Research - Specific Grant Guidelines

I. Eligibility

1. Principal investigator must be a professional or faculty member at appropriate educational, medical, or research institution and be qualified to conduct and supervise a program of original research. Non-faculty members are eligible if sponsored by faculty member.

2. Have access to institutional resources necessary to conduct the proposed research project.

3. Awards are available to applicants within the United States, only.

4. Conflict of Interest: Medical Board Members of ASAP can not be the Principal Investigator in any proposed research grant. They may, however, collaborate with any project as a collaborative investigator as long as they do not accept grant money to perform the research. Furthermore, no Medical Board Member may review a research proposal from his/her institution, or from one in which they collaborate.

II. Duration and distribution of awards:

1. Awards are made for fiscal year September 1 August 30.

2. Awards are granted for a one-year period. Extensions are possible depending on research progress and availability of funds.

3. Checks are made payable to the institution and not to an individual investigator. The institutions financial officer should establish an account from which research expenses may be paid under the terms of the approved award. Funds are disbursed in quarterly payments.

III. Authorized expenses:

1. Salary support for ancillary scientific personnel except for principal investigator and co-investigators;

2. Equipment and supply expenses necessary to fulfill the projects specific aims;

3. Travel expenses related directly to the conduct of the research;

4. Professional scientific/medical travel up to $3,000/year that includes travel to an ASAP meeting;

5. Costs associated with publication of research;

6. Indirect costs up to 8% are allowed;

7. No secretarial costs will be paid.

IV. Unauthorized expenses:

1. Salary or fringe benefits for the principal investigator;

2. Salary or fringe benefits for any ASAP co-investigator;

3. Salaries, travel, and/or housing related to sabbatical leaves;

4. Purchase or rental of office equipment (e.g., typewriters, furniture, copy machines, computers);

5. Expenses normally covered in the indirect cost allocation of the principal investigators institution;

6. Fees for tuition;

7. Membership dues, tuition, books or journals;

8. Service contracts;

9. Waste disposal;

10. Construction, alteration , maintenance, or rental of building space.

V. Human and/or animal subjects/tissues:

1. A copy of the institutions current IRB approval notice and a copy of the patient informed consent form must be submitted before any award money is transferred. The IRB does not have to be approved prior to submitting the application.

2. When human subjects, tissues, and/or materials are to be used in a research grant project that is awarded monies, it is the responsibility of the principal investigator and the institution to ensure that the institution has the following on file:

a. A complete copy of the research protocol approved by the institutions human subjects review board (IRB) and a copy of that boards current approval notice;

b. A copy of the patient informed consent to be used.

3. When experimental drugs and/or experimental medical devices are to be administered to patients, the materials required in the research protocol section above are necessary. In addition, it is the responsibility of the principal investigator and the institution to ensure that the institution has the following on file:

a. A complete copy of the requested exemption for Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) application that has been approved by the federal Food and Drug Administration (FDA) and a copy of the FDAs approval notice;

b. Copies of all correspondence during the application and award periods between the FDA and the ASAP principal investigator pertaining to the experimental drug and/or device study.

4. ASAP requires that patients participating in experimental drug and/or device studies not be charged directly for any research procedures included under the projects approved protocol.

5. ASAP investigators should use animals and animal tissues in their research only when reasonable and practical alternatives do not exist. When attainment of the specific aims of a project require the use of animals and/or animal tissues, a detailed justification must be included in the research grant application submitted to ASAP. The justification shall include statements confirming that institutional guidelines:

a. are at least as protective as those of the National Institutes of Health guidelines;

b. conform to all applicable laws and regulations;

c. meet the prevailing community standards for responsible scientific research;

d. apply throughout the project to ensure the humane treatment of any animals involved in the project.

It is the responsibility of the institution to ensure that no ASAP funds will be released for research involving humans and/or animals until the required documentation described above is on file with the appropriate official at the institution.

RESEARCH REPORTS AND PUBLICATIONS

I. Report of expenditures:

A Report of Expenditures form will be mailed to the principal investigator of the institution two (2) months prior to the end of each fiscal year of the grant application. The financial officer of the institution must, within twelve (12) weeks of the expiration date of the grant, return the completed form to ASAP with a check in the amount of all uncommitted and unexpended funds plus unexpended accrued interest, if any.

II. Report of progress:

Progress reports must be submitted at 6-month intervals during each funded grant year. A final report of progress must be submitted no later than one month following grant termination date. ASAP may require additional progress reports at any time during an award period as a condition of continuing the award.

III. Publications and news releases:

ASAP expects timely publication of the results of all research projects it supports and requires that every such publication whether in peer-reviewed journals, meeting abstract formats, review articles, or similar publications contain the following statement or its equivalent: This work was supported by a grant from the American Syringomyelia Alliance Project (ASAP). A copy of each research publication resulting fully or in part from funding from ASAP shall be submitted to ASAP.

Since funds to support ASAPs research program are primarily from donations from private citizens, it is essential to the growth and maintenance of ASAP and its research program that these donors be kept fully informed of the research progress that their contributions make possible. ASAP also endeavors to keep individuals and families affected with syringomyelia and/or Chiari type I malformation informed of research progress. For these purposes, ASAP may issue press releases on newsworthy research developments and produce various publications for the public that report research activities after careful review of its Medical Board. Such a press release or report may be issued on the occasion of the publication of an article in a professional journal or a presentation at a scientific or medical meeting.

In addition, ASAP requires funded investigators to submit short reviews (3-5 paragraphs) of their research plans and progress for publication in its newsletter and on its website. ASAP may invite funded investigators to present their research at its annual patient education conference. ASAP award money may be used for the purpose of travel to this conference.

Budget revisions, expenditures beyond grant expiration date, change in status:

1. The continued use of grant funds following any major change in status (sabbatical, unexpected leave of absence, move to new institution, or withdrawal from project) of the principal investigator requires prior written authorization from ASAP.

2. Expenditures may not be committed against a grant after the expiration date of the grant, except when authorized in writing by ASAP.

3. ASAP requires the submission of a revised budget when a grant is awarded for less than the amount originally requested. The revised budget must reallocate the amount awarded for items requested in the original budget, except for any items specifically described in the award letter that must be deleted from the budget. A revised budget must be submitted to ASAP and to the business office of the institution within four (4) weeks of receipt of the notice of award.

4. The principal investigator must submit a written request for authorization to reallocate funds, reappoint personnel, or change equipment purchases of an approved budget to ASAP. Such requests must include the amount of the reallocation, the budget items affected by the reallocation and a detailed justification. Requests will be considered up to four (4) weeks prior to the termination date of the award. ASAP does not permit budget revisions exceeding 15% of the total budget for that year or a budget reallocation adding funds to a budget category for which there is no prior approved budget. Reallocations are permitted only during the current funding year. Discretionary budget revisions totalling under $1,000 are permitted without ASAP authorization.

ASAP reserves the right at all times to cancel a grant if circumstances render the individual on whose behalf the award was made unfit, unqualified, and/or unable to perform under the terms and conditions of the grant program policy. Such circumstances include, but are not limited to, abandonment of the project, loss of license, conviction of a crime, or withdrawal of insurance or other material institutional protections.

Review Process:

Each grant application will be reviewed in a uniform manner. The ASAP Research Committee will review all grant applications in a timely manner after submission. All Conflicts of Interest of the Medical Board Members, review board, and applicant must be declared prior to the initiation of the formal review process. The Medical Board may recommend a team of reviewers or a single outside review expert if the grant subject matter or analysis of the scientific methods fall outside the scope of the ASAP reviewers. The grant applications will be reviewed on the basis of 1) applicability (falling within the realm of the ASAP vision statement), 2) scientific merit, 3) utility of methodology employed, 4) originality of the proposal, 5) and the qualifications of the investigators carrying out the proposed research. Each category will be rated and tabulated. Both the cumulative and individual category raw scores will be passed directly on to the Board of Directors of ASAP. The final decision to award monies based on the scientific recommendations of the Research Committee and consultation with the Medical Advisory Board, rests with the Board of Directors of ASAP.