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"