Information on Using Humans in Research Studies
for members of the Department of Computer Science

Last updated 14 February 2009 by Mary Whitton.

Important  Links

Always check the OHRE web site for the latest version of their forms BEFORE you start writing!

If your work is in any way NIH funded (*all* CISMM and EVE studies), you must:
1.  Collect demographic information on your participants and
2.  Fill out a "Enrollment" form when you're done.  
We are required to submit the forms with the annual report. Links are below.

Site Link
Office of Human Research Ethics  (OHRE) Home Page http://ohre.unc.edu/
OHRE Guide to the IRB Process http://ohre.unc.edu/guide_to_irb.php
IRB application forms and instructions http://ohre.unc.edu/forms.php
Required Training Overview http://ohre.unc.edu/educ.php
Which Training Modules to Compete? http://ohre.unc.edu/educ.php#which
Enter Training Site https://www.citiprogram.org/default.asp
Link to Demographics Survey  
Link to Enrollment Form  

Preparing an Application for Study Approval

    HINT: Completely design your study, then fill out the IRB forms.
    That will make doing the IRB forms a snap.

Need help designing your study?  I'm often willing to help, but use your advisor first.
       
While it is not required that I review IRBs for the department, I am willing to do so before you submit them to the department for signature.  The department chair and associate chairs can sign for the department.

    Forms and IRB Specific Guidelines

IRB application forms and instructions

How to generate the certificate of training to go in your application.  Training is required.

Form for Local Committee Approval Signature and recommendation for level of review.

Process within the Computer Science Department
for Studies to be reviewed by the Behavioral IRB

If your study is done with collaborators from the medical school, you may need to submit your to the Biomedical IRB. Consult with your med school colleagues to make this decision.  I'm familiar with only the Behavioral IRB process.

1.  Complete the IRB form and have it reviewed and signed by the faculty advisor.
       NOTE:  This includes verifying that everyone who will interact with the participants has completed IRB training.

The Guide to the IRB Process includes descriptions of "What kinds of IRB review are there?"  Most often studies from the CS department are "minimal risk" and quality for "Expedited, Category 7." 

2.  Take completed forms to either the department chair or one of the associate chairs.  As of this writing, that means Jan Prins, David Stotts, or Tim Quigg.  Tim will likely ask you if I've read your form and OK'd it.

3.  Submit the complete, signed package to the IRB office.  The instructions for where and how many copies, etc. are part of the application form.

Training  

Training is required for everyone who will interact with the participants or the collected data.

How to generate a certificate of training to go in your application.