Preparing a Protocol
1. Complete Training and Save Certificate
CITI Human Subjects Research Compliance Training
UW-Green Bay's newest research compliance training program. CITI training is available for all campus principal investigators and student investigators seeking research compliance training and certification on research involving human subjects.
Registration Instructions:For Students | For PIs | For Other Researchers
Completing the CITI Course Instructions: For Students | For PIs | For Other Researchers
NIH Protecting Human Research Participants Training
Please use the link below if you need to access your NIH training certificate. Note that investigators who have existing NIH certification can retain that valid certification for five years from the date of completion-as long as the date of completion is prior to August 1, 2017. Once expired, investigators will need to become certified through the CITI program.
2. Determination of Risk/Review Status
There are three levels of IRB review: Exempt, Expedited, and Full Board Review.
Full Committee
Research does not qualify for exempt or expedited level review, presents more than minimal risk to subjects, and/or involve vulnerable populations, as defined in the Common Rule.
Expedited
Research falls into any of nine regulated categories. Involves collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
Exempt
Research falls into any of six categories delineated in the federal regulations. Risk is minimized through anonymity of responses or through the use of non-invasive paradigms that will not harm subjects.
3. Complete the Protocol Form
Submission Documents
Protocol Submission Form
Media Release Form (If needed)
Sample IRB Supplemental Documents
Informed Consent Form Sample
Recruiting Script Sample
4. Combine All Forms as PDF Files
All campus computers should have access to Adobe Acrobat DC. This is the best program for combining documents into one PDF.
Instructions for Combining Documents Into One PDF
Giving Read-Only Access to Qualtrics Surveys
To allow the IRB Chair to only view the actual survey(s), do the following:
1. Log-in to Qualtrics
2. Select "Collaboration" from the same row as the survey name
3. In the box on the top left, type the IRB Chair's email address
4. Click "Add"
5. Click "Copy"
6. Click "Save"