pfd week 2020 | pfd week - nih training/career ......k99/r00, p01, etc.) if they have a formal...
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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 [email protected] [email protected]
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
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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
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DASH Data Request – Process
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DASH Data Use Agreement – Terms
• Executed between Data Recipient and NICHD
• Valid for three years; can be renewed
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• 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 [email protected]. 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)