An Amendment submission in eRA must be submitted by Investigators when any document or procedure within an IRB approved research protocol is revised. The review must be prospective. The change must not be implemented until after IRB approval has been given.
Amendments involving minor changes that pose no more than minimal risk to subjects can be reviewed on an expedited basis. When a proposed change in a research study is not minor or might adversely affect the willingness of current participants to remain in the study, then the IRB must review and approve changes at a convened meeting before changes can be implemented.
Investigators must submit the following documentation to inform the IRB about the proposed change:
- Completed Amendment eForm;
- Revised research protocol (if applicable);
- Revised or new consent/parental permission/assent documents (if applicable) 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.
Examples of amendments that may be reviewed using the expedited procedure include:
- The addition or deletion of key personnel;
- Changes 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;
- Alterations in human research participant payment or liberalization of the payment schedule with proper justification;
- The addition of study sites (which may require a Federal Wide Assurance(FWA) and appropriate IRB approval) or the deletion of study sites.
Examples of amendments not eligible for review using the expedited procedure 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;