Amending a Research Project
- What amendments or changes must be submitted to the HSIRB for approval?
- “What” to submit to the HSIRB
- “How to submit: electronically or by mail
- HSIRB review of Amendments: Expedited or full board review
What amendments or changes must be submitted to the HSIRB for approval?
Amendments or any change to an approved project must be submitted to the HSIRB for approval before implementing the change. This includes any addition or deletion to, or revision of:
- the protocol,
- consenting document(s) (consent, permission, or assent),
- advertisements or other recruitment materials,
- questionnaires, surveys, or screening documents,
- study personnel,
- the investigator’s brochure,
- study site location(s), or
- any other changes.
“What” to submit to the HSIRB:
Complete the Amendment Form: Request for HSIRB Review of Modifications/Changes to an Approved Protocol and submit it together with any associated support documents. Amendment requests must include an explanation and justification for the proposed changes.
“How” to submit to the HSIRB: Electronically or by mail
See: Submission Deadline Dates and How To Submit Materials for HSIRB Review
HSIRB Review of Amendments: Expedited or full board review
Amendments may be reviewed by the full board or by expedited review. Generally, amendments may qualify for review by the expedited process if the changes are entirely clerical or administrative in nature and have no effect on the conduct of the research, its underlying science or methodology, associated risks and benefits, or potential willingness of subjects to continue participation (e.g., correction of clerical or typographical errors; changes in text formatting; addition of a site; changes in personnel; or changes to phone numbers, addresses, or other contact information).
Amendments that affect the risk/benefit assessment of the project or substantially change the specific aims or design of the study must undergo full board review (e.g., changing the inclusion or exclusion criteria such that it increases risk; alterations in the dosage or route of administration of an administered drug; a project change in response to a serious event or problem (SEP).