Anesthesia Patient Safety Foundation (APSF)

Guidelines for Grant Applications Scheduled to Start January 1, 2008

PRIORITIES

The APSF accepts applications in one of two categories of identified need: CLINICAL RESEARCH and EDUCATION AND TRAINING.

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; or
• Innovative methods of studying processes that lead to medication errors.

AREAS OF RESEARCH

• Areas of research interest include, but are not limited to
• New clinical methods for prevention and/or early diagnosis of mishaps including medication errors;
• 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/anesthesiologist assistant/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; and
• Development, implementation, and validation of educational content or methods of relevance to patient safety (NOTE: both patient and care provider educational projects qualify).

REVIEW PROCESS

Applications will be accepted electronically ONLY (see below). All completed applications will be distributed to members of the Scientific Evaluation Committee (SEC) who will score applications on a priority scale (1 – highest priority; 5 – lowest priority). Applications that do not meet APSF criteria will be disallowed and given a score of 8. Applications that attain sufficient priority will then be selected for full-committee presentation and scoring. This second round of reviews takes place at the full Scientific Evaluation Committee meeting, which occurs in conjunction with the ASA Annual Meeting. Winners are announced at the APSF Board of Directors Meeting that is held on the Saturday of the ASA Annual Meeting.

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 health care 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 responsible personnel. 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/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.

BUDGET

The budget request must not exceed $150,000 (including a maximum of 15% institutional overhead). Projects may be for 2 years in duration, although shorter anticipated time to completion is encouraged.

ELIGIBILITY

Awards are made to a sponsoring institution, not to individuals or to departments. Any qualified member of a sponsoring institution in the United States or Canada may apply. Only one person may be listed as the principal investigator. All co-investigators, collaborators, and consultants should 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.

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.

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 applicants only if requested from the Scientific Evaluation Committee Vice-Chair.

AWARDS

Awards for projects to begin January 1, 2008, will be announced at the meeting of the APSF Board of Directors on Saturday, October 13, 2007 (2007 ASA Annual Meeting, San Francisco, CA).

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, 2007.

PAPERLESS APPLICATIONS

All applications and accompanying documents MUST INCLUDE

• application
• applicant’s curriculum vitae
• applicant’s acceptance form
• departmental chair letter of support
• budget justification; and
• Institutional Review Board approval or submission letter.

These documents will be accepted in ELECTRONIC Adobe PDF format only. Electronic files in PDF format are acceptable for all text, charts, and graphics, and must be uploaded to the APSF website:

https://dev2.apsf.org/grants-and-awards/

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

APPLICATION FORMAT

1. Cover Page
   1. Title of research project
   2. Designation of proposal as “Clinical Research” or “Education and Training”
   3. Name of applicant with academic degrees, office address, phone number, fax number, and e-mail address
   4. Name, office address, and phone number of departmental chairperson
   5. Sponsoring institution and name, office address, phone number, and e-mail address of the responsible institutional financial officer
   6. Amount of funding requested
   7. Start and end dates of proposed project.
2. Research Summary—a 1-paragraph description of the project.
3. Research Plan (limited to 10 pages, typed, double-spaced, excluding references; appendices are discouraged):
   1. Introduction
      1. Objectives of the proposed clinical research or education and training project.
      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. If the application is a resubmission, describe changes from the prior application, and specifically address the reviewers’ comments point-by-point.
   2. Methods to be employed
      1. Describe data collection procedure, specific techniques, and number of observations or experiments. For educational projects, describe how the effects of the intervention program will be assessed. Qualitative methodologies are acceptable.
      2. Describe types of data to be obtained and their treatment, including statistical and/or power analyses, if indicated.
      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 a statement that approval has been requested.
4. Budget—include all proposed expenditures. Indicate under each category the amount requested or provided from other sources.
   1. Personnel (limit salaries of individuals to NIH Guidelines)
   2. Consultant costs
   3. Equipment
   4. Supplies
   5. Patient costs
   6. Other costs
   7. Total funds requested (including a maximum of 15% institutional overhead)
   8. 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.
   9. List all current or pending research support (federal, foundation, industrial, departmental) available for the proposed project to the principal investigator, his collaborators, or his mentor. List all other research support for the principal investigator, stating percentage of effort devoted to current projects, and percentage of effort expected for pending projects .
   10. List the facilities, equipment, supplies, and services essential for this project and indicate their availability.
5. Abbreviated CV (maximum of 3 pages) of the principal investigator only.
6. Letter from the departmental chairperson indicating
   1. 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.
   2. The availability of facilities essential to the completion of the proposed research.
   3. An agreement to return unused funds if the applicant fails to complete the project.
7. Sign and date the Acceptance of Conditions of the Grant form and upload this form as an Adobe PDF file to the website along with the application.

GUIDELINES FOR PREPARATION OF APPLICATIONS AND ELIGIBILITY REQUIREMENTS CAN BE OBTAINED FROM THE APSF WEB PAGE:

https://dev2.apsf.org

The original application must be submitted electronically to the website no later than Monday, June 18, 2007. Once the completed application is uploaded, an automatic confirmatory e-mail will be generated and sent to the Chair of the Scientific Evaluation Committee:

Sorin J. Brull, MD
Chair, APSF Scientific Evaluation Committee
Professor of Anesthesiology
Mayo Clinic College of Medicine
4500 San Pablo Road, JAB-4035
Jacksonville, FL 32224
Telephone: (904) 296-5688
Facsimile: (904) 296-3877
E-mail: [email protected]