Submitting Changes to Research

Sponsors and PI’s are responsible for submitting changes to research materials.Study changes may not be implemented prior to receiving IRB approval. Amendments may be submitted to full board following the same timelines listed for Initial Submissions. However, changes to research may also qualify for expedited review. Expedited review items will be reviewed within 72 hours of submission. Your IRB contact will inform you of the type of review your submission will follow. All changes to research must be submitted through AllianceNet. Examples of changes that should be submitted for approval include:

  • Amendments and changes to the protocol including any administrative changes
  • Recruitment materials, questionnaires, instructions, etc. developed after the initial submission or changed during the course of the study
  • Changes occurring at the Site
    • Change in PI
    • Any change in Primary or Additional site locations
    • Increases in enrollment
    • Changes to planned study population
    • Protocol deviations (even deviations pre-approved by the sponsor)
    • Notification of study closure/completion
 
 

Awards

IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

 
 
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