Anesthesia Patient Safety Foundation (APSF)

Guidelines for Grant Applications to Be Selected in October 2009,
and Scheduled for Funding Starting January 1, 2010

The Anesthesia Patient Safety Foundation (APSF) Grant Program supports research directed toward enhancing anesthesia patient safety. Its major objective is to stimulate studies leading to prevention of mortality and morbidity resulting from anesthesia mishaps.

NOTE: The grant award limit is $150,000 per project (including up to 15% institutional overhead). Additionally, there have been changes in areas of designated priority, in requirements for materials, and specific areas of research. For the current funding cycle, APSF is placing a specific emphasis on PATIENT SAFETY EDUCATION and MEDICATION & DEVICE SAFETY.

To recognize the patriarch of what has become a model patient safety culture in the United States and internationally, the APSF inaugurated in 2002 the Ellison C. Pierce, Jr., MD, Merit Award. The APSF Scientific Evaluation Committee will designate one of the funded proposals as the recipient of this nomination that carries with it an additional, unrestricted award of $5,000.

The APSF inaugurated The Doctors Company Foundation Ann S. Lofsky, MD, Research Award in 2009. This award is made possible by a $5,000 grant from The Doctors Company Foundation that will be awarded annually for the next 5 years to a research project deemed worthy of the ideals and dedication exemplified by Dr. Ann S. Lofsky. The recipient of this nomination will receive an additional, unrestricted award of $5,000. It is the hope of the APSF that this award will inspire others toward her ideals and honor her memory.

NAMED AWARDS IN 2009

• APSF/American Society of Anesthesiologists (ASA) President’s Endowed Research Award ($150,000)
• APSF/American Society of Anesthesiologists (ASA) Endowed Research Award ($150,000)
• APSF/Anesthesia Healthcare Partners (AHP) Research Award ($150,000)
• APSF/Cardinal Health Foundation Research Award ($150,000)
• APSF/Eisai, Inc. Research Award ($150,000)
• APSF/Covidien Research Award ($100,000)

PRIORITIES

The APSF accepts applications in one of two categories of identified need: CLINICAL RESEARCH and EDUCATION AND TRAINING. Each year, at least one grant in each of the two categories will be funded. Highest priority is given to

• Studies that address peri-anesthetic problems for relatively healthy patients; or
• Studies that are broadly applicable AND that promise improved methods of patient safety with a defined and direct path to implementation into clinical care; or
• Innovative methods of education and training to improve patient safety.

AREAS OF RESEARCH

• Areas of research interest include, but are not limited to
• New clinical methods for prevention and/or early diagnosis of mishaps.
• Evaluation of new and/or re-evaluation of old technologies for prevention and diagnosis of mishaps.
• Identification of predictors of negative patient outcomes and/or anesthesiologist/anesthetist clinical errors.
• Development of innovative methods for the study of low-frequency events.
• Measurement of the cost effectiveness of techniques designed to increase patient safety.
• Development or testing of educational content to measure, develop, and improve safe delivery of anesthetic care during the perioperative period.
• Development, implementation, and validation of educational content or methods of relevance to patient safety; and
• Development of innovative methods for prevention of medication errors.

SCORING

Studies will be scored on

• Soundness and technical merit of proposed research with a clear hypothesis and research plan.
• Adequacy of assurances detailing the safeguarding of human or animal subjects.
• Uniqueness of scientific, educational, or technological approach of proposed research.
• Applicability of the proposed research and potential for broad healthcare adoption.
• Clinical significance of the area of research and likelihood of the studies to produce quantifiable improvements in patient outcome such as increased life-span, physical functionality, or ability to function independently, potential for reductions in procedural risks such as mortality or morbidity, or significant improvements in recovery time.
• Ability of research proposals to maximize benefits while minimizing risks to individual human research participants. Each proposal should proscriptively enunciate the criteria for instituting rescue therapy whenever there is the remotest possibility of an untoward adverse event to a human research volunteer. In some instances, the rescue therapy may be triggered by more than one variable (e.g., duration of apnea [in seconds], oxygen saturation <90%, etc.). Additionally, the protocol should specify the nature of the rescue procedure(s), including the rescue therapy and dosages, and the personnel responsible for oversight. If other departments are involved in the rescue process, the application should specify if such departments are to be informed when a new volunteer is participating in the trial.
• Priority will be given to topics that do not have other available sources for funding.
• Proposals to create patient safety education content or methods that do not include a rigorous evaluation of content validity and/or benefit will be unlikely to attain sufficient priority for funding.

NOTE: Innovative ideas and creativity are strongly encouraged. New applicants are advised to seek guidance from an advisor or mentor skilled in experimental design and preparation of grant applications. Poorly conceived ideas, failure to have a clear hypothesis or research plan, or failure to demonstrate clearly the relationship of the work to patient safety are the most frequent reasons for applications being disapproved or receiving a low priority score.

EDUCATIONAL and TECHNOLOGY PROJECTS

Proposals involving the development of educational curricula, training interventions, software, or technology should include a formal assessment of their impact using meaningful measures relevant to patient safety. In addition, for new metrics or tools, the proposal should include an analysis of their reliability and validity.

BUDGET

The budget request must not exceed $150,000 (including a maximum of 15% institutional overhead). Projects must not exceed 2 years in duration, although shorter anticipated time to completion is encouraged. Unused funds must be returned to APSF if: 1) funds remain after completion of the project (i.e., actual expenditures were less than the budgeted funding); or 2) the project is not completed within the approved time period.

ELIGIBILITY

Awards are made to a sponsoring institution, not to individuals or to departments. Any qualified member of a sponsoring institution (hospital, university, clinic, etc.) in the United States or Canada may apply. Only one person may be listed as the principal investigator. All co-investigators, collaborators, and consultants must be listed. Applications will not be accepted from a principal investigator currently funded by the APSF. Re-applications from investigators who were funded by the APSF in previous years, however, will be accepted without prejudice.

Previous applicants are strongly encouraged to respond to the reviewers’ comments in a letter indicating point-by-point how the comments and suggestions were addressed in the re-application.

Applications that fail to meet these basic criteria will be eliminated from detailed review and returned with only minimal comment. A summary of reviewers’ comments and recommendations will be provided to all applicants within 8 weeks after grant selection.

AWARDS

Awards for projects to begin January 1, 2010, will be announced at the annual meeting of the APSF Board of Directors (2-3:30 PM) on Saturday, October 17, 2009 (New Orleans, LA).

NOTE: No award will be made unless the statement of institutional human or animal studies’ committee approval is received by the committee prior to October 1, 2009.

PAPERLESS APPLICATIONS

A complete Application Packet consists of the following documents, arranged in the following order:

A. Application

B. Budget justification

C. Applicant’s curriculum vitae

D. Departmental chair’s letter of support

E. Applicant’s “Acceptance of Grant Conditions” form; and

F. Institutional Review Board approval or copy of submission letter.

These documents must be converted to Adobe PDF format and merged as a SINGLE file. Should the applicant obtain the IRB approval after submission of the application packet (but prior to October 1), please upload the IRB Approval Letter as a separate Adobe PDF file.

Please name the Adobe PDF Application Packet file as: Lastname.Firstname-App-2010 (example: Smith.John-App-2010.pdf).

Please name the IRB Approval Letter file as Lastname.Firstname-IRB-2009 (example: Smith.John-IRB-2009).

The complete Application Packet (application, applicant’s CV, Acceptance of Grant Conditions Form, chair’s letter of support, budget justification, and IRB approval or submission letter)
must be uploaded to the APSF website:(https://dev2.apsf.org/grants/application/applicant/login.aspx).

Please follow the Application Format instructions carefully; applications not conforming to the requirements will be disallowed.

APPLICATION PACKET

A. APPLICATION

I. Cover Page

a. Title of research project

b. Designation of proposal as “Clinical Research” or “Education and Training”

c. Name of applicant with academic degrees, office address, phone number, fax number, and e-mail address

d. Names and affiliations of all investigators and consultants

e. Name, office address, and phone number of departmental chairperson

f. Sponsoring institution and name, office address, phone number, and e-mail address of the responsible institutional financial officer

g. Amount of funding requested

h. Start and end dates of proposed project

i. Number all pages (bottom right corner) sequentially, starting with the cover page.

II. Research Summary—a 1-paragraph description of the project (250-500 words)

III. Research Plan—Format: maximum of 10 double-spaced pages (excluding references); 1-inch margins; Times New Roman font; font size 12; appendices are discouraged.

a. Introduction

i. Objectives of the proposed clinical research or education and training project.

ii. Background: reference work of other authors leading to this proposal and the rationale of the proposed investigation or project. Describe the relationship to the priorities highlighted in the first paragraph of the APSF guidelines. Include copies of in-press manuscripts containing pilot data, if available.

iii. Specific aims: what questions will be answered by the investigation? If applicable, what hypothesis will be tested? For an educational project, what are the specific learning objectives or objectives of the methodology being developed?

iv. Significance and applicability: briefly describe the historical prevalence and severity of the morbidity and mortality of the studied anesthesia mishaps. Quantify the potential improvements in patient outcome or recovery time and identify how the proposed work can be broadly applied to reduce procedural risks in health care.

v. If the application is a resubmission, describe changes from prior application, and specifically address the reviewers’ comments.

b. Methods to be employed

i. Describe data collection procedure, specific techniques, and number of observations, subjects or experiments. For educational projects, describe how the effects of the intervention program will be assessed. Qualitative methodologies are acceptable. Provide a justification for sample size (power analysis).

ii. Describe types of data to be obtained and their treatment, including statistical and power analyses, if indicated.

iii. Point out and discuss potential problems and limitations of project.

iv. If appropriate, include a statement of approval of this proposal by the institutional committee reviewing human or animal investigations, or a statement that approval has been requested.

IV. Discussion—Format: maximum of 2 double-spaced pages; 1- inch margins; Times New Roman font; font size 12.

a. Describe the impact of the proposed study on patient safety and the applicability of the expected results to clinical care or education in patient safety.

B. BUDGET JUSTIFICATION— include all proposed expenditures. Indicate under each category the amount requested or provided from other sources.

I. Personnel (limit salaries of individuals to NIH Guidelines)

II. Consultant costs

III. Equipment costs

IV. Supplies

V. Patient costs

VI. Other costs

VII. Total funds requested

VIII. Budget justification – CLEARLY and COMPLETELY justify each item, including the role of each person involved in the project. If computer equipment is requested, explain why such resources are not already available from the sponsoring department/institution. NOTE: Failure to adequately justify any item may lead to reduction in an approved budget.

IX. List all current or pending research support (federal, foundation, industrial, departmental) available for the proposed project to the principal investigator, investigators, and his or her collaborators or mentor. List all other research support for the principal investigator, stating percentage of effort devoted to current projects, and percent effort expected for pending projects.

X. List the facilities, equipment, supplies, and services essential for this project and indicate their availability.

C. ABBREVIATED CV (maximum of 4 pages) of the principal investigator and any co-investigators.

D. LETTER OF SUPPORT from the departmental chairperson indicating:

I. The number of working days per week available to the applicant for the proposed research, the degree of involvement of the applicant in other research projects, and the chair’s degree of enthusiasm for the proposed project.

II. The availability of facilities essential to the completion of the proposed research.

III. An agreement to return unused funds if the applicant fails to complete the project, or any remaining funds after the completion of the study.

E. SIGN AND DATE THE ACCEPTANCE OF GRANT CONDITIONS form and upload this form to the website as part of the complete Application Packet (see above).

F. APPROVAL LETTER from the Investigational Review Board (IRB) or Animal Care and Use Committee (ACUC) or copy of submitted application to IRB or ACUC.

The original application must be submitted electronically to the website no later than Monday, June 1, 2009. Once the completed application is uploaded, an automatic confirmatory email will be sent to the applicant and to the Chair of the Scientific Evaluation Committee.

Sorin J. Brull, MD
Chairman, APSF Scientific Evaluation Committee
Professor of Anesthesiology
Mayo Clinic College of Medicine
4500 San Pablo Road
Jacksonville, FL 32224
Telephone: (904) 956-3331
Email: [email protected]

Further information about the Grant Program and applicant eligibility may be found at “Frequently Asked Questions,” under the “Grants” tab on the APSF website.