1. How to Participate in Research Eric Kleerup, M.D. & Donald Tashkin, M.D. David Geffen School of Medicine at UCLA Los Angeles, California

2. What is Human Research? Human subjects are living individuals about whom an investigator conducting research obtains: Data through intervention or interaction with an individual or Identifiable private information Research is a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.

3. Why do we perform research? To understand the disease process To develop treatments for diseases

4. How does a drug get approved for use? Preclinical, animal and laboratory studies Phase 1: human toxicity Phase 2: safety in patients with disease Phase 3: efficacy Phase 4: other questions –Comparison to other treatments –Cost effectiveness –Marketing issues

5. Informed Consent Identification of investigators Purpose of the study Procedures Risks and benefits Alternative treatments Payments and costs Privacy Withdrawal from the study Subject’s rights

6. Informed Consent Ask Questions

7. Inclusion and Exclusion Criteria Does the subject have the disease being studied? Is the subject too sick or too well? Is it safe for them to take the drug and have the procedures? Do they have other diseases that might effect the outcome of the study?

8. Flavors of Studies Observational or cohort Open label Placebo controlled Single blind or double blind Cross-over Salvage or rescue Quality of life Mechanistic

9. How can I be in a research study at UCLA?