Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Incorporated (NACI)

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, DrPHNative American Cancer Initiatives, Incorporated (NACI)

3022 South Nova Road Pine, CO 80470-7830

http://www.NatAmCancerInitiatives.org

Lynne Bemis, PhD, Head of Biomedical Sciences DepartmentUniversity of Minnesota School of Medicine, Duluth Campus

AssumptionsThis 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

Please turn off your cell phones or switch them

to “vibrate” mode

Audience Response System (the Keypads)

(TP)

5Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles

Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org

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



Audience Response System (ARS) – keypads

This is how we vote on different items and issuesAlthough 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 itemYou press the number on the keypad that best describes your answer (use “0” for “10” on the keypad)



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

4 Demographic items(TP)

What is your gender?

1 2 3

33%

0%

67%1. Male2. Female3. Don’t want to answer

brthyr5

About How Old are You?

1 2 3 4 5 6 7 8 9

0% 0% 0%

67%

0%0%0%0%

33%

1. 81 and older2. 65-803. 50-644. 41-495. 31-406. 21-307. 13-208. Under 129. Don’t want to answer

Race-ethn3

What is Your Primary Race or Ethnicity?

1 2 3 4 5 6 7 8

100%

0% 0% 0%0%0%0%0%

1. American Indian / Alaska Native (AIAN)2. Pacific Islander3. Asian4. African-American5. Non-Hispanic white (Caucasian)6. Hispanic / Latino / Chicano7. Other8. Don’t know / Don’t want to answer

Educ3

How Much Schooling have You Completed?

1 2 3 4 5 6 7 8 9 10

0% 0% 0% 0% 0%0%0%

33%

67%

0%

1. Elementary (kindergarten through grade 6 / grade school)

2. 7th , 8th , or 9th grade (middle school)3. 10, 11, or 12th grade (no degree)4. High school graduate / GED5. Technical school /apprentice training6. Some college (no degree)7. College AA degree8. College BA, BS degree9. Masters’ degree10. Doctorate or more

Personal Experience

Questions (TP)2 items

How much science education have you completed?

1 2 3 4 5

0%

67%

0%

33%

0%

1. None2. Between 1-6 hours3. Between 7-14 hours4. 15+ hours 5. Don’t know / Don’t want to

answer`

cancer-dx

Have You ever been Told by a Healthcare Provider that you have Cancer?

1 2 3 4

100%

0%0%0%

1. No2. Yes3. Don’t know4. Don’t want to answer



Pre-Workshop Knowledge 3 Items

You won’t see the answers

(until the end of the workshop)

Which is TRUE about Biobanks and Biospecimens?

1 2 3 4 5

33%

0% 0%

33%33%1. All Biospecimens have DNA2. Biobanks are primarily managed

by federal agencies3. Biospecimens can be used to

diagnose a health condition4. Tribal specimens are not

included in any federal biobank5. Don’t Know / Not sure

For which would most American Indian and Alaska Native tribal / village communities object?

1 2 3 4 5

0% 0% 0%

33%

67%1. AI/AN specimens used for a single

study with informed consent2. A biospecimen DNA research study

on obesity genetic markers3. Tribal / Village ownership and

control of data and biospecimens4. AI/AN biospecimens used to create

patents (e.g. medications)5. Don’t Know / Not sure



All are common sources of biospecimens EXCEPT?

1 2 3 4 5

0% 0% 0%

100%

0%

1. Flaked skin cells2. Hair root3. Fingernails4. Eye color5. Don’t know / Not sure

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]

http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 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

Objective 1:

Describe biospecimens

and biobanking.



QUESTION: What are biospecimens?

Materials taken from the human body.Contain information, about the human being and also about their disease

Pho

to c

redi

t: R

omel

Jac

into

Primarily DNA, RNA and Proteins



QUESTION: What are common sources of biospecimens?

BloodSalivaHair rootFingernailsFlaked off skin cells (e.g., from clothing)Biopsy tissueBronchoscopySpermSurgical Procedure




http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org 25



Uses of Biospecimens

Biospecimens can be used:To diagnose a conditionTo treat a person’s diseaseFor researchTo educate medical students and providersIn forensics



Methods for Collecting of Biospecimens

Cheek swab (as seen on TV)QUESTION: What are other ways to collect specimens?

Blood drawUrine collectionHair pull (need follicle)BiopsySurgery



Biobanks (also called “Repositories”)

The US has thousands of biorepositoriesVary in size, type of biospecimens collected, uses and purposes

Can be owned and run by Government agenciesState governmentsPublic health departments Individual investigators

Private companiesUniversitiesResearch Institutes







How is a donor’s privacy protected?Tissue is coded with a unique identifier.Categories of biospecimens:

IdentifiedIdentifiableAnonymizedAnonymous

Photo credit: Katherine Briant Source: Fred Hutchinson Cancer Research Center







After Research Is CompletedResearch results may not be ready for many years.Donors don’t get to decide what type of research for which their specimen is usedDonors receive results of own medical tests, but usually not results of research performed with leftover tissue.

Photo credit: Rhoda Baer | Source: NCI



Biobank for a Single Study

May be limited to a specific type of:Condition:

CancerDiabetesHeart disease

Specimen (blood, tumor tissues)Informed consent process is limited to studies about the specified condition only



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

DiseaseEnvironmental exposures

Personal information may include:AgeGenderEthnicity



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?



Biobanked specimens can be used is for “Personalized Medicine”

Goals of personalized medicine:Identify genetic differences between people that affect drug responseDevelop genetic tests that predict an individual’s response to a drugTailor medical treatments to the individual

Increase effectivenessMinimize adverse side effects



Kerri Lopez, NPAIHBTolowa 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.



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



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 processPart 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



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 ASUWhat happened to the PI? New job, promoted



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



Issues Identified through GENA®

Ownership of the specimens / dataQUESTION: Who owns the data and the study results?QUESTION: What is your tribe’s opinion about owning data or specimens?




Storage of data or specimensQUESTION: Who or what organization would your tribe be likely to trust to store tribal data or specimens?




Cultural perspectives about specimens Such hair, hair roots/ follicles or blood for certain tribes is prohibitedBlood tests for prenatal health is usually acceptableQUESTION: Are any tissues protected by your tribal beliefs?




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




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/ANsGenetic / specimen research on diabetes, substance abuse, mental conditions such as depression = high interest by many tribal Nations




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)



Case Studies Interactive Activity Please form groups of ~5 individualsPlease 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.







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.”







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








2 years later, the girlfriend turned the blood over to the obnoxious worker (her boyfriend) because his father promised the girlfriend a medical fellowship3 years later (2011), another student comes up to Strong Arm and says, “I’m testing your DNA for a specific type of cancer”








The specimen was linked with the student’s name and was in a personal (an illegal /not approved by IRB) biobankNo informed consent process ever conductedStudent struggled with this all weekend, very upset His tribe has an ordinance about sharing specimens







Real Story: Strong ArmHis immediate supervisor reported the condition to the University Ombudsman and to her immediate supervisor

She subsequently left the universityQUESTION: 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).







Benefits & Drawbacks for an Individual Donating Biospecimens for Research

Benefits:Helps determine diagnosis, disease stage, prognosis and treatment for other future patientsHelps get information to cure or manage the disease

Drawbacks:No individual benefitsPhysical

PainBruisingSwellingInfectionA risk in poorly conducted research may be

Loss of privacy Breach of confidentiality







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 membersLack of access to quality care even though contributed to creating the body of knowledge







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 participantSaves limited research monies

Drawbacks:Anecdotal information (phenotype) may not be linked to the biospecimenUnable to provide individual results back to participant (biospecimens are supposed to be anonymous

Objective 4: Explain informed decision-making

(Abridged version)







Deciding to donate biospecimens

Entirely voluntaryMay want to donate to diabetes database but the repository is limited only to diabetes-related researchTalk with your tribal leaders to learn of tribal perspectives and/or ordinancesTalk with tribal spiritual leaders for potential cultural issues



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 studyAlmost all AI/AN groups (through GENA®) were opposed to “passive” consent processes

Informed decision making: Questions to ask

Is it right for you and your communityHave I received enough and accurate information?Are the risks explainedDo I have alternative choicesHow is my privacy protectedThese are components of an informed consent process



Interactive Activity

GENA® Jeopardy

Summary

Take Home Messages







Summary / Take Home MessagesTribal Nations and urban Indian programs differ in their opinions about biospecimens and biobankingYou need to understand if your tribal Nation has a formal position about taking part in biospecimen researchIf you choose to take part, you have rights (informed decision-making)







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 NationSome specimens (e.g., hair or blood) may have tribal sanctions prohibiting donations to biobanks







Summary / Take Home MessagesThere are both potential benefits and drawbacks to taking part in genetic tests and research; The individual needs to understand their tribal Nation’s perspectives and review the potential impacts to make an informed choice

Post-Workshop Knowledge 3 Items

67

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org

Which is TRUE about Biobanks and Biospecimens?

1 2 3 4 5

0% 0% 0%0%

100%1. All Biospecimens have DNA

2. Biobanks are primarily managed by federal agencies

3. Biospecimens can be used to diagnose a health condition

4. Tribal specimens are not included in any federal biobank

5. Don’t Know / Not sure

68

Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org

For which would most American Indian and Alaska Native tribal / village communities object?

1 2 3 4 5

0% 0% 0%

33%

67%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



All are common sources of biospecimens EXCEPT?

1 2 3 4 5

0%

33%

0%

67%

0%

1. Flaked skin cells2. Hair root3. Fingernails4. Eye color5. 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 114609] http://www.NatAmCancer.org 71E_undrst1a

Overall, this session was understandable to me.

1 2 3 4 5

33%

67%

0%0%0%

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 114609] http://www.NatAmCancer.org 72E-useful

Overall this session provided useful information to me.

1 2 3 4 5

67%

33%

0%0%0%

1. I strongly agree

2. I agree

3. I don’t agree



Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org 73E_quality

Overall, the quality of the content was appropriate for me

1 2 3 4 5

67%

33%

0%0%0%

1. I strongly agree

2. I agree

3. I don’t agree



Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org 74E_rec

Would you recommend this workshop to your friends or colleagues (who already have

general knowledge about cancer)?

1 2 3 4

0% 0%0%0%

1. Yes

2. Maybe

3. No

4. Not Sure



Thank you for allowing us to share the current version of this Native

Cancer 101 module with you



How would you recommend this

workshop be changed?



For further informationJudith S. Kaur, MD Spirit of E.A.G.L.E.S.

Charlton 6Mayo Comprehensive Cancer Center

200 First Street, S.W.Rochester, MN 55905

Phone: (507) 266-3064 Fax: (507) 266-2478

[email protected]

Kerri Lopez, BANorthwest Portland Area Indian

Health Board2121 SW Broadway, Suite 300

Portland, Oregon 97201Phone: 503-228-4185

Fax: [email protected]

www.npaihb.org

Mayo SoE Native Cancer 101 Working GroupsPaulette A. Baukol, BS Dana Kontras. RN, MSNLinda Burhansstipanov, MSPH, DrPH Kerri Lopez, BA

Scientific Expertise: Lynne T. Bemis, PhD, Head of Biomedical Sciences Department, University of Minnesota School of Medicine, Duluth Campus

mailto:[email protected]







AcknowledgementsThank you

Katherine J. Briant, MPH, CHESCommunity Health Educator

Center for Community Health PromotionFred Hutchinson Cancer Research Center

1100 Fairview Ave. N., M3-B232P.O. Box 19024

Seattle, WA 98109Tel: 206-667-1137 Fax: 206-667-5977

for drafting original slides for Module 8: Biospecimens and Biobanking (~8 used within this module)

Linda Burhansstipanov, MSPH, DrPH Native American Cancer Initiatives, Incorporated (NACI)

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