2015 PNH Research Grant Guidelines | Aplastic Anemia and MDS International Foundation

2015 PNH Research Grant Guidelines

2015 PNH Grant Application Portal Now Cosed

Research grant awards will be announced in September 2015.

Purpose

The Aplastic Anemia and MDS International Foundation, Inc. (AAMDSIF) is pleased to help researchers dedicated to the study of bone marrow failure advance the understanding and treatment of aplastic anemia, myelodysplastic syndromes (MDS), and paroxysmal nocturnal hemoglobinuria (PNH).  For more than twenty five years, AAMDSIF has provided financial support to research that leads to new insights into the causes of the bone marrow failure and that leads to the development of new therapeutic approaches. 

With funding provided by the Patricia and Vincent Geczik Legacy Gift to Fund PNH Research, AAMDSIF is requesting proposals for research grant projects on the following topics:

  • Anti-complement therapies and/or immune regulation
    • Increased understanding of C3 inhibitors
  • Role of bone marrow failure in the selection of PNH clones of hematopoietic stem cells
  • Cause of the expansion of the PNH clone to clinically significant levels
  • Genetic components of PNH
  • Increased understanding of thrombosis within PNH, including mechanisms, detection and diagnosis, and treatment
  • Health outcomes of extended use of eculizimab
  • Reasons for continued clinical manifestations despite or because of the response to eculizimab
  • Advances in drug delivery mechanisms
  • More effective dosing levels and combination therapies

In addition, the following criteria will be considered by reviewers:

  • The likelihood that the goals of the proposal are attainable with the funding from AAMDSIF;
  • The project is independent research and not part of a large, multi-funded study;
  • The translational nature of the research and whether the findings can be rapidly applied to benefit patients;
  • For New Investigators, the likelihood that the project will contribute toward the professional development of the researcher. 

Applications that do not fall within the selection criteria will be disqualified. Reviewers will recuse themselves from review of grants submitted by them or by institutional colleagues or collaborators who submit a grant.

Eligibility

To be eligible to apply for a research grant, an applicant must hold a Doctor of Medicine, Doctor of Philosophy, Doctor of Science, or other doctoral level degree (e.g., PharmD).  There are no nationality restrictions.  Research may be carried out in the United States or abroad but not at a for-profit laboratory in the private sector.  The project must represent independent research conducted by the applicant.

Grants can be awarded to New Investigators and Established Investigators.  New Investigators are post-doctoral fellows, instructors, and those who have been assistant professors for fewer than five (5) years.

Established Investigators have been assistant professors for five (5) years or more or are associate or full professors.

Application Peer Review

Reviewers will be subject matter experts in PNH and may include members of the AA&MDSIF Medical Advisory Board (MAB) and/or ad hoc reviewers. It is the AAMDSIF policy not to reveal the names of the individuals who have reviewed the specific application. 

Selection

Awards are based on the scientific quality of the research plan, the relevance of the proposed research to AAMDSIF's goals, the applicant’s qualifications, and the quality of the research institution and facility where the research will be conducted.  In the case of New Investigators, the quality and support of the research mentor also will be considered. 

Application Due Date

Applications are due by July 15, 2015 and must be submitted via the online grant application on the AAMDSIF website. Notices of awards are expected to be sent by September 15, 2015 with funding to begin October 2015.

Amount of Foundation Support

Successful applicants can be funded up to $100,000 for one year, or $250,000 over two years.  Currently, AAMDSIF anticipates awarding 1 grant per year. Grant funds may be used only to support the direct costs of research and indirect costs of up to 10% of the grant.  Grant funds may not be used for purchase of permanent equipment (defined as equipment expected to last at least three years and computer hardware) or for repair or service contract costs for institutional equipment; the construction or renovation of facilities; furniture; salaries of collaborators at other institutions; honoraria; membership dues; subscriptions; books; or journals.   

Allowable use of grant funds includes salary for the principal investigator and for scientific personnel directly engaged in the research project at the principal investigator’s institution; consumable supplies, disposables, and animals necessary to fulfill the project's specific aims; and travel necessary to conduct research or to present the results of the research at appropriate scientific or medical meetings sponsored by non-profit associations.  The maximum amount of funds expendable for travel is $2,000 per year.  Travel funded by this grant must be done during the funding period.

Support from Other Sources

An applicant may not apply for, use, or accept AAMDSIF funds for a research project or part of a project already supported by AAMDSIF. Accordingly, full disclosure of all available and pending funds for research support must be made in the budget included with the grant application.  If funds from other sources become available to the applicant during the review or tenure of an AAMDSIF research grant, the principal investigator must inform AAMDSIF in writing. AAMDSIF and its advisors will then make a decision about the continuation of the research award.

Grant Payments

Electronic payments to the grantee's institution and are issued quarterly. The institution's financial officer should establish an account from which research expenses may be paid under the terms of the approved award.  No funds will be released before receipt by AAMDSIF of a signed copy of the Notice of Award. Additionally, AAMDSIF reserves the right to withhold payments for failure to meet the Foundation's reporting requirements outlined in this document and the Notice of Award.

Expenditures Beyond the Grant Period

Expenditures may not be made against a grant after its expiration date except with prior authorization in writing from AAMDSIF.

At the termination of the grant unexpended funds may, under exceptional circumstances, be used for an approved period of time. The grantee must request in writing such an extension of the use of grant funds. The request must state the amount of unexpended funds and how those funds will be used during the extension period. In addition, the grantee must provide a detailed justification satisfactory to AAMDSIF and its MAB. Such a request must be made no later than two (2) weeks after the termination date of the award.

Change in Status

The continued use of grant funds following any change in the status of the principal investigator requires approval in writing by AAMDSIF.  Such changes include, but are not limited to, a move by the investigator to a new institution, the institution’s withdrawal from the project, the investigator’s termination from the institution, or an absence of the grantee longer than six weeks.  Because the grant is awarded to the investigator and not to the institution, upon approval by AAMDSIF, grant funds remain with the principal investigator.  

Should the Foundation not approve the use of funds following the change of status, a financial report and progress report must be sent via electronic mail four weeks following the Foundation’s decision.  The progress report must justify the spending to date and will be reviewed by the initial reviewers. All funds not spent before the investigator’s change in status must be returned within six weeks following the Foundation’s decision not to approve the use of funds following the change of status.  Funds that are found by the reviewers to be spent without justification must also be returned.

Cancellation of Grant

If, for any reason, the grantee must relinquish the award, he/she must notify AAMDSIF in writing within two weeks of the decision to relinquish the award. AAMDSIF reserves the right to discontinue a grant if circumstances render the grantee unqualified and/or unable to perform under the terms and conditions of this policy and the Notice of Award.  Such circumstances include, but are not limited to, loss of license, conviction of a crime in relation to research or clinical activities, or withdrawal of insurance. Failure to submit a progress report by the specified deadline will result in withdrawal of funding.

Reports

A financial report form will be mailed to the grantee's financial officer with a copy of the award letter.  The completed form must be returned to AA&MDSIF within twelve (12) weeks after the termination date of the award. 

A detailed progress report must be submitted to AAMDSIF by October 21, 2016 the report should explain how the research results have to date met the objectives established in the application.  The report must be reviewed and approved by the AAMDSIF Medical Advisory Board (MAB) in order to receive the second year of funding.  In addition, a one-page summary of the above information in lay language intended for patients must be submitted at the same time. The Foundation may use the summary in its website, newsletters, annual reports, and other material. 

A final report is due to AAMDSIF six weeks after the close of the award period (November 15, 2016 for one year awards and November 2017 for two year awards). The report will include an outline as well as a detailed discussion of the work performed, results (particularly as they compare to the objectives established in the application), and future plans for related research.  Reprints of any publication written by the grant recipient and relating to the work performed during the award period must be included. Additionally, a one-page summary of the above information in lay language intended for patients must be submitted. The Foundation may use the summary in its website, newsletters, annual reports, and other material.

Publications and Oral Presentations

All manuscripts on findings produced with assistance from the research grant must be submitted to AAMDSIF within one month of publication.  Recipients must cite support from AAMDSIF in all published work and in all oral presentations that relate to findings produced with assistance from the research grant.  

Human and/or Animal Subjects/Tissues

When human subjects or tissues are to be used in a research project, it is the responsibility of the grantee and the institution to ensure that the institution has on file: 

  • A complete copy of the research protocol approved by the Institutional Review Board with oversight on human subjects and a copy of that Board's current approval notice (or, for research conducted outside of the United States, the equivalent of an IRB), and
  • A copy of the informed consent form(s) to be used by patients.

When animals and/or animal tissues are used, it is the responsibility of the grantee and the institution to ensure that the institution has a complete copy of the institution's animal care and use committee approval on file.

A copy of these documents must also be submitted with the application or delivered upon notice of award and before grant funds are transmitted.

AAMDSIF Policy on the Use of Animals in Research

All entities that receive funding from AAMDSIF adhere to the following principles:

  • Animals shall be used in biomedical research only when no other means of obtaining scientifically sound, valid, and useful results are available.
  • The minimum number of appropriate animals required to obtain and to validate results shall be used.
  • The acquisition, care, and use of animals must be in accordance with all applicable federal, state, and local laws and regulations, whether the research is conducted in the United States or abroad.
  • Certifications must be received from research facilities prior to being approved for a research fellowship that the facility(ies), its researchers, and its employees adhere to the Animal Welfare Act, National Research Council Guide for the Care and Use of Laboratory Animals, and any appropriate U.S. Department of Agriculture and/or National Institutes of Health regulations and standards, whether the research is conducted in the United States or abroad.
  • In research requiring the death of an animal, only the most appropriate and humane form of euthanasia shall be used consistent with the purpose of the research.

Conflict of Interest

Any real or potential conflict of interest on the part of the grantee or any collaborators/mentors in relation to the project must be revealed.  It is expected that AAMDSIF grantees will observe the highest ethical standards while conducting research.

TERMS OF THIS POLICY ARE SUBJECT TO REVISION OR ALTERATION AT ANY TIME.

Questions?

Contact Ellen J. Salkeld, PhD., Senior Director of Research and Health Professional Programs at salkeld@aamds.org or (301) 279-7202 x123.