INITIAL REVIEW
The first time you submit a proposal for IRB review you need to submit the following forms with your protocol and other materials:
- Form A
- Form B -OR- Form C (depending on your level of review)
- Form D (if your study involved deception of the research subjects)
AMENDMENTS
After initial approval, if any of the following aspects of your research study have changed, please submit Form E for approval:
- Changes to research personnel
- Changes to the research protocol or instruments
- Changes to the research subjects’ identity or umber recruited/enrolled
- Changes to the consent documents
- Any other substantive changes
NOTIFICATION OF CLOSURE
If the participant recruitment and data collection phases of your research are complete and only data analysis remains, or if the research has been discontinued or fully completed, please submit Form F.
ADVERSE EFFECTS
Each time you encounter a serious adverse event, unanticipated problem, or significant deviation from the approved protocol you should submit Form G within 48 hours.
