Institutional Review Board

Student Handbook on Human Subject Research

August 2006

USM IRB Application Checklist

A review will not be started until application is complete.

Applications for IRB Review must include the following elements to be considered complete:

• Request for IRB Review form (or other appropriate USM IRB Review form)
• Research Proposal Summary (must be in the same format listed below, using lay language, as brief as possible, and not to exceed 3 pages Important Tips
  1. Introduction
     • References/Brief Literature Review
     • Should show thoughtful consideration of the research topic, particularly if the study involves greater than minimal risk
     • Should be current and should reflect recent advances or changes in the field of inquiry.
  2. Specific Aims
  3. Methods of Data Collection and Analysis (Qualitative and Quantitative)
  4. Description of the subject population, research setting, subject recruitment procedures
  5. Informed Consent procedure
  6. Provisions for subject and data confidentiality
  7. Statement of potential research risks to subjects (e.g. breech of confidentiality, treatment complications)
  8. Statement of potential research benefits to subjects (Monetary compensation is not a benefit of participation)
  9. Investigator experience (Attach a current copy of your C.V., unless one is on file with the IRB already)
• Copies of all advertisements/flyers used for recruitment of subjects
• Copies of all questionnaires, guiding questions, survey instruments, tests, etc.
• Other pertinent documentation Supplementary Information
  • Debriefing scripts/forms
  • Grant application (complete application, including grant face page)
  • Section of the thesis or dissertation that describes the human subjects portion of the research
  • Complete Research Proposal (if study needs Full Board Review or if requested by IRB)
  • Letters of cooperation from any cooperating groups, schools, etc.
  • For research conducted in foreign countries, documentation of local approval (e.g. approval by a local ethics review committee) AND the informed consent document(s) to be used in the foreign country.
  • Other institution IRB approvals of research studies to be conducted by USM faculty/staff/students or at USM facilities when the Principal Investigator is from the other institution.