Below are a Glossary of Terms explaining the various letters and messages from the IRB:
- Acknowledgement notification – the IRB has received your protocol and it will now be sent out for review to Board members.
- Modifications notification – You will be receiving a modifications letter with the changes that you need to make on your protocol.
- Modifications Letter – Lists all of the changes that the reviewers want made before approval can be granted.
- Unlocked protocol – your protocol will be unlocked when changes need to be made; do not begin a new protocol
- Locked protocol – Lock your protocol after the initial submission and when you have completed your modifications
- Track Changes – place your documents on track changes so that they can be easily viewed
Forms that need to be submitted when working with adult populations:
- IRB application Lay Summary Consent Form Informed consent process Participant Information Form Risks and Benefits Confidentiality of data form Any research tools such as surveys, questionnaires, etc.
- Agency consent form – letter from agency on letterhead
Additional Forms when working with underage children:
- Parent consent form
- Child Assent form – children under 12 years of age
Forms when working with additional assistants:
- Transcriber confidentiality form
- Research Assistant confidentiality form
- Conclusion of research
- Executive Summary form which demonstates results of study