1. Ethical Issues

2. Obligations to Study Subjects Informed consent involves several issues including: full disclosure privacy and confidentiality limitation of the individuals rights informing the subject of study findings

3. Privacy and Confidentiality Why are medical records needed? Generate data and validate info. Identify indiv. for eventual follow-up How did it come about? Two major legislative proposals

4. Protection of Privacy and Confidentiality Informed consent required All data secured Only study numbers used Individual identifying data destroyed Results published in aggregate Individual identifying data not stored on computers Education of staff

5. Access to Data One very important question Who owns the data???

6. Race and Ethnicity Used to characterize individuals Can be useful Possibly ill-defined and useless Ethnicity vs. race?

7. Can inclusion in study be beneficial? Can inclusion be a “negative”? Is race ever used as a surrogate? Give an example, either real or hypothetical. Race and Ethnicity Your Assignment: 1. Define race & ethnicity. 2. Distinguish between the two terms. 3. Consider & discuss these questions.

8. Conflict of Interest Actual and perceived biases Most work in academia, government or industry Study subject to overt, subtle pressure “Silver Blaze” bias (from Sherlock Holmes short story by Sir Arthur Conan Doyle) Should be openly acknowledged

9. Interpreting Findings When should studies be reported? Should newspapers be allowed to publish reports of studies? Do they effect the public’s perception?

10. Epidemiologist’s Responsibility Communicate health risks as accurately as possible Useful to policymakers Should an epidemiologist be an advocate? On occasion, “Yes”

11. Future Considerations Epidemiology has a pivotal position Moral and ethical issues will continue to evolve Epidemiologists and customers must continue to improve dialogue