How To Begin Doing Human Subjects Research

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. OSU-CHSIRB New Research Study Submission Flow Chart OSU-CHS IRB New Research Study Submission Flow Chart OSU-CHS IRB New Research Study Submission Flow Chart OSU-CHS IRB New Research Study Submission Flow Chart OSU-CHS IRB New Research Study Submission Flow Chart New Study Submitted New Study Submitted New Study Submitted New Study Submitted IRB Administrator provides PI with feedback IRB Administrator provides PI with feedback IRB Administrator provides PI with feedback IRB Administrator provides PI with feedback Request for Exempt or Expedited approval sent to 2 Board members Request for Exempt or Expedited approval sent to 2 Board members Request for Exempt or Expedited approval sent to 2 Board members Request for Exempt or Expedited approval sent to 2 Board members Study to IRB Study returned to PI for changes (study specific) Study to Scientific Review Committee Study to IRB Study returned to PI for changes (study specific) Study to Scientific Review Committee Study to IRB Study returned to PI for changes (study specific) Study to Scientific Review Committee Study to IRB Study returned to PI for changes (study specific) Study to Scientific Review Committee Changes made Approved contingent upon changes Approved contingent upon changes Approved contingent upon changes Approved contingent upon changes Approved Changes made Approved Changes made Approved Changes made Approved Not Approved Not Approved Not Approved Not Approved Resubmit Approval memo & copy of stamped approved ICF sent Resubmit Approval memo & copy of stamped approved ICF sent Resubmit Approval memo & copy of stamped approved ICF sent Resubmit Approval memo & copy of stamped approved ICF sent Changes made Documentation of education requirement met Changes made Documentation of education requirement met Changes made Documentation of education requirement met Changes made Documentation of education requirement met Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Free to begin study Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Free to begin study Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Free to begin study Memo to PI with suggested changes PI contacted by IRB Administrator PI can talk with Committee Chair Free to begin study PI opts not to make suggested changes PI opts not to make suggested changes PI opts not to make suggested changes PI opts not to make suggested changes Continuing review at least annually Continuing review at least annually Continuing review at least annually Continuing review at least annually 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. 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. 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. 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.

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/research/rsp/index.cfm • Click on IRB (on left in black box)

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

12. Protocol • Elements • Handout

13. HIPAA (effectiveApril 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