Investigator-initiated studies are managed by the same regulations that apply to the sponsor initiated studies. As an investigator, regardless of the study type, whether it is a chart review or a formal clinical trial, you will be responsible for the proper and safe conduct of your study from initiation until the completion of the study project. It is your sole responsibility to ensure compliance with the federal and state laws, codes of ethics and good clinical practices.

The OCR provides research support to the investigator to facilitate the overall process of a clinical research study. We recommend you follow these steps in order to facilitate the submission and approval process.

Step 1

Formulating a Research Question

• Choose an interesting relevant topic and know the science behind it
• List all the questions you will have derived from that topic
• Be precise and choose the best question based on your own practical knowledge. You might find that it is difficult to establish a hypothesis for some of your questions
• Quantify both what you will measure and what will be considered a "difference"
• Your research question should lead into a specific "testable" hypothesis
• Aim for one primary objective and 2-3 secondary objectives (your sample size is typically determined using the primary objective)
• Evaluate your research question based on significance and feasibility

Examples:

Research Question: Is Drug A better than Drug B?

Basic Hypothesis: We hypothesize that Drug A is better than Drug B

Improved Hypothesis: In pediatric populations aged 10-17 years, we hypothesize that Drug A will extend the remission period by at least an additional 5 years over that experienced by patients utilizing Drug B.

Notes: Be sure to address the specific population (pediatric population aged 10-17), quantify the outcome variable (remission period) and be precise about what you are testing (increased remission period that’s at least 5 years longer).

Step 2

Literature Search

The goal of the literature review is to determine what research has been conducted on your topic of interest and how has it been conducted. This information is necessary because:

• It will help you get ideas about how to structure your own study
• It will help you identify gaps in the knowledge base of the scientific community
• It will aid you in determining the sample size necessary for your study
• You can learn from other study mistakes and limitations and try to prevent such problems in your own study

Helpful Notes:

• When conducting a literature review, we typically recommend using PubMed or MedlinePlus as the main search databases, but other databases can be tried as well.
• Try using a variety of search terms/combinations in your review. For instance- in conducting a literature review on the incidence of pediatric brain tumors, try the following search terms: Pediatric brain tumors, pediatric brain cancers, brain cancers in pediatric populations, incidence of pediatric cancers, epidemiology of pediatric cancers, epidemiology of pediatric brain tumors, etc…
• When you find a useful article- read over the references cited for that paper. They can often help you identify additional relevant articles that may not have shown up in the initial database search.
• While establishing a bibliography, we recommend using EndNote or Reference Manager. These are software tools for publishing and managing bibliographies and are used frequently for citations and managing endnote libraries. Our USF Health Shimberg Health Sciences Library offers training for using EndNote.
• Try to find papers that are utilizing a population similar to the one that you will be using- this will very helpful when it comes time to do sample size calculations

Step 3

Discuss your research question with knowledgeable peers, department chair, mentor, and the biostatistician.

Step 4

Consider the steps necessary to conduct your study for example, type and phase of the clinical trial, budget, informed consent, sites, resource constraints of both personnel and facilities, study duration.

Step 5

Draft a Final Protocol for departmental ethical and scientific review. Review should be done in the following order

1. Departmental Scientific Review/Approval/Signature
2. Departmental Chair Review/Approval/Signature

While drafting a protocol follow the Guidelines for Designing a Clinical Study Protocol.

It may be helpful to use a template when writing your protocol. Click here for a Chart Review protocol template. Click here for a Clinical Trial protocol template.

Step 6

IRB and Site Submission and Approval

IRB application and your USF Division of Sponsored Research (DSR) submission can be done simultaneously in order to expedite the process. The DSR submission consists of the Internal Form with the following support documents attached electronically via the File Attachments functionality built into the web-based Research Online Internal Form system:

• Research Proposal, Protocol, Abstract or other scientific document that describes the project
• Budget to include:
  • Grant Proposal budget justification page showing PI and key personnel name, percent effort, and salary allocated to the study
  • Additional budget elements such as patient care costs, etc.
• Financial Management Plan from eCOI Module in ARC, if applicable
• Reporting Outside Activities Database (ROAD), if there is outside activity that is or could be perceived as conflicting with the research
• Nepotism Memo, if there are any relatives or related persons participating in the research
• Completed Grant Budget Release form signed by the PI

The Internal Form must be fully executed at the time of proposal submission to the sponsor. Contact your DSR Sponsored Research Administrator for assistance.

The USF IRB application is found at this website: USF eIRB Sign On 
Investigator initiated studies are not eligible for WIRB submission for USF investigators. Once the IRB Approval letter is received, forward a copy to your DSR Sponsored Research Administrator for their files.

Step 7

Start the study.