Institutional Review Board Guidelines

Submission Instructions and Forms for IRB Review of Research/Study Protocols
The following forms and information are provided to facilitate the Institutional Review Board (IRB) review of research projects/studies submitted to the Missouri Department of Health and Senior Services (DHSS).  The forms are to be completed electronically, whenever possible.  The electronic version and paper copy are to be submitted to the DHSS staff person working with you on the project/study. 

Note:  These documents were created in Microsoft Word 2000.   Users with more recent Word applications should open the documents in Microsoft Word 2000.

• Abstract of Protocol
• IRB Form 1  ‘Request for Review of Research Protocol’
• Protocol Template
• Checklist for Submission of Research/Study Protocols
• Cover Sheet for DHSS IRB Submissions (DHSS internal use only)
• IRB Form 2  ‘Information for Continuing Review of a Previously Reviewed Project’

Other Information of Interest for Investigators
DHSS IRB Guidelines

• Organization and Functions
• Procedures
• Definitions of Terms
• Information for Research Investigators
• Informed Consent Guidelines (includes sample form and checklist for consent development)
• Template of an Agreement for Reliance on Other Institution’s IRB

References and Related Documents

• Department of Health and Human Services, Office of Human Research Protection
  http://www.dhhs.gov/ohrp
• Code of Federal Regulations (CFR) including Title 45 Part 46 Protection of Human Subjects and listing of other agency CFR references
  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• Institutional Assurance of Compliance (FWA) and IRB registration numbers
  http://ohrp.cit.nih.gov/search/asearch.asp#ASUR  
• Missouri Department of Health and Senior Services
  http://www.dhss.mo.gov/DataAndStatisticalReports/index.html

Contact Information
Tricia Schlechte, MPH, BSN                                               Sharon Ayers, Chair
Department Signatory Official                                            Institutional Review Board
Tricia.Schlechte@dhss.mo.gov                                          Sharon.Ayers@dhss.mo.gov