NIH Training/Career Development Opportunities and Data and Specimen Hub (DASH)

NIH Training/Career Development Opportunities and Data and Specimen Hub (DASH) Donna Mazloomdoost, MD Medical Officer, Project Scientist for the Pelvic Floor Disorders Network (PFDN) Gynecologic Health and Disease Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health

Disclosures None

Overview Basics Grant Mechanisms Research Grants Training Fellowships Career Development Networks Supplements to existing grants NIH Extramural Loan Repayment Programs DASH

Basics

Basics National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering

Organization of NIH Institutes Office of the Director Extramural Intramural Program Review Grants Management Laboratory Clinical

Applying Each IC has distinct mission that focuses on a specific disease area, organ system, or stage of life Important to apply to IC that would be interested in research idea Ensure IC is listed as a participating organization on the funding opportunity announcement (FOA) Cannot consider your application if not How to determine Speak with Program Officials Use RePORTER ( Matchmaker tool)

NIH Extramural Team Scientific Review Officer Program Officer Grants Management Specialist

NIH Guide Terminology Request for Applications (RFA) Identifies a more narrowly defined area for which one or more NIH institutes have set aside funds for awarding grants Usually has a single receipt (received on or before) date specified in the RFA announcement Usually reviewed by a Scientific Review Group convened by the issuing awarding component (e.g., NICHD)

NIH Guide Terminology Program Announcement (PA) Highlights an area of interest to NIH May have more than one receipt date Notice (NOT) Announces policy and procedures, changes to RFA or PA announcements, RFPs and other general information items

Investigator-Initiated vs. Specific Funding Opportunity Announcement (FOA) Investigator-Initiated or Unsolicited Parent announcement http://grants.nih.gov/grants/guide/parent_announcements. htm Funding Opportunity Announcement (FOA) RFA: Requests for applications ($$$) Program Announcements (PA) Program Announcements with special Receipt, Review or Referral (PAR) Listed on NIH Funding Opportunities and Notices (weekly) http://grants.nih.gov/grants/guide/index.html

Foreign Scientists Temporarily in the U.S. Foreign nationals temporarily in the U.S. on a visa can apply for NIH research support (e.g., R01, R03, K99/R00, P01, etc.) if they have a formal written appointment (no salary necessary) with a U.S. institution. Can not apply for training (F, T) or many career awards (K) Visa can not be extended because of the grant award

Review of proposals Standard NIH criteria for research grants Significance Does it address important problem? Approach Is study well designed? Innovation Involve novel concepts, approaches, methods or challenge existing paradigms? Investigator Does PI have appropriate training or experience? Environment Are institutional resources adequate?

Time Line: Application to Award Receipt Dates http://grants.nih.gov/grants/funding/submiss ionschedule.htm Review: 5-6 months later Council: 3-4 months Award: 1-2 months Total time until award: 9-10 months

Timeline Planning and Submission variable NIH Staff PO Receipt and Referral Peer Review After Peer Review 1-3 months 2-3 months 2-4 months SRO PO Notice of Grant Award 1-2 months GMS Post Award Management 2-5 years PO/GMS

Grants

NIH Grant Nomenclature Research Grants (R) R01 R03 R21 Training (F, T) F: Individual fellowship T: Institutional training grants Career development (K) Networks (U)

Clinical and Research Training Career Stage MED / GRAD STUDENT RESIDENT Fellowships & Career Awards T32 /T35 Short-term Institutional Training Grant slots F30 Pre-doctoral Fellowships (MD/PhD Programs) Parent F31, Diversity F31 Research Grants R03 Small Grant R21 Exploratory- Developmental Grant R01 Research Project Grant (Clinical Training) FELLOW (Research Training) INSTRUCTOR FACULTY T32 Institutional Training Grant (Fellowship slots) F32 Individual NRSA Fellowship K12 Institutional Career Development Award K99-R00 Pathway to Independence Award K01 Mentored Research Scientist Development Award K08 Mentored Clinical Scientist Development Award K23 Mentored Patient-Oriented K Award K02 Independent Scientist Award (R01 req d) K24 Mid-career Award in Patient-Oriented Research

R01: Research Project Grant Program Objective: Eligibility: Support: When to apply: New: Resubmitted/ Renewals Support discrete, specified, circumscribed project to be performed in an area representing the investigator's specific interest and competencies Domestic or foreign institution/organization investigator Up to 5 years (renewable) February, June, October March, July, November

R03: NIH Small Grant Program Objective: Eligibility: Support: Support small research projects that can be carried out in a short period of time with limited resources, relevant to mission and priority areas Investigator from a domestic or foreign institution/organization No concurrent grant application on same topic Cannot be used by doctoral student to support thesis $50,000/year, up to 2 years Cannot be renewed

R03: Small Grant Eligible Projects Pilot or Feasibility Studies Limited Research Studies Development of Research Methodology Reanalysis of Existing Data Starter grant Support to generate sufficient data for R01 submission Preliminary data not required but advised To support hypothesis or show feasibility of methodology

R21: Exploratory/Developmental Research Grant Objective: Eligibility: Support: Support exploratory/developmental research by providing support for the early and conceptual stages of project development Investigator from domestic or foreign institution/organization $275,000 in direct costs combined over 2 years No more than $200K in single year Cannot be renewed

R21: Exploratory/Developmental Eligible studies Novel New scientific paradigms Model systems Tools Agents Targets Technologies High risk, high reward Projects that increase knowledge in well-established area not be considered R01

Comparison of R03, R21, and R01 Award Mechanism Title Parent Announcement Scope R03 R21 R01 NIH Small Grant Program NIH Exploratory/ Development Grant Award Research Project Grant PA-13-304 PA-13-303 PA-13-302 Pilot or feasibility; small selfcontained; secondary analysis Exploratory; novel techniques, agents, methods or models; may require risk Discrete, circumscribed project in are of expertise Length Up to 2 yrs Up to 2 yrs Up to 5 yrs Allowable Costs (Direct) Up to $50,000/yr Not to exceed $275,000 for entire period Up to $250,000/yr (unlimited)

Training & Career Development

Training & Career Development Fellowship Grants Postdoctoral Fellowship Award (F32): individual programs for basic or clinical postdoctoral training Institutional Training Grant (T32): support to institutions for basic or clinical pre- & postdoctoral training programs

National Research Service Award (F30/F31/F32 and T32) U.S. citizen, noncitizen national or permanent resident Full-time commitment (40 hours/week) Support for living expenses, tuition, fees, and limited travel & supplies Institution allowed to provide additional support, but can not interfere, detract from or prolong fellowship No similar concurrent federally-funded awards

F32: Kirschstein Postdoctoral Individual NRSA Objective: Eligibility: Support: When to apply: Enhance research training promising postdoctoral candidates who have potential to become productive, independent investigators in scientific health-related research fields relevant to the missions of the participating NIH Institutes and Centers Doctoral degree (MD, DO, PhD, etc.) with experienced sponsor with research support to supervise research Up to 5 years (renewable) April, August, December (with start dates ~ 9 months later)

F32: National Research Service Award Postdoctoral recipients have service payback requirement Service obligation: engage in health-related biomedical or behavioral research training, research, and/or teaching Service obligation of 1 month for each month of support for the first 12 months Basically need to pay back 1 year after 1 year of award Two years of fellowship or clinical service satisfies service obligation

F32: National Research Service Award Living expenses: based on years of postdoctoral experience ($47,484-$58,560 for FY2017) Tuition, Fees: 60% up to $4,500 Training-related expenses: $8,850 for FY2017 Includes health insurance Parental leave

T32: National Research Service Award Objective: Eligibility: Support: Promote institutions to develop or enhance research training opportunities at the predoctoral, postdoctoral or health professional levels Predoctoral or postdoctoral level (basic or clinical) <3 years postdoc Payback provisions if <2 years Trainees apply directly to the program site, not NIH http://grants.nih.gov/grants/guide/pa-files/pa-14-015.html

Career Awards (K)

Common Career Development Mechanisms Based on stage of career development Mentored research training K08, K12, K23 (clinicians with exceptions) Protect time of mid-career investigator and mentor young investigators K24 (clinicians only)

Mentored K Awards Career Development to Independence Mentored Clinical Scientist Development Award (K08): mentored basic or clinical research project Mentored Patient-Oriented Research Career Development Award (K23): mentored patient oriented research project Mentored Clinical Scientist Development Program (K12): institutional programs for mentored training and research for pediatrics & Ob/Gyn clinicians Pathway to Independence Award (K99/R00)

K Awards (K08/K23) Eligibility Clinical doctoral degree (e.g., MD, DO, DDS, Nursing etc.) Accepted for PhD is considered on a case-by-case basis. Special circumstances must be shown, such as a degree earned in a nonmedical field or a substantial intervening period of clinical or nonresearch activities since completion of the PhD. US Citizen, non-citizen national, permanent resident No concurrent or pending NIH career development award Previous NIH PIs on RO1, R29, P01, K Award grants are NOT eligible But previous R03 or R21 PIs are eligible

K Awards (K08/K23) Requires at least one mentor Duration: 3-5 years Full time employment Level of research effort: 75% Support: $75K to $105,100 (Institute dependent) + $25K (supplies, tuition, etc.) Non-renewable Recipient encouraged to apply for independent research grant support during the award period (e.g., R03, R01)

K Awards (K08/K23) Review NICHD Review Committees Criteria Candidate academic record & future potential Career development plan appropriateness for the achievement to scientific independence Research plan merit & appropriateness to career plans Mentor qualifications & mentoring track record Environment appropriateness & quality Institutional commitment assurance of 75% protected time, career development, facilities to support candidate

K12: Mentored Clinical Scientist Development Programs Objective: Support institutional programs for research training and career development for clinicians in pediatrics & obstetrics & gynecology committed to careers in academic medicine Programs: Pediatric Scientist Development Program (PSDP) Reproductive Scientist Developmental Program (RSDP) Women s reproductive health research career development centers(wrhr) Child health research career development centers (CHRCD) Building Interdisciplinary Research in Women's Health (BIRCWH) Trainees apply directly to the program site, not NIH

K12: Women s Reproductive Health Research Program (WRHR) Initiated in 1998 200+ scholars since inception Mentored career development/junior OB/GYN faculty 75% protected time for 2 to 5 yrs Basic, translational, or clinical projects in array of OB/GYN research topics 15 WRHR sites/30 Scholars $315K/site direct costs ORWH pays majority OHSU

K12: Building Interdisclipinary Research Careers in Women s Health (BIRCWH) ORWH, NICHD, NCI, NIAID, NIDCR, NIDA, NIAAA Initiated 2000; 540+ scholars since inception Programmatic leadership through the Office of Research on Women s Health (ORWH) NICHD provides co-funding/grants management Clinical PhD, MD, MD-PhD, DVM, other Junior faculty with plan to conduct interdisciplinary basic, translational, behavior, clinical or health services relevant to women s health (emphasis on sex differences) Each site: $350K/yr direct costs NICHD supports 3 sites at $90K/yr (UCSF, BWH, Mayo)

K99/R00: Pathway to Independence Award Up to 5 years of support Two phases 1-2 years of mentored support Up to 3 years of independent support contingent on an independent research position Non citizens are eligible PA-15-083 http://grants.nih.gov/grants/guide/pafiles/pa-14-042.html

K99/R00: Pathway to Independence Award No more than 4 years of postdoctoral research experience and no previous major NIH support or non- NIH grant support >$100,000 (direct costs)/year Applicants Final years of their mentored research experience Poised to embark on an independent research career in a tenure-track or equivalent position If applicant has faculty or non-mentored research position not eligible PI on current or prior R03 or R21 not eligible

Networks

U01: Research Project Cooperative Agreement Supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interests and competencies Used when substantial programmatic involvement is anticipated between the awarding Institute and Center One of many types of cooperative agreements No specific dollar limit unless specified in FOA

NICHD Pelvic Floor Disorders Network (PFDN) Mission To conduct multicenter studies to improve the diagnosis, treatment, and prevention of female pelvic floor disorders including pelvic organ prolapse, urinary incontinence, and fecal incontinence >100 peer-reviewed publications of which approximately 50% are related to pelvic organ prolapse

NICHD Pelvic Floor Disorders Network (PFDN) Active Studies SUPeR: Study of Uterine Prolapse Procedures. Vaginal hysterectomy with native uterosacral ligament suspension versus uterine conservation with mesh hysteropexy DEMAND: Defining mechanisms of anterior vaginal wall descent via MRI at 3 yrs or time of reoperation eoptimal: Long-term effectiveness of sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) +/- perioperative behavioral therapy/pelvic muscle training ASPIRe: Sacral colpopexy with mesh vs. apical transvaginal mesh versus vaginal native tissue repair in patients with posthysterectomy apical cuff prolapse

Researcher Scientific Review Panel NIH Grant Proposal Initiates grant proposal: New project Continuing project Scientists evaluate scientific merit of grant proposal Program Officer Funds Institute Director Congress Institute National Advisory Councils Main contact for applicant Helps interpret review results Makes final decision Allocates funds Provides annual justification to Congress Assess programs Approve applications Public members

Supplement Programs

Diversity in Health Related Research PA- 15-322 Administrative supplements to an ongoing grant Application submitted by PI of R01, R10, R18, R22, R24, R35, R37, R43, R44, R41, R42, P01, P20, P50, P51, P60, U01, U10, U19, U41, U42, U54, S06 Submit to awarding component of parent grant Improve diversity of workforce UNDERREPRESENTED students, post docs, eligible investigators Underrepresented racial and ethnic groups Disabilities Socially, culturally, economically or educationally disadvantaged backgrounds that have inhibited ability to pursue career

NIH Extramural Loan Repayment Purpose: To recruit and retain highly qualified health professionals as investigators with a commitment to a research career

Loan Repayment Program (LRP) Qualified areas: NICHD: clinical research, contraception and infertility research, pediatric research NCI: cancer-focused clinical or pediatric research Doctoral Health Professions: MD, PhD, OD, DDS, DVM, etc. Citizenship: U.S. citizen, U.S national, or permanent resident Debt: educational debt > 20 percent of salary NICHD Dr. Steve Kaufman kaufmans@mail.nih.gov NCI Dr. Mark Damico ncilrpinquiries@mail.nih.gov

Loan Repayment Programs (LRP) Pediatric Research Loan Repayment Program Doctoral degree Pediatric-related research Contraception and Infertility Research Loan Repayment Predoctoral students, doctoral degree, nurses, pas Contraception or infertility related research Research must be performed at qualified domestic nonprofit institution Clinical Research Loan Repayment Program Doctoral degree Patient-oriented research (direct patient contact)

Loan Repayment Programs (LRP) Health Disparities Research Investigators conducting research focusing on one or more minority health disparity populations defined by NIMHD and the Agency for Healthcare Research and Quality Clinical Research for Individuals from Disadvantaged Backgrounds Clinical investigators coming from an environment that inhibited the individual from obtaining the knowledge, skill, and ability required to enroll in, and graduate from, a health professional school, or from a family with an annual income below lowincome thresholds.

Loan Repayment Programs (LRP) Total per year is $35,000 NIH will offset Federal tax liability in addition to $35,000 Could be an additional $11,550 (for 33% tax bracket) or $9,800 (for 28% tax bracket) Total could be as much as $46,550 per year Work/service requirement must engage in qualified research 50% effort during contract

Loan Repayment Programs (LRP) Great program for those that want to pursue research career Designed for those who wish to pursue careers in biomedical, behavioral, social, and clinical research NOT intended to subsidize loan repayment for those pursuing private clinical practice

Other

NICHD Funding Approach Move from strict payline approach Applies to R01, R03, R21, R13, and R15 Each branch has identified research gaps and strategic priorities Flexibility to fund projects that best align with these priorities or a stated public health emergency. We will continue to welcome, encourage, and support investigator-initiated applications that help advance our mission goals.

Goal: Support the Best Science Problem: Applications increasing Available dollars relatively stable Payline decreasing Many applications for good science not being supported NICHD compared to other ICs: More human subjects studies Higher requested budgets (population characteristics) High reliance on definitive payline

NICHD Funding Rates over Time Number of Applications/Awards 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500-100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Success Rate (%) 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Applications Success Rate Awards

More Information

www.nichd.nih.gov

NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html

Information NICHD: http://www.nichd.nih.gov NICHD Website: Funding by NICHD http://www.nichd.nih.gov/funding/funding-mechs.htm NIH Website Welcome to Extramural Research at the NIH http://grants.nih.gov/grants/welcome.htm NIH Career Award Website K Kiosk http://grants.nih.gov/training/careerdevelopmentawards.htm NIH Peer Review Revealed: CSR videos for an inside look at how scientists from across the country review NIH grant applications for scientific and technical merit. http://cms.csr.nih.gov/resourcesforapplicants/insidethenihgrantreview ProcessVideo.htm

NICHD Data and Specimen Hub (DASH)

Data and Specimen Hub (DASH)

Purpose Maximize NICHD s investment in research studies through promotion of data sharing Broad research portfolio > 2000 clinical research studies annually Generates wealth of data that can be utilized for primary and secondary scientific discovery

Purpose Address current data sharing challenges Data stored in silos Many physical locations Variety of devices (hard drives, CDs, DVRs) Storage locations not catalogued Data stored in different formats and structure without uniformity SAS annotated files, relational databases, proprietary systems

Purpose Comply with federal and NIH initiatives/policies White House OSTP Holdren Memo, Feb 2013, Increasing Access to the Results of Federally Funded Scientific Research Store digitally formatted scientific data enabling search, retrieve, and analyze capabilities White House/OMB Open Data Policy, May 2013 ensure that data are released to the public in ways that make the data easy to find, accessible, and usable. NIH Data Sharing Policies: 2003, 2007, 2014, 2015 (Intramural)

NIH Data Sharing Policies 1. NIH Statement on Sharing Research Data, Feb 2003 NIH expects and supports the timely release and sharing of final research data (i.e., no later than the acceptance for publication of the main findings from the final data set) from NIHsupported studies for use by other researchers Applications with direct costs greater than $500,000 in any single year expected to address data sharing in their application Note: NIH s Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research issued in February 2015 proposes all NIH-funded researchers prepare data management plans 2. Policy for Sharing Data Obtained in NIH Supported or Conducted GWAS Studies, Aug 2007 NIH-funded GWAS data to be made available in central GWAS data repository, dbgap 12 month exclusivity period 3. NIH Genomic Data Sharing (GDS) Policy, Aug 2014 GWAS Policy extended to wider range of genomic data Data release: Depends on data processing level, generally 6 months or time of initial publication 4. NIH Intramural Research Program Human Data Sharing (HDS) Policy, Jul 2015 Effective on October 1, 2015; proposed studies beginning scientific review on or after that date must comply with this Policy It governs the sharing of data among intramural investigators as well as the sharing of intramural Data from intramural investigators to investigators outside of the NIH. 15

Overview A publicly accessible centralized resource for researchers to store and access de-identified data from NICHD-funded studies for use in secondary research A mechanism for NICHD-funded extramural and intramural investigators to share research data from studies and comply with the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy Governed by the DASH Committee composed of representatives across Divisions, Branches, Centers and Offices of NICHD Next phases of DASH to include providing researchers the ability to view and request associated biospecimens, connect with related databases, view and use analytic tools, and visualize data

Data Submission Process 9

Data Request DASH Policy Requirements Data requestors are required to submit: 1. Online Data Request Form, which includes a brief description of the proposed research use of the data 2. Data Use Agreement, co-signed by the Data Recipient (Lead Investigator) and the Authorized Organization Representative 3. IRB approval (Optional), for the requested data as determined by the study submitter Data request approvals: 1. DASH Data Access Committee to determine whether the proposed research use is scientifically and ethically appropriate and does not conflict with constraints or data use limitations identified by the institutions that submitted the data 2. Study-Specific Approvals (Steering Committee, PI, etc.), if required as per the study submitter 10

DASH Data Request Process 12

DASH Data Use Agreement Terms Executed between Data Recipient and NICHD Valid for three years; can be renewed 11

DASH Data Use Agreement Terms Recipient agrees to: Use data only for the approved research Not share data with individuals other than those listed in request Protect data confidentiality; Not attempt to identify Follow all applicable laws, regulations, and local institutional policies and procedures for handling data Report violations of Data Use Agreement Acknowledge contribution of data submitter(s) and NICHD DASH with regard to publication and intellectual property Provide annual progress reports on research using data

Study Topics Represented in DASH (Number of studies in parentheses; some studies with overlapping topics) Autism Spectrum Disorder (1) Children's Bone Health and Calcium (1) Diabetes (1) Early Learning (1) High Risk Pregnancy (2) HIV/AIDS (23) Infant Care and Infant Health (3) Infant Mortality (1) Labor and Delivery (2) Necrotizing Enterocolitis (1) Pharmacology (2) Preconception Care and Prenatal Care (1) Preeclampsia and Eclampsia (2) Pregnancy (9) Preterm Labor and Birth (6) Rehabilitation Medicine (1) Stroke (1) Sudden Infant Death Syndrome (1) Women s Health (1) https://dash.nichd.nih.gov Centralized resource for researchers to store and access de-identified data from studies supported by NICHD Can help investigators meet NIH s data sharing requirements for their own studies and find others study data for secondary analyses Aims to accelerate scientific findings and improve human health Launched in August 2015 and governed by the NICHD DASH Committee 45 Studies Available https://dash.nichd.nih.gov 19 Study Topics 9,800+ Users 58 Data Requests Questions? Contact supportdash@mail.nih.gov. For NICHD studies not archived in DASH, visit: https://dash.nichd.nih.gov/resource/linkstootherarchives. Last Updated 08/31/2017