Protocol Description

The IRB Protocol in IRIS is the entire submission process.  A protocol (proposal, story of the research, description of your proposed work) is a written document to be attached in the IRB Protocol submission.  The document is a written description of the research (work) the investigator intends to conduct.  Each of the following five areas should be addressed.  There is no appropriate length of any area.  The goal is to describe what you wish to do.  If you intend to use any survey instruments, copies of those should be included as a part of the IRB Protocol submission.

The protocol document should at least contain:

  1. the problem statement,
  2. justification for the research,
  3. methodology,
  4. the plan of analysis, and
  5. the timetable.

The following expands on the above

TITLE OF THE RESEARCH PROJECT

PROJECT SUMMARY

STATEMENT OF THE PROBLEM (scientific or scholarly justification)

JUSTIFICATION AND USE OF THE RESULTS (final objectives, applicability)

THEORETICAL FRAMEWORK (argumentation, possible answers, hypothesis)

RESEARCH OBJECTIVES (general and specific)

METHODOLOGY

  • Operational Definitions (operationalization)
  • Type of Study and General Design
  • Universe of Study, Sample Selection and Size, Unit of Analysis and Observation, Selection
  • Criteria
  • Proposed Intervention (if applicable)
  • Data Collection Procedures, Instruments Used, and Methods for Data Quality Control
  • Procedures to Ensure Ethical Considerations in Research with Human Subjects

PLAN FOR ANALYSIS OF RESULTS

  • Methods and Models of Data Analysis according to Types of Variables
  • Programs to be Used for Data Analysis

BIBLIOGRAPHIC REFERENCES

TIMETABLE

ANNEXES (Data collection instruments, elaboration on methods and procedures to be used, etc.)

  • Proposed studies that involve retrospective review of a subjects' medical records, the use of questionnaires or guides for data collection should have an annex containing copies of the instruments and should indicate their stage of preparation (e.g., version for pilot testing, final version, etc.).