Ethical Issues Obligations to Study Subjects Informed consent

Ethical Issues

Obligations to Study Subjects • Informed consent involves several issues including: üfull disclosure üprivacy and confidentiality ülimitation of the individuals rights üinforming the subject of study findings

Privacy and Confidentiality • Why are medical records needed? üGenerate data and validate info. üIdentify indiv. for eventual follow-up • How did it come about? üTwo major legislative proposals

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

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

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

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

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

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

Epidemiologist’s Responsibility • Communicate health risks as accurately as possible üUseful to policymakers • Should an epidemiologist be an advocate? üOn occasion, “Yes”

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