Native Cancer 101 Module 8: Biospecimens and Biobanking (Community version) estimated time: 2 hours with Participant interactivity version + ARS Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Incorporated (NACI) 3022 South Nova Road Pine, CO Lynne Bemis, PhD, Head of Biomedical Sciences Department University of Minnesota School of Medicine, Duluth Campus

Assumptions This is a workshop that should 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 includes scientific and cultural information specific to biobanks and biospecimens. The workshop facilitator / faculty is/are NOT interested to collecting biospecimens from you.

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

Audience Response System (the Keypads) (TP)

5 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 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 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 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 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 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

5 Demographic items (TP)

What is your gender? 1.Male 2.Female 3.Don’t want to answer

brthyr5 About How Old are You? 1.81 and older Under 12 9.Don’t want to answer

What is Your Primary Race? 1.American Indian / Alaska Native (AIAN) 2.Pacific Islander 3.Asian 4.African-American 5.Non-Hispanic white (Caucasian) 6.Other 7.Don’t know / Don’t want to answer

Are you Hispanic, Latino or Chicano? 1.Yes 2.No 3.Don’t Know / Not sure 4.Don’t want to answer

How Much Schooling have You Completed? 1.Elementary (kindergarten through grade 6 / grade school) 2.7 th, 8 th, or 9 th grade (middle school) 3.10, 11, or 12 th grade (no degree) 4.High school graduate / GED 5.Technical school /apprentice training 6.Some college (no degree) 7.College AA degree 8.College BA, BS degree 9.Masters’ degree 10.Doctorate or more

Personal Experience Questions (TP) 2 items

How much science education have you completed? 1.None 2.Between 1-6 hours 3.Between 7-14 hours hours 5.Don’t know / Don’t want to answer`

Have You ever been Told by a Healthcare Provider that you have Cancer? 1. No 2. Yes 3. Don’t know 4. Don’t want to answer

17 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] Pre-Workshop Knowledge 2 Items You won’t see the answers (until the end of the workshop)

Which is TRUE about Biobanks and Biospecimens? 1.All Biospecimens have DNA 2.Almost all biobanks are managed by federal agencies 3.Biospecimens can be used to diagnose a health condition 4.Urine is an excellent source for DNA 5.Don’t Know / Not sure

For which issue do most American Indian and Alaska Native tribal / village communities object? 1.AI/AN specimens used for a single study with informed consent 2.A biospecimen DNA research study on obesity genetic markers 3.Tribal / Village ownership and control of data and biospecimens 4.AI/AN biospecimens used to create patents (e.g. medications) 5.Don’t Know / Not sure

Assumptions This is a workshop that should follow several other topics Thus, it is not an introductory topic. This includes scientific and cultural information specific to biobanks and biospecimens. The workshop facilitator / faculty is/are NOT interested to collecting biospecimens from you.

21 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] Why am I here today? 1.Research can only be done on the samples that are available in biobanks. 2.Historically, most biobanks contain samples from white men. 3.This means that research conducted will be more likely to benefit those people. 4.The lack of samples from people of other race/ethnicity means that long-standing disparities in research may continue. 21 “Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap Version Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] /

22 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] About this Workshop: What is Cancer 101? 1.It’s an education program that covers different topics about cancer. 2.It’s designed with input from our community. 3.It’s for you or any loved one – please share it with others. 4.3 of the Cancer 101 modules are modified for cultural relevance to American Indians. 22

23 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] Cancer 100 “Overview of Cancer” (Burhansstipanov) Native Navigators and the Cancer Continuum (NNACC) [NCMHD R24MD002811] 23 QUESTION: What is cancer? 1.A group of over 100 diseases in which abnormal cells 1.Divide without control or 2.Don’t die when they should (Apoptosis) 2.Cancer: 1.Is primarily a disease of older people 2.Occasionally occurs in young people 3.But, the majority of cancers appear in people who are older (over 45)

Native Cancer 101 Module 8 Biospecimens and Biobanking Objectives. By the end of this session the participant will be able to: 1.Describe biospecimens and biobanking. 2.Discuss ethical, legal, social, spiritual and cultural considerations and policies related to tissue donation for research. 3.Identify potential benefits and drawbacks of taking part in biobanking (individual, AIAN community, researchers). 4.Explain informed decision-making.

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 25 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

Objective 1: Describe biospecimens and biobanking.

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 27 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 27 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 27 Cancer Care Research Every day science makes new progress to: Find cancer sooner Find better treatments Help people live better with cancer Help people live longer after cancer Lance Whitehair, MD Navajo Nation Lab Discoveries with Dr. Lynne Bemis, Cancer Research

How you can help: Learning more about cancer Researchers may ask both cancer patients and non-cancer patients to help by: Donating a sample (called “biospecimens) Joining a research study (clinical trial) 28 Wilma Mankiller Former Principal Chief, Cherokee Nation of Oklahoma; Nov 1945 – April 2010 participant in clinical trials for 2 types of cancer; “Native people need to take charge of your own health care.” Mankiller, 2005

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 29 QUESTION: What are biospecimens? Materials taken from the human body. Contain information, about the human being and also about their disease Photo credit: Romel Jacinto Primarily DNA, RNA and Proteins But not all biospecimens contain DNA

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 30 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] / 31 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 31 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 31 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] / 32 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] / 33 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] / 34 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 34 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 34 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] / 35 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 35 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 35 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] / 36 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] / 37 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 Disease Environmental exposures Personal information may include: Age Gender Ethnicity

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 38 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] / 39 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 Hyperlink to optionalpharma- cogenetics files

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 40 Kerri Lopez, NPAIHB Tolowa Tribe of Northern California I would participate in biobanking, if asked December 2011 Tribal Nations vary in their opinions about taking part in biospecimen / biobanking research

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

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 42 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] / 43 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] / 44 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] / 45 Based on Tribal Discussion Groups conducted through “Genetic Education for Native Americans” (GENA®) According to GENA® participants (>3,000 AIANs), most tribes and urban Indian programs ARE interested in taking part in research that addresses: Diabetes Obesity Cancer Heart conditions

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 46 Based on Tribal Discussion Groups conducted through “Genetic Education for Native Americans” (GENA®) ( ; 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] / 47 Issues Identified through GENA® Ownership of the specimens / data Most tribes / urban programs want to own study data Access it for additional programs/services 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] / 48 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? Storage of specimens requires a minus 80 degree freezer with back-up generators … ~$100,000 for the freezer

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 49 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] / 50 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] / 51 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] / 52 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

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

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 54 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] / 55 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 55 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 55 Case Study Real Story: Strong Arm 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.”

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 56 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 56 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 56 Real Story: Strong Arm 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

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 57 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 57 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 57 Real Story: Strong Arm 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”

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 58 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 58 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 58 Real Story: Strong Arm The specimen was linked with the student’s name and was in a personal (an illegal /not approved by IRB) biobank No informed consent process ever conducted Student struggled with this all weekend, very upset His tribe has an ordinance about sharing specimens

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 59 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 59 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 59 Real Story: Strong Arm His immediate supervisor reported the condition to the University Ombudsman and to her immediate supervisor She subsequently left the university QUESTION: What are other strategies the student needs to do to address this situation?

Objective 3: Identify potential benefits and drawbacks of taking part in biobanking (individual, AIAN community, researchers).

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 61 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 61 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 61 Benefits & Drawbacks for an Individual Donating Biospecimens for Research Benefits: Helps determine diagnosis, disease stage, prognosis and treatment for other future patients Helps get information to cure or manage the disease Drawbacks: No individual benefits Physical Pain Bruising Swelling Infection A risk in poorly conducted research may be Loss of privacy Breach of confidentiality

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 62 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 62 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 62 Benefits & Drawbacks for a Tribal Nation for Donating Biospecimens Benefits: Tailoring (individualizing) treatments based on knowledge learned (childhood leukemia Clinical Trials standard or tailored care) CYP450 and pain management (50% of SW tribes have variability in 3A5 within CYP 450 family) Drawbacks: Discrimination against tribal members Lack of access to quality care even though contributed to creating the body of knowledge

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 63 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 63 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 63 Benefits & Drawbacks for a Researcher for Collecting Biospecimens Benefits: Once the specimen is collected, if in a repository can use for multiple studies without requiring subsequent informed consent from participant Saves limited research monies Drawbacks: Anecdotal information (phenotype) may not be linked to the biospecimen Unable to provide individual results back to participant (biospecimens are supposed to be anonymous

Objective 4: Explain informed decision-making (Abridged version) Hyperlink to optional informed consent process files

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 65 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 65 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 65 Deciding to donate biospecimens Entirely voluntary May want to donate to diabetes database but the repository is limited only to diabetes-related research Talk with your tribal leaders to learn of tribal perspectives and/or ordinances Talk with tribal spiritual leaders for potential cultural issues

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 66 Making an Informed Choice Active vs Passive Informed Consent Process “Active” means you have to say “yes” for your specimen or data to be included in the study “Passive” means you have to say “no” for your specimen or data to be excluded in the study Almost all AI/AN groups (through GENA®) were opposed to “passive” consent processes

Informed decision making Examples of questions to ask: Is it right for you and your community? Have I received enough and accurate information? Are the risks explained? The benefits? Do I have alternative choices? How is my privacy protected? These are components of an informed consent process Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 67

Interactive Activity GENA® Jeopardy

Summary Take Home Messages

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 70 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 70 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 70 Summary / Take Home Messages Tribal Nations and urban Indian programs differ in their opinions about biospecimens and biobanking You need to understand if your tribal Nation has a formal position about taking part in biospecimen research If you choose to take part, you have rights (informed decision-making)

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 71 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 71 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 71 Summary / Take Home Messages A biobank / repository CAN be limited to a single study … but you need to ask to confirm this is true if that is important to you or your tribal Nation Some specimens (e.g., hair or blood) may have tribal sanctions prohibiting donations to biobanks

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 72 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 72 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 72 Summary / Take Home Messages There are both potential benefits and drawbacks to taking part in genetic tests and research. The individual needs to understand one’s tribal Nation’s perspectives and review the potential impacts to make an informed choice.

Post-Workshop Knowledge 2 Items

74 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] Which is/are TRUE about Biobanks and Biospecimens? 1.All Biospecimens have DNA 2.Almost all biobanks are managed by federal agencies 3.Biospecimens can be used to diagnose a health condition 4.Urine is an excellent source for DNA 5.Don’t Know / Not sure

75 Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] For which issue do most American Indian and Alaska Native tribal / village communities object/oppose? 1.AI/AN specimens used for a single study with informed consent 2.A biospecimen DNA research study on obesity genetic markers 3.Tribal / Village ownership and control of data and biospecimens 4.AI/AN biospecimens used to create patents (e.g. medications) 5.Don’t Know / Not sure

Workshop Evaluation 4 Items (you won’t see the results on the screen)

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 77 E_undrst1a Overall, this session was understandable to me. 1.I strongly agree 2.I agree 3.I don’t agree 4.I strongly disagree 5.I don’t want to answer

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 78 E-useful Overall this session provided useful information to me. 1.I strongly agree 2.I agree 3.I don’t agree 4.I strongly disagree 5.I don’t want to answer

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 79 E_quality Overall, the quality of the content was appropriate for me 1.I strongly agree 2.I agree 3.I don’t agree 4.I strongly disagree 5.I don’t want to answer

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA ] 80 E_rec Would you recommend this workshop to your friends or colleagues (who already have general knowledge about cancer)? 1.Yes 2.Maybe 3.No 4.Not Sure

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 81 Thank you for allowing us to share the current version of this Native Cancer 101 module with you

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 82 For further information Judith S. Kaur, MD Spirit of E.A.G.L.E.S. Charlton 6 Mayo Comprehensive Cancer Center 200 First Street, S.W. Rochester, MN Phone: (507) Fax: (507) Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Inc. (NACI) 3022 South Nova Road Pine, CO Phone: Mayo SoE Native Cancer 101 Working Groups Paulette A. Baukol, BS Dana Kontras. RN, MSN Linda Burhansstipanov, MSPH, DrPHKerri Lopez, BA Scientific Expertise: Lynne T. Bemis, PhD, Head of Biomedical Sciences Department, University of Minnesota School of Medicine, Duluth Campus

Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] / 83 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 83 Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605] http: NativeAmericanPrograms.org / 83 Acknowledgements Thank you Katherine J. Briant, MPH, CHES Community Health Educator Center for Community Health Promotion Fred Hutchinson Cancer Research Center 1100 Fairview Ave. N., M3-B232 P.O. Box Seattle, WA Tel: Fax: for drafting original slides for objective 1, Module 8: Biospecimens and Biobanking