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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