Grants
Guidelines
ANESTHESIA PATIENT SAFETY FOUNDATION (APSF) 2013 GRANT PROGRAM
Guidelines for Grant Applications to be Selected on Saturday, October 12, 2013 (ASA Annual Meeting), and Scheduled for Funding Starting January 1, 2014.
The original application must be submitted electronically to the website no later than Sunday, June 16, 2013 (23:59:59 EDT).
The Anesthesia Patient Safety Foundation (APSF) Grant Program supports research directed towards enhancing anesthesia patient safety. Its major objective is to stimulate and fund studies that will clearly improve patient safety and lead 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 2013-2014 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.
ANTICIPATED 2013-2014 NAMED AWARDS
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/Covidien Research Award ($150,000)
PRIORITIES
APSF accepts applications in one of two categories of identified need: CLINICAL RESEARCH and EDUCATION AND TRAINING. Each year, we strive to fund at least one grant in each of the two categories. Highest priority is given to:
- Studies that will yield results that directly increase patient safety, improve patient outcomes, and/or decrease incidence or severity of complications, morbidity, or mortality;
- Studies that address peri-anesthetic safety problems for relatively healthy patients;
- Studies that are broadly applicable to large numbers of patients 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; or
- The use of information technology to enhance perioperative patient safety; or
- Standardization of perioperative protocols to improve patient safety.
Research proposals will be evaluated primarily for a potential contribution to patient safety, and subsequently for scientific merit, feasibility, and applicability.
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.
PROPOSALS WITH LOW LIKELIHOOD OF FUNDING
- Proposals whose results would not have a clear and direct link to near-term improvements in clinical care and patient safety.
- Proposals that seek to develop products or equipment for commercial purposes.
- Basic science proposals involving cells, tissues, or animals. Whole animal studies may be considered, however, but only in the rare circumstance in which an alternative testing of a critical patient safety hypothesis in human studies is not feasible.
- Research proposals that have other available sources for funding.
- Proposals to create patient safety education curricula or that propose methods that do not include a rigorous evaluation of content validity and/or benefit.
NOTE: Applicants are encouraged to read the latest summary of funded APSF grants in the Winter 2011 APSF Newsletter. http://www.apsf.org/newsletters/pdf/winter_2011.pdf
SCORING
Proposals will be screened for their potential contribution to patient safety. Those proposals judged related to patient safety will then 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 clearly describe 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 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.
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. Please include the mentor's CV with the application as part of the Appendix. 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; or 3) substantive changes are made to the original approved proposal.
PROJECT DURATION
It is the stated purpose of APSF to support successful applications and ensure delivery of high quality results that improve patient safety. We encourage applicants to be realistic in their proposals both in terms of objectives and time required for completion. On rare occasion, the committee may vote to extend the funding cycle at no cost, but such extensions will require a detailed explanation from the applicant, and may not involve significant changes in the initial approved proposal. Substantive changes in protocol may require that funds be returned and that a new application be submitted. Requests for extension, if approved, must include a detailed progress report that outlines any preliminary conclusions.
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 APSF in previous years, however, will be accepted without prejudice.
Submission of previously unfunded applications is strongly encouraged. Resubmissions must respond to the reviewers' comments, 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 returned without review by the scientific committee. A summary of reviewers' comments and recommendations will be provided to all applicants within eight (8) weeks after grant selection.
AWARDS
Awards for projects to begin January 1, 2014 will be announced at the annual meeting of the APSF Board of Directors on Saturday, October 12, 2013 (San Francisco, CA).
NOTE: No award will be made unless a copy of the APPLICATION to the institutional human review board (IRB) or animal studies' committee (ACUC) is received by the committee prior to October 1, 2013. Final IRB or ACUC APPROVAL will be needed prior to actual disbursement of funds.
PAPERLESS APPLICATIONS
A complete Application Packet consists of the following documents, arranged in the following order:
A. Application
B. Budget and 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
Please name the PDF Application Packet file as: LastName.FirstName-APP-2013 (example: Smith.John-APP-2013.pdf).
Please name the IRB Approval Letter file as: Lastname.Firstname-IRB-2013 (example: Smith.John-IRB-2013.pdf).
The complete Application Packet (Application, Budget justification, Applicant's CV, Chair's Letter of Support, Acceptance of Grant Conditions form, and IRB approval notification or, if approval has not yet been obtained, a copy of the IRB submission letter) must be uploaded to the APSF website: (http://www.apsf.org/grants.php).
Please follow the Application Format instructions carefully. Applications not conforming to all of the requirements will be returned without formal review.
APPLICATION PACKET
A. APPLICATION
I. Cover Page -- This should include:
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 one-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; size 12.
NOTE: Appendices are strongly discouraged but if used, should ONLY include either extensive data collection instruments that will be used in the project and have not been previously published, OR critical manuscripts that have been accepted for publication in a peer-reviewed journal but are otherwise not yet publicly available. The mentor's CV may be included in the Appendix.
a. Introduction
1. Objectives of the proposed Clinical Research or Education and Training project; specifically address how those objectives will lead to an improvement in patient safety, patient outcomes, and/or a reduction in mortality and morbidity.
2. 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.
3. 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?
4. 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.
5. Response to Reviewers' Suggestions. If the application is a resubmission, describe changes from prior application, specifically detailing how the revised application has addressed the reviewers' comments.
6. Preliminary Results. Provide as appropriate data from previous or pilot studies that demonstrate the significance, feasibility, and validity of your proposed work. If a new data collection instrument or analysis method is proposed, please provide evidence of its reliability and validity in this section.
b. Methods to be employed
1. 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 the sample size (power analysis).
2. Describe types of data to be obtained and their treatment, including statistical and power analyses.
3. Point out and discuss potential problems and limitations of the project.
4. If appropriate, include a statement of approval of this proposal by the institutional committee reviewing human or animal investigations, or, if the approval has not yet been obtained, a copy of the submitted application.
IV. Discussion -- Format: maximum of 2 double-spaced pages; 1-inch margins; Times New Roman font,
size 12.
a. Interpretation of Results. Describe how you will interpret the results you have obtained and what you will do (and what it will mean) if you obtain results that are different than you expected.
b. Limitations. Point out and discuss potential problems and limitations of project. Describe how you propose to address each study limitation.
c. Significance and Impact. 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.
d. Future Directions. Describe how your proposal will lead to future patient safety research. What will be the logical next studies that could be performed?
V. Timeline -- Format: maximum of 1 double-spaced page; 1-inch margins; Times New Roman font, size 12. Provide a Gantt chart that describes by month the expected start and end date of each step of the project.
VI. Protection of Human Subjects -- Format: maximum of 2 double-spaced pages; 1-inch margins; Times New Roman font, size 12.
All APSF grants for clinical evaluations shall comply with national regulations governing Good Clinical Practices* and investigational drugs, biologics, and/or medical devices. Applicants should refer to appropriate guidance documents published by their national regulatory authority.
The APSF grant proposal shall include:
a) A statement of approval of this proposal by the institutional committee reviewing human or animal investigations, or a copy of the submitted application;
b) A sample patient informed consent form that describes the risks to human subjects enrolled in the study, and how the investigator will mitigate those risks. If there are residual risks, explain why the benefits of conducting the study outweigh those risks;
c) A data safety monitoring plan of the study;
d) Samples of all records and reports required by the national regulatory authority of the country in which the study is being conducted. For significant-risk studies in the U.S. that involve investigational use of drugs or devices, a statement of compliance to FDA regulations regarding an Investigational New Drug (IND) application** or an Investigational Device Exemption (IDE) application.***
*ICH E-6 (R1) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH HARMONISED TRIPARTITE GUIDELINE - Guideline for Good Clinical Practice: Click here to download
**21 CFR 312 Investigational New Drug (IND) Applications, which includes the conduct of clinical studies involving any new use of a drug except for the indicated use of a marketed drug in the course of medical practice: Click here to download
B. BUDGET and BUDGET JUSTIFICATION
Please include all proposed expenditures. Indicate under each category the amount requested or provided from other sources.
I. Budget. Enumerate in an itemized table all proposed expenditures broken down by year of the proposal.
a. Personnel (limit salaries to NIH Guidelines)
b. Consultant costs
c. Equipment costs
d. Supplies and supplies cost
e. Patient costs
f. Other costs
g. Total funds requested
II. 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.
III. Current and Prior Support. List all current or pending research support (federal, foundation, industrial, departmental) available for the proposed project to the principal investigator, co-investigators, collaborators, and the mentor, if applicable. List all other research support for the principal investigator, stating percentage of effort devoted to current projects, and percent effort expected for pending projects.
IV. Facilities and Resources. List the facilities, equipment, supplies, and services essential for this project and indicate their availability.
C. APPLICANT'S CURRICULUM VITAE
Abbreviated CV of the principal investigator (maximum of four pages) and any co-investigators (maximum of four pages for each co-investigator).
D. LETTER OF SUPPORT
Please include a letter from the departmental chairperson indicating:
- 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 chairman's degree of enthusiasm for the proposed project.
- The availability of facilities essential to the completion of the proposed research.
- An agreement to return unused funds if the applicant fails to complete the project, and any remaining funds after the completion of the study.
E. "ACCEPTANCE OF GRANT CONDITIONS" FORM
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. IRB / ACUC APPROVAL
Please include the approval letter from the Investigational Review Board (IRB) or Animal Care and Use Committee (ACUC) or, if approval has not yet been received, a copy of the submitted application to IRB or ACUC.
The original application must be submitted electronically to the website no later than Sunday, June 16, 2013 (23:59:59 EDT).
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:
Steven K. Howard, MD
Chair, APSF Scientific Evaluation Committee
Staff Anesthesiologist
VA Palo Alto Health Care System
Associate Professor of Anesthesia
Stanford University School of Medicin
3801 Miranda Avenue, 112A
Palo Alto, CA 94304
Email: howard@apsf.org
Further information about the Grant Program and applicant eligibility may be found at Frequently Asked Questions