Supported by a generous contribution from Zimmer Biomet

INTRODUCTION

RJOS/Zimmer Biomet Clinical/Basic Science Research Grant**
Provides seed/start-up funding for promising clinical or basic science research projects. The Primary Investigator must be an Active or Candidate member of RJOS in good standing. Fellow, Resident and Student members are not eligible to apply for this grant. Preference will be given to topics related to women's musculoskeletal health issues. The review criteria for applications include the project's significance, its investigator(s), its innovation; its approach, the environment, and its budget. Applicants must be a member of RJOS in good standing, who are Board Certified or Board eligible orthopaedic surgeons. The recipient receives $30,000.00 specifically for their project.

**As a Zimmer Biomet supported offering and in conjunction with Zimmer Biomet’s reporting requirements as outlined in the Physician Payment Sunshine Act, RJOS is required to provide to Zimmer Biomet with the names and NPI Numbers of Grant recipients.

GRANT INFORMATION

The Ruth Jackson Orthopaedic Society (RJOS) supports the growth and leadership of current and prospective women orthopaedic professionals through education, mentoring, research and outreach. RJOS also promotes and advances musculoskeletal health and science. RJOS is pleased and proud to provide the RJOS/Zimmer Biomet Clinical/Basic Science Research Grant, made possible with generous support from Zimmer Biomet.

PLEASE NOTE: Only RJOS Active and Candidate members in good standing may apply. New applications for membership must be received on or before Thursday, August 31, 2023 to be eligible to receive the grant. Please visit www.rjos.org to complete a membership application. 

IMPORTANT INFORMATION

ALL applicants must follow the instructions to create a final electronic submission as detailed in the Required Documentation. The submissions must be in PDF file format.

All required information, including attachments, must be completed in their entirety. Applications with missing information or attachments are not eligible for review.

Deadline for applications for the RJOS/Zimmer Biomet Clinical/Basic Research Grant is 11:59 pm Central Time on Friday, September 15, 2023.  

GRANT RECIPIENT RESPONSIBILITIES

• Attend the 2024 RJOS Annual Meeting and Business Meeting in San Francisco, CA on Monday, February 12, 2024.
Recipient is also encouraged to attend the RJOS Annual Research Day session in San Francisco, CA on Monday, February 12, 2024.      
• Prepare a poster presentation for the 2025 RJOS Annual Meeting in San Diego, CA.  
• Submit a final research progress report (2 pages), including a final budget by August 30, 2024.
• Acknowledge the support of RJOS and Zimmer Biomet in any presentations or publications that result from your work.

INSTRUCTIONS

RJOS/Zimmer Biomet Clinical/Basic Science Research Grant

1. Application
a. Complete all sections of the Grant Application.

2. Essay Questions
a. Refer to the specific instruction for each essay question.

3. Collaborators and Consultants
a. Most scientific work requires collaboration among researchers. Determine the expertise needed for your research study.

b. Include letters of commitment in your application that clearly outline the roles of the collaborators. The grant application should contain a signed letter from each collaborator to the applicant listing the contributions he or she intends to make and his or her commitment to the work. These letters are often the primary assurance the reviewers have that this work will in fact be completed.
c. For consultants, letters should include rate/charge for consulting services.

4. Budget and Budget Justification
a. Enter budgets for the proposed budget period. Include justification for each expense and category in the Justification section.
b. Salaries and wages: Enter the name, percent of time on project and salary requested, as well as normal fringe benefits, i.e., pay for vacation, sick days, and holidays charged to the grant. Include details on what each person will do in the Justification section.
i. Funds may not be used to augment the salary or stipend of a resident.
c. Permanent equipment: Any major piece of equipment or apparatus costing more than $500 should be itemized and justifications made.
d. Consumable supplies: Glassware, chemicals, supplies and all expendable materials may be grouped in this category under appropriate subheadings.
e. No travel expenses, overhead or direct costs can be charged against this grant.
f. No indirect costs can be charges against this grant.

5. Research Plan
a. The Research Plan describes the proposed research, stating its significance and how it will be conducted. The Research Plan should be a maximum of six (6) pages including all figures and tables. A Research Plan usually includes:
i. Specific aims
ii. Background and significance
iii. Innovation
iv. Approach (including statistical analysis)
6. Additional Elements
a. Bibliography and references: Include a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication.
b. Care and use of animals in research
i. Use of animals and number requested for project must be justified by institution. If applicable, provide IACUC statement from your institution’s animal care committee approving use of and number of animals requested for project.
ii. All animals used in research supported by RJOS/Zimmer Biomet grants must be acquired lawfully and be transported, cared for, treated and used in accordance with existing laws, regulations and guidelines. Decisions as to the kind and sources of animals that are most appropriate for particular studies must be made by scientists and institutions. RJOS policy requires that such decisions be subject to institutional and peer review for scientific merit and ethical concerns and that appropriate assurances be given that NIH principles governing the use of animals are followed.
c. Consortium/Contractual Agreements
i. Explain all arrangements to be made between the applicant organization and the consortium organization(s).
d. Inclusion of women, minorities and children in research
i. The reviewers will assess the adequacy of plans to include subjects from all genders, racial and ethnic groups and subgroups, and children, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.
e. Protection of human rights
i. Use of human subjects and sample size must be justified. If applicable, IRB statements from your institution’s human subjects committee must be provided. IRB approval is required for patient x-rays.
ii. Reviewers will assess the potential risk to human subjects in proposed research and evaluate what protections are in place to guard against any research-related risk.
f. Resources and Environment
i. Ensure that the resources and environment address all the requirements of the research plan.
ii. Ensure that resources and budget are consistent.
iii. Ensure that letters of collaboration are included.
g. Biosketches
i. Include biosketches for all investigators and collaborators.

7. Additional Documents/Forms Required
a. Prepare and include the following required Lists:
i. List of facilities available at the institution
ii. Biographical sketches including research funding over past 5 years and funding with potential overlap with this project.
iii. RJOS FDA Form
iv. RJOS IRB Statement (if applicable)
v. RJOS Financial Disclosure for all authors/investigators

8. Policy on Transfer of Grant
a. If the grant has not started at the first institution and the principle investigator moves to a new institution, the grant will be cancelled. The principle investigator can re-apply from the new institution for the following year’s funding.
b. If the principle investigator moves to a new institution, s/he must submit a letter detailing resources, personnel and curriculum vitae of investigator at the new institution. The Scientific Committee Chair shall review the request to determine whether the change in institution is approved and respond to the principle investigator.

9. Final Reports
a. Grantees are required to submit a final report to RJOS sixty (60) days after termination of the grant.
b. RJOS reserves the right to deny additional grants to any institution where the final reports have not been submitted within six (6) months.
c. Grant recipients
10. Budget Policies and Reports
a. A twelve month budget report with a summary of the completed research shall serve as the final report for this one-year grant. It should be submitted no later than sixty (60) days after the grant has terminated.
b. Separate accounts must be maintained for each grant. These accounts, with substantiating invoices and payrolls, must be available at all times to representatives of RJOS.
c. Grantee may terminate a grant prior to normal expiration date by notifying the RJOS office in writing and stating the reasons for termination. Unexpended funds must be returned to RJOS within sixty (60) days, together with a final report of expenditures. RJOS reserves the right to terminate grants at any time upon three months written notice.

11. Publication
a. RJOS and Zimmer Biomet encourage free publication of research findings by grantees, but require that the following acknowledgement be used as a footnote on the first page of the text, “Aided by a grant from the Ruth Jackson Orthopaedic Society and Zimmer Biomet.”
b. Also, when a grantee presents a paper at a professional scientific meeting, the above credit line must be included.
c. RJOS should be sent reprints of all papers and publications resulting from work done under a grant, even those that appear after the grant has been terminated.
d. RJOS imposes no copyright or other restriction on publication(s) by grantee.

12. Patents
a. If any patents accrue from investigations supported by grants funded by RJOS, RJOS reserves the right to negotiate a proportionate interest in the resultant royalties.
REQUIRED DOCUMENTATION FOR GRANT SUBMISSION

Please complete all required information, and include all required attachments. Incomplete applications will not be reviewed.
To obtain information regarding the clearance status of a device or pharmaceutical refer to the product labeling or call the FDA 1-800-638-2041 or visit the FDA Internet site at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ 

In my ‘work’ for this RJOS/Zimmer Biomet Research Grant submission:
• The FDA has cleared all pharmaceuticals and/or medical devices for the use described in this presentation.
• The FDA has not cleared the following pharmaceuticals and/or medical devices for the use described in this presentation. The following pharmaceuticals and/or medical devices are being discussed for an off-label use.

NOTE:  RJOS’ policy provides that “off label” uses of a device or pharmaceutical may be described in the Society’s CME activities so long as the “off-label” status of the device or pharmaceutical is also specifically disclosed (i.e. that the FDA has not approved labeling the device for the described purpose).  Any device or pharmaceutical is being used “off label” if the described use is not set forth on the product’s approved label.
Required Forms: 

RJOS/Zimmer Biomet Clinical/Basic Research Grant Application
Download the application form here. 

Biographical Sketches 
• Biographical Sketches must be submitted for all investigators listed in the Key Personnel section. Download the biographical sketch form for each investigator, combine all completed biographical sketches into one PDF file, save to your computer and upload below.
Required Forms:  Budget Form 

• Download the budget form, complete form, save to your computer and upload below.
Required Forms:  Mandatory Financial Disclosure  
• Download the Mandatory Financial Disclosure (required for each author/investigator). Combine all completed disclosure forms into one PDF file, save to you computer and upload below.
Required Forms:  Research Plan and Bibliography   
• Research Plan describes the proposed research, stating its significant and how it will be conducted.  The Research Plan should be a maximum of six (6) pages including all figures and tables. Upload below as one PDF.
• Bibliography and references: Include a bibliography of any references cited in the Research Plan. Upload below as one PDF.

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* 1. RJOS/Zimmer Biomet Clinical/Basic Research Grant Application.

PDF file types only.
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* 2. Biographical Sketchor Sketches for each investigator. Upload as one PDF file.

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* 3. Budget, both initial and entire proposed period.

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* 4. Mandatory Financial Disclosure (required for each author/investigator). Upload as one PDF file.

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* 5. Research Plan. Upload as one PDF.

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* 6. Bibliography and references. Upload as one PDF.

PDF file types only.
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* 7. Additional Documents. Upload as one PDF.

PDF file types only.
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STATEMENTS AND ADDITIONAL QUESTIONS

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* 8. Today's date

Date

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* 9. Gender

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* 10. Ethnicity 

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* 11. Sexual Orientation

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* 12. Contact Information:

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* 13. STATEMENT OF CAREER GOALS: Please state the reasons for your interest in women’s musculoskeletal health issues. The statement must describe your objectives, clinical and research interests, and personal goals, and how these can best be accomplished by receipt of this grant. Please indicate what you would like to be doing in five to ten years.

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* 14. SPECIFIC INVESTIGATION PLANS: ABSTRACT: Please provide a 100-word executive summary with 5 underlined phrases for the planned project in the box below. State the broad, long-term objectives and scientific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This description is meant to serve as a succinct and accurate description of the proposed work when separated from the application.

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* 15. STATEMENT OF CLINCIAL RELEVANCE: Provide one paragraph (200-word limit) that explicitly and clearly describes how your research project will impact the clinical practice of orthopaedics. Describe how your project will change the way we think about clinical problems or how we treat them.

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* 16. POTENTIAL CLINICAL STRATEGIES: If your project is successfully completed (e.g. hypotheses confirmed or aims achieved) specify how the information could be used to develop strategies for treating a specified targeted patient population.

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* 17. PERFORMANCE SITE(S): Indicate where (Organization, City, State) the work described in the Research Plan will be conducted. If there is more than one performance site, list all the sites, including V.A. facilities and provide an explanation on the Resources Page of the application.

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* 18. Personal Statement: Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PI, mentor, participating faculty) in the project that is the subject of the application. Within this section you may, if you choose, briefly describe factors such as family care responsibilities, illness, disability, and active duty military service that may have affected your scientific advancement or productivity.

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* 19. Positions and Honors: List in chronological order previous positions, concluding with the present position. List any honors.

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* 20. RELEVANCE OF THE PROJECT TO THE MISSION OF THE RUTH JACKSON ORTHOPAEDIC SOCIETY: Provide a statement describing the relevance of the project to the mission of RJOS.

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* 21. RESOURCES: List facilities available at your institution and other sites where the research will be performed. Include laboratory space, office and major equipment available for use with this investigation.

To obtain information regarding the clearance status of a device or pharmaceutical refer to the product labeling or call the FDA 1-800-638-2041 or visit the FDA Internet site at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ 

In my ‘work’ for this RJOS/Zimmer Biomet Research Grant submission:
• The FDA has cleared all pharmaceuticals and/or medical devices for the use described in this presentation.
• The FDA has not cleared the following pharmaceuticals and/or medical devices for the use described in this presentation. The following pharmaceuticals and/or medical devices are being discussed for an off-label use.

NOTE:  RJOS’ policy provides that “off label” uses of a device or pharmaceutical may be described in the Society’s CME activities so long as the “off-label” status of the device or pharmaceutical is also specifically disclosed (i.e. that the FDA has not approved labeling the device for the described purpose).  Any device or pharmaceutical is being used “off label” if the described use is not set forth on the product’s approved label.
Documentation of FDA Status for Uses Described

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* 22. Manufacturer Name and Drug or Device

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* 23. Manufacturer Name and Drug or Device

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* 24. Manufacturer Name and Drug or Device

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* 25. Manufacturer Name and Drug or Device

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* 26. Manufacturer Name and Drug or Device

Institutional Review Board (IRB) Statement

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* 27. Please check the appropriate statement which most accurately reflects the involvement of your Institutional Review Board (IRB) in the investigation you are submitting to RJOS for consideration.

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* 28. By checking this box and submitting this application, I agree to abide by the criteria and responsibilities outlined should I receive this award.

THANK YOU

Thank you for your interest in the Ruth Jackson Orthopaedic Society. If you have questions regarding your submission, please contact the RJOS Office at info@rjos.org or 847-698-1626. 

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