Submission Instructions and Forms for IRB Review of Research/Study Protocols

The following information and forms are provided to facilitate the Department’s Institutional Review Board’s (IRB) review of research projects/studies submitted to the Missouri Department of Health and Senior Services (DHSS). All external researchers are required to collaborate with a DHSS Co-Investigator. The DHSS Investigator or assigned DHSS Co-Investigator is responsible for ensuring the electronic application packet is submitted with all required documentation, signatures, and appropriately routed to ensure a timely review.

DHSS IRB Guidelines

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

DHSS IRB forms are to be completed electronically. The checklist provided identifies additional required documentation needed to ensure a timely review.

DHSS IRB Initial Review forms:

• 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)

DHSS IRB Annual/Modification/Close Out Review forms:

• IRB Form 2  ‘Information for Continuing Review of a Previously Reviewed Project’

Note: Please be aware, the IRB Form 2 is utilized for annual continuation review, modification review, and project close out. The IRB Form 2 identifies additional required documentation. Please review the Information for Research Investigators for more details.

References and Related Documents

• Department of Health and Human Services, Office of Human Research Protection
• Code of Federal Regulations (CFR) including Title 45 Part 46 Protection of Human Subjects and listing of other agency CFR references
• Institutional Assurance of Compliance (FWA) and IRB registration numbers
• Missouri Department of Health and Senior Services - Data, Surveillance Systems & Statistical Reports

Training

These short instructional segments provide background for investigators on the development of the protection of human subjects in research.

• Evolving Concern (.wmv - 22 minutes)
  
• Balancing Society’s Mandate (.wmv - 36 minutes)
  
• The Belmont Report (.wmv - 28 minutes)

All DHSS investigators/co-investigators who submit projects to the IRB shall review DHSS Administrative Policies 30.8, 30.8A, 30.11, and 30.17 and familiarize themselves with relevant federal regulations, OHRP guidance, state laws, and DHSS procedures.  DHSS investigators and co-investigators are required to complete the CITI program training for investigators/co-investigators once every 3 years.  A copy of the certificate of completion should be included in any IRB review study packets. 

All external investigators are required to complete a reputable human subjects protection training course and provide proof of completion within the past 3 years.  Educational Resources for Investigators may be found at: https://www.hhs.gov/ohrp/sites/default/files/educational-resources-for-investigators.pdf.

Contact Information

Daniel Bogle, Chair
Institutional Review Board
Daniel.Bogle@health.mo.gov