how to begin doing human subjects research teri bycroft associate director of human subjects...
TRANSCRIPT
How To Begin Doing Human Subjects Research
Teri Bycroft
Associate Director of Human Subjects Research
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
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)
Types of Research
• Exempt
• Expedited
• Full Board Review
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!
OSU-CHSIRB New Research Study Submission
Flow Chart
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)
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)
Informed Consent
• 8th Grade Rural Level
• PROCESS
• Different from Medical Procedure Consent
• Handout
Protocol
• Elements
• Handout
HIPAA (effective April 14, 2003)
• Health
• Insurance
• Portability and
• Accountability
• Act
The New Kid on the Block
ClinicalTrials.gov
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