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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Presentation transcript:

Definitions Biospecimen Uses, Storage Ethical, Legal, Social, Cultural Issues (Optional) Informed Consent (Optional) Pharmaco- genetics

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

3 What types of tissues are used as biospecimens?

4 Mature cells do not have a nucleus (thus no DNA)

5 What are mature red blood cells?

6 ***** Daily Double *****

7 Contains the genetic code for humans

8 What is DNA? What are the chromosomes? What is the nucleus?

9 Also called "repository"

10 What is a "biobank"?

11 Specimens do not require informed consent for use in studies

12 What is a biobank?

13 To find better treatments for diseases

14 What is a purpose for biospecimen research?

15 Minus 80 degree freezer

16 How / where are biospecimens stored?

17 Does NOT require informed consent for future studies

18 What is a biobank / repository?

19 blood draw, biopsy, surgery

20 What are some sources for biospecimens?

21 Handling during collection, temperature fluctuations, exposure to air

22 What can damage the quality of biospecmens?

23 Havasupai Tribe

24 What is the name of the tribe that won a lawsuit in 2010 about unethical genetic research study?

25 Arizona State University

26 What is the name of the research institution involved with the 2010 Havasupai lawsuit?

27 Diabetes, obesity, cancer, heart condition studies

28 In what types of study topics / diseases are most tribes and urban Indian programs interested?

29 Research specimens that are used to create patents for drugs or devices

30 What type of biospecimen research studies do most tribal nations oppose?

31 The tribe thought the specimens were for 1 study only and researchers thought specimens were for repository / biobank

32 What was a key issue within the Havasupai lawsuit against ASU?

33 Who owns the specimen? Where and how stored? Who benefits from patents resulting from the research?

34 What are examples of tribal issues with biospecimen research?

35 For example: Your name, address, tribal affiliations

36 What are examples of "private" information?

37 Privacy, safety, confidentiality of study participants

38 What is the role / purpose of the IRB?

39 Requires questions / answers and discussion between participant and recruiter

40 What is the informed consent PROCESS?

41 Only a signed form, a legal contract, a binding document

42 What is NOT true about informed consent?

43 Safer drugs, fewer side effects, tailor treatments to tumor pathways

44 What are goals of pharmaco- genetics?

45 Science is close to its goals for only a small portion of medications so far

46 What is tailoring drug medications?

47 Included in codeine, acetaminophen, diazapam, Erythromycin

48 What is Cytochrome P-450?

49 The enzyme required to metabolize codeine into morphine

50 What is 2D6?

51 Balance results in the liver unable to convert codeine into morphine

52 What is likely if the body has more 3A4 than 2D6?