Enwk5- 2-8 White Ethics And Genetics

Front 1

What is an IRB? What do they do?

Back 1

Institutional review board... usually approve whether studies are ethical or not

Front 2

What is the difference between genetic and ethics
Give an example of how ethics changes

Back 2

Ethics- gray area and changes... ex. 1950's common treatment for ulcer are surgery, today AB treatment is used for H. pylori
- Today it is unethical to treat with major surgery
Genetics is black and white

Front 3

Alcholism study explain how it could be a "black and white study"

Back 3

finding a gene associated with alcoholism
- this could have ethical violations though

Front 4

Hemophilia is an example of where ethics has worked on genetics how

Back 4

Gene causes mutation in Factor VIII, so people were born without it and treatment was dangerous because of self reaction to replacement VIII
- new hamster factor VIII infusions worked

Front 5

Gene therapy where genetics and ethics went wrong

Back 5

Jesse Gelsinger volunteered for experimental treatment
- gene therapy with adenovirus vector
- died 4 days later

Front 6

Foundations of Bioethics

Back 6

Respect that participation in genetics research or testing is voluntary
- Beneficence
- autonomy
- follow the rule (HIPAA)

Front 7

Protocol reviews by the IRB in following case:
J. Doe has diverticulosis, annual visit is asked to participate in study which may cure diverticulosis for individuals with SNP for cyt P450, he signs the consent form, he is later told actual goal of study is to give non-theapeutic low dose ...

Back 7

1. Does this research seem scientifically sound? yes
2. Has it received prior scientific review? (FDA, sponsor, univ. committee) maybe
3. Are potential risks clearly presented?
4. Are personnel qualified?
5. Facilities adequate?
6. Data confidential?

Front 8

Example 1 problem in genetics:
Informed consent (details)

Back 8

– A statement that the study involves research,
– an explanation of the purposes of the research*,
– the expected duration of the subject's participation,
– a description of the procedures to be followed, and
– identification of any procedures which are experimental.
– A description of any reasonably foreseeable risks or discomforts to the subject.
- benefits to the subject
- disclosure of alt. procedures or courses of treatment
- confidential statement and IRB and FDA could check the records
- if harm is done... where and how payment for fixing occurs
- info on whom to contact in even of problems
- statement about pt. can quit at any time without penalty or loss of benefits
- protocol includes or doesnt include circumstances under which the subjects participation may be terminated by the investigator without regard to the subjects concent

Front 9

What happens when parent gives childs DNA and then child turns 18... can you still use DNA?

Back 9

have to get re-consent

Front 10

Example 2: doing what you say you are going to do no going beyond the research protocol (Havasupai Indian Tribe)

Back 10

High diabetes community- but blood was used for more than diabetes research

Front 11

what is 23andme company?
Good?
Bad?
Ugly?

Back 11

One of several companies in which genetic testing is done on an individual basis: DTC – Direct To
Consumer
Good? prevention
Bad? uninformed decisions, un-needed screening, inappropriate result interpretation, false reassurance
Ugly: involves you as physician

Front 12

1. Regulates tests that qualify as
devices (kits)
2. Sets standards for clinical labs?
3. Advertising claims about genetic testing

Back 12

FDA
2. ClIA
3. FTC

Front 13

What up in your va GINA?

Back 13

GINA: Genetic Information Non-
Discrimination Act- law that prohibits
discrimination in health coverage and
employment based on genetic
information.