HRHR) Programs Working Group: This group was charged with reviewing the effectiveness of the NIH HRHR programs, analyzing participation of women and underrepresented groups in the programs, examining the diversity of scientific topics supported by the programs and the institutions that submit applications, and proposing steps that the NIH might take to enhance the diversity of applicants and awardees while supporting the best science. The Working Group delivered its final report to the ACD, who delivered final recommendations, including: 

  1.  expanding the program to provide greater support for clinical projects;
  2.  implementing broader outreach efforts to institutions and groups that may not be aware of the program;
  3. using strategies such as better advertising directly to the trainee community to support new applicants and evaluating the review process to ensure that the review of applications is unbiased;
  4. making institutional diversity a programmatic priority with ongoing evaluation against benchmarks and requiring affirmations by awardee organizations that policies to prevent sexual harassment are in place. 

Changing the Culture to Change Sexual Harassment:  This Working Group was convened in December 2018 and has been working to tackle its ambitious charge to address sexual harassment in the biomedical research workplace and the underlying culture that facilitates it. As part of its effort to understand the devastating effects of sexual harassment on the research enterprise, the Working Group held a public listening session in May with targets and survivors of sexual harassment. The conversations at the listening session played a crucial role in the development of the actionable interim recommendations. These recommendations are expected to complement a number of existing NIH activities to address the pervasive issue of sexual harassment in biomedical research. The ACD chose to focus their discussion on egregious cases of sexual harassment and restoring the careers of those affected. The interim recommendations from the Working Group included:

  1. treating professional misconduct, including sexual harassment, as seriously as research misconduct;
  2. requiring all principal investigators named on NIH grant awards to attest that they have not violated and will not violate their institutional professional code of conduct when submitting NIH grant applications and progress reports;
  3. establishing mechanisms that would allow sexual harassment survivors to restore their careers and for NIH to recapture lost talent;
  4. developing novel approaches to allow trainee and junior investigator independence from their mentors.

NIH will be pursuing mechanisms and approaches to implement these interim recommendations, where feasible, while the Working Group continues to identify ways to address gender harassment and promote far-reaching culture change.  I look forward to seeing their final recommendations in December.

BRAIN Initiative 2.0: The NIH BRAIN Initiative has made remarkable progress in its first five years of funding, including the establishment of the BRAIN Initiative Cell Census Network, development of probes for recording and affecting the activity of neurons and neuronal ensembles, and a neural decoder that converts human cortical activity into speech. In its report, the ACD BRAIN Initiative Working Group 2.0 addressed eight key scientific priority areas for the next phase of the BRAIN Initiative, taking into consideration new opportunities for developing and applying new tools to revolutionize our understanding of the brain.  While emphasizing BRAIN’s remarkable success to date and proposing additional paths for the bold initiative’s research goals, the ACD also endorsed the importance of pursuit of large-scale transformative projects for the next phase of BRAIN Initiative, to include research such as:

  1. generating and implementing methods to access, manipulate, and model clinically relevant cell types across multiple species;
  2. generating an anatomically informed, highly granular cell census of the whole human brain;
  3. comprehensively mapping the entire mouse brain, enabling study of brain circuitry from synapses to coordinated function and behavior;
  4. achieving circuit-level understanding of, and interventions for, a vulnerable circuit as a move toward protecting or correcting a major human neuropsychiatric disease symptom;
  5. learning how the brain retrieves and leverages information from internal models and memory systems.

These projects will require focused resources, new technological inventions, and collaborations among diverse stakeholders, but have the potential to change the course of neuroscience research and exceptional impact on how we treat brain disorders.

The ACD also received a deeply thoughtful report from the Neuroethics Subgroup of the BRAIN Working Group, pointing out the need to consider the implications of this research for animal studies, human identity, and even the meaning of consciousness.  As the BRAIN Initiative research charts new frontiers of understanding, the ACD recommended that this research should be undertaken both thoughtfully and with the highest ethical standards. To that end, the ACD recommended that the final reports to the ACD include a framework for integrating the “neuroethics roadmap” into the scientific strategy for the BRAIN Initiative moving forward and beyond.

Foreign Influences on Research Integrity: This Working Group issued its final report at the December 2018 meeting, with a follow up presentation included in the June meeting.  In December, the ACD endorsed more than 30 recommendations, all of which have been carefully considered by NIH leadership, and many of which have been or are in the process of being implemented. As of today, the NIH Office of Extramural Research (OER) has notified more than 60 grantee institutions of concerns with investigators named on NIH grant awards, and OER continues to work closely with these institutions on their reviews. OER also has implemented a new mandatory electronic system for conflicts of interest reporting, an improved system of controls and cybersecurity measures, and specialized training for NIH extramural staff. NIH is in the process of re-evaluating existing policies and forms to ensure complete disclosure of other research support and financial conflicts of interest, as well as assuring security of confidential information. NIH is also considering updating the terms and conditions of grant awards to address peer review concerns. NIH continues to work closely with U.S. government departments and agencies, as well as with professional societies, to develop and share best practices and other useful information to mitigate the risk.  At the same time, NIH is deeply concerned about the potential for overreaction to this situation.  Foreign nationals are a critical and highly valued part of the American biomedical research workforce, and the potential for stigmatization and racial profiling of innocent and hard-working individuals must be scrupulously avoided.

As the largest public funder of biomedical research, NIH has the power to influence change to improve the biomedical research enterprise.  I recognize that NIH’s actions should benefit all who participate in this noble enterprise, and I take that responsibility seriously. 

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health