IRB Investigator Handbook
Please review the IRB Investigator Handbook prior to beginning an Application for New Protocol Review. This document will be updated regularly. If you would like additional information included in the handbook, please contact the IRB Office.
Required Education in Human Subject Protection:
CITI Training - Protecting Human Research Participants https://about.citiprogram.org/en/homepage/
When logging in for the first time, click the "Register" button in the top right hand corner of the home page. Under "Select an Organization Affiliation", start typing "UnityPoint" and UnityPoint Health Des Moines should populate. Continue to register your account.
All investigators and study team members must complete the appropriate training modules based on the type of research being conducted.
Which modules do I complete?
Biomedical Modules: Select this option if you are involved in a biomedical research study where an intervention is being conducted (drug, device, labs, medical testing), or where human subjects will be consented. There are 9 required modules to complete.
Social-Behavioral-Educational Modules: Select this option if you are involved in non-intervention studies, such as retrospective chart reviews, surveys, etc. More than likely, if you are requesting a waiver of informed consent, you can complete these modules. There are 9 required modules to complete.
You must complete the "Required Modules" before your research study materials will be reviewed by the IRB. There are several "Optional Modules" that you may complete, but they are not required to conduct human subjects research.
The IRB will accept CITI training completed at another institution if the training has been completed within the last 3 years. If training has been completed elsewhere, please send a copy of the CITI completion certificates to the IRB with the study submission materials.
Everyone involved in research must complete CITI training. NIH Training Certificates are considered obsolete and are not accepted by the IRB.
CITI completion certificates are good for 3 years. You do not need to submit completion certificates to the IRB Office.
If you need technical support, please contact the CITI Support Center by clicking "Support" on the home page. You may also call 1-888-529-5929 Monday-Friday from 8:30am-7:30pm EST.
Additional helpful educational links:
The Belmont Report
Common Rule Pre-2018 - These regulations are in effect through 1/20/19.
Common Rule 2018 - These regulations are in effect starting 1/21/19.
Who is OHRP?
IRB Glossary of Terms
Office of Human Research Protections (OHRP) Guidebook
Human Subject Regulations Decision Charts
OHRP Guidance for Investigators
OHRP Informed Consent
OHRP Vulnerable Populations