Human Subjects Protection

Infant Data is Protected

• HUGS data consists of infant video in which infant's faces are identifiable. It constitutes PHI (protected health information) on a vulnerable population (infants). 

• All study team members  must complete Research Ethics Training and be approved by the Catholic University Institutional Review Board (IRB) before they can be given access to infant data.

CITI Training
(Updated May 9, 2023)

Research Ethic Training is managed for Catholic University by the Collaborative Institutional Training Initiative  (CITI) Program at the University of Miami.

NB. Research training must be completed and approved by the Catholic University Institutional Review Board (IRB) before team members can look at any infant's protected health information (PHI). 

Turn-around with IRB can be a multi-week process so CITI training is in the critical path of doing any "real" data modeling. 

Research Ethics Training Step-Through VIDEO

To complete training, register at https://about.citiprogram.org/

• Click the "Register" button.

• Type "The Catholic University of America" into the "Institution Affiliation" box.

• Check the box agreeing to CITI's  Terms of Service and Privacy Policy

• Check the box affirming that you ARE  an affiliate of The Catholic University of America.

• Click "Continue To Create Your CITI Program Username/Password."

• Fill in your personal information, including two email addresses.

• It does not matter what they are. Your personal email is fine.

• Click "Continue to Step 3."

• Create your Username and Password on the next screen.

• Click "Continue To Step 4."

• Provide the information requested in Step 4.

• Click "Continue To Step 5."

• You can answer "No" to the continuing education questions.

• Click "Continue To Step 6."

• Fill in The Catholic University of America information minimally.

• You can use "schladen@cua.edu" for your institutional email address if you do not have CUA email.

• Type in "Biomedical Engineering" for the Department.

• Choose "Co-Investigator" for Role. 

• Click "Continue To Step 7."

• Question 1: Human Subjects Research

• Choose "Biomedical Research Investigators"

• Question 2: Laboratory Animal Welfare

• Leave all boxes unchecked.

• Question 3:  Responsible Conduct of Research

• Choose "Biomedical  Responsible Conduct of Research Course" (first option as of 230509)

• Question 4: Would you like to take the Conflict off Interest mini-course?

• Choose "no."

• Question 5: Did you take a basic course for the following group before?

• Choose "N/A."

• Question 5: GCP Social & Behavioral Research

• Choose "Not at this time."

• If offered "Back to Campus" COVID courses, you may take them if you wish, but they are not required.

• Click "Complete Registration"

• Click "Finalize Registration"

• Your modules will be in your dashboard.
  Complete your training - you can stop and re-start.

• When done, view your record and download a PDF of your completion certificates.

• E-mail them to Dr. Schladen.