Native Cancer 101
Module 8: Biospecimens and
Biobanking
(BASIC / Abridged Community version)
estimated time: 1½ hours with Participant interactivity
07-02-2012 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
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
Please turn off your cell
phones or switch them
to “vibrate” mode
Audience Response
System (the Keypads)
(TP)
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
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
5
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)
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
6
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 preworkshop knowledge items or workshop satisfaction
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
7
4 Demographic items
(TP)
What is your gender?
1. Male
2. Female
3. Don’t want to answer
67%
33%
0%
1
2
3
About How Old are You?
1.
2.
3.
4.
5.
6.
7.
8.
9.
81 and older
65-80
50-64
41-49
31-40
21-30
13-20
Under 12
Don’t want to answer
67%
33%
0%
0%
0%
1
2
3
4
5
0%
0%
0%
0%
6
7
8
9
brthyr5
What is Your Primary Race or Ethnicity?
1.
2.
3.
4.
5.
6.
7.
8.
100%
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
0%
1
2
0%
0%
0%
3
4
5
0%
0%
0%
6
7
8
Race-ethn3
How Much Schooling have You Completed?
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 / 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
67%
33%
0%
0%
0%
0%
0%
1
2
3
4
5
6
7
0%
0%
8
9
0%
10
Educ3
Personal
Experience
Questions (TP)
2 items
How much science education have you completed?
1.
2.
3.
4.
5.
67%
None
Between 1-6 hours
Between 7-14 hours
15+ hours
Don’t know / Don’t want to
answer`
33%
0%
1
0%
2
3
0%
4
5
Have You ever been Told by a Healthcare
Provider that you have Cancer?
100%
1.
2.
3.
4.
No
Yes
Don’t know
Don’t want to answer
0%
1
2
0%
3
0%
4
cancer-dx
Pre-Workshop Knowledge
3 Items
You won’t see the answers
(until the end of the
workshop)
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
16
Which is TRUE about Biobanks and Biospecimens?
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
For which would 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
All are common sources of biospecimens
EXCEPT?
1. Flaked skin cells
2. Hair root
3. Fingernails
4. Eye color
5. Don’t know / Not sure
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
19
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.
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
21
Objective 1:
Describe
biospecimens
and biobanking.
QUESTION: What are biospecimens?
Photo credit: Romel Jacinto
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
23
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
24
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
25
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
26
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
Private
State governments
companies
Public health departments Universities
Individual investigators
Research
Institutes
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EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org
27
How is a donor’s privacy protected?
Photo credit: Katherine Briant
Source: Fred Hutchinson Cancer Research Center
Tissue is coded
with a unique
identifier.
Categories of
biospecimens:
Identified
Identifiable
Anonymized
Anonymous
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
28
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
29
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
30
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
Disease
Gender
Environmental exposures
Ethnicity
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
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
32
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
33
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
34
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
Native American Cancer Initiatives, Incorporated (NACI) and Mayo Clinic’s “Spirit of
EAGLES Community Network Programs 2” [P.I. Kaur; U54CA153605]
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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
37
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]
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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
39
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
40
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]
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41
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
42
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
43
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
44
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
45
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 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]
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47
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
48
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
49
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
50
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
51
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?
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
52
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
Drawbacks:
Benefits:
No individual
Helps determine
benefits
diagnosis, disease
Physical
stage, prognosis and
Pain
treatment for other
Bruising
future patients
Swelling
Helps
get information
A risk
in poorly
conducted research may be
Infection
to cure
or manage the
Loss
of privacy
disease
Breach of 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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
54
Benefits & Drawbacks for a Tribal Nation for
Donating Biospecimens
Drawbacks:
Benefits:
Tailoring (individualizing)
Discrimination
treatments based on
against tribal
knowledge learned
members
(childhood leukemia
Lack of access to
Clinical Trials standard or
quality care even
tailored care)
though contributed to
CYP450 and pain
management (50% of SW
creating the body of
tribes have variability in
knowledge
3A5 within CYP 450
family)
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
55
Benefits & Drawbacks for a Researcher for
Collecting Biospecimens
Benefits:
Drawbacks:
Once the specimen
Anecdotal information
is collected, if in a
(phenotype) may not
repository can use
be linked to the
for multiple studies
biospecimen
without requiring
Unable to provide
subsequent
individual results
informed consent
back to participant
from participant
(biospecimens are
Saves limited
supposed to be
research monies
anonymous
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
56
Objective 4:
Explain informed
decision-making
(Abridged version)
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
58
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
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
59
Informed decision making: Questions to
ask
Is it right for you and your community
Have I received enough and accurate
information?
Are the risks explained
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org
60
Interactive Activity
GENA® Jeopardy
Summary
Take Home
Messages
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
63
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]
http://www.NativeAmericanPrograms.org
http: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
64
Summary / Take Home Messages
There 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
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
65
Post-Workshop Knowledge
3 Items
Which is TRUE about Biobanks and Biospecimens?
1. All Biospecimens have DNA
100%
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
0%
0%
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
1
2
3
0%
4
0%
67
5
For which would most American Indian and Alaska
Native tribal / village communities object?
1. AI/AN specimens used for a single
study with informed consent
67%
2. A biospecimen DNA research study
on obesity genetic markers
3. Tribal / Village ownership and
control of data and biospecimens
33%
4. AI/AN biospecimens used to create
patents (e.g. medications)
0%
0%
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
1
2
3
5. Don’t Know / Not sure
0%
4
68
5
All are common sources of biospecimens
EXCEPT?
1. Flaked skin cells
2. Hair root
3. Fingernails
4. Eye color
5. Don’t know / Not sure
67%
33%
0%
0%
Native Cancer 101 Module 8: Biospecimens and Biobanking;
Mayo Clinic’s
Spirit3 of Eagles 4
1
2
Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org
0%
5
69
Workshop Evaluation
4 Items
(you won’t see the results on the screen)
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 114609] http://www.NatAmCancer.org E_undrst1a
71
3
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 114609] http://www.NatAmCancer.org
E-useful 72
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 114609] http://www.NatAmCancer.org
E_quality73
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 Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles
Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org
E_rec 74
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org
75
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
76
How would you
recommend this
workshop be
changed?
Mayo SoE Native Cancer 101 Working Groups
Paulette A. Baukol, BS
Dana Kontras. RN, MSN
Linda 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
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 55905
Phone: (507) 266-3064
Fax: (507) 266-2478
Judith.Kaur@mayo.edu
www.nativeamericanprograms.org
Kerri Lopez, BA
Northwest Portland Area Indian
Health Board
2121 SW Broadway, Suite 300
Portland, Oregon 97201
Phone: 503-228-4185
Fax: 503-228-8182
klopez@npaihb.org
www.npaihb.org
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
78
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 19024
Seattle, WA 98109
Tel: 206-667-1137 Fax: 206-667-5977
for drafting original slides for Module 8:
Biospecimens and Biobanking (~8 used within this module)
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: NativeAmericanPrograms.org / http:///www.NatAmCancerInitiatives.org
/ http://www.NatAmCancerInitiatives.org
79