GUIDELINES FOR SUBMITTING RESEARCH PROPOSALS (version November 2004)

 

 The following is an outline of the points which should be covered in a research proposal (new or renewal), and the recommended length of each section.  Sections 1 through 6 should not exceed 10 pages.  Proposals requesting review of medical charts must also follow the outline below but may be shorter (sections 1-6 not less than 2 pages).

1. Abstract: (up to 350 words). Briefly: state the background, rationale, and aims of the project; describe the methodology and the analysis of data; and state the significance and relevance of the project.

2. Specific Aim(s): (up to 1 page). Enumerate and describe concisely the specific research objective(s) of this application.  Emphasize the specific hypotheses to be tested.

3. Background and Significance:  (1-2 pages). Describe the background to the present proposal, critically evaluating the existing knowledge on the topic, and specifically identify any gaps in knowledge the project is intended to fill.  Describe the goals and objectives that the project intends to achieve.  State the importance and relevance of the proposal to health care and medical sciences.

4. Progress Report/Preliminary Studies: (1-3 pages)  A progress report is required for renewals.  For new applications, this section may be used to report on preliminary pertinent studies and/or information that helps in appraising the experience and competence of the investigator. 

For Progress Reports: summarize the previous application's specific aims and provide an account of published and unpublished results which describes progress toward their achievement.  Summarize the importance of the findings.  Discuss any changes in the specific aims since the last review of the proposal.  List titles and complete references to all publications, manuscripts (accepted or submitted), and other printed materials resulting from this proposal since its last review.   

5. Research Design and Methods:  (up to 6 pages). Describe the research methods and procedures to be used to accomplish the specific aims of the project. Comment critically on them.  This section should include, where appropriate: 

  1. The specific data to be collected (the parameters to be measured).

  2. The means by which the data will be collected, analyzed and interpreted.

  3. A description of surgical procedures.

  4. The protocols of drug dosage regimens.

  5. The number of subjects per group, and its justification.

  6. A description of any new methodology and its advantage over existing methodologies.

  7. A discussion of potential difficulties and limitations of the work and possible alternatives.

  8. A tentative time-table for the investigation.

  9. A pointing out of procedures and materials that may be hazardous to personnel and the precautions to be exercised.

  10. A description of the statistical analysis of the data.

 Human Subjects:  If human subjects are involved, the following points should be addressed:

 a. A description of the subject population including number, gender, age, health status, ethnic groups, etc..., and criteria for inclusion and exclusion and their rationale.

 b. Source of material obtained from living subjects in the form of specimens, records, or data.  Indicate whether this will be obtained specifically for research purposes or whether use will be made of previously obtained material or material obtained in the course of standard clinical work-up of the patient.

 c. A description of plans for recruitment of subjects, the nature of the information provided to prospective subjects, the method of obtaining consent and, if applicable, a copy of the informed consent form to be used.

 d. Potential risks, their likelihood and seriousness. Describe alternative treatments and procedures that might be advantageous to the subject.

 e. If more than minimal risk exists, state specifically the procedures for protecting against or minimizing these risks.  Indicate how provision will be made to ensure necessary medical intervention and prolonged hospital stay in the event of adverse effects to the subject directly resulting from participation in the study.

 f. A discussion of why the risks to the subject are reasonable in relation to the anticipated benefits and in relation to the importance of the knowledge that may result.

 Vertebrate Animals: This section complements the "Animal Use Form".  The section should include:

 a. Description of the proposed use of the animals in the work described.  Identify the species, strain, sex, age, and number of animals to be used.

 b. Justification for their use, especially for their number.

 c. 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 use of analgesics, anesthetics, tranquilizing agents and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain and injury.

 d. Description of the method of euthanasia to be used and reason for this choice (if applicable).

 6. Interpretation of Results: Describe how the methodology and approach proposed will indeed give  the answers to the questions posed, and explain how the data collected will be analyzed and interpreted.  (This may be a separate section or an integral part of "Research Design and Methods"). 

7. Literature Cited. Provide the authors' names, title, journal, volume and page numbers and year of publication, in this order.  For books, mention in addition the book title, editors' names (if applicable), and publisher.

8. Budget: This should be itemized and detailed enough to allow judgment of its appropriateness based on the description of the research design and methods. A separate justification section may be included if necessary. The budget may be divided into 5 parts:

  1. Personnel. Indicate the percent of time that will be allocated to the proposal. Include salaries and benefits in the budget.

  2. Supplies.

  3. Equipment. (For supplies and equipment, make sure that the 35%-65% shipment expenses for foreign orders are considered).

  4. Others, e.g.: animal costs, compensation for human subjects.

  5. Overhead (if applicable).

 Note: If hospitalization, extended hospitalization or another form of medical intervention is a potential consequence of participation of the subject in the study, funds should be secured or available as insurance to cover these expenses.   

 9. Timeframe for the Study: Describe the duration of the proposed work and the division of labor during that time-period. Set landmarks for accomplishment of tasks or specific aims for the duration of the study. Make sure that the budget is in line with the proposed timeframe.

 10. Time Commitment and Funds Available: The investigator must clearly state the percent of his/her time he/she will spend on this proposal.  Mention other sources of funds for the proposal being now submitted and the amounts provided.  Also, a list of other research projects under way should be provided indicating percent time allocated to them, the granting agencies, the funds available and the dates they will expire. 

 11. Co-investigators:  This section should include a description of the role of each co-investigator in, and his/her contribution to, the accomplishment of the proposed work.  All co-investigators are also asked to indicate the percent of their time to be spent on the project.

 12. Forms to be Filled and Submitted:  Make sure to fill the necessary forms:

Submission Checklist:  Please refer to the required checklist and make sure to include all the required items in your submission.  Include the checklist itself and mark each applicable item in the left column

Cover sheets:  There are several cover sheets that need to be filled and signed by the investigators and the chairperson of the principal investigator's department, depending on where the proposal is to be submitted:  a Cover Sheet (Word Format) is requested by the Research Committee for all submissions, with signature of the principal investigator, each co-investigator, and the chairperson of the principal investigator's department.

In addition, some agencies have their own cover sheet to be filled as well:

a)  the URB Proposal Transmittal and Approval Form for submissions to the URB.

b) the Proposal Transmittal and Approval Form for submissions to outside funding agencies, required by the Grants and Contracts Office. 

c) Proposals submitted to the LNCSR must, in addition to the LNCSR Proposal Transmittal and Approval Form required by the Grants and Contracts Office, include a LNCSR Cover Sheet in Arabic and provide an abstract of the work in Arabic.

Investigators are encouraged to submit to all funding sources to maximize their chances of funding.

Informed Consent Form:  for any research involving human subjects (in Arabic). Check the informed consent checklist.

Radiation Safety Forms:  for any research that uses radioactive material or sources. There are 3 forms: one for animals, and two for humans.  The latter include one form for use of X-rays and another for unsealed radioactive material.  "Sealed" refers to any radioactive material that is encased in a capsule designed to prevent leakage or escape of the material. "Unsealed" refers to any radioactive material source that is not a sealed source.

Animal Use Form:  for any research using animals.

Investigational Drug Form:  for studies employing drugs not yet approved by the Food and Drug Administration of the U.S.A..  This form should be filled also if FDA-approved drugs are to be used as investigational agents for purposes other than those specified by the FDA.

 

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