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 DevelopmentNational 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

National Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof EnvironmentalHealth Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical SciencesNational Institute

of Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor AdvancingTranslational

Sciences

National Instituteof Biomedical Imaging and

Bioengineering

National Center on Minority Health

and Health Disparities

Office of the Director

National Institute of Child Health

and HumanDevelopment

Basics

Organization of NIH Institutes

Office of the Director

Extramural

Grants Management

Intramural

ClinicalProgram LaboratoryReview

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 TerminologyRequest 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/submissionschedule.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

Receipt and Referral 1-3 months Peer Review 2-3 months After Peer Review 2-4 months

Notice of Grant Award 1-2 months

Post Award Management 2-5 years

PO

PO/GMS

GMS

SRO

PO

NIH Staff

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)

T32 Institutional Training Grant (Fellowship slots) F32 Individual NRSA Fellowship

Fellowships & Career AwardsMED / GRADSTUDENT

FELLOW

FACULTY

K02 Independent Scientist Award (R01 req’d)K24 Mid-career Award in Patient-Oriented Research

T32 /T35 Short-term Institutional Training Grant slotsF30 Pre-doctoral Fellowships (MD/PhD Programs) Parent F31, Diversity F31

R03 Small Grant

R01 Research Project Grant

R21 Exploratory-Developmental

Grant

Research Grants

RESIDENT

INSTRUCTOR

(Research Training)

(Clinical Training)

Career Stage

K99-R00 Pathway to Independence Award

K12 Institutional Career Development Award

K01 Mentored Research Scientist Development AwardK08 Mentored Clinical Scientist Development Award K23 Mentored Patient-Oriented K Award

Clinical and Research Training

R01: Research Project Grant ProgramObjective: Support discrete, specified, circumscribed

project to be performed in an area representing the investigator's specific interest and competencies

Eligibility: Domestic or foreign institution/organization investigator

Support: Up to 5 years (renewable)

When to apply:New: February, June, October Resubmitted/Renewals March, July, November

R03: NIH Small Grant ProgramObjective: Support small research projects that can be

carried out in a short period of time with limited resources, relevant to mission and priority areas

Eligibility: Investigator from a domestic or foreign institution/organizationNo concurrent grant application on same topicCannot be used by doctoral student to support thesis

Support: $50,000/year, up to 2 yearsCannot 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: Support exploratory/developmental research by providing support for the early and conceptual stages of project development

Eligibility: Investigator from domestic or foreign institution/organization

Support: ≤$275,000 in direct costs combined over 2 years No more than $200K in single yearCannot 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

Award Mechanism

R03 R21 R01

Title NIH Small Grant Program

NIH Exploratory/DevelopmentGrant Award

Research Project Grant

Parent Announcement

PA-13-304 PA-13-303 PA-13-302

Scope Pilot or feasibility; small self-contained; 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 yrsAllowable Costs(Direct)

Up to $50,000/yr Not to exceed $275,000 for entire period

Up to $250,000/yr(unlimited)

Comparison of R03, R21, and R01

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: 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

Eligibility: Doctoral degree (MD, DO, PhD, etc.) with experienced sponsor with research support to supervise research

Support: Up to 5 years (renewable)When to apply: 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: Promote institutions to develop or enhance research training opportunities at the predoctoral, postdoctoral or health professional levels

Eligibility: Predoctoral or postdoctoral level (basic or clinical)

Support: <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 non-medical field or a substantial intervening period of clinical or non-research 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/pa-

files/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 femalepelvic 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 post-hysterectomy apical cuff prolapse

Initiates grant proposal:• New project• Continuing project

NIHGrant Proposal

Researcher

Assess programsApprove applications

Public members

InstituteNational Advisory

Councils

Scientists evaluate scientific merit of grant

proposal

Scientific Review Panel

Program Officer

Main contact for applicantHelps interpret review resultsInstitute Director

Makes final decisionAllocates funds

Provides annual justificationto Congress

Congress

Fund

s

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 researchNCI: 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 NCIDr. Steve Kaufman Dr. Mark Damicokaufmans@mail.nih.gov 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 low-income 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

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.

NICHD Funding Approach

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

Goal: Support the Best Science

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More Information

www.nichd.nih.gov

http://grants.nih.gov/grants/guide/index.html

NIH Guide for Grants and Contracts

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/InsidetheNIHGrantReviewProcessVideo.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 Policies1. 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 NIH-supported 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

• 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

DASH Data Use Agreement – Terms

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

Questions? Contact supportdash@mail.nih.gov. For NICHD studies not archived in DASH, visit: https://dash.nichd.nih.gov/Resource/LinksToOtherArchives.

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https://dash.nichd.nih.gov

19 Study Topics45 Studies

Available 58 DataRequests9,800+ Users

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)