RFA Bayer/NASPAG Young Investigator Grant · the levonorgestrel-releasing intrauterine systems Mirena® and Skyla®. ... stipend). RFA Bayer/NASPAG ... Each application will be reviewed

RFA Bayer/NASPAG Young Investigator Grant

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Bayer/ NASPAG Young Investigator Grant for Pediatric and Adolescent Contraceptive, Sexual and

Reproductive Health Research - Supported by Bayer HealthCare Pharmaceuticals and the North

American Society for Pediatric and Adolescent Gynecology.

Please read instructions carefully. Applications that do not follow these instructions with

regards to type size, length, format, and supporting documentation will be rejected. If the

application deadline has not passed, the application may be resubmitted after deficiencies

are addressed. No deadline extension will be granted to allow resubmission in this cycle.

Letter of Intent due March 10, 2017 no later than 11:00PM, EST

Letter of intent required for all applications

Information will be utilized to assist in planning for the review process

Include principal investigator and senior mentor’s names, project title, and 200 word abstract

Letter of intent should be submitted here

Grant Application due April 7, 2017 no later than 11:00PM, EST

Before submitting your application, please be sure that the following items have been addressed:

Information page is included as the first page of the application packet and is fully completed

Type size is no smaller than 12 point font

Signed Statement of Conditions is included in application packet

Letter of support from Mentor is included in application packet

Letter of support from Division Chief, Program Director, or Department Head is included in application

packet

Letter of support from each co-investigator is included in application packet

Biosketch for applicant, mentor, and all co-investigators

Other grant support is included in application packet

The entire packet should be submitted as one PDF here

http://www.naspag.org/?page=LetterofIntent

http://www.naspag.org/?page=BayerNASPAGGrantApp


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Bayer/ NASPAG Young Investigator Grant for Pediatric and Adolescent Contraceptive, Sexual and

Reproductive Health Research - Supported by Bayer HealthCare Pharmaceuticals and the North

American Society for Pediatric and Adolescent Gynecology.

GENERAL INFORMATION

2017-2018

Letter of intent deadline - March 10, 2017

Deadline for receipt of application - April 7, 2017

Notification of award - June 1, 2017

Funding - July 1, 2017 – June 30, 2018

Progress report due - December 31, 2017

Final Report due to NASPAG - July 31, 2018

Oral presentation at NASPAG ACRM - April, 2019

INTRODUCTION

The North American Society for Pediatric and Adolescent Gynecology (NASPAG) has partnered with the

Bayer HealthCare Pharmaceuticals to award funds for one U.S.-based training award to support the

development of expertise in Pediatric and Adolescent Contraceptive, Sexual and Reproductive Health

Research. All topics in these areas will be eligible for this award including those specifically focusing on

the levonorgestrel-releasing intrauterine systems Mirena® and Skyla®.

The goals of the Bayer/ NASPAG Young Investigator Grant are: 1) to promote knowledge of research-

based reproductive and gynecologic care in adolescent populations, 2) to advance reproductive and

gynecologic clinical care for adolescent patients, and 3) to facilitate the academic growth, advanced

education, and development of future practitioners and researchers, thereby investing in enhancing the

specialty of pediatric and adolescent gynecology care and research. Bayer/ NASPAG Young Investigator

Grant for Pediatric and Adolescent Contraceptive, Sexual and Reproductive Health Research

Research will offer one grant of $20,000 for research support (including up to $2,000 for a mentor

stipend).


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In an effort to deepen the blending of research evidence with policy and practice, this training award is

intended to support the academic advancement of adolescent gynecology clinicians from diverse

backgrounds (i.e., gynecology, pediatric gynecology, adolescent medicine, pediatrics, family medicine,

internal medicine) who are still in early stages of training (i.e., residents, fellows, and faculty in their first

five years post training) to participate in a mentored research project and to develop skills in adolescent

contraceptive, sexual, and reproductive health research. At the time of application and for the duration of

funding, the eligible candidate must be based in programs and institutions in the United States.

This training award will:

1) Provide up to one year of training and mentorship to strengthen knowledge and experience in the area of

adolescent contraceptive, sexual, and reproductive health research;

2) Foster mentored professional development relationship between the awardee and an experienced mentor

with expertise in adolescent contraceptive, sexual, and reproductive health research to conduct and

disseminate research;

3) Provide opportunity for preliminary data collection, data analyses, as well as conference presentation and

manuscript preparation experience to encourage success in obtaining NIH awards to pursue adolescent

contraceptive, sexual, and reproductive health research in subsequent years.

PROGRAM OVERVIEW

For early investigators, obtaining funding to conduct pilot research is critical, but is also the most difficult to

secure. This Bayer/NASPAG Young Investigator Award provides a one-year award to adolescent clinicians

for projects related to adolescent contraceptive, sexual, and reproductive health, including the

levonorgestrel-releasing intrauterine systems Mirena® and Skyla®. The awardee will conduct a

pilot/preliminary clinical research project related to adolescent and/or young adult reproductive health;

present a scientific abstract (oral presentation) at the 2019 NASPAG ACRM (note: award funds cannot be

used to support travel to the ACRM); and develop a research manuscript for publication in a peer-reviewed

journal. Types of projects may include original data collection, quality improvement, qualitative studies, as

well as secondary data analyses.

Award recipients will identify a faculty member/research mentor (with a MD, PhD, or other advanced

degree) with established research expertise with whom they will meet at least biweekly to review progress

on this training award. The mentor may be from an outside institution, but the application will need to

clearly state how the mentor will provide frequent, regular mentorship. The mentor is responsible for

providing a letter of support with plans for regular phone or video meetings; assisting with planning and

implementation of project; facilitating information and resources knowledge transfer; and assisting with

developing the ACRM presentation and peer-reviewed publication. A mentor stipend of up to $2,000 can be

provided.


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PURPOSE OF THE AWARD

The Bayer/NASPAG Young Investigator Award is intended to provide an opportunity for formal exposure

to and experience in adolescent contraceptive, sexual, and reproductive health research and to prepare the

applicant for further research experience. The applicant should be intimately involved in the conception,

planning, conduct, and reporting of the research. It is expected that the applicant will receive mentorship in

such topics as biomedical statistics, study design, grant writing, and regulatory and ethical concerns. At the

end of the award year, the awardee should have a firm foundation in the fundamentals that will prepare the

applicant to begin to conduct independent studies, effectively disseminate findings, and compete

successfully for additional funding.

APPLICANT ELIGIBILITY

The Applicant may be: a resident in an ACGME-approved residency training program with intention to

pursue a career related to adolescent reproductive health; a fellow in a fellowship program related to

adolescent reproductive health (e.g. pediatric and adolescent gynecology, adolescent medicine); a faculty

member in the first five years of appointment engaged in adolescent reproductive health care. The focus of

this training award is on clinicians, i.e., those who are providing direct care to adolescents. Eligible

candidates must be based in programs and institutions in the United States.

Applicants must either be NASPAG members or have a membership application pending (not paid by the

award).

AWARD ADMINISTRATION, APPLICATION, AND SELECTION PROCESS

NASPAG will evaluate Young Investigator Award applications and administer the award. Applications are

accepted through April 7, 2017 and award recipients are notified of application review results by June 1,

2017. Candidates cannot have had previous or simultaneous funding from the National Institutes of Health

(NIH) or other research funding sources (that is larger than $10,000). Eligible candidates may not have a

training award. Award recipients are selected through a competitive process. Applicants must submit the

following information:

A completed application form, abstract, candidate statement, project description and timeline for the

award year and training plan, role of participants, biographical sketches, budget and budget

justification, human subjects, literature cited, and other research support. Project description will

include specific aims, significance, innovation, and approach.

A letter detailing any current and previous research funding.

The applicant’s and mentor’s current biosketches.

A letter of support from a proposed mentor.

A letter of support from their current department chair (or appropriate program director).


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Each application will be reviewed by the NASPAG Research Committee. Each application will be judged

primarily by the likelihood of producing a dedicated, qualified adolescent reproductive health researcher as

indicated by 1) the qualifications of the Applicant, 2) the qualifications of the Mentor, 3) the scientific merit

of the project, 4) the adequacy of funding of the proposed budget to meet the scientific objectives, and 5) the

willingness of the institution to train providers in adolescent reproductive health care and provide the

necessary facilities and support to complete the project as described. The final funding decision will be

made by NASPAG Executive Board and all decisions are final.

FUNDING PRIORITIES

Proposals must entail research related to Contraceptive, Sexual, and Reproductive Health care in

adolescents. Potential topic areas include, but are not limited to:

Quality of life measures among adolescent contraceptive users;

Interventions for compliance, continuation, or management of contraceptive side effects;

Use of social networks (Facebook-Twitter-LinkedIn) to deliver interventions in adolescent health

care settings;

Integration of LARC services in primary care or medical home settings;

Integration or augmentation of electronic health records to include provider prompts or patient

material regarding contraceptive, sexual or reproductive health ;

LARCs in vulnerable adolescent populations or medically complicated adolescents ;

Screening and management of HIV/Hepatitis/STD infections in specific adolescent populations;

Regional variations of LARC uptake in adolescent health settings;

Development of curricula for teaching contraceptive, sexual and reproductive health counsei=kubg

for practitioners caring for adolescents

Projects of direct relevance to adolescent use of IUDs.

QUALIFICATIONS AND RESPONSIBILITIES OF THE MENTOR

It is required that the applicant submit a letter of support from the Mentor. This letter must describe the

mentor’s role and responsibilities. The mentor is responsible for supervising the work of the applicant. The

mentor must hold an MD, DO, PhD, or equivalent degree. In competitive applications, the mentor will have

proven his or her ability to pursue independent research as evidenced by original research publications in

peer-reviewed journals and/or funding from extramural sources and evidence of ongoing research activity.

The mentor must have a track record with adolescent contraceptive, sexual, or reproductive health research.

The mentor may be from an outside institution, but the application will need to clearly state how the mentor

will provide frequent, regular mentorship.

BUDGET

The Bayer/NASPAG Young Investigator Award is intended to promote the academic growth of the

awardee. The awardees will be awarded up to $20,000 over a one-year period. This amount includes


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potential funding of up to $2,000 for a mentor to defray costs directly related to providing guidance on the

project.

TERMS OF THE AWARD

Duration

Applications will be accepted for one-year of training only.

Extension of Award Period

In unusual circumstances, arrangements can be made for an extension of an award. Such a request must be

made by the Awardee at least 60 days before the expiration date of the award. This request must be made in

writing, specify reasons for requesting the extension, and state a new expiration date. Project extensions of

greater than six months will not be considered.

Change of Status of Designated Mentor or Awardee

If the named Mentor or Awardee changes affiliations and ceases research in the field for which the award

was made, the award will terminate and the remaining balance will be returned to NASPAG.

Location of work

Awards are for investigations in the United States at an accredited medical school, medical center, or

institution affiliated with a university teaching program. The Awardee, with the direction of the Mentor,

will make all arrangements for conduct of the proposed research projects.

Liability of the North American Society for Pediatric and Adolescent Gynecology and Bayer Healthcare

Pharmaceuticals

NASPAG and Bayer assume no financial liability if patient care responsibilities of any kind are undertaken

by the Awardee or Mentor. The Mentor, the Awardee, and their respective institution(s) acknowledge that

NASPAG and Bayer are not legally liable for the conduct of the Bayer/NASPAG Young Investigator

Award Awardee or the Mentor and associated investigators.

Patent Policy

The Mentor, the Awardee, and their respective institution(s) acknowledge that if a patentable invention or

discovery is conceived, or conceived and reduced to practice by the Bayer/NASPAG Young Investigator

Award during the term of the award year, Bayer and NASPAG must be apprised of the invention and the

institution’s plans for protecting such invention under existing institutional patent policy. The

Bayer/NASPAG Award program will defer to institutional policies where they are in compliance with


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those of the Federal government. The Bayer/NASPAG Award program reserves the right where the

institution has no patent policy, or policies not in compliance with those of the federal government, to

claim rights and interests in the invention or discovery consistent with FAR Clause 52.227-11, Patent

Rights-Ownership by the Contractor.

Limitations on Awardee

Awards are made with the stipulation they are to be used only as support for the named Bayer/NASPAG

Young Investigator Awardee. Cost for project completion, publications, travel, secretarial support, etc.,

must be borne by the program/institution and the funding sources identified.

SUPPORT FACILITIES

The Applicant must submit letters of support if the proposed project uses facilities not routinely available

to or directly under the supervision of the sponsoring program.

PUBLICATIONS

All discoveries resulting from work supported in part by the Bayer/NASPAG Young Investigator award

should be made available to the public and scientific community through approved scientific channels such

as national meetings and peer reviewed publications. Publications will acknowledge the support of the

Bayer/NASPAG Young Investigator Award. Two reprints of each publication should be forwarded to

NASPAG and to Bayer.

PROGRESS REPORTS AND MONEY MANAGEMENT

A 500-word progress report is due to NASPAG Research Committee on December 31, 2017. The

Mentor and designated Bayer/NASPAG Young Investigator Awardee are required to submit a final report

(due July 31, 2018). Failure to provide the report may negatively impact your institution’s ability to apply

for future awards. NASPAG will maintain the copyright of all such reports. This final report must include

an accounting report using Generally Accepted Accounting Procedures showing the distribution of funds

with a signature from an institutional official (e.g., accountant, grants manager, administrator from the

Office of Sponsored Research).

INSTITUTIONAL SUPPORT

The Applicant assumes responsibility for conducting the project and the Mentor for supervising the work

and advanced education of the Applicant and associate investigators. The Applicant and Mentor must

demonstrate that access to a suitable caseload or patient population will be available for study during the

funding period if a clinical project is proposed. The application must show that adequate and appropriately

equipped space will be available during the funding period. Projects involving human subjects must be

approved by the institutional review board (IRB), and IRB approval must be documented prior to


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disbursement of funds.

NASPAG ACRM 2019

Attendance is required at the NASPAG 2019 ACRM where the awardee will present their work following

the completion of the award as an oral presentation.

POST-AWARDEE SURVEYS

The awardee will be surveyed periodically (once a year) following completion of the award year regarding

career paths, subsequent grants/contracts obtained, and publications. The awardee will be expected to

respond to these surveys as NASPAG will rely on such information to support continuation of such training

awards.


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APPLICATION INSTRUCTIONS

Submission in electronic format is required. No paper copies please. INCOMPLETE PROPOSALS OR

PROPOSALS RECEIVED AFTER THE DEADLINE DATE INDICATED UNDER GENERAL

INFORMATION WILL NOT BE CONSIDERED.

Please submit the following required items via a single PDF here.

Note: All letters submitted electronically must contain signatures. Electronic signatures are acceptable.

Completed award application (see attached) including information sheet and statement of conditions.

An Abstract of no more than 300 words.

A Proposal, of no more than five pages (single spaced, no less than 12 pt. font and 1'' margins), to

include no more than one page candidate statement; two pages of project description; a one page

detailed project timeline; and a one page budget and justification. A separate human subjects section

(not to exceed 5 pages) is required as well as references.

1. Candidate Statement (1 page), including a brief description of background and interest in

adolescent contraception and commitment to a career in adolescent reproductive health.

2. The Project Description (2 pages) should include the following sections: significance and

specific aims, background and rationale, innovation, and approach, and a brief statement on

how this project will lead to further work in the proposed area.

3. The detailed Project Timeline (1 page) should list tentative dates of all procedures for the

proposed project. These include but are not limited to data collection processes, analysis of

results, and final report writing.

4. The Budget (1 page) should contain sufficient detail so that each item can be judged

separately. Computer related items (e.g., personal computers, printers, modems, etc.) are

extremely unlikely to receive budget approval. No salary support for the principal

investigator will be provided. No indirect costs for the institution will be provided. Typical

budget items may include but are not limited to: subject compensation for time and travel,

instrumentation costs, assay and lab test costs, data analysts, and/or payment to research

assistants. The budget may include up to $2,000 stipend for the mentor’s participation in

this training award. The budget may not include travel expenses for the awardee or mentor.

http://www.naspag.org/?page=BayerNASPAGGrantApp


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Human Subjects section (5 page limit) should include, but not be limited to, the risk,

protection, and benefits of human subjects; the inclusion or exclusion of women, minorities

and vulnerable populations; and education in the protection of human subjects, following the

application guidelines in:

http://grants.nih.gov/grants/funding/424/sf424_rr_guide_general_adobe_verb.pdf. More

information can be found at: http://grants.nih.gov/grants/policy/hs/index.htm.

If minorities will not be included, detailed justification of the rationale for their exclusion is

mandatory. Such exclusion may lower enthusiasm for the proposal.

A letter of support describing the resources, environment, and institutional support from current

training program or academic institution, i.e., residency training director, fellowship program

director, or department head, depending on applicant’s current position.

A letter of support from the proposed mentor, including a descriptive support of awardee and a brief

description on how he/she will play a key role in shaping and assisting the candidate in fulfilling the

needs of this award.

Candidate's current curriculum vitae (in NIH biosketch format)

Proposed mentor’s NIH biosketch

Co-Investigator NIH biosketch (if any)

Letter detailing any current non-Federal research funding (role on project, title, type of project,

amount and source of funds).

Note: All research protocols involving human and animal subjects must be approved and

undergo continuing review by an Institutional Review Board (IRB). This must be verified at

time of award and does not need to be included with the application.

http://grants.nih.gov/grants/funding/424/sf424_rr_guide_general_adobe_verb.pdf

http://grants.nih.gov/grants/policy/hs/index.htm


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Applicant/Principal Investigator (Last, first, middle): ___________________________________________

Bayer/ NASPAG Young Investigator Grant for Levonorgestrel-Releasing Intrauterine System Long-

Acting Reversible Contraception Research Grant Information Page

Full Name with Titles:

Name of Institution:

Project Title:

Amount Requesting:

Mentor:

Mentor Address:

Name of Institutional Official:

Address of Institutional Official:


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Project Summary/Abstract Section (300 words or less)

Enter the text here that is the abstract information for your application.


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STATEMENT OF CONDITIONS GOVERNING THE

Bayer/ NASPAG Young Investigator Grant for Levonorgestrel-Releasing Intrauterine System Long-

Acting Reversible Contraception Research

It is understood that any Bayer/NASPAG Young Investigator Award will be made with the following

conditions:

1. Institutional overhead is not allowed.

2. The applicant/principal investigator's institution is associated or organized for humanitarian

purposes and is not a profit making organization.

3. All reports of work achieved with this grant will acknowledge the support of the North American

Society for Pediatric and Adolescent Gynecology and Bayer Healthcare Pharmaceuticals.

4. Any discovery that arises from work supported in part by NASPAG will be submitted for

publication. Two copies of each publication will be furnished to NASPAG and to Bayer.

5. Independent progress reports and a final report by the applicant will be submitted to NASPAG as

stipulated in the request for applications. Additional reports may be required. NASPAG will

maintain the copyright of all such reports.

6. Participation in the NASPAG 2019 ACRM is required. Awardees will be expected to give an oral

presentation on their project.

7. If all requirements are met, funding will begin on July 1, 2017. NASPAG reserves the right to

terminate payments under this grant at its sole discretion.

8. If the named principal investigator leaves the institution and terminates the project in the designated

field, all remaining funds revert to NASPAG. If unused funds exist at the completion of the project,

all remaining funds revert to NASPAG.

9. Patent rights will conform to institutional standards. If none exist, NASPAG reserves the right to

protect such interests.

10. No project proposal will be funded unless the principal investigator and the Fiscal Officer of the

sponsoring institution affirm:


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a. That the investigation(s) proposed in this application are endorsed by the Animal and/or

Human Subjects Committee or other designated body of the preceptor's institution, and

b. That any project involving human subjects conforms with the principles of the Helsinki

Code of the World Medical Association, and

c. Projects involving animals or human subjects must be approved by the institutional review

board (IRB). IRB approval must be documented prior to dispensation of funds.

d. That projects involving vertebrate animals will conform with the "Guiding Principles in the

Care and Use of Animals" as approved by the Council of the American Physiological

Society.

e. Projects involving vertebrate animals must have approval from the institutional Animal

Care and Use Committee.

___________________________________ /___________________________________

Date Signature of Principal Investigator Type Name of Principal Investigator

___________________________________ /___________________________________

Date Signature of Mentor Type Name of Mentor

___________________________________/____________________________________

Date Signature of Fiscal Officer Type Name of Fiscal Officer

Documents

RFA Bayer/NASPAG Young Investigator Grant · the levonorgestrel-releasing intrauterine systems Mirena® and Skyla®. ... stipend). RFA Bayer/NASPAG ... Each application will be reviewed