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.
Requirements for Submission
Investigators must complete an Amendment Form in RSP Gateway and submit the following documentation as applicable:
- Revised local research protocol
- Revised or new consent/parental permission/assent documents
- Other relevant documents, revised or new, such as recruitment material, data collection or assessment tools, etc.
- Any other documentation that would be provided to subjects when such information might relate to their willingness to continue to participate in the study
Full Board Amendments
Certain types of minor revisions to approved greater than minimal risk studies (i.e. research requiring review at a convened meeting) may be reviewed via expedited procedures (i.e. one IRB member).
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
However, a revision that may either adversely affect the willingness of current participants to remain in the study or that may change the risk to benefit ratio for subjects must be reviewed at a convened IRB meeting. Following are examples of full board study amendments that must be reviewed at a convened meeting.
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.
Please review the Expedited Review Policy (Sections 5.4-5.6) for more information about IRB review requirements for amendments.
How do I submit an Amendment in RSP Gateway?
For step-by-step instructions for creating and submitting an Amendment submission refer to the How to Submit Continuing Review, Amendment, Reportable Event, Study Closure, and Miscellaneous Forms Guide.