1. Ethical Issues
Ethical issues are especially relevant to epidemiology because: 1. Direct and immediate social relevance, 2.) generally funded from public resources and (3) involve human subjects in one way or another.
We will discuss two types of issues: (1) those that relate to the conduct of the studies and (2) those that relate to broader societal 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
1. Patient consent should be required before investigators are allowed access to medical records.
2. Data from medical records should be made available to investigators without any information that would identify an individual.

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 Who owns the data???
One very important question
Who owns the data???
1. At what point is the study completed
2. Should it depend on who paid for the study.
3. Should it depend on whose asking for it and the person’s motivation
4. Under what conditions should identifiers be included?
5. How to protect investigator’s interests
6. Who will pay for the expenses
Best to strike a proper balance between indiviual and societal needs.

6. Race and Ethnicity Used to characterize individuals Can be useful
Possibly ill-defined and useless
Ethnicity vs. race?
(1) Use to include or exclude certain groups from studies
(2) Useful - can be used to assess subpopulations within large general grps
(3) Genetic diversity is a continuum with no clear breaks
(4) Ethnicity is complex - shared cultures and social backgrounds and traditions
Overall useful - helps to direct resources to needed areas

7. Race and Ethnicity 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.
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
Sherlock Holmes story - Pg. 294
shows that certain studies may not be done though needed.

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”
1. Premature publication may raise public’s anxiety
2. Should scientist’s wait for confirmation
3. Public latches on to “hot ssues” such as “risk from alar” and forget about such risks as alcoholism, smoking and sun exposure.
4. Epidemiologist must remain involved and draw best conclusions possible.
5. Therefore, must be an advocate, educator and researcher.

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