1. How To Begin Doing Human Subjects Research Teri Bycroft Associate Director of Human Subjects Research

2. What Is Research? “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. Title 45, code of federal regulations, part 46 §46.102

3. What Is a “Human Participant” A living individual about whom an investigator … conducting research obtains – data through intervention or interaction with the individual, or – identifiable private information. 45 CFR 46.102 (f)

4. Types of Research Exempt Expedited Full Board Review

5. When Do You Need IRB Approval to Conduct Research? If it involves a human(s) and It is for generalizable knowledge YOU NEED TO SUBMIT YOUR RESEARCH TO THE IRB FOR APPROVAL BEFORE STARTING YOUR RESEARCH!

6. For more information on IRB policies and procedures, visit: http://www.healthsciences.okstate.edu/research/rsp/irb.html or contact Teri Bycroft at 918-586-4609 or teri.bycroft@okstate.edu. OSU-CHS IRB New Research Study Submission Flow Chart New Study Submitted IRB Administrator provides PI with feedback Study returned to PI for changes (study specific) Changes made Resubmit Changes made Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Study to Scientific Review Committee Study to IRB Approved Approval memo & copy of stamped approved ICF sent Documentation of education requirement met Free to begin study Continuing review at least annually Request for Exempt or Expedited approval sent to 2 Board members Approved contingent upon changes PI opts not to make suggested changes Not Approved OSU-CHS IRB New Research Study Submission Flow Chart For more information on IRB policies and procedures, visit: http://www.healthsciences.okstate.edu/research/rsp/irb.html or contact Teri Bycroft at 918-586-4609 or teri.bycroft@okstate.edu. OSU-CHS IRB New Research Study Submission Flow Chart New Study Submitted IRB Administrator provides PI with feedback Study returned to PI for changes (study specific) Changes made Resubmit Changes made Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Study to Scientific Review Committee Study to IRB Approved Approval memo & copy of stamped approved ICF sent Documentation of education requirement met Free to begin study Continuing review at least annually Request for Exempt or Expedited approval sent to 2 Board members Approved contingent upon changes PI opts not to make suggested changes Not Approved For more information on IRB policies and procedures, visit: http://www.healthsciences.okstate.edu/research/rsp/irb.html or contact Teri Bycroft at 918-586-4609 or teri.bycroft@okstate.edu. OSU-CHS IRB New Research Study Submission Flow Chart New Study Submitted IRB Administrator provides PI with feedback Study returned to PI for changes (study specific) Changes made Resubmit Changes made Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Study to Scientific Review Committee Study to IRB Approved Approval memo & copy of stamped approved ICF sent Documentation of education requirement met Free to begin study Continuing review at least annually Request for Exempt or Expedited approval sent to 2 Board members Approved contingent upon changes PI opts not to make suggested changes Not Approved For more information on IRB policies and procedures, visit: http://www.healthsciences.okstate.edu/research/rsp/irb.html or contact Teri Bycroft at 918-586-4609 or teri.bycroft@okstate.edu. OSU-CHS IRB New Research Study Submission Flow Chart New Study Submitted IRB Administrator provides PI with feedback Study returned to PI for changes (study specific) Changes made Resubmit Changes made Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Study to Scientific Review Committee Study to IRB Approved Approval memo & copy of stamped approved ICF sent Documentation of education requirement met Free to begin study Continuing review at least annually Request for Exempt or Expedited approval sent to 2 Board members Approved contingent upon changes PI opts not to make suggested changes Not Approved

7. The Investigator Must: Submit an Appendix B Submit the protocol Submit the informed consent Submit other (CRF, advertisements) Appear before the Board (when the study is a full Board review)

8. Where to Get the Policy & Procedure Manual (& Forms) http://www.healthsciences.okstate.edu/res earch/rsp/index.cfmhttp://www.healthsciences.okstate.edu/res earch/rsp/index.cfm –Click on IRB (on left in black box)

9. Informed Consent 8 th Grade Rural Level PROCESS Different from Medical Procedure Consent Handout

12. Protocol Elements Handout

13. HIPAA (effective April 14, 2003 ) Health Insurance Portability and Accountability Act

14. The New Kid on the Block ClinicalTrials.gov

15. Where Do I Get Help? OMECO –Lisa Jenkins 561-8298 OSU-CHS Office of Research –Michelle Thrasher 586-4602 –Teri Bycroft 586-4609 –Dr. David Wallace 586-4600