New Submission - Full Board (>Minimal Risk)

Full board review is required for studies that are designated greater than minimal risk (e.g., clinical trials using investigational drugs or devices, or studies involving invasive procedures, or studies that have the potential to present risks that may exceed the definition of minimal risk). Full board review involves review by a convened IRB committee. Please see our dates and deadlines page for schedule of committee meeting dates.

If you are not sure whether your study involves minimal or greater than minimal risk, please call the HRPO office at 633-7400.

Click a link below to view information:

Does my study need HRPO Review?
Meeting Dates and Deadlines
Application Requirements
Instructions
Forms
Appendix Forms
Samples
Helpful Information

Application Requirements
The following materials are required of all new applications that require Full Board Review.  Any applications that do not meet the following criteria will be sent back to the PI without being reviewed.

• Four (4) complete copies.
  • original for HRPO records
  • two (2) copies; one for each primary reviewer
  • one (1) copy for the Billing Matrix
• A completed Form 1 including all signatures, spell checked, and typed
• All appendix forms that are relevant to your study
• Consent form(s), verbal script, materials for implied consent or waiver. (12 point font minimum)
• A complete typed protocol. A protocol is a detailed plan of the scientific experiment that includes:  background information, objectives, inclusion/exclusion criteria, treatment plan, a description of the data monitoring committee or plan and follow-up procedures. (12 point font minimum)
• Data Monitoring description

If applicable, please submit:

• Entire Grant application (except for appendix pages) and budget with confidential salary information and total dollar amounts blocked out
• Interviews/Questionnaires
• Investigator's Brochure
• Subject advertisements, recruiting materials, and other information relevant to recruitment
• Certificate of Confidentiality

Instructions

• Instructions for Prior Approval (Blocking & Non-Blocking Ancillary Committees)

Forms

Note: Forms on this page are only available in Rich Text Format (.rtf).  For forms in Word format please visit the All Forms page.

• Form 1: Research Proposal Involving Human Subjects, Request for Review
• Consent Templates/Forms
• Form 12: Treat a Single Patient, Request to
• Form 25: Research Involving Prisoners

Appendix Forms

• Form A: Multi-center Research Supported by DHHS
• Form B: Research at Performance Sites other than WUMC, BJH, & SLCH
• Form C: IND/IDE Indications
  • Form 4: Investigational Drug Data Form
• Form D: Third Party Consent
• Form E: Studies Including Minors (0-17 years)
• Form F:  Pregnant Women, Research Involving
• Form G: HIV Testing
• Form H: Genetic Tissue or Data Collection
• Form I: Audiotapes, Videotapes, and Photograph
• Form J: Sponsored Research
• Forms K1-K6: Consent Alternatives
• Form L: Cognitively Impaired Subjects, Research Targeting  
• Form M: Research Being Conducted Outside the United States
• Form N: Stored Data or Tissue for Future Research, Research Involving 
• Form O: Remuneration for Research Involving Washington University Employees
• Form P: Radiation Exposure, Research Related
• Form Q: Emergency Department, Conducting Research in the
• Form S: Justification for use of a Placebo
• Form T: Financial Conflict of Interest

Samples/Examples

• Data Monitoring Committee
• Data Monitoring Plan
• Protocol
• Screening Tool
• Screening Tool 2

Helpful Information

• Additional Protections/Options for Additional Safeguards
• Clinical Trial Definitions and Clinical Trial Phases
• Clinical Trial Phases
• Confidentiality Classifications
• Department Approvers List
• Exclusion of Minors from Research
• HIPAA Identifiers
• Instructions for Prior Approval
• Study Evaluations
• Standard Interviews/Questionnaires
• Participant Satisfaction Letter

Please note that the New Protocol Committees (NPC) limit the number of new protocols to 9 per meeting.  All protocols are scheduled on a first come, first serve basis.  Those studies exceeding the limit will be notified that the study will be scheduled for the next available meeting.

Last updated: 1/9/09