Where we’ve been: Attending the fall NIH advisory committee to the director meeting ?>

Where we’ve been: Attending the fall NIH advisory committee to the director meeting

 

The National Institutes of Health’s Advisory Committee to the Director met last week to provide updates on the NIH’s activities to increase diversity, efforts to ensure scientific rigor, implementation of the 21st Century Cures Act, efforts to support the next generation of researchers, and efforts to optimize administration at the agency.

The American Society for Biochemistry and Molecular Biology provided written comments to the committee prior to the commencement of the ACD convening. The ASBMB urged the NIH to develop initiatives that support the next generation of researchers and ensure that taxpayer-funded research is rigorous and productive. View the full written comment here.

Highlights from the meeting are below.  You can watch a recording of the meeting here (day 1/day 2), and we’re including timestamps on our highlights for your quick reference.

Day 1

NIH diversity working group

  • 2:49:43 – Hannah Valantine, chief officer for scientific workforce diversity, reported for the committee’s diversity working group. The working group is providing institutional support as well as resources to foster mentoring, career development, recruitment and retention.
    • The NIH has developed the scientific workforce toolkit, a central equity committee to provide input and recommendations to help increase diversity, and a graduate student diversity program.
    • Extramurally, the working group is monitoring the effectiveness of the Building Infrastructure Leading to Diversity initiative, National Research Mentoring Network and the Coordinating and Evaluation Center diversity program consortiums. Furthermore, an analysis of the NIH’s diversity supplemental grants, which was led by the National Institutes of General Medical Sciences, found that supplements account for the retention of 60 percent of faculty recruited through that method.
    • The Diversity Program Consortium is moving into phase II. Phase I began in October 2014 and included 10 BUILD institutions with funding that totaled $250 million over five years.  The program is structured to track affected students, faculty and institutions to evaluate the effect of site-specific BUILD intervention strategies.  One major difficulty has been utilizing the National Research Mentoring Network to rapidly link mentors to mentees online.  Phase II of the program will include a limited competition to allow meritorious BUILD sites to complete their experience and focus on site specific data with an emphasis on sustainability and dissemination.  There will also be a component for CECs to review strengths and weaknesses of a current center as well as ways to emphasize sustainability and dissemination.  The last component of phase II will solicit new projects that focus on translating current BUILD, NRMN and CEC activities nationally.  Phase II of the NRMN awards will move from a U54 mechanism to U01 and U24 with emphasis on science of mentoring and networking, coordinating and outreach centers and developing resources.

Rigor and reproducibility

  • 3:46:15 – Mike Lauer, deputy director for extramural research, presented ideas that arose from recommendations presented during the ACD summer meeting. As a result of Sec. 2309 of the 21st Century Cures Act, the NIH was tasked with developing methods to increase rigor and reproducibility of science being funded by the agency.   In January 2016, scientists were required to report additional information regarding their studies, including biological variables such as sex and key biochemical reagents. These new elements of rigor were incorporated into the application and review process.
    • Lauer proposed different options to fulfill the Cures mandate.
      • Option 1: add a separate rigor section for principle investigators to describe the project’s premise, rigor and biological variables. This section provides more space for the PI to describe the study, and would contribute to the proposal score. However, the new section would duplicate information, increase reviewer workload, and require approval from the Office of Management and Budget to add a new form to grants.
      • Option 2: embed the rigor section within the research strategy section of the grant, with new headings for the rigor and reproducibility criteria. No OMB clearance is required for its implementation, but would limit space for the PI to describe their research plan.
      • Option 3: include a separate “rigor and transparency” form with detailed separate sections to include premise, rigor, and biological variables. A section to collect granular information, such as the type of biological reagents used and number of animals in a study. This option provides increased transparency of the exact materials used in a study, and allow researchers to find studies based on materials used. However, variables contributing to rigor may be missed.
    • The NIH must ensure that any new sections are relevant to multiple scientific disciplines funded by the Institutes.
    • The NIH was asked by the scientific community to resource validation by developing an authentication system for biological products. However, the NIH encourages the community to take the lead.
    • The ACD is determining effective strategies to integrate rigor and responsible conduct in the laboratory. One recommendation is for departments to begin to integrate a spectrum of ethics training to faculty and students. The NIGMS’s new T32 Predoctoral Institutional Research Training Grant could address the integration of research integrity in training. Jon Lorsch, director of the NIGMS, also highlighted the institute’s R25 funding opportunity announcement for the development of training modules, resources on the institute’s webpage and T32 supplements to training grants to generate new ideas in rigor and reproducibility training.
  • 4:39:40 – Additional updates were given on policies related to the age of participants in clinical research. The NIH will be publishing a summary of challenges and themes applicable to ethical issues, study design, and data collection for age inclusion in clinical research, as well as new NIH policy to study participants of all ages. In addition, Congress tasked the NIH to coordinate with the Food and Drug Administration to award grants to develop regenerative medicine therapeutics. The Cures Act stipulates that the applicant must bring in non-federal contribution for every dollar received from the joint grant program.  The program seeks to bring in $60 million, with half coming from non-federal entities.

Day 2 

Supporting the next generation of researchers

  • 03:48 – Lawrence Tabak, principle deputy director of the NIH, provided an interim report on changes to the Next Generation of Researchers initiative. Last May, the NIH proposed a new policy, the Grant Support Index, to free up funds in support of new and early-career investigators.  The GSI presented a rubric to evaluate and cap the current federal funding levels for an investigator.  The GSI, however, was met with opposition from senior well-funded investigators and was subsequently replaced by the more nebulous Next Generation Researchers Initiative, or NGRI. Tabak acknowledged that the GSI was one of the most intense things discussed at the NIH in the last 10 years.  To avoid another outcry from the community, the NIH developed a working group to guide the implementation of the NGRI.  This working group is comprised of stakeholders ranging from a graduate student to late stage investigators. Recommendations from this working group will feed into the ACD, and ultimately advise director Collins.  While the goal has shifted from supporting younger investigators, it appears that the new focus of the NGRI will be to provide recommendations that slow down attrition in the biomedical research workforce.
    • The number of early-stage investigators (ESI), who have been an independent researcher for less than 10 years, has remained modest since the creation of this definition in 2008. The GSI and NGRI were developed in response to this tepid number, to the Cures Act mandate to support the next generation of researchers, and to the NIH’s own objective in its strategic plan (objective #3).  While the original and reformed policy appeared to be prescriptive to all of the institutes, “it was never meant to be every single person”. The policy moving forward will only be a guide for institutes to implement.  Initially, the NIH had announced a goal of funding ESIs and EEIs at a 25 percent payline. However, Tabak’s presentation stated that it will be an average payline across the different NIH institutes.  The committee felt that they had to shift from re-litigating the specific approach outlined in the GSI, to providing recommendations about how best to prioritize funds to ensure support for investigators at risk of losing all funding.
    • While using EEI and ESI as the target demographic was originally the goal of the policy, the working group voiced dissatisfaction with those definitions and wanted to focus on any at-risk population. Rather than anchor those eligible for special consideration on an arbitrary 10-year–from-degree cutoff, the working group proposed that the NIH should consider more flexible approaches to ensure support for highly meritorious investigators that are most at risk of losing funding.  It was felt that there is an equal urgent need to stabilize the career trajectories of successful and productive mid-career investigators as there is for new ones.
    • As the policy recommendations were being developed, confidence in the NIH’s support for at-risk researchers had been diminished. Therefore the working group recommended providing the community with more clarity as the policy evolves and is rolled out.  Additionally, the NGRI should be closely tied to diversity, and more attention needed to be placed on meaningful collaborations between senior and junior investigators.
    • Moving forward, the working group identified specific data points that they will pursue to craft their recommendations:
      • What is the capacity of the biomedical research enterprise to sustain investigators in the long-term?
      • What are the gaps in data, and what other influencing factors like participation in team science should be considered?
      • What affect has the shift to smaller, stable mechanisms like the Maximizing Investigators’ Research Award had on the community?
      • What are the best ways to measure and capture productivity? (e.g. Quality and number of trainees, patents, teaching commitments, outreach or an additional productivity section embedded into proposal biosketches.)
      • How is productivity influenced by institutional policy, geography or number of grants participated in and level of commitment in said grants?
      • How does the inclusion of non-life science disciplines in grant competitions affect funding?
      • What is the impact of variation in definitions of merit across review panels?
    • A number of NIH programs have successfully increased support for ESIs and EEIs, focusing on the accomplishments of investigators, prioritized projects that address a specific institute’s research need, used an advisory committee for oversight and mentoring, imposed selective pay for ESIs, utilized bridge awards at a higher extent and separated the review of established investigators from ESI applicants.
    • ACD members acknowledge that there probably won’t be a one-size-fits-all process. Having investigators compete among their demographics instills confidence in the funding process. Collins acknowledged that the way the GSI was removed probably contributed to the idea that the NIH was abandoning ESIs and prevented the NGRI from reaching its goal in fiscal 2017. ACD members also pointed out that the NIH has an “unhealthy obsession” with the R01 grant as a metric of gauging support, but it is not the only substantial grant funding opportunity. Instead, the NIH should focus on the first extramural research award within a certain dollar threshold as a better measurement to use as an indicator of career stage.
    • While the NGRI was implemented late in FY2017, with only a few months left in the year the policy missed its targeted goals of supporting more ESIs and EEIs. The working group is scheduled to present final recommendations during the ACD’s December 2018 meeting with the future of the working group assessed thereafter.

Reimagine HHS

  • 2:18:52 – In response to the Office of Management and Budget’s directive to improve efficiency and effectiveness across government, the Department of Health and Human Services launched Reimagine HHS.  This initiative seeks to identify opportunities to improve the ability to service the American people. The HHS plan began with a series of guiding principles informed by the Government Accountability Office and the Office of the Inspector General recommendations.  The ideas received were distilled into 28 solutions and 6 strategic shifts, which will advise the HHS.
    • The agency is now in the multiyear implementation phase. The shifts directly related to the NIH include:
      • Putting people at the center of HHS programs by supporting people during critical life transitions and expanding services to promote greater self-sufficiency.
      • Leveraging the power of data by creating data platforms for analytics and business operations and developing a governance structure to address barriers and protect data.
      • Generating efficiencies through streamlining processes focused on grants, reinventing how the agency evaluates and approves those grants, and removing burdensome grant-management processes to focus on actual impact and outcomes of grant programs rather than administrative tasks
      • Restoring market forces with a focus on bench-to–bedside and address overlapping and burdensome regulations.
      • Moving to a 21st century workforce by modernizing talent and maximizing employee performance.
    • Optimize NIH will be an initiative to address the relevant components of Reimagine HHS. The plan will focus on better addressing ethics, Freedom of Information Act requirements and advisory committee management. The NIH plans to begin implementing the Optimize NIH initiative in 2018.

View slide from each of the meeting’s presentations here.

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