1. Denise Viator Technical Assistance Project Manager Oak Ridge Associated Universities DOE Human Subject Working Group Workshop December 1, 2011 National Harbor, Maryland

2. CITI Human Subjects Research Education The CITI human subjects research education program consists of: 12 basic course modules for biomedical investigators 11 social behavioral research modules specifically prepared for investigators Several general interest modules The course is hosted on secure servers at the University of Miami and the University retains all records in strict confidence

3. CITI Process IRB Administrator will designate the Groups required to take CITI training IRB Administrator IRB Member Research IRB Administrator will designate the basic required (R) modules Each trainee will be given a Completion Report confirming that the required modules have been completed

4. CITI Process, cont. IRB Administrator is given a copy of the trainee’s Completion Report Refresher Courses: CITI sends out a reminder when the training has expired and people can take the refresher course

5. CITI Login Instructions Log into www.CITIprogram.orgwww.CITIprogram.org Click on New Users; Register Here Choose the Department of Energy drop-down box, then click on YOUR FACILITY from that drop down list. Do not choose the first drop-down box that says “Participating Institutions.” You will not find YOUR FACILITY on that list Select a username and password and verify password Enter Name and e-mail address; click on “Submit” Complete Member Information, click “Submit” Select Groups: Choose “YES” if this is the first time you have used the CITI Program, and choose your learner group On the page that says “Select your institution or organization,” YOUR FACILITY should come up. Check “NO” (you do not want to change affiliations) and continue Learner’s Menu Page: Click on “Enter” under Status (middle of the page). The modules should be self-explanatory

6. DoE Learner Group Order Form O = OPTIONAL R = REQUIRED H = HIDDEN FROM VIEW Your Facility's requirements The Available CITI Educational Modules Group 1. Biomedical research Investigator Group 2. Social & Behavioral Research Investigators Group 3. IRB members Your Biomedical Group Your SBR Group Your Other Group - please define RECOMME NDATIONS History and Ethical Principles - SBRORR Defining Research with Human Subjects - SBRORR The Regulations and the Social and Behavioral Sciences - SBRORR Assessing Risk in Social and Behavioral Sciences - SBRORR Informed Consent - SBRORR Privacy and Confidentiality - SBRORR Research with Prisoners - SBROOR Research with Children - SBROOR Research in Public Elementary and Secondary Schools - SBROOR International Research - SBROOR Internet Research - SBROOR

7. DoE Learner Group Order Form, cont. History and Ethical PrinciplesRHR Basic Institutional Review Board (IRB) Regulations and Review ProcessROR Informed ConsentROR Social and Behavioral Research for Biomedical ResearchersOOR Records-Based ResearchOOR Genetic Research in Human PopulationsOOR Research With Protected Populations - Vulnerable Subjects: An OverviewROR Vulnerable Subjects- Research With PrisonersOOR Vulnerable Subjects- Research Involving MinorsOOR Vulnerable Subjects- Research Involving Pregnant Women and Fetuses in UteroOOR Group Harms:Research With Culturally or Medically Vulnerable GroupsRRR FDA-Regulated Research.OOR Human Subjects Research at the VAHHR HIPAA and Human Subjects ResearchOHH Workers as Research Subjects-A Vulnerable PopulationRRR Hot TopicsROR Conflicts of Interest in Research Involving Human SubjectsOOR

11. QUESTIONS?