Philadelphia University + Thomas Jefferson University

Proposal Instructions

Goal: To fund small-scale clinical research studies that generate sufficient pilot data to justify either: 1) a larger, fundable clinical research grant; or 2) an Human Subjects Research study that is included in any competitive extramural grant (e.g., as an Aim in an R01).

Cover Page

Include name, department and contact for all investigators and an abstract summarizing proposal.  Click here to download the cover page.

Justification Page

This section should be considered a very important aspect of the proposal. Click to download the Justification Page

The Justification page queries:

1. The proposal’s goal(s). State primary (and secondary, if applicable) outcome.

2. The gap in knowledge the research will address and evidence that such research has not been performed to date.

3. Number and types of subjects to be recruited. Note inclusion and exclusion criteria. Note whether: a) the study had IRB approval; b) IRB review is pending; or c) IRB has judged the study Not Human Subjects Research.

4. Whether the proposed research is eligible for submission to any other intramural funding mechanism, and whether it been submitted for extramural funding.

5. Requested start date.

6. Future funding mechanism that will utilize the data collected

NIH Style Biosketch

The biosketch must contain a personal statement relevant to this application that addresses why the proposal is being submitted and why the investigator expects to be successful. This statement should show that the investigator has appropriate experience and training, ongoing record of accomplishments and how these accomplishments have advanced the investigator’s field of study. If this is a multi-investigator project, a biosketch should be submitted for each investigator. For such collaborative projects the personal statements should include comments on the investigators’ complementary and integrated expertise, any evidence of previous research successes from this collaboration, and programmatic funding envisioned down the road.

Specific Aims

Should not exceed one page.

Introduction- for resubmission only

Include a one page introduction explaining how you have addressed the reviewers' comments.

Research Strategy - not to exceed four pages

Significance. How does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field and lead to extramural grant funding?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are these novel to one field of research or in a broader sense?

Approach. Present a well-reasoned strategy, a brief methodology section that gives confidence in the proposed approach, how the data will be analyzed, and how the approach will accomplish the specific aims of the project. Include potential problems to achieving the goals of the project and what benchmarks will be used to determine success. The strategy must address feasibility. The approach must include a discussion of how the limited studies proposed in this intramural application fit into and enhance the bigger picture of the research goals.

Expected Outcomes. Specify expected scientific outcomes and the planned return on investment – how the results that are obtained from the proposed study will enhance the research mission of both the investigator and Jefferson. This section should include a detailed discussion of the expected return of Jefferson's investment in this proposal, including expected future extramural grant support.

Subject Recruitment. Provide evidence of the ability to recruit subjects for the study.

Statistical Analysis and Power Analysis. Note how data will be analyzed. Provide a power calculation that estimates the number of subjects required to demonstrate statistical significance (or an acceptable trend that would justify further pursuit), for data with specific mean group differences and variance, for each outcome.

Protection of Human Subjects

This section must conform to the rules for the Protection of Human Subjects sectioned required for NIH grants, also include statements regarding inclusion of women, minorities, and children, and should be organized as follows:

PROTECTION OF HUMAN SUBJECTS

Risks to the Subjects

  1. Human Subjects Involvement and Characteristics
  2. Sources of Materials
  3. Potential Risks
  4. Recruitment and Informed Consent
  5. Potential Benefits of the Proposed Research to Subjects and Others
  6. Importance the Knowledge to be Gained
  7. Data and Safety Monitoring Plan
  8. Women and Minorities Inclusion
  9. Inclusion of Children

Additional Documents (if applicable) not included in page limit:

  1. IRB approval letter OR IRB letter noting research is Not Human Subjects Research.
  2. Targeted/Planned Enrollment Table
  3. Informed Consent form

Budget & Budget Justification

Include a detailed budget of the funds that are requested to accomplish the goals of the proposal and a separate page that clearly justifies all requests. In addition, include a budget justification page that justifies all personnel and other expenses. Please note NO salary can be requested for principal investigator (PI) or faculty. (Download budget form).