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Announcements

Dr. Collins discussed the Anti-Sexual Harassment Statement and Rollout, and recent Hill briefings by IC directors.

Nonhuman Primate Resource Planning

Dr. Jim Anderson provided an overview of NIH non-human primate resources and planning needs. The group supported the formation of a trans-NIH working group for coordination of resource planning.

NIH OD Strategic Engagement Agenda

Dr. Tara Schwetz presented a draft plan for developing an NIH Office of the Director (OD) strategic plan.

Announcements

Dr. Collins welcomed Dr. Noni Byrnes as the director of CSR. He also reported on the first ACD working group meeting on changing culture to end harassment. Drs. Collins and Tabak provided a readout from the ACD Working Group on Artificial Intelligence initial meeting.

The group discussed feedback from the director’s review meeting, and new avenues to enhance IC relations with the Office of the Director.

Announcements

Dr Collins provided updates on: topics to be presented at the upcoming CCHRB meeting, and at the upcoming ACD Working Group on sexual harassment meeting.

Information Technology Review

Dr. Larry Tabak and Ms. Andrea Norris presented on NIH’s information technology portfolio and management initiatives.

Foundation for the NIH (FNIH)

Dr. Maria Friere provided an overview of the FNIH, highlighting some current FNIH programs, in particular the Accelerating Medicines Partnership.

Announcements

Dr. Collins discussed how the shutdown of the Federal Register impacts NIH review/council meetings, and efforts to hold review/council meetings. Dr. Tabak discussed the review of partnerships, external engagement, and program processes.

NIH Anti-Harassment Program

Jessica Hawkins presented on the NIH Anti-Harassment Program, including new web and telephone reporting options, harassment policy updates, the relationship policy statement, and communications campaigns to promote this information.

Announcements

The group discussed ways to increase transparency into NIH actions related to sexual harassment. Dr. Collins provided an update on the Combined Federal Campaign and data on IC participation. Drs. Collins and Tabak discussed review of partnerships, external engagement, and program processes as it relates to extramural grants. Drs. Collins and Lauer provided an update on the Next Generation Researchers Initiative for FY2019.

MBWG/CCGB/ADC FY19 budget recommendations

Management, clinical center, and administrative data center budget recommendations were presented and approved.

NIH Workplace Climate and Harassment Survey

Dr. Valantine presented on the NIH workplace climate and harassment survey, and the rollout and communications plans to promote it.

ACD Presentations

Drs. Tabak and Baker previewed presentations for the upcoming Advisory Committee to the Director (ACD) meeting December 13-14. The recommendations from the ACD Working Group for the Next Generation Research Initiative were presented and discussed. The Helping End Addiction Long Term (HEAL) Initiative Governance Structure was also presented.

Announcements

Dr. Wolinetz provided perspectives from the international summit on gene editing in Hong Kong, and described the news and reactions following the gene-edited embryo presentation.

ACD Presentations

Dr. Tabak previewed presentations for the upcoming Advisory Committee to the Director (ACD) meeting December 13-14. The followup to the ACD Working Group for Review of the Moderate Alcohol and Cardiovascular Health Trial Report, and the preliminary recommendations from the ACD Working Group on High-Risk, High-Reward Research were both presented and discussed.

Announcements

Dr. Collins announced Combined Federal Campaign updates and coming events, NIH responses to support a supportive and inclusive culture of scientific inquiry, and updates related to Reimagine HHS and grants management.

Addressing barriers for women in NIH-funded research

Dr. Walter Koroshetz presented on opportunities for intervention to address barriers for women in NIH-funded research. He presented data on NIH funding trends, a 2017 NINDS workforce survey, programs in place at private research funding institutions, and at other federal funding agencies, and major opportunities for NIH intervention.

Human Frontier Science Program

Drs. Glass and Lorsch presented on the Human Frontier Science Program, its background, notable scientists who had been supported by the program, and NSF-NIH participation in this program.

Hiring Metrics

Dr. Alfred Johnson provided an update on HR processes, and hiring-related metrics.

Announcements

Dr. Collins announced topics to be covered at the October 19 CCHRB meeting. Dr. Collins requested input on the draft data sharing provisions which were announced for public input, and announced a November 7 webinar to talk through the provisions and solicit additional ideas from the community.

Other Transaction Authority (OTA)

Drs. Lauer and Anderson gave a brief background on OT, how it is being used at NIH, the types of scenarios where it can be useful, and considerations for use.

Announcements

Dr. Collins announced that the Chief Data Strategist recruitment is still ongoing; detailees will join in the Office of Data Science Strategy in the interim. He updated ICDs on the anti-harassment policy and relationship policy statement rollout, and asked for ICDs to amplify the message to staff. Dr. Chris Austin announced the Combined Federal Campaign kickoff and activities.

Federal Employees Viewpoint Survey (FEVS)

Julie Berko and Jonathan Lappin of the Office of Human Resources presented on the 2018 Federal Employee Viewpoint Survey (FEVS): NIH Results Summary. Metrics included Response Rate by IC, Employee Engagement Index Comparisons, and Global Satisfaction Index comparisons. 

ReImagine HHS

Dr. Alfred Johnson described NIH participation in several of the Reimagine HHS Strategic Shift Initiatives related to data, maximizing employee engagement, and grants and purchasing systems.

Announcements

Dr. Collins provided updates on NIH-CMS Leadership meetings, an upcoming workshop on Rigor, Reproducibility and Transparency in NHP Research, and an upcoming forum with AAMC Medical School Deans.

The NIH Small Business Program in the Billion Dollar Era

Dr. Jodi Black presented on challenges and opportunities related to the NIH small business programs (SBIR and STTR) such as variable resources, and a need for a robust and diverse workforce.

Announcements

Dr. Collins led a discussion about Coalition S and open access. He also provided updates on anti-harassment policy discussions, and announced the selection of Dr. Bruce Tromberg of NIBIB director.

NIH All of Us Program

Eric Dishman presented updates on the All of Us Program, including progress since April 2018, upcoming milestones and challenges, and technology developments.

Optimize NIH

Dr. Larry Tabak provided updates on the opportunities for greater efficiency identified by the Optimize NIH effort. He focused on the outcomes in the areas of FOIA, Committee Management, and Ethics reviews.

Announcements

Dr. Collins provided a recap from the Senate HELP Committee hearing on 8/23, and gave an overview of the NIH efforts to assess and address workplace harassment.

HEAL Trials Networks

Drs. Austin and Koroshetz presented about challenges facing development of new pain medications, goals of the HEAL Early Phase Pain Investigation Clinical Network, and goals of the HEAL Pain Effectiveness Research Network (HEAL Pain-ERN).

Toward Interoperability of NIH Cloud Platforms

Dr. Jim Anderson presented on the current NIH cloud platforms, and ongoing and proposed consensus building for unified standards.

Announcements

Dr. Collins provided an update on the INCLUDE program, HEAL initiative coordination, and consideration of future ACD working groups forming on artificial intelligence and foreign influences on research integrity.

Follow-up to ACD MACH Review Working Group Recommendations

Dr. Tabak presented a follow-up to the ACD MACH Working Group recommendations, and key areas of consideration for future discussion and review.

Announcements

Dr. Collins described recent campus visits/tours by Senator Tom Udall and Congressman Ro Khanna. Dr. Collins recapped the July 25 subcommittee hearing on 21^st Century Cures.

Strides

Andrea Norris described the new Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative and partnerships with commercial cloud providers, announced on Tuesday, July 24. The initiative will help intramural and extramural scientists leverage NIH, academia, and industry partnerships, and access advanced cloud computing tools. The framework for these partnerships will incorporate standards endorsed by the biomedical research community on FAIR (Findable, Accessible, Interoperable, and Reusable) data principles.

Non-Parent Program Announcements

Dr. Michael Lauer described an approach to efficiently indicate IC interest in scientific research areas though “Notices of Intent”, published in the NIH Guide for Grants and Contracts.

Announcements

Dr. Collins summarized the NAS Committee Report: Return of Individual-Specific Research Results from Research Laboratories, and highlighted the upcoming Artificial Intelligence workshop. Dr. Tabak gave an update on the agenda for the July 20 Clinical Center Research Hospital Board meeting.

Working group on peer review

A working group looked at inputs on data-driven decision making and the evaluation of CSR study sections, and recommended paths forward to create or restructure study sections in response to new and emerging areas of science.

Updates on Optimize NIH

Dr. Tabak described Optimize NIH activities to coordinate and harmonize administrative processes and business processes at NIH (e.g., committee management efficiencies)

Announcements

Dr. Collins and Dr. Tabak briefly recapped the ACD meeting presentations. Dr. Collins announced an upcoming AI workshop on July 23. Dr. Collins announced OLPA plans to redesign the CJ format along a theme of “From Inspiration to Innovation” for FY2020.

Capital Equipment Fund

Dr. Katz presented the capital equipment fund proposal for approval.

U01 Opportunities for Collaboration with the Clinical Center

Dr. John Gallin presented the evaluation report of the U01-clinical center extramural grant collaborations, which was overall positive. There will be outreach to IDEA state PIs. The group discussed issues to resolve such as credentialing procedures, and terms to consider in the development of the next FOA.

Strategic Plan Template

Dr. Jim Anderson talked about the development of a new template design for strategic plans beginning January 2019. This included discussion of questions about where IC achievements fit into the strategic plan template, and how all ICs will need to use the elements of the template in their plans going forward.

Announcements

Dr. Collins provided a summary of his trip to the Vatican. He raised the topic of the General Data Protection Regulation (GDPR), recently passed in Europe, and how it will apply to NIH-funded research. Carrie Wolinetz and Rob Eiss are leads and are sending out guidance to internal NIH groups. Grantee questions are to be referred to the in the interim. Dr. Tabak announced that ICDs with opioid projects we intend to fund in FY2018 received notifications, and that we will follow up regarding receiving and reviewing FY19 proposals.

Global Alliance for Genomics and Health

Ewan Birney and Peter Goodhand presented on the Global Alliance for Genomics and Health (GA4GH), including the program’s history and operation, and current activities regarding genetic data sharing, data capture, and knowledge standards.

Announcements

Dr. Collins provided follow-up information from the House Appropriations Labor, Health and Human Services, and Education Subcommittee Fiscal Year 2019 Hearing, which was held on April 11, 2018. He also shared information from the Hever Group meeting which occurred on April 14, 2018, as well as updates from the Advisory Council to the Director Next Generation Researchers Initiative Working Group meeting, which occurred on April 16, 2018. Dr. Collins also provided updates on the trans-NIH opioid/pain and trans-NIH Down Syndrome initiatives.

Music & Health

Drs. Bob Finkelstein and Emmeline Edwards presented on Music & Health, an exciting collaboration between NIH and the Kennedy Center, in association with the National Endowment for the Arts. This effort was initiated by Dr. Collins and the renowned opera singer, Renee Fleming. The goal of this initiative is to increase our understanding of how music affects health, with emphasis on the basic neuroscience of music and potential clinical applications.

All of Us Launch Readiness and Roadmaps

Dr. Eric Dishman provided an update on the All of Us program.

Announcements

Dr. Collins shared a summary of a recent Congressional (Rep. Jamie Raskin (D-MD)) visit to NIH. He also provided information from the House Appropriations Labor, Health and Human Services, and Education Subcommittee Fiscal Year (FY) 2019 Hearing, which was held on April 11, 2018.

Pediatric Research Across NIH

Dr. Diana Bianchi shared information on child health research at NIH. The presentation included an overview of pediatric research funding at NIH and examples of the pediatric-related collaborative work at NIH.

Review of NIH Activities on Autism

Drs. Diana Bianchi and Josh Gordon presented on NIH’s Autism Spectrum Disorders (ASD) efforts. This included an overview of ASD features, prevalence, diagnosis, and genetic risk factors. Drs. Bianchi and Gordon also highlighted NIH’s involvement in ASD research.

Federal Employee Viewpoint Survey

Ms. Julie Berko presented on the FY 2017 Federal Employee Viewpoint Survey (FEVS) results. The FEVS is administered annually to all Federal employees from the U.S. Office of Personnel Management (OPM) and is designed to collect feedback from employees on their perceptions of work experiences, organizations, and leaders. The survey consists of 84 questions, which are mostly mandated by Congress.

Announcements

Dr. Collins provided a summary of his recent trips to Florida, Arkansas, and Atlanta. He also shared information from the NIH-FDA leadership council meeting on Thursday, March 29, 2018.

CTSA Trial Innovation Network

Dr. Chris Austin presented on the new Clinical and Translational Science Awards (CTSA) Trial Innovation Network, a new collaborative initiative within National Center for Advancing Translational Sciences’ CTSA Program, which includes a national laboratory to study, understand, and innovate the process of conducting clinical trials and studies. The mission of the Network is to develop, demonstrate effectiveness of, and disseminate scientific and operational innovations that dramatically increase the efficiency and effectiveness of clinical studies. This Network is critical for bringing new interventions to patients and communities, as well as supporting and encouraging clinical investigation as a career path.

Data Science Policy

Dr. Carrie Wolinetz presented on establishing a policy for data management and sharing. Specifically, Dr. Wolinetz highlighted the growing interest in this area, both NIH-wide and in the private sector. NIH formed a Data Science Policy Council and is working on creating a new data management and sharing policy that would enhance NIH’s data-sharing capabilities.

Announcements

Dr. Collins announced the upcoming Rx Summit and the opioid initiative, which will integrate partnerships. In addition, Dr. Collins shared his upcoming travel schedule with several Members of Congress. Finally, Dr. Collins provided an update on The House Appropriations Subcommittee on Labor, Health, and Human Services, Education and Related Agencies hearing on NIH’s FY 2019 Budget request on Wednesday, April 11, 2018.

NIH Assessment of Data Science Training

Dr. Patti Brennan provided an update on NIH’s Data Science Workforce Development program, including NIH-funded extramural training; key findings from 2010-2017; identifying three core content areas of data science; opportunities to expand the program; and overall recommendations for further expanding NIH’s data science efforts.

All of Us Launch

Dr. Alfred Johnson presented on the Clinical Center Capital Fund. The presentation included information on the fund’s purpose to provide funding for strategic Clinical Center investments such as infrastructure, major equipment, emergent programmatic issues, and Clinical Center defined projects. The fund, which is capped at $50M/year was established in FY 2019 to meet crucial Clinical Center programmatic and infrastructure modernization needs.

All of Us Launch

Dr. Eric Dishman provided an update on the All of Us Research Program, including information on NIH’s genomics plans and aspirations and plans for the national launch of the program.

ReImagine Update

Dr. Larry Tabak provided an update on HHS’ ReImagine initiative and NIH’s Optimize NIH efforts to improve efficiency and effectiveness.

Announcements

Dr. Tabak provided updates, including Secretary Azar’s visit to NIH’s campus. The visit included a Town Hall meeting, pain/opioid research presentation, and meetings with NIH’s IC Directors. He also announced the next phases of Optimize NIH, including a NIH-wide Town Hall. Dr. Tabak also shared information about the budget.

Facilities Working Group Update re: Status of the Campus

Dr. Paul Sieving presented on assessing the capital needs of the NIH main campus. Per the 2017 Appropriations Bill, NIH was to enter into a contract with the National Research Council, Division of Engineering and Physical Sciences to prepare a report that assesses the capital needs of NIH’s main campus. The report identifies facilities in greatest need of repair, describes the work needed to bring the facilities up to current standards, and includes cost estimates for each project. The September 2017 agreement between the NIH and the National Academies of Sciences, Engineering and Medicine convened an ad-hoc committee. In February 2018 Committee members were selected, and meetings are planned for March 19-21, 2018.

Clinical Center Capital Fund Discussion

Dr. Alfred Johnson presented on the Clinical Center Capital Fund. The presentation included information on the fund’s purpose to provide funding for strategic Clinical Center investments such as infrastructure, major equipment, emergent programmatic issues, and Clinical Center defined projects. The fund, which is capped at $50M/year was established in FY 2019 to meet crucial Clinical Center programmatic and infrastructure modernization needs.

P01 and R01

Dr. Mike Lauer presented on the Extramural Activities Work Group’s question: Should NIH allow simultaneous applications through R01 and multi-component mechanisms.

Prevention Research Portfolio Analysis FY 2017 Results

Dr. David Murray provided a portfolio analysis on NIH-funded primary and secondary prevention research in humans.

Announcements

Dr. Collins provided a summary of the White House Summit on Opioids, as well as an update on efforts of the NIH’s Advisory Committee to the Director Opioid Working Group. He also reminded the IC Directors of Health and Human Services Secretary Azar’s visit to NIH on March 20. In addition, Dr. Collins shared that on March 12, he will host Dr. Jim Yong Kim, President of the World Bank Group, for a screening of the documentary, Bending the Arc, which captures efforts by Dr. Kim; doctor and humanitarian Paul Farmer; activist Ophelia Dahl; and local communities to deliver world-class care for complicated diseases such as multidrug resistant tuberculosis and HIV, in the most impoverished settings in Haiti.

ReImagine

Dr. Tabak provided a brief update on NIH’s efforts for the ReImagine HHS initiative. Optimize NIH will examine how to improve effectiveness and efficiency in the areas of ethics, committee management, and Freedom of Information Act activities.

Loan Repayment Program

Dr. Mike Lauer presented on NIH’s loan repayment program.

Announcements

Dr. Collins provided updates regarding Sen. Maggie Hassan’s (D-NH) visit on February 16, 2018, and shared NIH’s tentative Congressional schedule for FY 2019.  Dr. Collins also provided updates on the new working groups for NIH’s Advisory Committee to the Director. 

Trans-NIH Pain Initiative Discussion 

Dr. Collins and Dr. Larry Tabak, Principal Deputy Director, led a discussion on the trans-NIH Pain Initiative effort. 

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Announcements

Dr. Collins provided updates regarding the President’s Budget, which includes $34.767 billion in fiscal year (FY) 2019 for the NIH, $699 million above the FY 2018 Continuing Resolution. Dr. Collins also shared that NIH’s Advisory Committee to the Director will have two new working groups:  one working group will discuss the ethical issues surrounding the acceptance of support from companies that have contributed to the opioid crisis; the second working group will review efficacy, demographics of applicants and awardees, and ways to increase applications from women and underrepresented groups. Finally, Dr. Collins provided highlights from the First Lady of the United States’ visit to the NIH Children’s Inn, as well as a reminder that Sen. Hassan will visit on Friday, February 16. 
Next Generation Researchers’ Initiative. 

Dr. Mike Lauer and Dr. Jodi Black presented on the Next Generation Researchers’ Initiative 
(NGRI)

Possible Interim Framework for 2018.  NGRI was established by the 21st Century Cures Act, Subtitle C – Supporting Young Emerging Scientists, with the goal of promoting opportunities for new researchers and earlier research independence by increasing opportunities for new researchers to receive funding and enhance workforce diversity. The NGRI policy was released in August 2017.  Drs. Lauer and Black provided information on a possible interim framework for 2018. 

Update: Anti-Harassment/Optimize NIH/Hiring 

Dr. Larry Tabak provided information on NIH’s Anti-Harassment effort, including a 3-phased approach to establish a hotline for harassment allegations, to develop an anti-sexual harassment policy, and to develop implementation approaches of the sexual-harassment policy. NIH will also continue to align hiring practices with Optimize NIH and ReImagine HHS efforts.

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Announcements

Dr. Collins provided brief remarks regarding the potential lapse in funding and Federal government shutdown.  Dr. Collins also provided information on NIH’s efforts to improve pedestrian safety on NIH’s campus, a summary from his trip to the World Economic Forum Annual Meeting in Davos-Klosters, Switzerland (January 23-26, 2018); information from his weekly meeting with Department of Health and Human Services Secretary Azar; and a summary of the Clinical Center Research Hospital Board Meeting (February 2, 2018). 

Reconstituting the NIH Coordinating Committee on Research on Women's Health (CCRWH)

Dr. Collins and Dr. Janine Clayton, Director, Office of Research on Women’s Health, provided information on reconstituting NIH’s CCRWH.  CCRWH support includes:

• Serving as a resource for women's health activities across the NIH
• Supporting methods to gather data by age and ethnic/racial groups of women's participation in clinical trials
• Supporting the development and expansion of clinical trials necessary to the health of women
• Encouraging and supporting research on women's health
• Identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities

Planning for a NIH-wide pain initiative

Dr. Collins and Dr. Larry Tabak, Principal Deputy Director of NIH, presented on NIH’s plan to help address the Nation’s opioid crisis.  This included a brief outline of NIH’s current efforts, including: 1) preventing, treating, and understanding the consequences of opioid use and overdose; and 2) enhancing options for pain management through the development of novel drugs and non-pharmacological treatments and dissemination of best practices.

Update:  Hiring

Dr. Larry Tabak and Dr. Alfred Johnson, Deputy Director, Office of Management, provided a summary on hiring updates that will align with the ReImagine/Optimize NIH efforts. 

Common Fund Programs

Dr. Jim Anderson, Deputy Director, Division of Program Coordination, Planning, and Strategic Initiatives, and Dr. Betsy Wilder, Director, Office of Strategic Coordination, presented on opportunities for expanding existing Common Fund programs in FY 2020.

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Updates:  Hiring and Optimize NIH

Dr. Larry Tabak provided a brief update on aligning NIH’s hiring strategies with HHS ReImagine/Optimize NIH efforts.

Announcements

Dr. Collins provided brief remarks regarding the potential lapse in funding and Federal government shutdown.  Dr. Collins also provided a summary from his weekly meeting with Department of Health and Human Services Acting Secretary Hargan, as well as a summary of the January 17, 2018, 2nd annual Congressional Reception for The Children’s Inn event in Washington, D.C. 

NIH Policy Against Sexual Harassment

Dr. Larry Tabak, Principal Deputy Director of NIH and Ms. Julie Berko, Acting Director, Office of Human Resources, presented on the NIH Policy Against Sexual Harassment.  Dr. Tabak and Ms. Berko outlined NIH’s efforts to develop and implement a NIH policy against sexual harassment, including establishing a working group to harmonize efforts among NIH leadership, Office of the Director offices, and stakeholders.  They also discussed a three-phased approach for addressing this important issue, including establishing a hotline for harassment allegations, developing an anti-sexual harassment policy, and creating approaches for implementing the anti-sexual harassment policy.  Dr. Tabak and Ms. Berko shared with the IC Directors a list of national and NIH-specific resources for individuals who need assistance, including the National Suicide Prevention Lifeline, the Divisions of Police, and the Employee Assistance Program.

Guest Speaker:  U.S. Surgeon General, Vice Admiral Jerome Adams, M.D., MPH

NIH welcomed U.S. Surgeon General, Vice Admiral Jerome Adams, M.D., MPH as the guest speaker at the IC Directors’ meeting.  Dr. Adams gave a brief overview of his professional life, including his time spent working at NIH.  He stressed the importance of maintaining a positive and productive relationship with NIH, particularly in regard to accomplishing his priorities of focusing on addiction as a public health crisis, especially with the opioid epidemic; building better partnerships to promote better health; and increasing outreach and communications to build trust and improve the health of the American people.  Dr. Adams complimented NIH on its continuing efforts and training programs in the field of health-related research, and asked for NIH’s continuing support and promotion of the Commissioned Corps, in both emergency situations and day-to-day activities.

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Announcements

Dr. Collins provided brief remarks regarding the current Fiscal Year (FY) 2018 Continuing Resolution and planning process for the FY 2019 budget.  He also discussed highlights from the January 10, 2018, first NIH-Centers for Medicare/Medicaid (CMS) Leadership meeting.  The meeting was successful and NIH looks forward to continuing to have an excellent and productive working relationship with CMS.  NIH is also exploring opportunities to work more closely with the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.  Dr. Collins also announced that the U.S. Surgeon General, Vice Admiral Jerome Adams, M.D., MPH is planning to attend the next IC Directors’ meeting on January 18, 2018.  Finally, Dr. Collins reminded all IC Directors about the Children’s Inn 2018 Congressional Networking Reception, occurring on January 17, 2018, at the Rayburn House Office Building Foyer in Washington, D.C.  Dr. Collins will present the keynote address at this reception.

IC Flexibility in NRSA Fellowship and Training Funding

Dr. Jon Lorsch, Director National Institute of General Medical Sciences, provided an update on IC flexibility with the Ruth L. Kirschstein National Research Service Awards.  Specifically, Dr. Lorsch explained some of the past challenges of using F30 and F31 research funding mechanisms.  He also outlined two proposals that would require a sustained commitment to training and career development, but allow flexibility in the use of funding mechanisms appropriate to the scientific mission and workforce needs of the ICs.

IC Funding Meritorious Applications When Not Signed onto the FOA

Dr. Michael Lauer, Office of Extramural Research, provided an update on IC funding meritorious applications when ICs are not signed onto the FOA.  Dr. Lauer explained past challenges and outlined a proposal that would provide ICs the maximum flexibility to fund meritorious applications.  The proposed process would allow NIH to fund the best science; foster inter-IC communications; implement a documented process to sign onto a FOA post review; and allow NIH to be more communicative and transparent.

Hiring Update

Dr. Tabak provided a summary on hiring updates that will align with the ReImagine/Optimize NIH efforts.  This includes developing a charter with guiding principles for all NIH hiring actions going forward.

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Announcements

Dr. Collins provided brief remarks regarding a recent visit by Senator Blunt.  He also provided a summary of the meeting with Department of Health and Human Services Acting Secretary Hargan.  Dr. Collins provided highlights from the Advisory Committee to the Director meeting on December 14-15, 2017.  In addition, he provided a brief update on opioids, as well as the Gain of Function Research Policy.

Data Security for Institute Centers Demographic Data

Dr. Michael Lauer, Office of Extramural Research, provided an update on Data Security for Institute Centers Demographic Data.  Congressional legislation (H.R.34 – 21^st Century Cures Act, Subtitle C – supporting Young Emerging Scientists, Section 2021 – Investing in the Next Generation of Researchers), states that, “The Director of the �鶹��ýӳ�� shall develop, modify, or prioritize polices, as needed … to promote opportunities for new researchers and earlier research independence, … , and enhance workforce diversity.”  

To accomplish the goal of promoting diversity in the extramural scientific workforce, NIH will review relevant data through portfolio analysis and the Next Generation Researchers Initiative (Notice number:  NOT-OD-17-101).  As this data may include personal identifiable information, Dr. Lauer introduced a data sharing agreement that NIH will use to ensure data is protected and safeguarded and that individuals handling this data are properly trained.

Increasing Diversity of the NIH Directors Pioneer Award Recipients

The IC Directors discussed their concern for increasing the diversity of the recipients of the NIH Directors Pioneer Award program.  Specifically, Dr. Tabak will begin a working group to further review why this award program is not attracting more female applicants.

ReImagine HHS and Shutdown Presentations

Dr. Tabak provided a brief update on NIH’s efforts for the ReImagine HHS initiative.  Optimize NIH will examine how to improve effectiveness and efficiency in the areas of ethics, committee management, and Freedom of Information Act activities.

Dr. Alfred Johnson provided information on preparing for the potential Federal Government Shutdown.

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Announcements

Dr. Collins provided a reminder of two events scheduled for November 9:  the 6^th annual Veterans’ Day Celebration and the 2017 Native American Heritage Month Lecture.

Inclusion Across the Lifespan

Dr. Marie Bernard, Deputy Director, National Institute on Aging, and Dr. Janine Clayton, Director, Office of Research on Women’s Health, presented on NIH’s new policy on Inclusion Across the Lifespan in research involving human subjects, which requires that applicants and grantees include individuals of all ages when conducting clinical research, unless there is a strong justification for their exclusion.  This new policy must be addressed in all grant applications submitted on/after January 25, 2019, and all responses to solicitations issued on/after this date.  Additional proposed policy changes include clarifying potentially acceptable reasons for excluding individuals based on age, as well as clarifying the expectation for clinical research studies to submit individual-level data on sex/gender, race, ethnicity, and age.

NIH’s Collaboration with AHRQ and the U.S. Preventive Services Task Force (USPSTF)

Dr. David Murray, Associate Director for Prevention and Director, Office of Disease Prevention, and Dr. Quyen Ngo-Metzger, Scientific Director, U.S. Preventive Services Task Force Program, Agency for Healthcare Research and Quality, provided an overview of the USPSTF.  The USPSTF is an independent, volunteer panel of national experts in prevention and evidence-based medicine.  USPSTF makes evidence-based recommendations about clinical preventive services in primary care, such as screenings, counseling, and preventive medications.  AHRQ convenes the USPSTF and provides scientific, administrative, and dissemination support for it.  NIH uses this information to determine potential prevention research opportunities. 

Reimagine HHS Update

Dr. Larry Tabak, Principal Deputy Director, provided a brief update on NIH’s efforts for the ReImagine HHS initiative.  Optimize NIH will examine how to improve effectiveness and efficiency in the areas of ethics, committee management, and Freedom of Information Act activities.

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Announcements

Dr. Collins reminded all IC Directors that Dr. Brenda Fitzgerald, Director, Centers for Disease Control and Prevention, would serve as the guest speaker at today’s meeting, and that Dr. Elinore McCance-Katz, SAMHSA Administrator, would visit NIDA in the afternoon.  Dr. Collins announced that Dr. Norman E. “Ned” Sharpless, took the oath of office late Tuesday, October 17, 2017, to become the 15th director of the National Cancer Institute.  In addition, Dr. Collins shared that NIH’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative launched a cell census network. The network of integrated centers, collaborating laboratories, and data resources will be funded by 11 grants projected to total about $50 million annually over five years.  The network will provide researchers with a comprehensive reference of the diverse cell types in human, monkey, and mouse brain, and will generate knowledge that is prerequisite to solving the mysteries of brain disorders, such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. 

Reimagine HHS Update

Dr. Larry Tabak, Principal Deputy Director, provided a brief update on NIH’s efforts for the ReImagine HHS initiative.  Optimize NIH will examine how to improve effectiveness and efficiency in the areas of ethics, committee management, and Freedom of Information Act activities.

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Announcements

Dr. Collins shared that he would be leading a discussion at an event honoring Louis Stokes today.  Dr. Collins also announced that NIH will partner with 11 leading biopharmaceutical companies to launch the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot.  PACT will initially focus on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer.  The partnership will be managed by the Foundation for the �鶹��ýӳ�� with the Food and Drug Administration serving in an advisory role.

National Library of Medicine Strategic Plan

Dr. Patti Brennan, Director, National Library of Medicine (NLM), presented on the National Library of Medicine Strategic Plan, which will include four themes:

1. Role of NLM in advancing data science, open science, and biomedical informatics

2. Role of NLM in advancing biomedical discovery and translational science

3. Role of the NLM in supporting the public's health: clinical systems, public health systems and services, and personal health
4. Role of NLM in building collections to support discovery and health in the 21st century

In addition, the Plan incorporates several cross-cutting topical threads, including: standards, partnerships, user communities, user engagement and education outreach, international engagement, health disparities, computing infrastructure, physical plant infrastructure, research needs and funding, and workforce development.

Scientific Data Council Vision for Biomedical Data Resource Ecosystem

Dr. Jon Lorsch, Director, National Institute of General Medical Sciences, and Dr. Steve Katz, National Institute of Arthritis and Musculoskeletal and Skin Diseases, presented on NIH’s effort to modernize the NIH-funded biomedical data resource ecosystem. The main proposal for this effort is to have separate support for databases, knowledgebases, and tool development; and to develop new grant mechanism templates.

Proposal for Storing Human Reads and Other Large Data Sets

Dr. James Ostell, Director of the National Center for Biotechnology Information, National Library of Medicine, and Dr. Stephen Sherry, Staff Scientist, presented on Modest Proposal to Support Access to Human Reads in the Cloud.  This effort would allow existing NIH policy, procedures, and software to be used for non-PI data access requests for human reads in the cloud and supports access to existing cloud resources using their own authentication systems.

Data Commons Pilot

Dr. Betsy Wilder, Director, Office of Strategic Coordination, and Dr. Vivien Bonazzi, Program Specialist, presented on the Data Commons pilot project, which would allow access, use, and sharing of large, high-value NIH data in the cloud.

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Announcements 

Dr. Collins discussed recent meetings on NIH’s opioids efforts.  Dr. Collins also provided an update on ReImagine HHS, NIH’s Combined Federal Campaign 2017 efforts, and shared that Dr. Eric Green would be featured in a PBS documentary, The Gene Doctors, on Monday, October 2.

Human Subjects’ Protections

Dr. Mike Lauer, Deputy Director for Extramural Research, presented on Human Subjects’ Protections when awarding applications.  The presentation included information on assessing applications, as well as current federal statutes, regulations, and NIH policies that must be followed when reviewing applications.

Clinical Center for Cellular Engineering

Dr. Jim Gillman, NIH Clinical Center CEO, discussed the Clinical Center for Cellular Engineering, including the history of the Center, a summary of cell processing activities, products manufactured, naming the working group members, and providing the working group’s immediate recommendations for this effort.

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Announcements 

Dr. Collins discussed NIH’s Policy for the Management of and Access to Scientific Collections, which will go into effect on October 1, 2017.  Dr. Collins also provided an update on the aftermath of hurricanes Harvey and Irma.

Possible Leadership Forum Topics

Dr. Larry Tabak, Principal Deputy Director, discussed potential topics and the format for the Leadership Forum (fiscal years 2019 and 2020 Common Fund Proposals).

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Announcements

Dr. Collins provided brief remarks regarding the First in Human – Discovery Documentary series.  Dr. Collins also provided a summary of his meeting with Secretary Price on (August 10, 2018) and highlights from his visit to Boise State University with Rep. Mike Simpson (R-ID) (August 22, 2018).

Extracellular RNA Communication Program

Dr. Kevin Howcroft, Program Director Division of Cancer Biology Cancer Immunology and Hematology Branch, National Cancer Institute, provided an overview of the Extracellular RNA Communication Program, including the five primary initiatives with three overarching questions: What exRNAs are found in healthy/diseased body fluids?; How are exRNAs sorted to pathways and impact target cells?; and Can exRNAs be used for clinical purposes?

Minority Health/Health Disparities Strategic Plan

Dr. Eliseo Pérez-Stable, Director of the National Institute on Minority Health and Health Disparities, presented on the Minority Health/Health Disparities Strategic Plan.  The Plan will be available later in the year/early next year.

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Announcements

Dr. Collins provided updates on the status of the ACD Next Generation Researchers Initiative Working Group, the new clinical trials definition guidance, and the Certificates of Confidentiality policy. He also discussed the upcoming visit to NIH by the HHS Secretary, as well as the premiere of the First in Human series on the Clinical Center. Dr. Collins also announced the retirement of a member of the NIH leadership.

Cybersecurity at NIH – Andrea Norris

Ms. Norris (CIT/CIO) began the presentation by outlining NIH’s cybersecurity priorities, infrastructure, and security program and capabilities. She also discussed potential threats and critical vulnerabilities. The IC Director discussion focused on the data generated, as well as enterprise approaches to cybersecurity.

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Announcements – Francis Collins

Dr. Collins (DIR) opened the meeting by updating the Directors on the status of the fiscal year 2018 House Appropriations bill. He also reported on the Senate Science Forum, recent visits from HHS Assistant Secretary for Administration John Bardis and Sen. Jerry Moran (R-Kan), and upcoming NIH meetings, including a Clinical Center Research Hospital Board meeting and an upcoming workshop on the NIH Guidelines.

Healthy People 2020/2030 – David Murray, Don Wright, Carter Blakey

Dr. Murray (OD/ODP) began the presentation by outlining NIH’s role in the Healthy People 2020/2030 Initiative. Don Wright (HHS) and Carter Blakey (HHS) then provided a more detailed description of the Initiative, progress for the 2020 portion of the Initiative, and goals for the 2030 portion. The IC Director discussion focused on the length and organization of the current set of objectives, how research findings are leveraged to affect health policy, and the inclusion of health and social disparities in the Initiative. 

Opioid Conferences – Nora Volkow, Walter Koroshetz

Drs. Volkow (NIDA) and Koroshetz (NINDS) presented an update on NIH efforts to address the opioid epidemic. Three workshops were held to discuss agency efforts in this area, focusing on: medications development for opioid use disorders and overdose prevention reversal; development of safe, effective, non-addictive pain treatments; and neurobiological mechanisms of pain. IC Director discussion focused on the role of the clinician in this effort, additional areas for research (e.g., models of harm reduction), and data considerations moving forward.

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Announcements – Francis Collins

Dr. Collins (DIR) updated the IC Directors on his visit to Texas, where he gave the commencement address at Southern Methodist University and spoke at the University of Texas at Southwestern. He also noted upcoming Congressional visits to NIH, including the Senate Appropriations Subcommittee and Senator Jerry Moran (R-OK), and provided a brief update on stakeholder responses to the Grant Support Index (GSI) policy. Finally, the IC Directors discussed the President’s Fiscal Year 2018 Budget, which was released earlier in the week.

OAR Priority Review and Funding Principles – Maureen Goodenow

Dr. Goodenow (OD/OAR) provided an update on the Office of AIDS Research (OAR) activities, including the 2015 portfolio review, the strategic fund for high priority HIV/AIDS research, and goals for the Innovation (discretionary) Fund. She also outlined strategies to improve the process of portfolio and strategic fund review, including the development of a 5-year framework for OAR activities. Discussion focused on allocation of OAR resources.

NIH-VA Collaborations – Rachel Ramoni

Dr. Ramoni (Chief Research and Development Officer, VA) met with the IC Directors to provide an overview of the Research and Development Office at the U.S. Department of Veterans’ Affairs, and to discuss potential research collaborations between the VA and NIH. 

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Announcements – Francis Collins

Dr. Collins (DIR) briefed the IC Directors on recent NIH activities, including a screening of “First in Human,” a new documentary about the Clinical Center airing on Discovery, and the Sound Health “Music and the Mind” concert, which will be jointly hosted by the Kennedy Center. Dr. Collins also reported out on a White House biomedicine meeting that was held on May 8, his attendance at the World Economic Forum and the Milken Global Conference, and upcoming meetings focused on the opioid addiction crisis. Finally, Dr. Collins discussed NIH’s involvement in Departmental efforts to “reimagine” HHS, and also noted that the House Appropriations Committee hearing will be held next week.

Update on Grant Support Index – Lawrence Tabak

Dr. Tabak (DEPD) updated the IC Directors on initial community feedback on the Grant Support Index (GSI), a metric that NIH proposes to use to limit the total amount of funding provided to an individual investigator through NIH-supported research. IC Director discussion focused on the reallocation of funds freed up by the implementation of this policy, the current GSI point value system, and additional policy implementation considerations.

Data Commons Pilots – James Anderson

Dr. Anderson (DPCPSI) updated the IC Directors on the NIH Data Commons pilots. The pilots are being tested in specific Institutes to determine the cost and feasibility of different platforms to enable the long-term goal of making NIH data and tools more accessible and shareable. IC Director discussion focused on the timeframe for implementation of the NIH Commons, the ability of the Commons to develop and incorporate new analytics and tools, data ownership considerations, and potential mechanisms for future input on Commons progress.

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Announcements – Francis Collins

Dr. Collins (DIR) briefed the IC Directors on recent events at NIH, including a visit from astronaut Kate Rubins and the premier of an upcoming Discovery documentary focusing on research participants in the Clinical Center. He also reported on the upcoming meeting of the Clinical Center Research Hospital Board, foreign dignitary visits, his recent visit with Secretary Price, and the announcement of the Clinical Trial Protocol template.

Grant Support Index – Lawrence Tabak

Dr. Tabak (DEPD) led a discussion on a proposed plan for NIH to utilize a new metric, the Grant Support Index (GSI), to limit the total NIH grant support provided to an individual principal investigator through NIH-supported research. The GSI is a measure of an individual investigator’s grant support, and researchers with GSIs over 21 (the equivalent of 3 single-PI R01 awards) will be expected to include a plan in their applications for how they would adjust their existing grant load to be within the GSI limits if their application is awarded. GSI is anticipated to free up about 1,600 new awards, which will help broaden the pool of investigators conducting NIH research and improve the stability of the enterprise. IC Director discussion focused on various implementation aspects of the policy, and well as other programs that are being used to support investigators at different career stages. 

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Announcements – Lawrence Tabak

Dr. Tabak (DEPD) led the meeting in Dr. Collins’ stead. Dr. Tabak informed the IC Directors about a recent Congressional visit, and an upcoming visit by Dr. Siddhartha Mukherjee to discuss his book “The Gene: An Intimate History.” He also updated the IC Directors on the Mexico City Policy and the memo to lift the federal hiring freeze.

OppNet Initiative – Richard Hodes and William Riley

Dr. Hodes (NIA) and Dr. Riley (OBSSR) discussed the OppNet Initiative, which is a Basic Behavioral and Social Science Initiative designed to promote activities and initiatives that focus on basic mechanisms of behavior and social processes. Dr. Riley provided some examples of research that was funded through OppNet, and Dr. Hodes concluded by discussing future directions for the Initiative. IC Director discussion focused on the success of the program in terms of PI abilities to secure future funding, the historical context which spurred the Initiative, and the importance of coordinating and communicating OppNet efforts between ICs.

Behavioral and Social Science Research (BSSR) and the Research Citation Ratio (RCR) – William Riley

Dr. Riley (OBSSR) presented information on the RCR as it applies to BSSR funded by NIH. He provided information on BSSR study sections and publication rate differences. IC Director discussion focused on the influence of NIH-funded BSSR research compared to other funders, and the appropriateness of different RCR thresholds to determine a grant’s influence on a research field.

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Announcements – Francis Collins

Dr. Collins (DIR) provided updates on Administration and Congressional items, including the President’s proposed budget and the upcoming appropriations hearings. He reported on an upcoming meeting of the Advisory Council to the NIH Director (ACD) to discuss implementation of the NIH activities outlined in the 21^st Century Cures Act, allocation of resources at the NIH Clinical Center, and ongoing strategies to increase funding for young investigators.

Diversity Policy – Mike Lauer and Jon Lorsch

Dr. Lauer (DDER) and Dr. Lorsch (NIGMS) presented NIH Steering Committee recommendations on a proposal to make changes to language in the diversity funding announcements. The most recent change was in 2015. Discussion focused on changes to awards made to researchers from underrepresented groups since the modifications were made in 2015 and additional suggestions for the current proposal.

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Announcements: Francis Collins

Dr. Collins (DIR) updated the IC Directors on Secretary Price’s recent visit to NIH, which included a discussion with a select group of IC Directors and a meeting with a Clinical Center patient. He also updated the Directors on plans for the FY2017 Federal Budget process, and Dr. Tabak (DEPD) updated the group on continued communication between NIH and the HHS policy team.

SDC Recommendations to the IC Directors Regarding BD2K: Jon Lorsch, Patti Brennan, Steve Katz, Carrie Wolinetz

Dr. Collins provided a short history of the establishment of the Big Data to Knowledge (BD2K) Initiative. Dr. Lorsch (NIGMS) then presented the recommendations of the Scientific Data Council regarding the next phase of BD2K, and asked for IC Director input. The discussion focused on data science training, infrastructure and service goals, communication about data models, long-term planning needs, and inter-agency relationships with regards to data science.

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Announcements – Francis Collins

Dr. Collins (DIR) reported on a recent Congressional visit to the NIH, during which members visited intramural labs, were updated on NIH initiatives such as the BRAIN initiative, and met with NIH trainees. Dr. Collins also provided updates on NIH’s communications with the new administration at HHS.

Orphan Applications – Mike Lauer and Jon Lorsch

Dr. Lorsch (NIGMS) presented information from an NIH working group charged with providing recommendations to address different types of challenges with reviewing and funding certain applications or research topics (i.e., “orphan” applications). The discussion focused on implementation of the recommendations and opportunities to streamline the grants application and review processes.

Pre-prints and Other Interim Research Products – Mike Lauer, Jon Lorsch, and Neil Thakur

Dr. Thakur (OER) presented on the results of a request for information that queried the research community about attitudes towards scientific impacts and potential policies surrounding pre-print products. Discussion topics included citation of preprints in research publications and grant applications.

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Announcements: Francis Collins

Dr. Collins (DIR) provided updates on the composition and activities of the new Congress, the first meeting of the NIH Cures Legislative Implementation Plan Working Group, and NIH activities surrounding rigor and reproducibility.

NCI Cancer Moonshot Spending Plan: Douglas Lowy

Dr. Lowy (NCI) presented information on NCI’s funding plan for the Cancer Moonshot, and highlighted specific areas where Institutes and Centers (ICs) may collaborate with NCI to advance this initiative. IC Directors expressed enthusiasm for collaboration opportunities.

Clinical Center Census: Stephen Katz

Dr. Katz (NIAMS) outlined the recommendations of an NIH working group charged with considering specific strategies to increase average daily census of inpatient participants at the Clinical Center.  The discussion focused on ensuring high quality science while managing clinical costs, and specific strategies to recruit new clinical investigators.

Clinical Center Adverse Event Reporting: Michael Gottesman and Andrew Griffith

Dr. Gottesman (DDIR) and Dr. Griffith (NIDCD) presented the self-report survey results of an internal examination of adverse event reporting activities by researchers at the Clinical Center.

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Announcements: Francis Collins

Dr. Collins welcomed Diana Bianchi as the new Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. He also reported on the recent Presidential and Congressional elections.

Administration Transition Update: Lawrence Tabak, Adrienne Hallett

Dr. Tabak (DEPD) provided an update on the transition materials that NIH developed for the new Administration and preparations for meeting with the NIH transition team.

Ms. Hallett (OLPA) discussed Congressional and Administrative changes that can be expected post-election and post-inauguration. The group discussed steps NIH can take to prepare for the new Administration.

Announcements: Francis Collins

Dr. Collins provided updates on transition planning, a recent Data Sustainability and Maintenance workshop, and the latest Clinical Center Hospital Board meeting, including the recent FDA inspections. An update on Congressional activities was also given.

Federal Employee Viewpoint Survey (FEVS) Results: Alfred Johnson

Dr. Johnson (Acting DDM) presented on the 2016 FEVS results and a proposed change to the accessibility of the data. The discussion focused on the pros and cons of changing the accessibility.

Referral Guidelines: Richard Nakamura

Dr. Nakamura (CSR) provided an overview of and data on the current referral guidelines. The discussion centered on dual assignments, orphan applications (particularly behavioral research applications), and a proposal to create a trans-NIH Referral Advisory Board.

Gene Drives: Carrie Wolinetz

Dr. Wolinetz (OSP) presented an update on gene drives, including potential applications, concerns, risk mitigation, and oversight. An overview of a recent National Academies of Science report was also provided. Discussion focused on the implications of the concerns and the benefits of the technology.

Announcements: Francis Collins

Dr. Collins reported on Congressional activities relevant to NIH, the UN general assembly meeting, the Rally for Medical Research, and the 20th Anniversary of Friends of Cancer Research. Updates on the ClinicalTrials.gov reforms and the announcement of the Environmental influences on Child Health Outcomes (ECHO) program awards were also provided.

Combined Federal Campaign (CFC): Nora Volkow

Dr. Volkow (NIDA) provided information on the 2016 CFC campaign, including how ICs can become involved in the campaign.

Precision Medicine Initiative (PMI) Cohort Program: Eric Dishman

Mr. Dishman (PMI) provided an update on the progress of the PMI Cohort Program, including information on the Cohort Program’s goals, governance structure, data collection strategies, and current awardees. Discussion focused on participant recruitment retention strategies (including outreach to hard-to-reach populations), innovation pipeline and infrastructure development, and data storage.

Adolescent Brain Cognitive Development (ABCD) Study: Nora Volkow and George Koob

Dr. Volkow (NIDA) and Dr. Koob (NIAAA) presented an update on the ABCD study, including information on the study rationale, collaborators, research objectives, recruitment and outreach strategies, and plans to share data with the research community. Discussion focused on collaborating with other pediatric programs to increase recruitment of hard-to-reach populations, and standardization and storage of imaging data.

Announcements: Francis Collins

Dr. Collins provided an overview of his visits to Perdue University, Northwestern, and the University of Chicago. He also reported on three recent events: the unveiling of the Cancer Moonshot Blue Ribbon Panel report, the workshop on Ensuring Continued Responsible Research with Non-Human Primates, and the Clinical Center Town Hall. Finally, Dr. Collins announced the launch of the NIAID/BARDA Antimicrobial Resistance Prize.

Transition Update: Larry Tabak

Dr. Tabak (DEPD) provided an update on changes to the current guidance for the Presidential transition materials, as well as agency and departmental due dates for the materials.

Minimum Percent Effort/Research Commitment Index: Mike Lauer

Dr. Lauer (DDER) presented on an OER-developed metric to examine how much NIH support is given to individual PIs as part of a broader discussion on the issue of increasing the number of investigators supported by NIH. The presentation was well-received by the IC Directors, who requested a follow up presentation with additional information on the metric’s capabilities and potential uses.

Secondary Assignments: Richard Nakamura

Dr. Nakamura (CSR) provided an overview of, as well as challenges in, the process of determining primary and secondary IC assignments for grant applications or medical conditions with overlapping institutional applicability.

Announcements: Francis Collins

Dr. Collins discussed his upcoming visits to Purdue University, Northwestern, and the University of Chicago. He also announced Dr. Diana Bianchi as the new NICHD Director and Dr. John Gallin as the new Chief Scientific Officer of the Clinical Center and Associate Director for Clinical Research, and welcomed Dr. Patti Brennan, the Director of NLM, to the meeting. A reminder about the upcoming Clinical Center town hall meeting and overviews of the Cancer Moonshot Blue Ribbon Panel report and recent briefings with Congressional staff also were given.

Transition Update: Larry Tabak

Dr. Tabak (DEPD) presented an overview of the current guidance for the Presidential transition materials. The discussion focused on the due date and what should be included in the materials prepared by the ICs.

OBSSR Strategic Plan: Bill Riley

Dr. Riley (OBSSR) presented on the OBSSR Strategic Plan, and provided information on the process and timeline, guiding principles, and scientific priorities. The discussion focused on the advisory committee and the key areas.

OER Budget Process: Mike Lauer

Dr. Lauer (DDER) provided an overview of the current OER budgeting process, data on the growing OER operations, and the proposed OER budgeting process. The IC Directors responded positively to the proposal.

BRAIN Update: Walter Koroshetz

Dr. Koroshetz (NINDS) discussed recent updates from the BRAIN initiative, including the timeline, recent scientific and technologic advances, the neuroethics group, the funding breakdown, the distribution of investigators, upcoming meetings, and major challenges. The discussion concentrated on the neuroethics and the management strategy (e.g., prioritization).

Announcements: Francis Collins

Dr. Collins provided an overview of his recent trip to East Africa, discussed the upcoming non-human primates workshop and the chimp retirement plan, and commented on the announcement of Josh Gordon as the new NIMH Director. An update on Zika, the HHS travel cap, and transition planning were also given.

FY17 Clinical Center Governing Board (CCGB) Budget Recommendations: Steve Katz

Dr. Katz (NIAMS) presented an overview of the current needs and the proposed recommendations for the FY17 Clinical Center budget. The discussion focused on the how to divide up the costs, any potential impact on the extramural community, and possible costs for FY18.

OBSSR Strategic Plan: Bill Riley

Postponed.

Sexual Harassment: Debra Chew, Hannah Valantine

Dr. Valantine (COSWD) provided data and examples to outline the problem of sexual harassment in science, discussed the goals, approach, design, validation, and administration of a survey to NIH staff, and proposed a timeline and next steps. The discussion focused on what, if any, role NIH has to address sexual harassment in the extramural community, including at scientific meetings.

Announcements: Francis Collins

Dr. Collins welcomed the new Office of the Director leadership to the meeting – Mr. Eric Dishman and Drs. Maureen Goodenow and Matthew Gillman, and announced the new NIMH Director, Dr. Joshua Gordon.

Appendix/Post-Submission Policies and Final RPPR: Mike Lauer

Dr. Lauer (DDER) provided an overview of the current appendix/post-submission policies and the challenges with these policies, as well as proposed policies. A presentation on the proposed changes to the RPRR policy was also given. The discussion focused on the impact on type 2 grants.

Physician Workforce: Larry Tabak

Dr. Tabak (DEPD) presented on a recent analysis of the current state and outcomes of the physician/clinician scientist workforce. Possible solutions to address the existing challenges were also provided. The discussion focused on the data for the MST program and T32s, additional solutions and the possible adverse incentives of all the proposed solutions, factors outside the influence of NIH and how to address them, and how to link and possibly shorten the career path stages.

Announcements: Francis Collins

Dr. Collins provided an overview of the Precision Medicine Initiative, the ClinicalTrials.gov Final Rule, the upcoming ACD meeting, and recent meetings with Congressional staff.

Analysis of AA/B Grant Application Outcomes: Hannah Valantine

Dr. Valantine (COSWD) provided an overview of the recent analysis of outcomes from African American/Black grant applicants. The discussion focused on the factors driving these data, how to address the issues, and the details of the recommended interventions.

Announcements: Francis Collins

Dr. Collins provided an overview of recent Congressional activities and meetings, as well as an upcoming visit by Governor Larry Hogan. Brief updates on the Clinical Center and the ACD “Red Team” report, Dr. Matthew Gillman’s announcement as the incoming Environmental influences on Child Health Outcomes (ECHO) Program Director, and Take Your Child to Work Day events were also given.  

R21 Program: Mike Lauer

Dr. Lauer (DDER) provided an overview of the differences between R21s and R01s, which ICs use them and how, the composition of the R21 applicant and awardee pool, and applicant outcomes.

CT.gov: Larry Tabak

Dr. Tabak (DEPD) presented a brief update on NLM and CT.gov funding.

Announcements: Francis Collins

Dr. Collins provided an overview of recent and upcoming Congressional hearings, activities, and visits, including a recent visit by Sen. Mikulski. Brief updates on Zika, the Pharmaceutical Development Section (PDS) Advisory Committee to the Director (ACD) Working Group (“Red Team”) report, the Rall Cultural Lecture with Diane Rehm, senior leadership searches, and the announcement of Eric Dishman as PMI Cohort Program Director were given.

Budget and Scope Negotiations: Mike Lauer, John Lorsch

Drs. Lauer (DDER) and Lorsch (NIGMS) presented on the current and proposed policies for revised aims and budgets. The discussion focused on the potential impact and support.

Tracking Investigators and Grants: Mike Lauer, John Lorsch

Dr. Lauer (DDER) provided an overview of the data on the number of submitted applications and individual awardees. The discussion centered on the implications for young investigators and physician scientists, potential impact of focusing on people rather than grants, communication of information and differences between application/workforce rate and success rate, and the R21 program.

NCI’s K08-K23/K24 Proposal: Doug Lowy

Dr. Lowy (NCI) provided a summary of the proposal to merge the K08 and K23 awards for NCI, including information on the similarities between the awards, the potential review caveats, and the possible unintended consequences.  The discussion centered on the historical rationale for the K23 awards, the impact on patient-oriented research and diversity, the messaging, and the evaluation of this program going forward.

Announcements: Francis Collins

Dr. Collins provided an overview of the Science letter on basic research, the Rall Lecture, and Senator Mikulski’s upcoming visit. He also discussed the changes to the NIH Guidelines regarding the review of human gene transfer protocols, as well as the NIH-FDA Joint Leadership Council.

Clinical and Translational Science Awards (CTSA) Update: Chris Austin

Dr. Austin (NCATS) presented an overview of the progress made towards implementing changes to the CTSA program, including streamlining clinical study startup, harmonizing investigator qualification, and improving clinical study recruitment. The discussion focused on the next steps, and the IC Directors will be updated again in the fall.

F30 Proposal and EAWG Processes: Mike Lauer, Jon Lorsch

Drs. Lauer (DDER) and Lorsch (NIGMS) discussed the proposed change to the F30 NRSA Individual Predoctoral MD/PhD or Other Dual Degree Fellowship Award Funding Opportunity Announcement (FOA), and provided an overview of the revised Extramural Activities Working Group charter.  The discussion centered on the ICs that would be impacted by the F30 FOA change and the potential implications.

Implementation of the Intramural Research Program (IRP) Plan: Michael Gottesman

Dr. Gottesman (DDIR) provided an update on the implementation of the IRP long-term plan.  The discussion focused on the practicalities of implementing each change.

Announcements: Francis Collins

Dr. Collins provided an overview of recent and upcoming Congressional activities, meetings, and visits. Brief updates on Zika, the Red Team meetings, NCBI, and the PMI retreat were given.

NCI R50 Staff Scientist Award: Doug Lowy, Dinah Singer

Drs. Lowy and Singer (NCI) presented an overview of the new NCI R50 Staff Scientist Award, including the issue, goals, process, application and review criteria, and plan for evaluating the program/award. The discussion focused on the expected number of awards, the flexibility given to the researcher, and the unintended consequences and benefits.

Biospecimen Policy: Kathy Hudson, Carrie Wolinetz

Dr. Hudson (DDSOP) provided a summary of the relevant provisions in the Common Rule NPRM, and potential options for addressing this issue.  The discussion centered on the pros and cons of each option, the practicalities for implementing each option, and potential pilots.

Announcements: Francis Collins

Dr. Collins provided an overview of the budget and the recent budget rollout events, as well as other Congressional activities and meetings. Brief updates on Zika virus-related activities were given.

FY15 FEVS Results: Rich Southers

Mr. Southers (OHR) presented an overview of the FY15 Federal Employee Viewpoint Survey results. The discussion focused on how IC Directors can promote employees taking the survey, as well as demonstrating the impact of the results.

Basic Research in Public Health Relevance Section of Applications: Mike Lauer

Dr. Lauer (DDER) provided a summary of the suggested changes to the instructions for the Public Health Relevance section of grant applications. The discussion centered on what language could/should be changed, how it should be modified, the process for doing so, and implementation and communication with the community.

Flint Water Contamination Update: Linda Birnbaum

Dr. Birnbaum (NIEHS) provided a summary of the potential health impact of the Flint water contamination issue, and the activities that HHS, particularly NIH, is supporting to assist with the response and research. The discussion centered on the exposure levels, known and unknown health outcomes, and the response and prevention efforts.

NCI R50 Staff Scientist Program: Doug Lowy, Dinah Singer

Postponed.

Announcements: Francis Collins

Dr. Collins provided an overview of the recent and upcoming Congressional activities and meetings.

PubMed Commons/bioRxiv: David Lipman

Dr. Lipman (NCBI) presented a description of bioRxiv, as well as a summary of the capabilities, progress, milestones, and steps to build participation.

Workforce Diversity and Inclusion: Gap Analysis Workgroup: Debra Chew, Shelma Little

Ms. Chew and Dr. Little (EDI) provided an overview of the scientific workforce demographics, current investments and issues, and recommendations. The discussion centered on the next steps.

Announcements: Francis Collins

Dr. Collins provided an overview of the recent and upcoming Congressional activities, meetings, and visits. An update on the NIH-wide Strategic Plan and NIH’s interest in and emphasis on basic research was provided.

MBWG Update: Griffin Rodgers, Steve Katz, Andrea Norris

Drs. Rodgers (NIDDK) and Katz (NIAMS) and Ms. Norris (CIT) presented an overview of the proposed MBWG recommendations for FY16. The discussion focused on the potential impacts of a Continuing Resolution and the sequester.

Leadership Forum Follow-up: Larry Tabak

To be discussed electronically.

Announcements: Francis Collins

Dr. Collins provided an update on the Precision Medicine Initiative report, roll-out, and response. An overview of the recent and upcoming Congressional activities, meetings, and visits also was given. The potential and preparation for a potential shutdown also was discussed.

CFC Discussion: James Battey

Dr. Battey (NIDCD) presented an overview of the upcoming Combined Federal Campaign (CFC) activities.

NIH-wide Strategic Plan Update: Larry Tabak

Dr. Tabak (DEPD) provided an update on the NIH-wide Strategic Plan, including the feedback received, the status of the draft, and next steps.

Environmental influences on Child Health Outcomes (ECHO) Update: Larry Tabak

Dr. Tabak (DEPD) provided an overview of the current ECHO program plan. Information on the focus, the potential research questions that could be addressed, the overall program structure, and the governance model. The discussion centered on linkage between ECHO and PMI, the biorepository, tracking non-infectious diseases/disorders, newborn screening measures, and cohort diversity.

Announcements: Francis Collins

Dr. Collins provided an update on the NIH-wide Strategic Plan and the FY16 National Children’s Study redirection efforts. Brief descriptions of recent Congressional events and the status of the proposed Alzheimer’s Bypass Budget plan also were given. Dr. Collins reminded everyone to continue to send ideas for his blog.

Steering Committee Diversity Working Group Update: Hannah Valantine, Garry Gibbons

Dr. Valantine (COSWD) provided an overview of the working group’s recent efforts. A particular focus of the presentation was on training-related ideas and pilot programs to diversify the workforce in both the intramural and extramural programs. Methods of addressing implicit bias also were described. Dr. Valantine briefly discussed the hallmarks of success that will be used to evaluate the programs as well. The discussion focused on the potential for reaching students early (high school) and retaining their interest in research.

ADDS Update: Phil Bourne

Dr. Bourne (ADDS) presented an update on BD2K, and described The Commons, including its advantages and disadvantages. The role of the Data Discovery Index Coordination Consortium (DDIC), and an overview of the pilot programs and their preliminary results also was provided. The discussion focused on the providers and the cost/business model.

VIP Visit: Surgeon General Vivek Murthy

Dr. Murthy (Surgeon General) provided some information on his background and personal interests, as well as the priorities for his term as Surgeon General. These priorities include things such as leveraging and modernizing technologies, promoting walkability efforts, opioids, dietary sugar, mental health stigma, and tobacco/e-cigarettes. A brief discussion on capitalizing on the Commissioned Corps and prevention also occurred.

H3Africa Update: Eric Green, Jennifer Troyer, Mark Guyer

Dr. Troyer (NHGRI) provided an overview of the vision and goals of the program, as well as an update on the progress and publications thus far. The discussion focused on the potential for collaborations, particularly clinical research collaborations, and partnership opportunities.

GTEx Update: Simona Volpi, Susan Koester, Kristin Ardlie

Drs. Volpi (NHGRI) and Ardlie (Broad Institute) provided a summary of the goals, data release and sample access, future/ongoing needs, pilot data results, deliverables, and publications. The discussion focused on the racial/ethnic and gender diversity within the population and the tissue types collected.

Announcements: Francis Collins

Dr. Collins described the status of the 21st Century Cures bill. A brief update on the recent PMI workshop and briefing for President Obama also were provided. Dr. Collins discussed the recent SMRB meeting as well.

Announcements: Francis Collins

Dr. Collins described the visit by the Chinese Delegation and the meeting with AAU. The results of the recent appropriations discussions and the latest meetings with Congressional members also were discussed. Dr. Collins also provided a brief update on the Clinical Center/PDS response.

Basic/Translational/Clinical: Neil Shapiro, Sally Rockey, Walter Koroshetz, George Santangelo

Mr. Shapiro (OB) and Drs. Rockey (DDER), Koroshetz (NINDS), and Santangelo (DPCPSI/OPA) provided an overview of basic, translational, and clinical research supported by NIH, including a discussion on RCDC categorization and recent portfolio analyses. The discussion focused on the complications of the definitions, the trends in biomedical research, and the need to address reviewers’ and applicants’ expectations of what NIH expects.

ADDS Update: Phil Bourne

Dr. Bourne (ADDS) provided a summary of the redeveloped framework for the NIH-wide Strategic Plan. The discussion focused on providing feedback on the new framework and the path going forward.

Announcements: Francis Collins

Dr. Collins briefly discussed the recent Congressional visits and meetings. Dr. Collins also mentioned the Precision Medicine Initiative workshop that is being held May 28-29. A reminder to encourage staff to complete the Employee Viewpoint Survey also was provided. 

Physician-Scientist Recommendations: Sally Rockey, Sherry Mills

Drs. Rockey (DDER) and Mills (OER) provided an overview of the ACD Physician-Scientist Workforce Working Group report and recommendations. The proposed implementation plan also was described. The discussion focused on areas of concern and interest to the IC Directors. 

Cores Follow-Up: Jim Anderson, Sally Rockey

Drs. Anderson (DDPCPSI) and Rockey (DDER) presented an overview of the Core consolidation, including background, outcomes, and lessons learned. The recommendations and outcomes of a recent relevant workshop also were described. The discussion focused on the best path moving forward.

Announcements: Francis Collins

Dr. Collins briefly discussed the recent Congressional hearings, the formation of the NIH Caucus, and the Weicker Building Dedication. Dr. Collins also provided an overview of the draft 21st Century Cures legislation. Summaries of the upcoming PMI workshop and the Gabriella Miller Kids First Act progress were provided. Finally, Dr. Collins reviewed the results from the Employee Viewpoint Survey.

Climate Health Data Challenge Update: Linda Birnbaum, John Balbus

Drs. Birnbaum and Balbus (NIEHS) provided background on the Climate Health Data Challenge, as well as an update on its activities and collaborations. The discussion focused on areas where those ICs who are not involved can get involved.

KOMP2 Update: Eric Green, Jim Battey, Jim Anderson

Drs. Green (NHGRI), Battey (NIDCD), and Anderson (DPCPSI) presented an overview of the KOMP2 planning process and discussed two topics being considered. The discussion focused on the best path moving forward.

Poolesville Update: Larry Tabak

Dr. Tabak (DEPD) provided an update on the planning regarding the future of the Poolesville facility, as well as the proposed recommendations. The discussion centered on the potential implications of the recommendations.

Announcements: Francis Collins

Dr. Collins briefly discussed the upcoming PMI workshops, communication activities with the media, and the Weicker Building dedication. Summaries of recent Congressional visits and meetings, as well as upcoming Congressional hearings, were provided.

FY16 Appropriations Discussion: Francis Collins

Dr. Collins provided an overview of proposed NIH activities to enhance stewardship. The discussion focused on areas of concern and concensus.

Conference Policy Guidance: Larry Tabak, Colleen Barros

Dr. Tabak and Ms. Barros presented an overview of the changes to the conference approval policies and processes.

Common Fund: KOMP2 Update: Jim Anderson, Betsy Wilder, Colin Fletcher

Dr. Fletcher (NHGRI) provided an update on the progress and successes of the KOMP program, which began as a multi-IC co-funded effort to knock out all the mouse protein-coding genes. He also discussed a proposal going forward. The discussion centered on the potential goals and direction going forward, as well as the lessons learned from the program.

Common Fund: H3Africa Update: Jennifer Troyer, Mark Guyer

This presentation and discussion will be rescheduled for another meeting.

Announcements: Francis Collins

Dr. Collins welcomed the new Acting IC Directors, and Dr. Fauci provided an Ebola update. Dr. Collins also briefly discussed the 4th Annual Rx Drug Summit, the NAS Gene Drives Study, and NIH’s Genomic Data Sharing Policy. Summaries of recent Congressional visits and meetings, as well as upcoming Congressional hearings, were provided.

Outcomes of the Technical Centers for Networks and Pathways (TCNP) Program: Jim Anderson, Douglas Sheeley, and Michael Rout

Dr. Sheeley (NIGMS) presented an overview of the TCNP program, including the goals, timeline, budget, and a brief summary of the developed technologies. Dr. Rout (Rockefeller U.) provided details on the National Center for Dynamic Interactome Research (NCDIR), the methods and technologies developed to understand the dynamics of macromolecular assemblies, the data acquisition and analysis process, and the applications. Outreach activities also were outlined. The discussion focused on the potential goals going forward, and the lessons learned from the program.

Announcements: Francis Collins

Dr. Collins briefly discussed the ACD NLM working group’s progress and the upcoming 4th Annual Rx Drug Summit. Dr. Collins also provided summaries of recent Congressional hearings, as well as upcoming Congressional visits. Gratitude was expressed toward Drs. Lindberg (NLM) and Varmus (NCI), who are departing NIH.

Precision Medicine Initiative (PMI) Update: Kathy Hudson

Dr. Hudson (DDSOP) presented an update on the PMI, including the recent NIH workshop on precision medicine. She also provided details on the ACD working group charged with developing a plan for establishing the research cohort, and the IC Directors’ working group that will be working in concert with the ACD working group to coordinate internal planning and activities. The discussion focused on the potential impact of the PMI, and the processes and potentials going forward.

Common Fund — Center for Regenerative Medicine (CF-CRM): Jim Anderson, Chris Austin

Drs. Anderson (DPCPSI) and Austin (NCATS) discussed the ongoing activities (i.e., white papers, workshops) in the CRM and the details of two efforts with NEI and NCATS, including milestones and budget information. An overview of an external expert panel and a trans-NIH working group to coordinate these activities across NIH also were provided. The IC Directors discussed the connection between these programs and NIH reproducibility activities, as well as current Japanese efforts and industry interest in this space.

Clinical and Translational Science Award (CTSA) Update: Chris Austin, Petra Kaufmann

Drs. Austin and Kaufmann (NCATS) provided an update on the changes to the CTSA program, including pilot projects that are being implemented and methods to improve efficiency, collaboration, and recruitment. The IC Directors discussed potential approaches for collaboration across the NIH ICs.

Extramural Activities Working Group (EAWG) Update: Sally Rockey, Jon Lorsch

Drs. Rockey (DDER) and Lorsch (NIGMS) presented an update on the current EAWG activities. They provided information about the focus and progress of two subcommittees — 1. Developing efficient and sustainable funding policies, and 2. Decreasing the age for reaching research independence. The discussion focused on details of the subcommittees’ efforts and how to more effectively collaborate with the extramural community (particularly academic institutions and administrators).

Dr. Collins discussed the departure of Dr. Harold Varmus (NCI), and Dr. Fauci (NIAID) provided an update on Ebola-related activities. Dr. Collins also provided a recap of the recent House Appropriations Committee and Senate HELP Committee hearings, as well as upcoming Congressional visits. An overview of Pi Day (3.14.15) events was discussed, and a Story Corps clip of two long-time NIH employees was played.

Cryo-EM Expansion: Sriram Subramaniam

Dr. Subramaniam (NCI) presented an overview of the cryo-EM field, including seminal and recent advances, and major challenges facing the field currently. He also provided potential opportunities for trans-NIH partnerships and future applications. The discussion focused on the advantages and disadvantages, as well as current and amended models for moving forward.

Gabriela Miller Kids First Research Act Update: Jim Anderson

Dr. Anderson (DPCPSI) provided an update on the ongoing efforts to develop a program in the Common Fund on pediatric research. The IC Directors discussed the current proposal, as well as specifics of its focus and implementation.

FITARA Update: Andrea Norris, Colleen Barros, Larry Tabak

Ms. Norris (CIT) presented a detailed summary of FITARA — a recent law governing federal IT services — and its potential implications for and impact on NIH. The discussion focused on details of the legislation and information on the OMB guidance that is being developed.

Announcements: Francis Collins

Dr. Collins (DIR) provided a recap of the recent Precision Medicine Initiative events. An overview of Congressional visits and hearings, and the proposed bills impacting NIH funding that were introduced in Congress recently also was presented. Dr. Collins discussed the upcoming NIH-FDA Leadership Council as well.

FY16 President’s Budget Request: Neil Shapiro

Neil Shapiro (OB) presented an overview of the FY16 President’s Budget Request, including mention of the BRAIN Initiative, Alzheimer’s disease, and Precision Medicine. The discussion focused on the anticipated number of RPGs and success rates for FY16.

Rigor and Reproducibility Implementation Update: Sally Rockey

Dr. Rockey (DDER) provided an update on the ongoing efforts to include rigor and reproducibility components, including scientific premise, within the grant application. The IC Directors discussed the specifics of how these changes will be integrated into the grant application and review process, and their concerns about the potential implications.

National Children’s Study (NCS) Funding Redirection: Larry Tabak

Dr. Tabak (DEPD) presented a more detailed overview of the plan for the redistribution of NCS funds, which was recently cleared by Council of Councils. Dr. Jim Anderson (DPCPSI) discussed the Gabriela Miller Kid’s First Research Act and how the programs that will be developed will be integrated into and synergized with the NCS redirection and other initiatives. The discussion focused on details of the projects, as well as support of the projects going forward.

Announcements

Dr. Collins welcomed everyone to the meeting, and reminded the IC Directors of the upcoming release of the IOM report on Clinical Trial Data Sharing. The Clinical Trials and Common Rule NPRMs, as well as upcoming Congressional visits and activities, were discussed. A brief update on the Ebola response also was provided.

IRP Plan: Michael Gottesman

Dr. Gottesman (DDIR) provided an overview of the steps going forward to develop an implementation plan to address the recommendations for the IRP developed by the ACD working group. The discussion focused on the steps going forward to develop the plan and concerns with specific recommendations.

NSF Visit: France Cordova and James Olds

Drs. Cordova and Olds (NSF) discussed the various NSF activities relevant to NIH, including their reproducibility and BRAIN efforts. The discussion focused on NSF’s specific approaches to address reproducibility in science and issues associated with the grant review process, as well as various competitions and experiments NSF is conducting to evaluate different policies and processes.

Announcements

Dr. Collins welcomed everyone to the meeting, and provided an overview of the FY 2015 budget, including the approval of the new NCCAM name – National Center for Complementary and Integrative Health (NCCIH), the Heads of International Research Organizations (HIROs) meeting, and the Advisory Committee to the Director (ACD) meeting. A brief update on the Ebola response also was provided.

Environmental Pediatric Research: Kathy Hudson

Dr. Hudson (DDSOP) provided an overview of environmental pediatric research as a follow-up to the National Children’s Study (NCS) report presented at the ACD meeting. The discussion focused on the language in the appropriation’s bill that referenced the NCS.

Addressing the Science of Health Disparities Research: Yvonne Maddox

Dr. Maddox (NIMHD) discussed the differences between health disparities research and minority health research, and provided the OMB standards for minority health and population sciences. Dr. Maddox also summarized eight identified domains of health determinants, and the importance of and potential approaches to the science of health disparities research. The discussion focused on research priorities and interest across the ICs.

Announcements

Dr. Collins welcomed everyone to the meeting and provided an overview of the Presidential visit last week, as well as the status of the FY 2015 appropriations bills, including funds for Ebola research. A brief summary of the new single IRB policy also was provided.

Rigor Implementation: Sally Rockey

Dr. Rockey (OER) provided a definition for scientific rigor and expanded upon the need for differing terminology – scientific rigor and transparency, rather than reproducibility. She also summarized the proposed modifications to the application instructions and progress reports, including scientific rigor/premise, authentication of resources, and sex as a biological variable, and the notification strategy. The discussion focused on location of these items in the application instructions, and there were concerns about the burden placed on applicants.

AIDS Portfolio Update: Jack Whitescarver

Dr. Whitescarver (OAR) presented a brief overview of the NIH AIDS portfolio, and a summary of the AIDS Research Portfolio Review Working Group’s recommendations, priority areas, and identified areas requiring further assessment. The discussion centered on the difficulties of classifying AIDS-related research, especially basic research.

ACD LT-IRP Working Group Update: Larry Tabak

Dr. Tabak (DEPD) summarized the recommendations developed by the ACD Long-Term Intramural Research Program (LT-IRP) Planning Working Group.  The discussion focused on areas/recommendations of concern and those in which the ICDs were supportive, and the potential steps to take going forward.

Announcements

Dr. Collins welcomed everyone to a special meeting of NIH IC Directors to discuss the recommendations on the future of the National Children’s Study (NCS) that will be presented to the Advisory Committee to the Director (ACD) in mid-December.

National Children’s Study: Kathy Hudson

Dr. Hudson (DDSOP) provided an overview of the background, history, timeline, and budget of the NCS. Dr. Hudson also summarized the proposed recommendations for the NCS developed by the ACD working group, as well as the next steps to move forward. The discussion focused on the data collected from the study thus far, the announcement of the recommendations, and the successes of other NIH cohort studies.

Announcements

Dr. Collins welcomed everyone to this special meeting of NIH IC Directors, which was called to provide additional information on the NIH IRP-Pfizer Centers for Therapeutic Innovation.   

NIH IRP-Pfizer Centers for Therapeutic Innovation: Chris Austin

Dr. Austin (NCATS) provided an overview of the proposed collaboration model, governance structure, and evaluation criteria for the joint project with the NIH IRP and the Pfizer Centers for Therapeutic Innovation (CTI). He also summarized the statistics of the selected projects, the advantages to NIH, and the potential logistical issues associated with this collaboration. The discussion focused on the dispute resolution process, the roll-out to the extramural community, status of trainees, potential expansion of the program, publication procedures, and policies for project approval.

Announcements

Dr. Collins provided brief updates on the expected changes in Congressional representation. Dr. Fauci provided updates on Ebola-related efforts.

Central Services Budget

Dr. Rodgers, Dr. Katz, and Ms. Norris provided an overview of the recommendations from the Management and Budget Working Group. This included information on the ongoing initiative budget assessments, the Clinical Center budget, and the IT infrastructure budget.

The IC Directors were appreciative of the updated and supported the recommendations.

Announcements

Dr. Collins provided an update on the Ebola activities, recent Congressional hearings and activities, and a meeting with the President of the United States. NIH governance and policies matters also were discussed.

Update on the Clinical and Translational Science Award (CTSA) Program: Chris Austin and Petra Kaufmann

Drs. Austin and Kaufmann (NCATS) presented an overview of the CTSA program, including its current program sites, how the IOM report and NCATS Advisory Council working group recommendations are being implemented, and the next steps. The discussion focused on leveraging existing networks, and enhancing clinical trials and communication.

Data Act/PMA Benchmarks/HHS Enterprise Risk Management: Colleen Barros

Colleen Barros (DDM/CFO) provided an update on the successful implementation of the DATA Act at HHS, the President’s Management Agenda and the Benchmarking Initiative, and the alignment of science and risk management. The discussion centered on the implementation process, the advantages to employing these activities, and the concerns the IC Directors had about specific items.

Announcements

Dr. Tabak provided brief updates the recent rollout for the BRAIN initiative, the potential gain-of-function moratorium, and upcoming rollouts of NIH BD2K and Diversity initiatives. Dr. Fauci provided updates on Ebola-related efforts.

IT Infrastructure

Ms. Norris the issue of NIH’s IT infrastructure challenges, including network congestion and low storage capacity, as well as the updates that have been made, which include higher capacities for storage and networking, more flexibility to address a variety of computing needs, better reliability, and science-specific security controls. In addition, the Biowulf Cluster, the only large-scale central computational resource dedicated to biomedical computing in the IRP, will be expanded in its capacity over the next 4 years.

IC Directors expressed appreciation for these expansion efforts, and also discussed the need for utilizing this increased capacity as an incentive for IRP recruitment and for sharing more concrete examples of how the improvements have facilitated enhanced research efforts.

Ethics Discussion re: Service on Professional Boards

Ms. Beckerman Jaffe presented the recent change to the policy on service on the boards of professional organizations. This change is an option that allows for federal employees to serve in leadership roles on the boards of professional societies in one’s official capacity as a federal employee. The policy is designed to allow for flexibility while complying with the necessary statutes and regulations. The NIH Ethics Office will collect data and feedback on policy implementation, as well as post public information for organizations on the policy.

ICDs expressed appreciation for the policy and their hope that it be publicized widely.

Announcements

Dr. Collins provided updates on recent talks with the Henrietta Lacks Family regarding the recent sequencing of the HeLa genome. An overview of recent and upcoming Congressional action and visits was also provided.   

Health Care System Collaboratory: Josie Briggs, Michael Lauer, and Catherine Meyers

Drs. Briggs (NCCAM), Lauer (NHLBI), and Meyers (NCCAM) provided an update on the Health Care System Collaboratory. The IC Directors discussed the relationship of the Collaboratory efforts with other ongoing activities, such as how to address consent in the standard of care research. There was also discussion of how this effort provides another avenue for gaining knowledge about how best to do clinical studies in addition to other existing models for clinical research. 

Manuscript Clearance: Lawrence Tabak

Dr. Tabak provided an overview of the guidance for clearing manuscripts with IC Directors and OD Deputy Directors as authors. Discussion touched upon the importance of keeping communication channels with the OD open.

Sponsored Travel: Larry Tabak

Dr. Tabak provided an overview of the guidance for sponsored travel. IC Directors discussed the importance of considering individual judgment in cases of potentially sponsored travel, along with the regulations.

Announcements

Dr. Collins provided brief updates on the Ebola vaccine trials, the NIH Lab Sweep, and the rescheduling of an NIH visit by Secretary Burwell of HHS. The issue of ethical considerations for Ebola vaccine trials was suggested for further discussion by IC Directors at a subsequent meeting.

Modular Grants

Dr. Landis provided an update on the EAWG discussions and recommendations regarding the budget caps for modular grants. Some of the concerns about the current budget cap are changing research costs, perceptions of investigators, and broader effects on the research enterprise.

There was a vigorous discussion and the ICDs voted to discuss this topic further at a subsequent IC Directors’ meeting.

IT Governance Model

Dr. Tabak and Ms. Barros provided an update on the HHS IT Governance Model. IC Directors were appreciative of the information and Ms. Barros stated that she would keep them updated on its progression.

Procurement Forecast

Ms. Barros also provided an update on the HHS efforts to ensure savings by consolidating procurement efforts across the department. She also stated that she would continue to the keep the ICDs updated on this issue.

Announcements

Dr. Collins provided brief updates on the Ebola response efforts, emergent legislative issues, the NIH Genomic Data Sharing Policy, NIH efforts related to funded clinical trials, and a potential NIH visit by Secretary Burwell of HHS.

Single IRB Policy

Dr. Hudson provided an overview for the proposed single IRB policy for NIH-funded human subjects research, including the timeline for implementation.

The proposal was discussed, and the ICDs were supportive of moving forward, with Dr. Hudson keeping them updated on its progress.

KOMP and Common Fund FY16

Dr. Battey and Dr. Anderson gave the ICDs an overview of the Knockout Mouse Project (KOMP) and the Knockout Mouse Production and Phenotyping (KOMP2) effort. This is a trans-NIH initiative to creete quality mouse knockouts. Information on the progress of the project and its current timeline was discussed. ICDs discussed the outcomes and were appreciative of the update.

Dr. Anderson provided an overview of potential Common Fund concepts for FY16, and the ICDs provided feedback. Dr. Anderson planned to discuss the feedback with staff and return to the ICDs with an update.

Announcements

Dr. Collins provided an update of new NIH procedures for select agents, and gave and overview of the Heads of International Research Organizations (HIRO) and the Global Alliance of Chronic Diseases (GACD) meetings. Dr. Collins also provided an overview of the upcoming hearings and meetings with Congressional members.

Physician Data Query (PDQ) Database: Barry Kramer, Richard Manrow, Margaret Beckwith

Drs. Kramer, Manrow, and Beckwith (NCI) provided the background for the development of PDQ, as well as information on the editorial boards and an update of progress thus far. The discussion focused on the database’s usage statistics and the mechanisms for recruiting and retaining racial and ethnic minorities.

LGBTI Research Coordinating Committee (RCC) Update: Larry Tabak

Dr. Tabak presented a summary of the recent efforts of the LGBTI RCC, including the recent analysis of the NIH LGBTI research portfolio. The development of a strategic plan also was provided. The following conversation centered on the consideration of a supplement for LGBTI research and the need to identify and address research opportunities.

Announcements

Dr. Collins provided summaries of the BIO meeting and Presidential briefing on genomics, personalized medicine, and big data. An overview of Congressional hearings and meetings in which NIH leadership were involved, as well as recent legislative efforts that impact the NIH, was given. Dr. Collins described the activities at NIH with LabTV, which will be interviewing early career intramural and extramural investigators about how they became interested in science to show the footprint of NIH-funded research.

WISER Survey Data/IC Diversity Report: Roderic Pettigrew and Hannah Valantine

Drs. Pettigrew (NIBIB) and Valantine (COSWD) provided an update of the Working towards creating an Inclusive and Supportive Environment for Research (WISER) survey data and response rate, and a summary of IC diversity challenges and potential solutions. The discussion centered on the importance of diversity in the workforce and the need for tracking outcomes.

Clinical Trials Data Sharing: Kathy Hudson

Dr. Kathy Hudson (DDSOP) presented a summary of NIH’s clinical trials statistics (e.g., budget, publications), and reviewed the NIH’s data sharing efforts as a result of the Clinical Trials Working Group recommendations. The discussion focused on compliance and data quality issues.

Announcements

Dr. Collins provided an overview of his trip to tour the Walk Again Project lab in Sao Paolo and his meeting with Dr. Miguel Nicolelis, whose team helped develop the thought-controlled, robotic exoskeleton that kicked a ball to launch the 2014 FIFA World Cup opening ceremony. He also discussed the White House Healthy Kids and Safe Sports Concussion Summit, and the June Advisory Committee to the Director (ACD) meeting. Dr. Collins described the upcoming workshop on reproducibility, which will be held on June 2nd and is co-sponsored by NIH, Nature Publishing Group, and Science Magazine/AAAS.  

Clinical Center Governing Board (CCGB): Steve Katz

Dr. Katz (NIAMS) provided information on a group that will study and review the impact of various clinical protocols, including their utilization. The discussion centered on the timeline by which the group will report to the CCGB.   

AIDS Research Priorities: Jim Anderson and Larry Tabak

Dr. Anderson (DPCPSI) presented an overview of the charge to the Office of AIDS Research Advisory Council, the process to address the charge, and the priority areas. The discussion focused on the portfolio analysis that will be performed and the next steps.

Announcements

Dr. Collins provided an update on the BRAIN initiative and the President’s Bioethics Commission, which will release a report on May 14 detailing the integration of ethics into neuroscience research. He also described the roundtable discussion, which kicked off the 21st Century Cures meetings, and various recent and upcoming Congressional meetings involving NIH leadership. Dr. Collins discussed the approaching confirmation hearing of Sylvia Burwell, nominee for Secretary of the Department of Health and Human Services.  

Medical Education Partnership Initiative (MEPI): Roger Glass

Dr. Glass (FIC) provided information on MEPI – the goal of which is to build human capacity for health in Africa by strengthening the medical education system in an environment that values and nurtures research. Dr. Glass presented on the programmatic (PFAR and NIH) and linked awards (ICs and the Common Fund), citing specific examples. The discussion centered on further leveraging the next round of investments by broadening the partnering organizations and providing additional stability.   

Gulf Long-Term Follow-Up Study Update: Linda Birnbaum

Dr. Birnbaum (NIEHS) presented information on the background, timeline, cohort characteristics, preliminary observations and accomplishments, and proposed new efforts of the Gulf Long-Term Follow-Up study. The discussion focused on budgetary items.

Recombinant DNA Advisory Committee (RAC) Update: Amy Patterson

Dr. Patterson (OSP) presented an overview of the review process for select gene transfer protocols.

Announcements

Dr. Collins provided an update on the Senate Appropriations hearing and the upcoming visit to NIH by Senate Appropriations staff. He also discussed a meeting scheduled for later in the week to discuss the proposed STEM education reorganization. Dr. Collins discussed the celebrating on the planting of the Tree of Hippocrates clone, in which the Greek ambassador was in attendance.  

Big Data to Knowledge (BD2K) Update: Eric Green, Mark Guyer, and Phil Bourne

Dr. Bourne (ADDS) presented information on the programmatic themes and possible challenges of BD2K, and the potential capability that Data Commons could provide to enhance quality and reproducibility. The discussion focused on the role of the ICs, issue surrounding clinical research data, and the timeline for funding applications.

Conference Approvals: Larry Tabak

Dr. Tabak (DEPD) provided information on the conference approval process and data for FY12 and FY13.

Announcements

Dr. Collins described several previous and future Congressional visits, meetings, and hearings. He also mentioned his upcoming “Disruptive Innovator” award reception at the Tribeca Film Festival. Information about the ceremony for the planting of a clone of the original Tree of Hippocrates was provided as well.

Molecular Libraries Team Briefing: Tom Insel, Chris Austin, and Hugh Rosen

Drs. Insel (NIMH), Austin (NCATS), and Rosen (Scripps) provided an overview of the Molecular Libraries and Imaging Program, including goals, initiatives, milestones, and accomplishments. Selected accomplishments from the Molecular Libraries Probe Production Centers Network (MLPCN) also were presented. The discussion focused on the accessibility of the program and components of the transition planning.

Announcements 

Dr. Collins described several upcoming Congressional visits and hearings. A Nature News in Focus article also was mentioned.

Leadership Forum Follow-Up: Larry Tabak

Dr. Tabak (DEPD) provided an update on the items that arose during the January NIH Leadership Forum. The discussion focused on the progress made to date and the next steps.

Reproducibility Follow-Up: Larry Tabak and Sally Rockey

Dr. Tabak (DEPD) provided an overview of the ongoing pilots, resource development, and stakeholder engagement thus far. Dr. Rockey (DDER) discussed various issues surrounding reproducibility and rigor in research, including cell line authentication and consideration of sex as a biological variable. The discussion focused on how best to address issues surrounding reproducibility, and items that should be considered to move forward.

Announcements 

Dr. Collins mentioned recent appointments and departures of NIH senior staff. The Porter Neuroscience Center dedication and neuroscience symposium also were briefly discussed.

Senate Appropriation Hearing Debrief: Francis Collins, Anthony Fauci, Gary Gibbons, Story Landis, Harold Varmus, and Chris Austin

Drs. Collins (DIR), Fauci (NIAID), Gibbons (NHLBI), Landis (NINDS), Varmus (NCI), and Austin (NCATS) provided an overview of the Senate Appropriation Hearing in which they participated. The discussion focused on the items raised during the hearing.

Science of Behavior Change Program: Richard Hodes

Dr. Hodes (NIA) provided an overview of the importance, goals, initiatives, and budget of the Common Fund program on the Science of Behavior Change. The discussion focused on the current initiatives and the budget.

Announcements 

Dr. Collins mentioned the upcoming Porter Neuroscience Center dedication and neuroscience symposium. Various Congressional meetings, briefings, and hearings also were briefly discussed. Information on the recent Congressional Taskforce on Biomedical Research and Innovation meeting was provided as well.

House Appropriation Hearing Debrief: Francis Collins, Anthony Fauci, Gary Gibbons, Story Landis, and Harold Varmus

Drs. Collins (DIR), Fauci (NIAID), Gibbons (NHLBI), Landis (NINDS), and Varmus (NCI) provided an overview of the House Appropriation Hearing in which they participated. The discussion focused on the overall positive support for the NIH and specific items raised during the hearing.

U01 Grants Update: John Gallin and Sally Rockey

Drs. Gallin (CRC) and Rockey (DDER) provided an overview of the purpose, participating ICs, funding and resources, and the awards portfolio for the first grants cycle, as well as the participating ICs and number of applications for the second cycle. The discussion focused on the lessons learned from the first cycle and the role of the intramural investigators.

Announcements 

Dr. Collins mentioned recent appointments of NIH senior staff and provided information on the recent meeting. An update on the Gabriella Miller Kids First Research Act and upcoming Congressional hearings were briefly discussed as well.

NIH Grant Scores/Scientific Impact: Michael Lauer

Dr. Lauer (NHLBI) provided an overview of challenges with and possible limitations to predicting or determining impact, while summarizing the results of an NHLBI portfolio prediction and performance analysis. The discussion focused on other aspects that should be included or further considered in future analyses.

Assessing Review Group Outcomes (ARGO) Update: Jim Anderson

Dr. Anderson (DPCPSI) discussed the additional capabilities of current analysis software, the approaches being developed to identify emerging areas of scientific opportunity, and the validity of current analysis ratings. The discussion focused on concerns about specific criteria used in the analysis.

A0/A1 Discussion: Richard Nakamura and Sally Rockey

Drs. Nakamura (CSR) and Rockey (DDER) summarized the impact of changes to grant application submissions (i.e., the number of resubmissions), and discussed potential resubmission models. The discussion centered on the advantages and disadvantages of the various proposed resubmission models.

Announcements 

Dr. Collins provided summaries of several Congressional visits, meetings, and hearings. An overview of recent antimicrobial resistance (AMR) activities, including the NIH-FDA Leadership Council also was described.  

Sub-IC BRAIN Group: Kathy Hudson

Dr. Hudson (DDSOP) described the composition of the Sub-IC BRAIN group and the steps going forward.

Potential Common Fund (CF) Topics: Jim Anderson

Dr. Anderson (DPCPSI) presented a summary of four potential Common Fund topics for consideration, including glycoscience. The discussion focused on particular scientific aspects of each topic, concerns, and integration across the ICs.

Announcements 

Dr. Collins mentioned several upcoming Congressional visits, meetings, and hearings. Information about the scheduled visit by His Holiness the Dalai Lama also was provided.

Central Services FY14 Budget Discussion: Griffin Rodgers and Steve Katz

Drs. Rodgers (NIDDK) and Katz (NIAMS) described the recommendations from the budget review process and the Clinical Center Governing Board, as well as recommendations focused on IT strategic administration initiatives. The discussion focused on the specific concerns about the recommendations and their implementation.

Changes in the NIH-Lasker Research Scholars Program: Michael Gottesman

Dr. Gottesman (DDIR) presented a summary of the NIH-Lasker Research Scholars Program, including a program overview, candidate eligibility, the selection process, and challenges faced. An overview of proposed changes was provided as well. The discussion focused on potential areas in which the program could be modified or enhanced to increase its status.

Announcements 

Dr. Collins provided information on an upcoming Congressional visit, and a discussion of the FY14 budget.  

NIH Funding in China and Emerging Countries/Foreign Grant Policies: Roger Glass and Sally Rockey

Drs. Glass (FIC) and Rockey (DDER) presented an overview of NIH foreign grant portfolio, including current global research collaborations and its advantages. The discussion focused on potential partnerships and the means by which to more effectively leverage NIH resources.

Announcements 

Dr. Collins provided summaries of the meeting with the President of the United States, as well as the upcoming Congressional visits. An update on the FY 2014 omnibus appropriations also was described.

Management Agenda and Implications for NIH: Colleen Barros and Andrea Norris

Colleen Barros (DDM/CFO) and Andrea Norris (CIT) provided an overview of the President’s Management Agenda, the potential implications for NIH, and the necessary steps to move forward. The discussion focused on key issues that are most relevant to NIH.