All changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures and funding.

Amendments involving minor changes that pose no more than minimal risk to subjects can be reviewed using expedited procedures. Proposed changes that might adversely affect the willingness of current participants to remain in the study or change the risk to benefit ratio for participants must be reviewed at a convened IRB meeting.

Investigators must complete an Amendment Form in eRA and submit the following documentation as applicable:  

  • Revised research protocol
  • Revised or new consent/parental permission/assent documents  or other documentation that would be provided to subjects when such information might relate to their willingness to continue to participate in the study
  • Any other relevant documents, revised or new, such as recruitment material, data collection or assessment tools, etc.

Amendments that may be reviewed using the expedited procedure may include:

  • The addition or removal of key personnel
  • Revisions to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement
  • Changes in participant payment
  • Adding or revising recruitment materials

Amendments that must be reviewed at a convened IRB meeting may include:

  • The addition of a description of serious unexpected adverse events or other risks
  • Substantial alteration to the research design or methodology
  • Personnel or site changes that affect the qualifications of the research team or facilities available to support the safe conduct of research.

For step-by-step instructions for creating and submitting an Amendment submission refer to the eRA Amendment Submission Guide. 

 

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