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1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal, Social, Cultural Issues (Optional) Informed Consent (Optional) Pharmaco- genetics

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Page 1: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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DefinitionsBiospecimen

Uses, Storage

Ethical, Legal, Social, Cultural

Issues

(Optional)InformedConsent

(Optional)Pharmaco-genetics

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skin, hair, nails, cheek cells, blood, urine

saliva

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3

What types of tissues are used as

biospecimens?

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Mature cells do not have a

nucleus (thus no DNA)

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5

What are mature red blood cells?

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*****

Daily Double

*****

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Contains the genetic code for

humans

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8

What is DNA? What are the

chromosomes? What is the nucleus?

Page 9: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Also called "repository"

Page 10: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is a "biobank"?

Page 11: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Specimens do not require informed

consent for use in studies

Page 12: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is a biobank?

Page 13: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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To find better treatments for

diseases

Page 14: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is a purpose for

biospecimen research?

Page 15: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Minus 80 degree freezer

Page 16: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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How / where are biospecimens

stored?

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Does NOT require informed consent for future studies

Page 18: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is a biobank / repository?

Page 19: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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blood draw, biopsy, surgery

Page 20: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

20

What are some sources for

biospecimens?

Page 21: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Handling during collection,

temperature fluctuations,

exposure to air

Page 22: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What can damage the

quality of biospecmens?

Page 23: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Havasupai Tribe

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What is the name of the tribe that won a

lawsuit in 2010 about unethical genetic research study?

Page 25: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Arizona State University

Page 26: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is the name of the research

institution involved with the 2010

Havasupai lawsuit?

Page 27: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Diabetes, obesity, cancer, heart

condition studies

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In what types of study topics / diseases are

most tribes and urban Indian programs

interested?

Page 29: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Research specimens that are

used to create patents for drugs or

devices

Page 30: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What type of biospecimen research studies do most tribal

nations oppose?

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The tribe thought the specimens were for 1

study only and researchers thought specimens were for repository / biobank

Page 32: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

32

What was a key issue within the

Havasupai lawsuit against ASU?

Page 33: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Who owns the specimen? Where and how stored?

Who benefits from patents resulting

from the research?

Page 34: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

34

What are examples of tribal issues with

biospecimen research?

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For example: Your name,

address, tribal affiliations

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What are examples of

"private" information?

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Privacy, safety, confidentiality of

study participants

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What is the role / purpose of the

IRB?

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Requires questions / answers and

discussion between participant and

recruiter

Page 40: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is the informed consent

PROCESS?

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Only a signed form, a legal

contract, a binding document

Page 42: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is NOT true about informed

consent?

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Safer drugs, fewer side effects, tailor

treatments to tumor pathways

Page 44: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What are goals of pharmaco-genetics?

Page 45: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Science is close to its goals for only a

small portion of medications so far

Page 46: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is tailoring drug

medications?

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Included in codeine,

acetaminophen, diazapam,

Erythromycin

Page 48: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is Cytochrome

P-450?

Page 49: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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The enzyme required to metabolize

codeine into morphine

Page 50: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is 2D6?

Page 51: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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Balance results in the liver unable to convert codeine into morphine

Page 52: 1 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 200 300 400 500 100 Definitions Biospecimen Uses, Storage Ethical, Legal,

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What is likely if the body has more 3A4

than 2D6?


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