Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Incorporated (NACI) 3022 South Nova Road Pine, C

1. Native Cancer 101Module 8: Biospecimens and Biobanking(BASIC / Abridged Community version)estimated time: 1½ hours with Participant interactivity07-02-2012 version + ARS Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Incorporated (NACI) 3022 South Nova Road Pine, CO 80470-7830 http://www.NatAmCancerInitiatives.org Lynne Bemis, PhD, Head of Biomedical Sciences Department University of Minnesota School of Medicine, Duluth Campus

2. Assumptions • This is a workshop that would follow several other topics (e.g., overview of cancer among AI/ANs, importance of cancer screening, etc.) • Thus, it is not an introductory topic • This is a pilot test to review scientific and cultural information specific to biobanks and biospecimens • We appreciate your help in modifying this workshop • Please write your suggestions down and at the end of the workshop, we will share comments and recommendations for changes

3. Please turn off your cell phones or switch them to “vibrate” mode

4. Audience Response System (the Keypads)(TP)

5. Turning Point Keypads Lanyard that goes around your neck These are NOT calculators and need to be returned to the faculty at the end of the session please

6. Audience Response System (ARS) – keypads This is how we vote on different items and issues Although the keypads are “anonymous” (we don’t know who uses which keypad); but we would like you to use the same one throughout the workshop You do not need to “point” the keypad (like a TV remote control) You will see a counter on the screen that shows how many people have “voted” on any item You press the number on the keypad that best describes your answer (use “0” for “10” on the keypad)

7. Audience Response System (ARS) – keypads You can change your vote up until the final vote has been collected and the slide advances A top bar appears and the upper right-hand box needs to be “green” before you vote. A summary of bar graphs appears on the screen after the votes are completed for most items so that everyone can see the total tallies The summary bar graph will not appear for pre-workshop knowledge items or workshop satisfaction

8. 4 Demographic items(TP)

9. What is your gender? • Male • Female • Don’t want to answer

10. About How Old are You? 81 and older 65-80 50-64 41-49 31-40 21-30 13-20 Under 12 Don’t want to answer brthyr5

11. What is Your Primary Race or Ethnicity? American Indian / Alaska Native (AIAN) Pacific Islander Asian African-American Non-Hispanic white (Caucasian) Hispanic / Latino / Chicano Other Don’t know / Don’t want to answer Race-ethn3

12. How Much Schooling have You Completed? Elementary (kindergarten through grade 6 / grade school) 7th , 8th , or 9th grade (middle school) 10, 11, or 12th grade (no degree) High school graduate / GED Technical school /apprentice training Some college (no degree) College AA degree College BA, BS degree Masters’ degree Doctorate or more Educ3

13. Personal Experience Questions (TP) 2 items

14. How much science education have you completed? None Between 1-6 hours Between 7-14 hours 15+ hours Don’t know / Don’t want to answer`

15. Have You ever been Told by a Healthcare Provider that you have Cancer? No Yes Don’t know Don’t want to answer cancer-dx

16. Pre-Workshop Knowledge 3 ItemsYou won’t see the answers (until the end of the workshop)

17. Which is TRUE about Biobanks and Biospecimens? • All Biospecimens have DNA • Biobanks are primarily managed by federal agencies • Biospecimens can be used to diagnose a health condition • Tribal specimens are not included in any federal biobank • Don’t Know / Not sure

18. For which would most American Indian and Alaska Native tribal / village communities object? • AI/AN specimens used for a single study with informed consent • A biospecimen DNA research study on obesity genetic markers • Tribal / Village ownership and control of data and biospecimens • AI/AN biospecimens used to create patents (e.g. medications) • Don’t Know / Not sure

19. All are common sources of biospecimens EXCEPT? • Flaked skin cells • Hair root • Fingernails • Eye color • Don’t know / Not sure

20. Native Cancer 101 Module 8 Biospecimens and Biobanking Objectives. By the end of this session the participant will be able to: • Describe biospecimens and biobanking. • Discuss ethical, legal, social, spiritual and cultural considerations and policies related to tissue donation for research. • Identify potential benefits and drawbacks of taking part in biobanking (individual, AIAN community, researchers). • Explain informed decision-making.

21. QUESTION: Why is this topic important for AIANs? • Science is rapidly changing and AIANs may want to take part (inclusiveness) • As part of research advancing, do AIANs want to contribute to the body of knowledge? • Genetic specimens in biobanks and repositories may contribute to medicines (targeted therapies) tailored to the individual or the community Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

22. Objective 1: Describe biospecimens and biobanking.

23. Photo credit: Romel Jacinto QUESTION: What are biospecimens? • Materials taken from the human body. • Contain information, about the human being and also about their disease • Primarily DNA, RNA and Proteins Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

24. QUESTION: What are common sources of biospecimens? • Blood • Saliva • Hair root • Fingernails • Flaked off skin cells (e.g., from clothing) • Biopsy tissue • Bronchoscopy • Sperm • Surgical Procedure Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

25. Uses of Biospecimens • Biospecimens can be used: • To diagnose a condition • To treat a person’s disease • For research • To educate medical students and providers • In forensics Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 25 25

26. Methods for Collecting of Biospecimens • Cheek swab (as seen on TV) • QUESTION: What are other ways to collect specimens? • Blood draw • Urine collection • Hair pull (need follicle) • Biopsy • Surgery Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

27. Biobanks (also called “Repositories”) • The US has thousands of biorepositories • Vary in size, type of biospecimens collected, uses and purposes • Can be owned and run by • Government agencies • State governments • Public health departments • Individual investigators • Private companies • Universities • Research Institutes Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

28. How is a donor’s privacy protected? Tissue is coded with a unique identifier. Categories of biospecimens: Identified Identifiable Anonymized Anonymous Photo credit: Katherine Briant Source: Fred Hutchinson Cancer Research Center Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 28 28

29. After Research Is Completed Research results may not be ready for many years. Donors don’t get to decide what type of research for which their specimen is used Donors receive results of own medical tests, but usually not results of research performed with leftover tissue. Photo credit: Rhoda Baer | Source: NCI Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 29 29

30. Biobank for a Single Study • May be limited to a specific type of: • Condition: • Cancer • Diabetes • Heart disease • Specimen (blood, tumor tissues) • Informed consent process is limited to studies about the specified condition only Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

31. Annotated or Anecdotal Data • Native Cancer 101 Module 4 describes collecting information about one’s family history. • This personal and medical information may be associated with a biospecimen • Personal information may include: • Age • Gender • Ethnicity • Disease • Environmental exposures Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

32. Advancing Cancer Prevention and Treatment Research on biospecimens can… Answer questions: Why does cancer develop? How does cancer grow? Who is at greater risk of developing it? How can side effects be lessened? Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

33. Biobanked specimens can be used is for “Personalized Medicine” Goals of personalized medicine: Identify genetic differences between people that affect drug response Develop genetic tests that predict an individual’s response to a drug Tailor medical treatments to the individual Increase effectiveness Minimize adverse side effects Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

34. Tribal Nations vary in their opinions about taking part in biospecimen / biobanking research I would participate in biobanking, if asked December 2011 Kerri Lopez, NPAIHB Tolowa Tribe of Northern California Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

35. Objective 2: Discuss ethical, legal, social, spiritual and cultural considerations and policies related to tissue donation for research.

36. Havasupai Study & Case (1989 – 2010) • In 2010, the Havasupai Tribal Nation settled a class action lawsuit against Arizona State University and the University of Arizona • Misuse of blood samples and DNA originally collected for research on diabetes Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

37. Havasupai Study & Case (1989 – 2010) • These research specimens were later used for multiple other purposes including research on “schizophrenia, inbreeding and population migration.” • Insufficient informed consent process • Part of the Havasupai conflict was that the tribe thought their specimens were being used for a single study and the researchers thought the specimens were for biobanking Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

38. Havasupai (continued) • Researchers need to be careful about violations of research ethics for individual studies versus biospecimen storage that allows many researchers to access the specimen for studies without subsequent tribal or individual donor approvals • $700,000 fine paid by Arizona State University and tribal sanctions prohibiting research studies with ASU • What happened to the PI? New job, promoted Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

39. Based on Tribal Discussion Groups conducted through “Genetic Education for Native Americans” (GENA®) (1999-2004; PI: Burhansstipanov, HG01866]: • Tribal Nations differ greatly on their perspectives about: • The storage of biospecimens • Inclusion within repositories that do not require individual informed consent processes Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

40. Issues Identified through GENA® • Ownership of the specimens / data • QUESTION: Who owns the data and the study results? • QUESTION: What is your tribe’s opinion about owning data or specimens? Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

41. Issues Identified through GENA® • Storage of data or specimens • QUESTION: Who or what organization would your tribe be likely to trust to store tribal data or specimens? Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

42. Issues Identified through GENA® Cultural perspectives about specimens Such hair, hair roots/ follicles or blood for certain tribes is prohibited Blood tests for prenatal health is usually acceptable QUESTION: Are any tissues protected by your tribal beliefs? Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

43. Issues Identified through GENA® • Uses of specimens • For research on a single disease (e.g., dedicated use of specimens only for cancer, heart disease, HIV) • Specimens should not be used to create patents for drugs or devices • Some tribes have brokered agreements to have access to new patented drugs and devices Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

44. Issues Identified through GENA® • Research on topics of little to no interest to the tribal nation • Mitochondria DNA to trace roots to Africa of little to no interest to AI/ANs • Genetic / specimen research on diabetes, substance abuse, mental conditions such as depression = high interest by many tribal Nations Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

45. Issues Identified through GENA® • Publication of genetic research findings without obtaining previous tribal approvals • Most tribal groups have policies requiring review of findings prior to submission as abstract for conferences, publication • Tribal sanctions: scientific inadequacy to appropriately protect cultural mores, privacy and confidentiality Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

46. Participant Interactive ActivityNOTE: Facilitator can make this case study into a handout (or retain the slides if not feasible to make a handout)

47. Case Studies Interactive Activity • Please form groups of ~5 individuals • Please select a recorder for your group. This individual will take notes and report summary comments back to the entire group. • The Case of Strong Arm and background information about his situation followed by a series of questions. • Please answer each question and come to consensus within your group. Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org

48. Case Study Real Story: Strong Arm Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org When entering the lab where the students were doing their summer fellowship, an obnoxious worker from the next door lab kept hounding them to give him a blood specimen. Strong Arm said, “no” multiple times. After a few weeks of refusals, the obnoxious worker said, “we just want to get practice taking blood specimens so that my girlfriend can pass a test to be a phlebotomist.” 48 48

49. Real Story: Strong Arm Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org • Strong Arm finally relented and said, “you can take my blood, but you cannot use it for anything else and you cannot store it.” • The girlfriend who collected the blood specimen agreed it would not be used for anything • She was supposed to dispose of the residue 49 49

50. Real Story: Strong Arm Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 2 years later, the girlfriend turned the blood over to the obnoxious worker (her boyfriend) because his father promised the girlfriend a medical fellowship 3 years later (2011), another student comes up to Strong Arm and says, “I’m testing your DNA for a specific type of cancer” 50 50