FAQ: What documents do I need to submit with my IRB application?

The following types of documents should be submitted with the appropriate application as applicable.

Initial Application

  • Application signature page for expedited and full board
  • Instrument(s) or measures (e.g. survey(s), interview questions, questionnaire(s), case report(s), protocol)
  • Consent form(s) or script(s) for verbal consent (unless requesting waiver of consent)
  • Assent form(s)
  • Recruitment material(s), including advertisement(s)
  • Contract or grant application and MSU Office of Sponsored Programs (OSP) number for externally funded research
  • Debriefing form(s)
  • Translation of instrument(s) and consent(s) provided to non-English speaking subjects
  • Letter(s) of permission from school administration to allow researchers to conduct research in individual schools
  • Letter(s) of permission from non-MSU sites not subject to a reliance agreement (e.g. hospitals, nursing homes, companies)
  • Health Insurance Portability and Accountability Act authorization form(s)
  • Investigator brochure(s)
  • U.S. Department of Health and Human Services (DHHS) approved sample informed consent(s) and complete DHHS approved protocol(s) for DHHS sponsored multi-center clinical trials
  • If submitted to other IRB(s), that institution(s) approval letter(s)
  • Package insert(s) if using a U.S. Food and Drug Administration approved drug/device/diagnostic test
  • U.S. Food and Drug Administration (FDA) form 3454 or 3455
  • FDA form 1572
  • Curriculum vitae when research is more than minimum risk
  • Any other pertinent documents related to the proposed research study

Renewal

  • Current consent form(s) (not required if study closed to accrual and only undergoing data analysis)
  • Data safety monitoring board report(s)
  • Relevant multi-center trial report(s)

Revision

  • Any document(s) with proposed revisions (e.g. consent, instrument, advertisement)