MEDSTAR RESEARCH INSTITUTE

INTRAMURAL RESEARCH GRANT PROGRAM

GUIDELINES FOR FISCAL YEAR 2006

 

MedStar Health provides research funding annually through the MedStar Research Institute. Grants will be awarded in the following three categories:

Young Investigator

• Only open to full-time MedStar Health employees or private-practitioners who are full-time active attendings at a MedStar facility who have completed their professional training within the past 5 years.
• Must include an experienced investigator as a mentor or faculty advisor, who will agree to supervise and train the novice investigator. The mentor/faculty advisor would need to submit a letter of support and agreement to provide training for the study.
• Must be an original project, not an adjunct to work already being done by the faculty advisor.
• The purpose of these grants is to foster and promote the career goals of new researchers.
• The proposals will be evaluated based on the potential career of the investigator, the track record of the mentor and the feasibility of the project leading to publishable data and future funding.

 

Research Development

• Funding for experienced investigators who want to initiate a project in an area where they have not received previous funding.
• Proposals to provide additional or supplemental funding for projects with outside funding sources are not acceptable.
• Priority will be given to pilot studies and laboratory studies with potential for development into long-term research projects with potential for R01 or other outside funding.

 

System-wide Research Initiative Award

This award will be a single grant with a 3-year funding period. It is anticipated that the first year will be devoted to initiating the protocol and defining project procedures; the main focus of the second year will be patient recruitment and data collection and the third year will focus on data analysis and manuscript preparation.

The objectives of this grant are:

• Increased collaboration among all MedStar hospitals.
• Advancement in targeted clinical programs by fostering an academic environment throughout the hospitals and promoting public recognition of research programs developed at MedStar Health facilities.
• Development of preliminary data for future outside funding activities.

 

 

The MedStar Intramural Research Grant program is open to full-time MedStar Health employees or private practitioners who are full-time active attendings at a MedStar Health facility. Investigators may be involved as a PI in no more than one project for funding per fiscal year. The maximum budget request for the Young Investigator Awards is limited to $25,000. The Research Development Awards may be submitted as one or two-year studies, with a budget limit of $40,000 per year. The decision to grant funding for the second year will be at the discretion of the review committee. Systemwide Initiative Awards may be budgeted for no more than $150,000 over three years. All approvals will be for one year of funding, beginning July 2005 through June 2006. Funding for additional years will be contingent on work completed, progress reports submitted, adherence to program requirements and the discretion of the review committee.

Projects initiated and funded in FY05 may be submitted for funding for a second year, but must compete for funding with all other submitted projects. A progress report must be submitted with evidence of adequate progress. Applications submitted without a progress report will not be accepted. If an investigator has received funding for the same or similar research study for two successive years, evidence that external funding sources have been sought must be provided.

The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial; should meet all the qualifications specified by the applicable regulatory requirement(s); and should provide evidence of such qualifications through up-to-date curriculum vitae (CV) and/or other relevant documentation, research training from the web. For the Young Investigator’s grants, the PI must be a full-time MedStar Health employee who has completed professional training within the last 5 years. These applications must be accompanied by a letter of support from an experienced investigator who has agreed to serve as faculty advisor/mentor to the new investigator.

For nursing projects, the PI must be a registered nurse or possess a professional degree. Proposals involving human subjects must have a physician on the institution’s Medical Staff as a co-investigator. All research studies initiated with a MedStar Health-employed nurse as the PI must contain the signature of the Senior Vice President of Patient Care Services. The institutions’ Nursing Research Committee (if applicable) must review and approve the proposed study before submission.

For research involving Biomedical Instrumentation, the PI can be a member of the Biomedical Engineering Department with a minimum of a bachelor’s degree. If the proposal involves human subjects, it must have a physician on the institution’s Medical Staff as a co-investigator.

When to Apply: The application must be received electronically no later than 4:00 pm., Friday, April 15, 2005. A hard copy of the application with required signatures must be submitted by April 22, 2005 to the Office of Administrative Research Services, 201 E. University Parkway, Suite #526, Baltimore, MD 21218. This should be accompanied by any documentation (CVs, etc.) that was not submitted electronically. Hand-written or hard-copy only applications will not be accepted. Any applications not submitted in this manner and by these dates will not be considered for funding.

 

Where to Apply: Application forms will be available on the Office of Administrative Research Services webpage of the MedStar website (www.medstarresearch.org).

 

How to Apply: All applications for funding must be submitted using the MRI Intramural Research Grant Application Form. The principal investigator, the Chair of the clinical department and any co-investigators must sign the application.

To assure a fair review, all of the elements listed below must be addressed in the protocol. Start a new section for each item. The total proposal should not exceed 20 pages.

Application Criteria: Intramural Research Grant application should include the following:

1. MRI FY2006 Intramural Research Grant Program Application
2. Research Proposal/Protocol*
3. CVs for all investigators and study personnel

REMINDER: The award of an intramural grant does not include IRB or IACUC approval. If your project is funded, it must also be approved by the appropriate committee. The information for submission of the project can be found on the website www.medstarresearch.org. No funds will be disbursed until documentation of approval is received by the Office of Administrative Research Services.

Research Protocol

Definition: A formal written document, which states the rationale, objectives, methodology and statistical design of the study, with the conditions under which it is to be performed and managed.

*Protocol Criteria: At a minimum, the protocol must address the following headings:

1. Objectives and Aims – state the questions and goals of the research study; including the hypothesis being tested;
2. Background and Significance – give a summary of findings and evaluate existing knowledge; include results from preliminary studies (if any); explain the significance/benefits of this research;
3. Research Study Design – describe the design chosen to answer the question(s) (e.g., randomized controlled study, case control study, etc.);

 

4. Methods – this section should include the following subsections:
1. Procedures – define how the research design will be implemented. Include a section defining any measurements that are to be taken and how data will be collected. Include examples of data forms/instruments in an Appendix if applicable. Describe sampling and randomization procedure. Describe how participants will be chosen. Define the disease criteria; include medically defined inclusion and exclusion criteria (with a rationale for exclusions).
2. Data analysis and sample size justification –Describe the methods you will use for data tracking, data entry, methods and storage. How will the quality of the data be insured? Include your plan for statistically testing each hypothesis. A sample size calculation should be included for the major hypothesis. Sample size estimate must include the following:

 

1. Type I error rate (the probability of accepting the alternative hypothesis when it is not true);
2. Type II error rate (the probability of rejecting the alternative when the alternative is true);
3. Documented variance estimates (some estimate of dispersion);
4. Expected differences (the difference in measures of central tendency, these must be referenced, and must be clinically significant differences);
5. The statistical test (state if it is one or two sided).

 

It must be shown that the sample size is adequate for testing any secondary hypotheses. Sample size estimates must be adjusted for dropouts, multiple comparisons (comparing more than two groups), multiple testing (testing more than one hypothesis), and interim analyses (testing before the end of the study). For more information and/or assistance on data analysis, please contact Dr. Norman Dubin at: 410 554-4500.

3. Project organization – Give the project organization/reporting structure. Define staff positions, and include a description of personnel and their qualifications. The PI must demonstrate the ability to conduct this research by showing adequate experience in this research area.
4. Project schedule – Give a detailed schedule describing work to be completed during approved study time period. Include plans for publication after the study has ended.
5. Problems/weaknesses – Describe any anticipated problems in getting this research completed. Point out any weaknesses in the study design/methods.

 

5. Human Subjects –
1. Study sample – Justify the sample chosen for the study. Demonstrate how this study sample is adequate to extrapolate results to a larger group.
2. Confidentiality–Include a statement about how patient confidentiality will be maintained.
3. Risk/Benefit Assessment – Include an explanation of why the study presents the stated level of risk. Risks to the participants posed by participation in the research study are to be justified by the anticipated potential for benefit to the participants or society.
4. Study Population – Gender/Ethnic Inclusion – must include: a) rationale for research subject selection based on review of gender/ethnicity categories at risk for the disease/condition being studied; b) strategies/procedures for recruitment; and c) rationale and justification for any exclusions.
5. Recruitment Plan – describe in detail strategies and procedures to ensure appropriately balanced recruitment of participants based on gender and ethnicity.
6. Facilities – Laboratory, clinical, computer. Designate laboratory or clinical space available and other pertinent equipment needed to conduct the study (e.g., computer or specialized laboratory equipment).
7. Vertebrate Animals – Submit a separate completed "Request for Institutional Care & Use Committee Approval of Animal Use" form.
8. Consultants – Provide appropriate letters from all individuals confirming their roles in the project.
9. Curriculum Vitae – Include signed and dated curriculum vitas/resumes for the principal investigator, each co-investigator and any other study personnel.
10. Literature Cited – include references for all literature cited in the document.
11. Compliance –The protocol and conduct of the study must also comply with the mandates of the Department of Health and Human Services (DHS), Food and Drug Administration (FDA), the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and all applicable institutional, state and local requirements.
12. Appendix – Should include all supporting documents of the project, e.g., questionnaires, abstracts, sample size work sheets, pertinent reference articles, etc.

Required Signatures: The required signatures (listed below) must be submitted by Friday, April 22, 2005. Any applications not submitted with the required signatures by this date will be considered invalid and will not be reviewed.

• Signature of the PI
• Signature(s) of the co-investigators (if any)
• Signature of the Department or Section Chair
• Signature of the institution’s Medical Director/VPMA (if the Department Chair is the investigator)

For additional information or questions about this process, please contact the Office of Administrative Research Services at 410-554-4501.

 

 

LINKS

Main Page   Guidelines   Download Forms   Sign-up Online