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Page 1 of 15 Thrombosis and Hemostasis Societies of North America (THSNA) Program Announcement (Rev. 11-4-14: Italicized sections on pages 1-3 have been updated/clarified.) 2015 THSNA Mentored Research Award Pre-proposals are due Wednesday, December 10, 2014 by 5:00 PM CT Full Proposals (by invitation only) are due Monday, February 23, 2015 by 5:00 PM CT About the 2015 THSNA Mentored Research Award The 2015 Thrombosis and Hemostasis Societies of North America (THSNA) Mentored Research Award (MRA) provides financial support for a clinical or basic science research project in hemostasis and/or thrombosis under the guidance of an experienced mentor. The goal of this award is to mentor professionals in the early stages of their research career in hemostasis and/or thrombosis in order to encourage them to continue working in benign hematology. Eligible applicants and mentors may be from any of a variety of health related disciplines represented within THSNA as outlined under the sections pertaining to eligibility requirements. The 2015 THSNA MRA is funded by the Thrombosis and Hemostasis Societies/Summit of North America (THSNA). THSNA (the “Societies”) is a federation of professional organizations dedicated to the disciplines of thrombosis and hemostasis. Every other year, THSNA offers a comprehensive scientific meeting focused on thrombosis and hemostasis topics (the “THSNA Summit”). The Summit held in April 2014 was a collaboration of 13 leading non-profit organizations (see Appendix A) in both fields that are now sponsoring the 2015 THSNA Mentored Research Award. This award is being administered for THSNA by one of the 13 member organizations, the Hemostasis and Thrombosis Research Society (HTRS). The research project funded by the 2015 THSNA MRA will run for two academic years, from July 1, 2015 through June 30, 2017. (The budget period for the 2015 THSNA MRA is July 1, 2015 - December 31, 2017.) THSNA reserves the right to determine the therapeutic category of the grant awarded based on the number and quality of submitted proposals (i.e. hemostasis vs. thrombosis, basic science vs. clinical).

Thrombosis and Hemostasis Societies of North America (THSNA) Program Announcement 2015 THSNA Mentored Research Award

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Page 1: Thrombosis and Hemostasis Societies of North America (THSNA)  Program Announcement  2015 THSNA Mentored Research Award

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Thrombosis and Hemostasis Societies of North America (THSNA)

Program Announcement

(Rev. 11-4-14: Italicized sections on pages 1-3 have been updated/clarified.)

2015 THSNA Mentored Research Award

Pre-proposals are due Wednesday, December 10, 2014 by 5:00 PM CT

Full Proposals (by invitation only) are due Monday, February 23, 2015 by 5:00 PM CT

About the 2015 THSNA Mentored Research Award The 2015 Thrombosis and Hemostasis Societies of North America (THSNA) Mentored Research Award (MRA) provides financial support for a clinical or basic science research project in hemostasis and/or thrombosis under the guidance of an experienced mentor. The goal of this award is to mentor professionals in the early stages of their research career in hemostasis and/or thrombosis in order to encourage them to continue working in benign hematology. Eligible applicants and mentors may be from any of a variety of health related disciplines represented within THSNA as outlined under the sections pertaining to eligibility requirements.

The 2015 THSNA MRA is funded by the Thrombosis and Hemostasis Societies/Summit of North America (THSNA). THSNA (the “Societies”) is a federation of professional organizations dedicated to the disciplines of thrombosis and hemostasis. Every other year, THSNA offers a comprehensive scientific meeting focused on thrombosis and hemostasis topics (the “THSNA Summit”). The Summit held in April 2014 was a collaboration of 13 leading non-profit organizations (see Appendix A) in both fields that are now sponsoring the 2015 THSNA Mentored Research Award. This award is being administered for THSNA by one of the 13 member organizations, the Hemostasis and Thrombosis Research Society (HTRS). The research project funded by the 2015 THSNA MRA will run for two academic years, from July 1, 2015 through June 30, 2017. (The budget period for the 2015 THSNA MRA is July 1, 2015 - December 31, 2017.)

THSNA reserves the right to determine the therapeutic category of the grant awarded based on the number and quality of submitted proposals (i.e. hemostasis vs. thrombosis, basic science vs. clinical).

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Application for a 2015 THSNA MRA is a two-step process: Step 1: Pre-proposal Submission Applicants are required to submit a pre-proposal to be reviewed by the THSNA Grant Review Committee. The deadline for the THSNA MRA pre-proposal submission is Wednesday, December 10, 2014 by 5:00 PM CT. For complete pre-proposal guidelines and submission instructions, see page 8 of this Program Announcement or visit www.htrs.org and click on the heading “Grants,” and then “THSNA Mentored Research Award.” Applicants whose pre-proposals are favorably reviewed will be invited to submit a full proposal. Please note that pre-proposal review can take several weeks following the pre-proposal submission deadline. Applicants invited to submit a full proposal by the deadline of Monday, February 23, 2015 at 5:00 PM CT will be notified that a full proposal is requested approximately 5-6 weeks after the December 10, 2014 pre-proposal submission deadline. Step 2: Full Proposal Submission (Invited Applicants Only) Applicants whose pre-proposals are favorably reviewed and advanced to the full proposal round will be invited to submit full proposals by the deadline of Monday, February 23, 2015 at 5:00 PM CT. For complete full proposal guidelines and submission instructions, see page 10 of this Program Announcement or visit www.htrs.org and click on the heading “Grants” and then “THSNA Mentored Research Award.”

Eligibility Requirements Eligible applicants and mentors may be from any of a variety of health related disciplines represented within the THSNA societies (i.e. physicians, nurses, pharmacists, laboratory technologists, scientists) as detailed in the following sections. The goal of this award is to mentor professionals in the early stages of their research career in hemostasis and/or thrombosis in order to encourage them to continue working in benign hematology. The award it not meant for mid- to senior level professionals already well-experienced in the field of benign hematology. NOTE: Applicants who have submitted pre-proposals for the 2015 HTRS MRA may submit a pre-proposal for the THSNA MRA with the same institution/laboratory and the same mentor, but the project must be a different project with a different topic, aims and methods. Previous recipients of the HTRS MRA are not eligible for the THSNA MRA. After reviewing the eligibility requirements, if applicants have any questions about whether they, their mentor, or their project meet the eligibility requirements, please contact HTRS at [email protected] or 414-937-6569.

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Applicant Eligibility Please review the following requirements carefully, as there are three categories (A, B, or C) for eligible applicants. Eligible applicants should fall into the A, B, or C category. Eligible applicants may be:

A. A fellow (MD or DO), PharmD, or PhD candidate, who is either: 1. In training for a career in hemostasis and/or thrombosis

OR 2. In training for a career that will have a substantial component of, or overlap with, the

disciplines of hemostasis and/or thrombosis

B. A junior attending (MD or DO); junior faculty/faculty member (MD, DO, PhD, PharmD, RN – Registered Nurse with a bachelor’s or higher degree, MT – Medical Technologist with a bachelor’s or higher degree); scientist/researcher (PhD); or practicing clinician (PharmD, RN with a bachelor’s or higher degree or MT with a bachelor’s or higher degree), who is either:

1. Within five years of completing fellowship training or a post-doctoral fellowship (post-PhD) towards a career in hemostasis and/or thrombosis as of July 1, 2015 OR

2. Within five years of completing training for a career that will have a substantial component of, or overlap with, the disciplines of hemostasis and/or thrombosis as of July 1, 2015

Exceptions to the five year requirement may be made for candidates who can provide a legitimate explanation for being more than 5 years out of fellowship or post-doc training (e.g., family circumstances, such as time off for child rearing, or the decision to pursue benign hematology as a new career direction). If you believe you may be exempt from the five year requirement, please email your explanation to [email protected] so that a determination may be made as to your eligibility before you put time into your application.

C. Nurses, nurse investigators, pharmacists, pharmacist investigators, coagulation laboratory

technologists and laboratory researchers carrying out advanced post-graduate research. For these persons the five year limit above does not apply.

In addition, eligible applicants are required to: 1. Be a current member in good standing of one of the THSNA organizations

OR

2. Have a primary mentor who is a current member in good standing of one of the THSNA organizations

If the applicant and/or primary mentor is not currently a member of one of the THSNA organizations, see Appendix A for a listing of THSNA organizations to which the applicant and/or mentor may apply.

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Additional Eligibility Requirements:

Fellows must be enrolled in accredited fellowship training programs in the United States or Canada. Faculty applicants must hold a faculty position in a U.S. or Canadian academic institution.

Only applicants associated with non-commercial institutions are eligible.

U.S. or Canadian citizenship is not required.

Applicants may be enrolled in a higher degree program during the tenure of the THSNA MRA as long as they demonstrate that they have sufficient time to conduct the research program proposed in their application.

Mentor Eligibility and Letters of Support Applicants are required to select a primary mentor who agrees to supervise the applicant and accepts the conditions of the award. It is preferred that the applicant’s primary mentor be present at the same institution where the applicant proposes to do the majority of the proposed research. The primary mentor must be a senior researcher in hemostasis and/or thrombosis and be either:

1. An MD, DO, PharmD, PhD, RN with a Bachelor’s or higher degree, or MT with a Bachelor’s or higher degree

AND/OR

2. A nurse, nurse investigator, pharmacist, pharmacist investigator, coagulation laboratory technologist, or laboratory researcher carrying out advanced post-graduate research

In addition, the primary mentor must be:

1. Working in the fields of hemostasis and/or thrombosis (i.e. directly involved in either clinical or basic science research pertaining to patients with bleeding and/or thrombotic disorders) OR

2. Working in another area that has a substantial component of, or overlap with, hemostasis and/or thrombosis

If the primary mentor’s expertise is outside the field of hemostasis and/or thrombosis, he/she is required to be a current member in good standing of one of the THSNA organizations in order to be an eligible primary mentor. (For example, a primary mentor who is an obstetrician/gynecologist specializing in thrombotic issues in pregnancy who is also a member in good standing of one of the THSNA organizations is an eligible mentor). If the primary mentor is not currently a member of one of the THSNA organizations, see Appendix A for a listing of THSNA organizations to which the mentor may apply. In addition to securing a primary mentor with the above credentials, applicants may also select a co-mentor who provides medical or scientific expertise in addition to the primary mentor. The co-mentor is not required to be a member of one of the THSNA organizations.

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If the applicant is invited to submit a full proposal, formal letters of support are required from the mentor and co-mentor as well as from the appropriate institutional official (e.g. department chair or division chief) indicating institutional commitment of sufficient time to permit the applicant to conduct the research.

Project Eligibility

Eligible research projects in hemostasis and/or thrombosis include:

1. Clinical projects related to one of the sub-disciplines of THSNA (hematology, science of hemostasis and/or thrombosis, laboratory medicine, obstetrics and gynecology, nursing, pharmacy and pharmacology, and coagulation laboratory technology), including, for example, epidemiological or translational studies, with or without a secondary component of laboratory work

OR

2. Basic science/laboratory projects related to one of the same sub-disciplines of THSNA, including, for example, molecular biology, physiology, pharmacology, or translational studies where the primary emphasis is laboratory work, with or without a secondary component of clinical work

After reviewing the eligibility requirements, if applicants have any questions about whether they, their mentor, or their project meet the eligibility requirements, please contact HTRS at [email protected] or 414-937-6569.

Available Funding The maximum THSNA MRA for 2015 is U.S. $150,000 ($75,000 per year for two years). This includes $138,888 for research project costs ($69,444 per year) plus an additional maximum $11,112 (8% of $138,888, or $5556 per year), for recipient institution program management fees (i.e. facilities or lab fees). Second-year THSNA MRA funding is contingent upon the acceptance of a formal progress report to the THSNA Grant Review Committee featuring a narrative report of research conducted and a financial summary of grant expenditures made during the first year of the award. Successful applicants are required to acknowledge THSNA’s support of this grant in print publications and oral presentations. Instructions for acknowledgment are communicated to awardees in their award notification letters and grant agreement contracts.

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Use of THSNA MRA Funds THSNA MRA funds must be used to support the costs of the funded research project, including, but not limited to:

Full or partial salary support for the awardee or other key project personnel

Equipment and supplies necessary to conduct the research project

Program management fees (including lab or facility fees) as required by the recipient institution. The line item for these fees may not exceed 8% of $138,888, or $11,112 over two years ($5,556 per year). If recipient institution program management fees are less than 8%, the amount allotted for other research project costs may be correspondingly higher up to a maximum total award of $150,000.

Registration, travel, and lodging fees for the awardee to attend a national scientific meeting during Year Two of their project to present the results of their funded research. (THSNA MRA funds may not be used to cover registration, travel, or lodging expenses to attend professional meetings outside of the meeting required in Year Two of the award period, unless specifically approved in advance as essential to THSNA MRA project outcomes.)

An applicant’s two-year THSNA MRA project budget, including program management fees of up to $11,112, may not exceed and should be as close as possible to a grand total of U.S. $150,000.

Current and Pending Support Requirement Applicants must report all current and pending funding sources for their proposed projects in their full proposal budgets. In the event that additional funding becomes available to cover salary support or other research costs, applicants will be asked to provide documentation that budgetary items requested from THSNA do not overlap. Applicants are also encouraged to apply to their institutional GCRC for supplemental funds and support.

Required Travel for MRA Grantees Grantees are required to make a good faith effort to present an abstract, poster, or oral presentation of their THSNA MRA funded research at a national meeting during their two-year project (e.g. ASH, NHF, HTRS, THSNA, Anticoagulation Forum, etc.). Funds to support conference registration fees, travel, and lodging for this meeting should be figured into the total grant budget. Instructions for acknowledging THSNA’s support of the grant in written or oral presentations will be included in the award recipient’s notification letter and grant agreement contract.

Other Conditions and Responsibilities Submission of a THSNA MRA pre-proposal and invited full proposal implies acceptance of the following conditions by the applicant and the mentor and/or co-mentors:

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1. Purpose of THSNA MRA Award. It is expected that the principal focus of the selected award recipient will be to further his/her experience in performing clinical or basic science research in hematology and/or thrombosis. Grantees are expected to spend a minimum of 50% time on research-related activities.

2. Change in Status. The grantee is responsible for contacting the THSNA MRA administrator

(HTRS) if there are any changes in status in the grantee’s institution, mentor or co-mentors, project budget, or in the status of pending grants. In the event that other funding is secured to cover research costs, the recipient institution will be asked to return unused funds. Carryover of budgeted funds from Year One to Year Two may not exceed 25% of the total project budget and must be accompanied by appropriate justification in the required progress reports. Requests for no-cost extensions (NCEs) beyond the two-year project timeframe are granted at the discretion of the THSNA Grant Review Committee after receiving a written NCE Request Letter outlining the justification for the extension from the grantee and the mentor. Grantees may move their MRA-funded research to another institution as a result of promotion or other career development opportunity during the course of the funded project; however, they must: 1) work with the THSNA MRA administrator (HTRS) to facilitate the transfer, and 2) confirm in writing that mentoring, protected time, and other project support necessary to continue the aims and objectives of the funded project are in place at the new institution.

3. Award Management. Once awarded, day-to-day expense tracking and payments related to the

successful 2015 THSNA MRA project will be managed by the awardee’s university department or hospital research department. Funds are not sent to the awardee directly. The university or hospital (the “recipient institution”) will then manage the award according to their own procedures and payment schedules.

4. Rights of Human Subjects. The recipient institution has the primary responsibility for protecting

the rights and welfare of human subjects in any research activity supported by a THSNA MRA. Applicants requesting funding for research involving human subjects must submit written approval of the research project from their institution’s Institutional Review Board before funding can be awarded.

5. Animal Studies. For research projects involving animal studies, certification that the facility and

its researchers and employees adhere to the Animal Welfare Act, National Research Council Guide for the Care and Use of Laboratory Animals, the standards for laboratories established by the Association for the Assessment and Accreditation of Laboratory Animal Care International, and any appropriate U.S. Department of Agriculture or National Institutes of Health regulations and standards must be submitted before funding is awarded.

6. Required Grant Agreement. Upon acceptance of a THSNA MRA award, the awardee, his/her

mentor and/or co-mentors, and the appropriate institutional representative will sign a grant agreement contract prepared by the THSNA MRA administrator (HTRS) and submitted to the applicant’s OSR or other financial/legal representative. Full proposal applicants are responsible for providing HTRS with the name and contact information of the appropriate individual at the recipient institution who should receive the grant agreement contract.

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7. Acknowledgment: Any publication, thesis, or formal presentation resulting from the awardee’s work must acknowledge the support of THSNA as outlined in the award notification letter and the signed grant agreement. A copy of any publications, manuscripts, abstracts, presentations, etc. resulting from the funded research must be submitted to the THSNA MRA administrator (HTRS) during and after the duration of the award program with the appropriate acknowledgments listed.

8. Progress Report: All awardees are required to submit a progress report describing the first year

of funded research within 12 months of receiving the award. Funding for the second year of research is contingent upon satisfactory progress having been made by the awardee as determined by the THSNA Grant Review Committee and as reflected in the goals and objectives of the submitted full proposal and a financial accounting of grant expenditures prepared by the OSR or other institutional representative. (Exact submission dates for required reports will be reflected in the signed grant agreement.)

9. Final Report: A final report consisting of a narrative summary of the research accomplished and

a list of related publications (prepared by the awardee), and a financial accounting of grant expenditures (prepared by the grantee’s OSR or other institutional representative) is due within six (6) months of the grant award period. (Exact submission dates for required reports will be reflected in the signed grant agreement.)

Preparing a Pre-proposal A pre-proposal describing the proposed research project, an outline of the applicant’s qualifications and future career plans, and a description of the primary mentor’s and/or co-mentor’s credentials is due on or before Wednesday, December 10, 2014 by 5:00 PM CT. Applicants are required to use the online grant application system at www.htrs.org to submit pre-proposals. A complete submission includes the required Application Form available at www.htrs.org under the heading “Grants” and then “THSNA Mentored Research Award” or on the grant application website. Information regarding how to access the grant application site is available at www.htrs.org under the heading “Grants,” and then “THSNA Mentored Research Award.” Pre-proposals must be submitted in PDF format and be a maximum of three pages, excluding references. References may be listed on a separate page. Please use a basic font such as Times New Roman (no less than 11 points) and 1-inch page margins. Required Pre-proposal Application Form Applicants are required to complete the Application Form (writable PDF) available now at www.htrs.org under the heading “Grants” and then “THSNA Mentored Research Award” or on the grant application site in addition to uploading their 3-page pre-proposal narrative. Applications that do not include this required form will not be reviewed.

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Pre-proposal 3-Page Narrative The 3-page pre-proposal narrative should address the following:

Rationale and objectives of the proposed research

The research plan, including statistical considerations. Statistical considerations must be addressed in the pre-proposal, if only preliminarily. Applicants are encouraged to identify statistical resources within their own institutions.

The research plan should include sufficient detail to allow the reviewers to judge the potential for new knowledge

Relevance of the research to the applicant’s stated career goals. Note: Those applicants who are not training or working primarily in the fields of hemostais and/or thrombosis, but whose careers have substantial overlap with the disciplines of hemostasis and/or thrombosis (e.g. obstetricians/gynecologists) must include not only the relevance of their proposed research to their career, but also how the disciplines of hemostasis and/or thrombosis overlap with, and have substantial relevance to, their career.

Brief listing of the primary mentor’s and/or co-mentor’s qualifications. If the primary mentor’s expertise is outside the field of hemostasis and/or thrombosis, he or she is required to be a current member in good standing of one of the 13 THSNA organizations in order to be an eligible primary mentor. (For example, a primary mentor who is an obstetrician/gynecologist specializing in thrombotic issues in pregnancy who is currently a member in good standing of one of the THSNA organizations is an eligible mentor.)

A clear explanation of the applicant’s role vs. the role of the mentor and/or co-mentor in the research concept and design and the implementation of the study. If relevant, specify the specific parts of the project to be carried out by the applicant, as opposed to the mentor and/or co-mentor

Pre-proposal Review Pre-proposals are reviewed by the THSNA Grant Review Committee which is comprised of experienced, established members of the health related disciplines represented within the THSNA organizations and reflected within the applicant and mentor eligibility requirements. Please prepare your pre-proposal such that your work can be understood by reviewers from the variety of disciplines represented. Members of the THSNA Grant Review Committee with direct or indirect conflicts of interest (i.e. members serving as a mentor or co-mentor for an applicant) are asked to recuse themselves from the selection process. Pre-proposal Review Criteria The THSNA Grant Review Committee performs the best possible pre-proposal review based on data submitted by each applicant. The Committee's goal is to advance only the most competitive proposals to the full proposal round to be considered for the limited pool of THSNA MRA grant funding. 2015 pre-proposals will be judged according to the following criteria:

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Are the rationale and the objectives of the proposed research clearly stated?

Does the applicant clearly describe how research will proceed?

Is the proposed research topic competitive (i.e. in line with current priorities in the field)? Does the project have the potential to generate new knowledge?

Are statistical considerations appropriately identified? Is a plan for obtaining needed statistical support from within the applicant’s institution outlined?

Is the proposed research in keeping with the applicant's stated career goals? Will it help to advance the applicant's career? In addition, for the applicant who is not training or working primarily in the fields of hemostasis and/or thrombosis, do the disciplines of hemostasis and/or thrombosis overlap with and have substantial relevance to the applicant’s career?

Is the mentor and/or co-mentor qualified to support the applicant in the proposed research? Is the research environment appropriate?

Does the pre-proposal clearly explain the roles of the applicant and the mentor and/or co-mentor in the proposed research?

Pre-proposal Review Timeline The THSNA Grant Review Committee completes a thorough review of all submitted pre-proposals, which can take some time. If the pre-proposal is favorably reviewed by the Committee, the applicant will be informed within 5-6 weeks of the pre-proposal submission date that a full proposal is requested by the Monday, February 23, 2015 deadline. The THSNA MRA administrator (HTRS) will make every effort to notify successful 2015 pre-proposal applicants that they have been invited to submit full proposals within 5-6 weeks after the submission deadline.

Preparing a Full Proposal Applicants invited to submit full proposals must do so on or before Monday, February 23, 2015 by 5:00 PM CT. Applicants are required to use the online grant application system available at www.htrs.org to submit full proposals. A complete submission includes the required Application Form available at www.htrs.org under the heading “Grants” and then “THSNA Mentored Research Award” or on the grant application website. Information regarding how to access the grant application site for full proposal submission will be available at www.htrs.org under the heading “Grants,” and then “THSNA Mentored Research Award.” Full proposals must be submitted in PDF format. Components of the full proposal include: 1. Required Full Proposal Application Form

This form will be available as a writable PDF at www.htrs.org under the heading “Grants” and then “THSNA Mentored Research Award” or on the grant application site. Applications that do not include this required form will not be reviewed.

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2. Career Goals Statement Must be a maximum of two pages using a basic font such as Times New Roman of no less than 11 points with 1-inch page margins. The career goals statement should address:

a. Background preparation for the research fellowship b. List of specific objectives for the research fellowship c. Plans for the research based on the specific objectives d. Future career plans and the relevance of the research to the applicant’s stated career goals.

Note: Those applicants who are not training or working primarily in the fields of hemostasis and/or thrombosis, but whose careers have substantial overlap with the disciplines of hemostasis and/or thrombosis (e.g. obstetricians/gynecologists) must include not only the relevance of their proposed research to their career, but also how the disciplines of hemostasis and/or thrombosis overlap with, and have substantial relevance to, their career.

3. Project Narrative The project narrative must be a maximum of 10 pages, excluding references. References may be listed on a separate page. Use a basic font such as Times New Roman of no less than 11 points with 1-inch page margins. Full proposals/project narratives are reviewed by the THSNA Grant Review Committee which is comprised of experienced, established members of the health related disciplines represented within the THSNA organizations and reflected within the applicant and mentor eligibility requirements. Please prepare your full proposal/project narrative such that your work can be understood by reviewers from the variety of disciplines represented.

The project narrative should include:

a. A statement of the hypothesis and specific aims b. Background and significance of the proposed research c. Feasibility analysis, with patient or sample numbers and statistical methods identified d. Preliminary data, if any e. Experimental design and methodology, potential limitations, and future studies envisioned

if specific aims are accomplished f. If the research proposal requires additional funds, the narrative should describe the source

of this funding (obtained or applied for) and should include a brief discussion of alternatives if funding is not successful

g. The research proposal should contain a clear explanation of the applicant’s role vs. the role of the primary mentor and co-mentor in the research concept and design, and the implementation of the study. If relevant, specify the specific parts of the project to be carried out by the applicant, as opposed to the primary mentor and/or co-mentor

4. A copy of the applicant’s current CV or NIH biosketch 5. A copy of the primary mentor’s and co-mentor’s current NIH biosketch. If the primary mentor’s

expertise is outside the field of hemostasis and/or thrombosis, he or she is required to currently be a member in good standing of one of the THSNA organizations in order to be an eligible primary mentor. (For example, a primary mentor who is an obstetrician/gynecologist specializing in

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thrombotic issues in pregnancy who is currently a member in good standing of one of the THSNA organizations is an eligible mentor.)

6. A letter of support from the proposed primary mentor and co-mentor (if applicable) outlining:

a. The strengths of the candidate and any challenges that the candidate has or will have to be successful as a THSNA MRA awardee

b. The research facilities and resources available to the candidate c. The proportion of time the candidate will spend on research, in light of course work, clinical

duties, and any teaching responsibilities (research should be 50% time) d. A clear explanation of the applicant’s role vs. the mentor’s and co-mentor’s role in the

research concept and design, and the implementation of the study. If relevant, specify the specific parts of the project to be carried out by the applicant, as opposed to the mentor and co-mentor

e. The nature of week-to-week interactions between the mentor, co-mentor and the applicant

7. A letter of support from the current department chairperson or division chief supporting the applicant’s potential and committing institutional support for the project

8. Project Budget

The following expenses are permitted by THSNA as part of the project budget, which may not exceed, and should preferably be equal to, $150,000. Please provide a detailed explanation of each line item requested.

a. Salary and fringe benefits for the grantee proportional to his/her percent effort on the

project b. Salary and fringe benefits for other key personnel required for implementation of the

research project c. Equipment and supplies necessary to fulfill the project’s specific aims d. Program management fees for the recipient institution. Program management fees may

include lab or facility fees, or costs associated with the recipient institution’s management of the grant such as staff time, which should be explained in detail [e.g. 148 hours x $75/hour (salary and fringe) = $11,100]. Program management fees for the entire project budget may not exceed $11,112, or 8% of $138,888, and must be included as part of a complete $150,000 project budget. If recipient institution program management fees are less than 8%, the amount allotted for other research project costs may be correspondingly higher up to a maximum total award of $150,000. Please do not add an additional 8% on top of the $150,000 project budget for program management, as this will exceed the amount permissible for the THSNA MRA project budget.)

e. Travel expenses directly related to training or implementation of the proposed research. Successful applicants are required to make a good faith effort to present their research findings at a national meeting during their grant period. Conference registration, travel, and lodging fees should be written into the project budget for this purpose.

f. Patient care costs if required for the study and not covered by third-party payments g. Human subjects payments h. Consultant costs for statistical or data management support

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Full Proposal Review Full proposals are reviewed by the THSNA Grant Review Committee which is comprised of experienced, established members of the health related disciplines represented within the THSNA organizations and reflected within the applicant and mentor eligibility requirements. Please prepare your full proposal such that your work can be understood by reviewers from the variety of disciplines represented. Members of the review committee with direct or indirect conflicts of interest (e.g. members serving as a mentor or co-mentor for an applicant) are asked to recuse themselves from the selection process. Full Proposal Review Criteria Final funding approval is granted by the THSNA Board of Directors. Applicants will be judged according to the following criteria:

a. The quality and potential of the applicant, including the demonstration of a sincere commitment to a career in hemostasis and/or thrombosis (or a related area that has a substantial overlap with the disciplines of hemostasis and/or thrombosis)

b. The relevance of the research to the applicant’s stated career goals. In addition, for the applicant who is not training or working primarily in the fields of hemostasis and/or thrombosis, but whose career has substantial overlap with the disciplines of hemostasis and/or thrombosis, the relevance of the disciplines of hemostasis and/or thrombosis to the applicant’s career

c. The scientific merit of the research proposal d. The adequacy and appropriateness of the statistical analysis plan e. The accuracy and feasibility of the project budget f. The quality of the research environment and the mentor and/or co-mentors g. The presence of a clear explanation of the applicant’s role vs. the mentor’s and co-mentor’s

role in the research concept and design, and the implementation of the study

Announcement of Awardee Announcement of the 2015 THSNA MRA awardee will be made in late March 2015 for projects beginning on July 1, 2015 and running until June 30, 2017. (The budget period for the 2015 THSNA MRA is July 1, 2015 - December 31, 2017.)

Questions Additional questions about the THSNA MRA Program should be directed to the THSNA MRA administrator, HTRS, at [email protected] or (414) 937-6569. If applicants have any questions about whether they, their mentor, or their project meet the eligibility requirements, please feel free to inquire.

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APPENDIX A

Partner Organizations Comprising the 2014 Thrombosis and Hemostasis Summit of North America

American Thrombosis & Hemostasis Network (ATHN) provides stewardship of a secure national

database, adherent to all privacy guidelines, which will be used to support clinical outcomes analysis,

research, advocacy and public health reporting in the hemostasis and thrombosis community. ATHN

Affiliates include over 125 hemophilia and thrombosis centers across the U.S.

American Venous Forum (AVF) is dedicated to improving the care of patients with venous and

lymphatic disease.

Anticoagulation Forum (ACF) is a multidisciplinary organization of healthcare professionals that works

to improve the quality of care for patients taking antithrombotic medications. The AC Forum has over

5,000 physician, nurse, and pharmacist members representing over 1,500 anticoagulation clinics.

Association of Hemophilia Clinic Directors of Canada (AHCDC) is an organization of Hemophilia Clinic

Directors from across Canada with a common interest in improving the treatment of people with

hemophilia. The organization has a registry of individuals with hereditary bleeding disorders.

Canadian Pediatric Thrombosis and Hemostasis Network (CPTHN) is a group of healthcare

professionals dedicated to improving the lives of children and families dealing with inherited and

acquired bleeding and clotting disorders.

Foundation for Women & Girls with Blood Disorders (FWGBD) is dedicated to achieving correct

diagnosis and treatment of blood disorders and accompanying reproductive problems in women and

girls with von Willebrand Disease (VWD), other factor deficiencies, thrombophilias, sickle cell disease

(SCD) and sickle cell trait (SCT), hemoglobinopathies, immune thrombocytopenic purpura (ITP) and

anemias.

Hemostasis and Thrombosis Research Society (HTRS) is dedicated to to advancing care for people with

bleeding and thrombotic disorders through investigator-initiated research, mentoring, and continuing

medical education. Members include pediatric and adult physicians, allied health professionals, and

industry representatives, including many of the directors of hemostasis and thrombosis treatment

centers in the United States and Canada.

National Blood Clot Alliance (NBCA) is a patient-led, voluntary health advocacy organization.

Programs include patient education and professional training on the signs, symptoms and prevention

of blood clots and clotting disorders. Volunteers include many of the nation's foremost experts on

blood clots and blood clotting disorders.

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National Hemophilia Foundation (NHF) is dedicated to finding better treatments and cures for

bleeding and clotting disorders and to preventing the complications of these disorders through

education, advocacy and research. Established in 1948, the National Hemophilia Foundation has

chapters throughout the country. Its programs and initiatives are made possible through the

generosity of individuals, corporations and foundations as well as through a cooperative agreement

with the Centers for Disease Control and Prevention (CDC).

North American Society on Thrombosis and Hemostasis (NASTH) is a regional professional society

dedicated to the advancement of thrombosis and hemostasis research, education and clinical care.

North American Specialized Coagulation Laboratory Association (NASCOLA) provides external quality

assessment for tests used to diagnose bleeding or prothrombotic disorders, thereby promoting high

standards of performance and practice for specialized coagulation laboratories in the USA, Canada, and

Mexico, and in countries in Central America and the Caribbean.

Platelet Disorder Support Association (PDSA) is a non-profit corporation dedicated to enhancing the

lives of people with immune thrombocytopenia (ITP) and other platelet disorders through education,

advocacy, research and support.

Thrombosis Canada (TC) is dedicated to furthering education and research in the prevention and

treatment of thrombosis. The group consists of Canadian health care professionals from medicine,

pharmacy, nursing and laboratory technology whose primary interest is investigation and management

of arterial and venous thrombosis as well as related issues.