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Young Investigator Grant Guidelines

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					 AMERICAN ORTHOPAEDIC SOCIETY FOR SPORTS MEDICINE
                          YOUNG INVESTIGATOR RESEARCH GRANT

                                           GENERAL INFORMATION

CRITERIA OF A YOUNG INVESTIGATOR:
This is an application for a Young Investigator Grant. These grants will be awarded to the principal
investigators who fulfill the following criteria:

      1)        Definition of a Young Investigator: The principal investigator has not received any peer
                reviewed external funding. The principal investigator has not received any external funding
                greater than $15,000. One will not be considered a Young Investigator if there is a significant
                history of presentations, publications, or experiments which have been carried out through either
                self-funding or funding through one’s own institution.
      2)        The principal investigator must be an orthopaedic surgeon who has graduated from an approved
                residency program or is a resident currently in an approved program.
      3)        The principal investigator must document and play the primary role in the proposed
                investigation. The goal of this grant is to help train new investigators with the assistance of
                an experienced supervisor rather than to help an experienced investigator complete an in-
                progress project. Ideally, the principal investigator would play a large role in generating the
                hypothesis, designing the experiment, carrying out the experiment, and interpreting the results.
                The greater the role of the principal investigator participates in all areas of the experiment, the
                more strongly the grant will be considered.
      4)        The principal investigator must stay at the parent institution while completing the project.

FUNDING:
The “Young Investigator Grants” are intended for young investigator grantee(s) who are undertaking sports
medicine research and meet the above criteria. AOSSM will issue awards in the amounts of up to $40,000,
aimed at providing “seed money,” or start-up funds, for pilot projects. These are “one time only” awards;
funds will be distributed over 24 months, with completion date of two years. The gross total for an award
under this category of grants will not exceed $40,000. Any investigative team seeking such a grant must
include at least one member of AOSSM in good standing. No AOSSM Board officer may be a named
investigator on any “Young Investigator Grant” application. The information to follow applies specifically to
applicants for AOSSM “Young Investigator Grants.”

GUIDELINES TO COMPLETE THE APPLICATION:
I.    APPLICATION PROCEDURES
      A.  The grant application must be completed in full and submitted together with the supporting
          data requested in the application form. Any application not completed in full will not be
          considered.

           B.      The completed application must be accompanied by an up to date biographical sketch of the
                   principal investigator, as well as a brief biographical sketch for all co-investigators. Limit
                   publications to most recent publications or those most pertinent to the investigation being
                   proposed.

II.         PRE-REVIEW PROCEDURES (strongly encouraged but not required)
           In an effort to improve the quality and competitiveness of the “Young Investigator Grant”
           offering, the AOSSM Research Committee will “pre-review” and critique applications
           prior to the final application deadline. Members of the grant review committee will
           provide feedback on any application submitted for pre-review. This pre-review is
           STRONGLY RECOMMENDED but not required. It is anticipated that by participating
           in the pre-review process, the applicant’s chances for funding will improve.
       Applications that have been pre-review have a much higher rate of receiving funding than those that
       have not.

       The pre-review will focus on:

       1)    Significance of proposed research
       1)    Scientific quality
       2)    Statistical methods
       3)    Realistic nature of goals
       4)    Long term value of results
       5)    Pilot date

III.   DEADLINE FOR PRE-REVIEW
       All materials must be received at the AOSSM office no later than August 15. The applications will
       be returned to the Investigators by October 1. This should allow time for revisions prior to final
       application.

IV.     FINAL APPLICATION PROCEDURES
       Download the application forms from the AOSSM website. Complete the forms off-line and
       combine into one Portable Document File (PDF). Some type of PDF-creation software is necessary
       to create the PDF. (The free Adobe Reader will not create a PDF.) To assist applicants searching
       for PDF-creation software, Grants.gov has published the following list of available tools and
       software: http://www.grants.gov/assets/PDFConversion.pdf. Additionally, applicants may find
       Planet PDF’s “Find PDF Software” feature (http://www.planetpdf.com/find_software.asp) useful
       to browse or search a comprehensive database of free, shareware, or commercial PDF products.
       Applicants should choose the PDF-creation software that best suits their needs.
       It is recommended that, as much as possible, applicants avoid scanning text documents to produce
       the required PDFs. Instead,we recommend producing the documents electronically using text or
       word-processing software and then converting documents to PDF. Scanning paper documents,
       without the proper Optical Character Recognition (OCR) process, will hamper automated
       processing of your application for NIH analysis and reporting.
       DISCLAIMER: References to software packages or Internet services neither constitute nor should
       be inferred to be an endorsement or recommendation of any product, service, or enterprise by
       AOSSM. No warranties are stated or implied.


       Once you have created the PDF, upload the file via the AOSSM grant submitter.

V.     DEADLINE FOR FINAL APPLICATION
       You must complete your submission no later than 11:59pm, December 1 to be considered for this
       program.

VI.    MODIFICATIONS
       Grantee(s) must receive written permission from AOSSM prior to moving funds between budget
       categories, changing effective dates of the grant, or making any other desired modifications.
       Grantee(s) may terminate a grant prior to normal expiration by notifying the AOSSM office in
       writing and stating the reasons for termination. Unexpended funds must be returned to AOSSM
       within sixty (60) days, together with a final accounting of expenditures under the grant. AOSSM
       reserves the right to terminate the grant at any time upon three months written notice to the
       grantee(s).
VII.   FISCAL PROCEDURES AND POLICIES
       A.  Facilities to be provided by the grantee(s) or their parent institutions.

             Research grants are designed to serve as supplementary funding for meritorious projects
             initiated or contemplated by the grantee(s) and their parent institutions. Therefore, the
             grantee(s) and such institutions are expected to provide all the necessary basic facilities and
             services normally expected in professional environments qualified to undertake research
             related to sports medicine. In particular, AOSSM expects that the grantee(s) will have
             available, whether from their own resources, funds other than those assigned by AOSSM, or
             from their parent institutions the following, unless otherwise specifically agreed upon:

             1.     Laboratory space;
             2.     Maintenance services, including maintenance supplies and service contracts;
             3.     Telephone service, if needed;
             4.     Library services, including subscriptions to periodicals and the purchase of
                    books;
             5.     Laboratory furniture;
             6.     Salaries of principal investigator or other project personnel, unless otherwise
                    agreed upon;
             7.     Foreign and local travel expenses of personnel working under the AOSSM
                    grant;
             8.     Society dues and memberships of personnel working under the AOSSM grant;
             9.     Workers' compensation, public liability or other hazard and special insurance;
             10.    Office equipment;
             11.    Employee group life, disability, medical expense or hospitalization insurance;
             12.    Audio/visual project support devices and items; and
             13.    Hospital bed expense, nursing or related services, even when used for research
                    studies pertinent to the subject of the AOSSM research grant.

             As a matter of policy, AOSSM grant funds may not be spent for remodeling or building
             construction costs or travel expense.

             AOSSM funds under the grant may not be used to pay institutional overhead/indirect
             (facilities and administrative) expenses.

             The purpose of this grant is primarily to design and carry out a project that will provide basic
             education in clinical or laboratory research. Since funds are relatively small, the bulk of the
             grant should generally be dedicated to purchasing those materials that are directly related to
             completion of the project. The cost of animals and animal care, cadavers, disposable or non-
             reusable experimental equipment or costs for use of equipment in the institution are generally
             justified. The purpose of this grant is not to stock laboratory with relatively permanent
             equipment or to pay an outside institution to perform work of the experiment. For example,
             paying for interpretation of x-rays or histological sections by an outside institution would
             usually not be considered acceptable.

       B.    Budgets

       PERSONNEL
       Name. Starting with the principal investigator, list the names of all applicant organization
       employees who are involved on the project during the initial budget period, regardless of whether
       a salary is requested. Include all collaborating investigators, individuals in training, and support
       staff. Please note that AOSSM does not provide salary for principal investigators or co-
       investigators.
       Role on Project. Identify the role of each individual listed on the project. Describe their specific
       functions under Justification on Form Page 5. Provide budget narrative for ALL personnel by
       position, role, and level of effort. This includes consultants and any “to be appointed” positions.
Type of Appointment/Months. List the number of months per year reflected in an individual’s
contractual appointment to the applicant organization. PHS staff assume that appointments at the
applicant organization are full time for each individual. If an appointment is less than full time,
e.g., 50 percent time, identify with an asterisk (*) and provide a full explanation under
“Justification” on Form Page 5. Individuals may have split appointments, for example for an
academic period and a summer period. For each appointment, identify and enter the number of
months on separate lines. In cases where no contractual appointment exists with the applicant
organization and salary is requested, enter the number of months for that period.
Percent of Effort on Project. For each individual at the applicant organization, list the percent of
each appointment to be spent on this project.
Institutional Base Salary. An applicant organization may choose to leave this column blank.
Salary Requested. Enter the dollar amounts for each position for which funds are requested. The
salary requested is calculated by multiplying the individual’s institutional base salary by the
percent of effort on this project. Explain under “Justification” on Form Page 5 if a lesser amount is
requested (e.g., endowed position or institutional sources.)
Fringe Benefits. Fringe benefits may be requested, in accordance with institutional guidelines for
each position, provided the costs are treated consistently by the applicant organization as a direct
cost to all sponsors.
Totals. Calculate the totals for each position and enter the subtotals in each column where
indicated.

CONSULTANT COSTS
Whether or not costs are involved, provide the names and organizational affiliations of all
consultants, other than those involved in consortium/contractual arrangements. Include consultant
physicians in connection with patient care and persons who serve on external monitoring boards or
advisory committees to the project. Describe the services to be performed on Form Page 5 under
“Justification.” Include the number of days of anticipated consultation, the expected rate of
compensation, travel, per diem, and other related costs.

EQUIPMENT
List each item of equipment separately and justify each purchase on Form Page 5.

SUPPLIES
Itemize supplies in separate categories, such as glassware, chemicals, radioisotopes, etc.
Categories in amounts less than $1,000 do not have to be itemized. If animals are to be purchased,
state the species and the number to be used.

TRAVEL
Itemize travel requests and justify on Form Page 5. Provide the purpose and destination of each
trip and the number of individuals for whom funds are requested.

PATIENT CARE COSTS
If inpatient and/or outpatient costs are requested, provide the names of any hospitals and/or clinics
and the amounts requested for each on Form Page 5.
State what basis is used for calculating costs. Indicate, in detail, the basis for estimating costs in
this category, including the number of patient days, estimated cost per day, and cost per test or
treatment. If both inpatient and outpatient costs are requested, provide information for each
separately. If multiple sites are to be used, provide detailed information by site.
Include information regarding projected patient accrual for the project/budget periods and relate
this information to the budget request for patient care costs. If patient accrual is anticipated to be
lower at the start or during the course of the project, plan budget(s) accordingly.
Provide specific information regarding anticipated sources of other support for patient care costs,
e.g., third party recovery or pharmaceutical companies. Include any potential or expected
utilization of General Clinical Research Centers.
ALTERATIONS AND RENOVATIONS
Itemize, by category and justify on Form Page 5, the costs of essential alterations and renovations
including repairs, painting, removal or installation of partitions, shielding, or air conditioning.
Where applicable, provide the square footage and costs. Costs for alterations and renovations are
not allowed on grants made to foreign organizations.

OTHER EXPENSES
Itemize any other expenses by category and unit cost. These might include animal maintenance
(unit care costs and number of care days), patient travel, donor fees, publication costs, computer
charges, rentals and leases, equipment maintenance, service contracts, and tuition remission in lieu
of salary. Justify costs on Form Page 5.

CONSORTIUM/CONTRACTUAL COSTS
Each participating consortium/contractual organization must submit a separate detailed budget for
both the initial budget period (Form Page 4) and the entire proposed project period (Form Page 5).
Consortium arrangements may involve personnel costs, supplies, and other allowable costs.
Contractual costs for support services, such as the laboratory testing of biological materials,
clinical services, or data processing, are occasionally sufficiently high to warrant a similar
categorical breakdown of costs.
For the applicant organization budget, list the sum of all consortium/contractual costs (direct and
F&A). Insert additional page(s) after Form Page 5, numbering them sequentially. (Do not use 5a,
5b, 5c, etc.)

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT
Enter the totals under each budget category for all additional years of support requested. Identify
with an asterisk (*), and justify any significant increases or decreases from the initial year budget.
Also, justify budgets with more than a standard escalation from the initial to the future year(s) of
support.

C.    Expenditure Reports
      At six (6) month, twelve (12) month, eighteen (18) month, and twenty-four (24) month
      intervals from date of receipt of the AOSSM grant, the grantee(s) must prepare, sign (together
      with the countersignature of the responsible financial official of the parent institution where
      appropriate), and submit to the AOSSM office in duplicate, reports of grant expenditures.
      AOSSM sends the forms required for these reports when it distributes disbursement checks.
      The twelve (12) month report will serve as the final report if the research supported by the
      AOSSM grant is completed. A written narrative report is also required at six (6) month,
      twelve (12) month, eighteen (18) month, and twenty-four (24) month intervals outlining the
      status of the project. The grantee also agrees to furnish a final report and complete
      periodic questionnaire concerning the presentation publication, or further funding of
      the project.

D.    Financial Records
      Separate accounts must be maintained for each grant. These accounts, with substantiating
      invoices and other expenditure data, must be available at all times to representatives of
      AOSSM.

E.    Unexpended Balances -- Completed Grants
      Any unexpended balances of $100 or more at the scheduled conclusion, or other
      termination of any AOSSM grant must be refunded to AOSSM within sixty (60) days or by
      July 31 of the year the grant is ended, together with the final report of the grant fund
      expenditures.
VIII.   OTHER INSTRUCTIONS

        BIOGRAPHICAL SKETCH
        Follow the instructions on the “Biographical Sketch with Sample.” This section must contain the
        biographical sketches of all KEY personnel including consultants following the order as listed on
        Form Page 2.
        Use the sample format on the “Biographical Sketch with Sample” to prepare this section for all
        grant applications.
        Note: The Biographical Sketch may not exceed four pages. Items A and B (together) may not
        exceed two of the four-page limit.
        Complete the educational block at the top of the format page, and complete sections A, B, and C.
        A. Positions and Honors. List in chronological order previous positions, concluding with your
        present position. List any honors. Include present membership on any Federal Government public
        advisory committee.
        B. Selected peer-reviewed publications or manuscripts in press (in chronological order). Do
        not include manuscripts submitted or in preparation.
        C. Research Support. List both selected ongoing and completed (during the last three years)
        research projects (federal or non-federal support). Begin with the projects that are most relevant to
        the research proposed in this application. Briefly indicate the overall goals of the projects and
        responsibilities of the key person identified on the Biographical Sketch. Note: Do not include
        percent of effort or direct costs.
        This information will be used by the reviewers in the assessment of each individual’s
        qualifications for a specific role in the proposed project, as well as to evaluate the overall
        qualifications of the research team.
        Information on other support beyond that required in the biographical sketch should NOT
        be submitted with the application.

        RESEARCH PLAN
        There is no Form Page for the Research Plan. The Research Plan should include sufficient
        information needed for evaluation of the project, independent of any other document. Be specific
        and informative, and avoid redundancies. Organize Items a-d of the Research Plan to answer these
        questions:
        1. What do you intend to do?
        2. Why is the work important?
        3. What has already been done?
        4. How are you going to do the work?

        PAGE LIMITATIONS
        Do not exceed 25 pages for Items a-d. All tables, graphs, figures, diagrams, and charts must be
        included within the 25-page limit. Applicants are encouraged to be succinct and are reminded
        that there is no necessity to use all 25-pages allotted to Items a-d of the Research Plan.


        RESEARCH PLAN FORMAT AND PAGE DISTRIBUTION
        We recommend the following format and page distribution.

        a. Specific Aims.
        List the broad, long-term objectives and what the specific research proposed in this application is
        intended to accomplish, e.g., to test a stated hypothesis, create a novel design, solve a specific
        problem, or develop new technology. One page is recommended.

        b. Background and Significance.
        Briefly sketch the background leading to the present application, critically evaluate existing
        knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the
     importance and health relevance of the research described in this application by relating the
     specific aims to the broad, long-term objectives. Two to three pages are recommended.

     c. Preliminary Studies/Progress Report.
     Preliminary Studies. For new applications, use this section to provide an account of the principal
     investigator/program director’s preliminary studies pertinent to the application information that
     will also help to establish the experience and competence of the investigator to pursue the
     proposed project. Peer review committees generally view preliminary data as an essential part of a
     research grant application. Preliminary data often aid the reviewers in assessing the likelihood of
     the success of the proposed project. Six to eight pages are recommended for the narrative
     portion of the Preliminary Studies/Progress Report.

     d. Research Design and Methods.
     Describe the research design and the procedures to be used to accomplish the specific aims of the
     project. Include how the data will be collected, analyzed, and interpreted as well as the data
     sharing plan as appropriate. Describe any new methodology and its advantage over existing
     methodologies. Discuss the potential difficulties and limitations of the proposed procedures and
     alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or
     timetable for the project. Point out any procedures, situations, or materials that may be hazardous
     to personnel and the precautions to be exercised. Although no specific number of pages is
     recommended for the Research Design and Methods section, the total for Items a-d may not
     exceed 25 pages, including all tables and figures. Applicants are encouraged to be as succinct as
     possible and reminded that there is no requirement that all 25 pages allotted for this section be
     used.

     e. Human Subjects Research.
     If you have marked “Yes” for Item 4 on the Face Page of the application, create a section heading
     entitled Human Subjects Research immediately following the last entry in the Research Design
     and Methods section. Although no specific page limitation applies to this section of the
     application, be succinct.

     HUMAN SUBJECTS RESEARCH SECTION
     In the Human Subjects Research section, applicants must (1) address the involvement of human
     subjects and protections from research risk relating to their participation in the proposed research
     plan (see Non Exempt Human Subjects Research for specific requirements), or (2) provide a
     justification for exemption with sufficient information about the involvement of the human
     subjects to allow a determination by peer reviewers and AOSSM staff that a claimed exemption is
     appropriate.

     f. Vertebrate Animals.
     If you have marked Item 5 on the Face Page of the application “Yes,” create a section heading
     entitled “Vertebrate Animals.” Place it immediately following the “Research Design and
     Methods” section of the application (or after Item e, if applicable.)
     Under the Vertebrate Animals heading address the following five points. In addition, when
     research involving vertebrate animals will take place at collaborating site(s) or other performance
     site(s), provide this information before discussing the five points. Although no specific page
     limitation applies to this section of the application, be succinct.

1.   Provide a detailed description of the proposed use of the animals in the work outlined in the
     Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of
     animals to be used in the proposed work.

2.   Justify the use of animals, the choice of species, and the numbers to be used. If animals are in
     short supply, costly, or to be used in large numbers, provide an additional rationale for their
     selection and numbers.
      3.   Provide information on the veterinary care of the animals involved.

      4.   Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to
           that which is unavoidable in the conduct of scientifically sound research. Describe the use of
           analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where
           appropriate, to minimize discomfort, distress, pain, and injury.

      5.   Describe any method of euthanasia to be used and the reasons for its selection. State whether this
           method is consistent with the recommendations of the Panel on Euthanasia of the American
           Veterinary Medical Association. If not, present a justification for not following the
           recommendations.


           g. Literature Cited.
           List all references. The list may include, but may not replace, the list of publications required in
           the Progress Report for competing continuation applications.
           Each reference must include the title, names of all authors, book or journal, volume number, page
           numbers, and year of publication. The reference should be limited to relevant and current
           literature. While there is not a page limitation, it is important to be concise and to select only those
           literature references pertinent to the proposed research.

           h. Consortium/Contractual Arrangements.
           Explain the programmatic, fiscal, and administrative arrangements to be made between the
           applicant organization and the consortium organization(s). If consortium/contractual activities
           represent a significant portion of the overall project, explain why the applicant organization, rather
           than the ultimate performer of the activities, should be the grantee.

           i. Consultants.
           Attach appropriate letters here from all individuals confirming their roles in the project. Do not
           place these letters in the Appendix.

           APPENDIX
           Applications may include the following materials in the appendix:

       • Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed
         materials directly relevant to this project. Manuscripts submitted for publication should not be
         included.

       • Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled
         as sets.

       • Cover letter (optional)

IX.        PROGRESS REPORTS TO OBTAIN FUNDING INSTALLMENTS
           Grantee(s) are required to submit the following reports to the AOSSM office:

           To obtain the second installment: (Within 6 months of acceptance) Grantee(s) must provide a
           summary (progress) report describing the research accomplished under the AOSSM grant to include
           the report of financial expenditures (form to be supplied by AOSSM upon acknowledgment of
           receipt). The second grant payment will be awarded after receipt of the manuscript.

           To obtain the third installment: (Within 12 months of acceptance) Grantee(s) must provide a
           summary (progress) report describing the research accomplished under the AOSSM grant to include
        the report of financial expenditures (form to be supplied by AOSSM upon acknowledgment of
        receipt).

        To obtain the fourth installment: (Within 18 months of acceptance) Grantee(s) must provide a
        summary (progress) report describing the research accomplished under the AOSSM grant to include
        the report of financial expenditures (form to be supplied by AOSSM upon acknowledgment of
        receipt).

        To obtain the fifth and final installment: (Within 24 months of acceptance) Grantee(s) must provide
        a final manuscript summarizing research findings that includes a final report of the grant
        expenditures and an agenda for the research noting possible publications, presentations, etc. The
        fifth and final grant payment will be awarded after receipt of the final manuscript. Grantee(s) are
        also required to submit the final manuscript to the American Journal of Sports Medicine for review
        for possible publication. See PUBLICATION section for grant publishing requirements.


X.      PUBLICATION
        AOSSM encourages free publication of research findings by all grantee(s).

        AOSSM should be sent reprints of all papers and publications resulting from work done under an
        AOSSM grant, including those that appear after the grant has been terminated.

        AOSSM imposes no restrictions on the copyrighting of publications by grantee(s).

        REQUIREMENTS when considering publication of your grant research:
        1) The following acknowledgment must appear as a footnote on the first page of the manuscript or
        printed text: “SUPPORTED BY A GRANT FROM THE AMERICAN ORTHOPAEDIC
        SOCIETY FOR SPORTS MEDICINE.” The same credit line must be included when
        grantee(s) presents a paper at a professional or scientific meeting.

        2) AOSSM’s first right of publication of grantee(s) research findings resulting from AOSSM grants
        be reserved for consideration of publication by the Editorial Board of The American Journal of
        Sports Medicine.

XI.     INVENTIONS OR FINANCIAL GAIN
        The American Orthopaedic Society for Sports Medicine (AOSSM) reserves the right to
        be reimbursed for the amount of the grant if any financial gain is realized as a result of the
        development of a commercial product that occurs during the research process under an AOSSM
        grant.

        Any patents generated by the funded research cannot become property of any of the investigative
        team. Assignments of such rights would be made by the AOSSM.

XII.    OWNERSHIP OF EQUIPMENT
        Equipment purchased under AOSSM grants becomes the property of the parent institution of the
        grantee(s) or its associated facilities.

XIII.   CORRESPONDENCE
        Any questions or requests should be directed to Bart Mann, Director of Research, American
        Orthopaedic Society for Sports Medicine (bart@aossm.org; 847-292-4900).
                    ADDITIONAL GUIDELINES FOR A SUCCESSFUL GRANT

1)   The proposed grant may use methods and/or apparatus previously proven by one of the co-investigators.
     However, the grant should not simply be a clear extension of work previously done or continuation of
     work currently being done by one of the co-investigators.

2)   A grant will have more support if a pilot project and/or a sample size estimate are done first. This does not
     have to be extensive or include large number of experiments. However, a pilot project will often
     demonstrate that the principal investigator has thought through the project from beginning to end, and that
     there is reasonable expectation that the project will result in tangible results. When possible, simple power
     calculations should be made using the results of the pilot study to justify the number of experiments
     requested in the budget. This will also give the reviewers some assurance that a statistically significant
     result might be detected.

3)   The results of any pilot project should be used in the budget justification.

4)   Due to the relatively limited nature of the grant, the methods to be used in the grant should be clearly
     established as valid or easily tested. A pilot project is usually necessary to prove that the experimental
     technique is workable. If a pilot project is not done in advance, one should be sure to explain how
     previously used techniques should be applicable to the project being proposed.

5)   To assist the young investigator, it is strongly encouraged that the grant be submitted for pre-review.