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