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Transcript of Native Cancer 101 Module 8: Biospecimens and Biobanking (Community version) estimated time: 2 hours...
Native Cancer 101Module 8: Biospecimens and
Biobanking(Community version)
estimated time: 2 hours with Participant interactivity02-01-2013 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 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)
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
6Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles
Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org
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)
7Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles
Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org
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 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
What is Your Primary Race?
1 2 3 4 5 6 7
14% 14% 14% 14%14%14%14%
1. American Indian / Alaska Native (AIAN)2. Pacific Islander3. Asian4. African-American5. Non-Hispanic white (Caucasian)6. Other7. Don’t know / Don’t want to answer
Are you Hispanic, Latino or Chicano?
1 2 3 4
25% 25%25%25%1. Yes
2. No
3. Don’t Know / Not sure
4. Don’t want to answer
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`
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
17Native Cancer 101 Module 8: Biospecimens and Biobanking; Mayo Clinic’s Spirit of Eagles
Community Network Programs [NCI U01 CA 114609] http://www.NatAmCancer.org
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 2 3 4 5
20% 20% 20%20%20%
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 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
Why am I here today?
Research can only be done on the samples that are available in biobanks.
Historically, most biobanks contain samples from white men.
This means that research conducted will be more likely to benefit those people.
The lack of samples from people of other race/ethnicity means that long-standing disparities in research may continue.
20
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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
About this Workshop:What is Cancer 101?
It’s an education program that covers different topics about cancer.
It’s designed with input from our community.
It’s for you or any loved one – please share it with others.
3 of the Cancer 101 modules are modified for cultural relevance to American Indians.
21
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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
Cancer 100 “Overview of Cancer” (Burhansstipanov)Native Navigators and the Cancer Continuum (NNACC) [NCMHD R24MD002811] 22
QUESTION: What is cancer?
A group of over 100 diseases in which abnormal cells
Divide without control or Don’t die when they should (Apoptosis)
Cancer:
Is primarily a disease of older people
Occasionally occurs in young people
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 24
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 26
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 26
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 26
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, MDNavajo 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)
27
Wilma MankillerFormer 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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 28
QUESTION: What are biospecimens?
Materials taken from the human body.
Contain information, about the human being and also about their disease
Ph
oto
cre
dit:
Ro
me
l Ja
cin
to
Primarily DNA, RNA and ProteinsBut 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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 29
QUESTION: What are common sources of biospecimens?
BloodSalivaHair rootFingernailsFlaked off skin cells (e.g., from clothing)Biopsy tissueBronchoscopySpermSurgical 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 30
How do researchers get samples?
Cheek swab (as seen on TV)
QUESTION: What are other ways to collect specimens?
Blood drawUrine collectionHair pull (need follicle)BiopsySurgery
Why are samples important?
They have a lot of information and clues
They can be used to come up with new tests or treatments
They can help find disease or measure how a treatment works
They can be stored for later research
31
3232
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 32
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
How are samples used in research?
They are used to:Find ways to send drugs to certain cellsSee how diseases are different and change over timeGroup patients to find out
33
which treatment might work bestMake tests to find cells linked to certain stages or types of a disease
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
What questions can samples help answer?
Research on samples can answer questions:Why does someone get cancer?How does cancer grow?Who has a higher chance of getting cancer?What treatments work best?
It can also help find treatments that attack certain cancer cells (targeted treatments)
34Native 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://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 35
Where are samples stored?Samples are kept safe in a biobank (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 agenciesState governmentsPublic health departments Individual investigators
Private companiesUniversitiesResearch 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 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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 37
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 37
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 37
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 38
What questions can samples help answer?
Research on biospecimens can answer questions:
Why does someone get cancer?
How does cancer grow?
Who has a higher chance of getting cancer?
What treatments work best?
It can also help find treatments that attack certain cancer cells (targeted treatments)
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
How can research on samples benefit YOU?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 effectivenessMinimize adverse side effects
Example of Personalized Medicine
QUESTION: How many people die each year in the U.S. from medication side effects?
100,000
QUESTION: How many people suffer from serious side effects from medications in the U.S. each year?
2,000,000 (2 million)
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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
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
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 41
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 41
QUESTION: What factors can influence how a person responds to medication?
WeightDietFood in stomachFatigueAgeSun exposurePhysical condition / lack of exerciseDrug interactions (i.e., Cross reactivity, synergism)Genetic make-up
Obviously, many factors affect people’s
responses to drugs other than genes.
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
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 42
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 42
The Enzyme “Cytochrome P-450” contributes to ~ ½ of all medications
Examples of medicines ...
Codeine (opiate to treat pain or relieve cough by converting to morphine in the body)
Acetaminophen
Diazepam (dye az' e pam)
Cyclosporin A
Erythromycin
Balance of 3A4 and 2D6 within P-450
You always have 3A4.
But, if 3A4 is too high in comparison to the amount of 2D6, the liver cannot metabolize codeine into morphine
Instead = “norcodeine” which cannot be used by the body
Grapefruit juice can reduce your 3A4
Quinidine (used for heart arrhythmia or malaria) reduces 2D6.
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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
3A4 2D6
Grapefruit Juice Quinidine
Group A Group B
Group C
Grapefruit Juice
Quinidine
Will be distributed by workshop faculty shortly
Interactive Activity
Please form groups of 4 people each
Each group represents one human liver
Each group (liver) receives a sack of candies
Look at the balance of 3A4 (Hershey’s kisses) and 2D6 (peanut butter cups).
Interactive Activity Can the liver convert codeine into morphine?
Eat or remove a few candiesNow can the liver convert codeine into morphine?
Addition of grapefruit juice or quinidine; how does that affect your metabolism?
2D6
SUMMARYMore 2D6 than 3A4 = can convert codeine into morphineMore 3A4 than 2D6 = cannot convert codeine (makes norcodeine)Grapefruit Juice = reduces 3A4Quinidine = reduces 2D6
3A4
Grapefruit Juice
Quinidine
Read Rx labels
Many say, “do not drink grapefruit juice”
QUESTION: Why? What does too much grapefruit juice do to the 2D6, 3A4 balance?
Reduces 3A4 and changes the effectiveness of the medication
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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
Pharmacogenetics Study in Indian Country
University of Montana
Working in partnership with ~5 tribal nations
Examining the P-450 enzyme to learn if American Indians metabolize medications differently than Whites or other racial groups
~1/2 of Southwestern American Indians have variation in 3A5 (same family as 3A4)
How do MT Tribal Nations differ?“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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 49
Genetic Information Nondiscrimination Act of 2008This law does not let health plans deny insurance to a person because they may have a greater chance of getting a disease.
The Belmont Report
A report issued in 1979. It outlines 3 basic principles of the ethical treatment of persons joining research studies.
1.Respect2.Protect3.Be fair
How are your rights protected?Institutional Review Board (IRB)•A group of scientists and community members
•Reviews studies to make sure the people taking part will be safe and protected.
1960 1970 1980 1990 2000 2010 2015
50
It is a process where you learn the facts and ask questions about a study like:
What is being researchedWhat will happen during the researchLength of time of the studyRisk and benefits
Your rights:Taking part is your choiceYou can leave the study at any time
What is Informed Consent?
51
How do I donate to a study?
Confirm your tribal nations ordinances (if any) related to sharing samples for research studies
Ask your doctor or nurse what samples you may be able to donate.
Confirm the type of sample does not violate tribal cultural beliefs (hair, skin, blood)
There are two ways you can donate:“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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 52
How do I donate to a study?
Donate samples
Collected during a medical procedure.
Often, parts of your samples are left after your doctor uses what he or she needs for tests.
Confirm you tribe has no issues with how the residue sample is handled.
Through a procedure not related to your care, like a blood draw or saliva swab.
“Native Cancer 101 Module 8: Biospecimens and Biobanks” Gmap VersionNative 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 53
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 54
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
For More Information
Talk to your doctor or nurse
Contact Mayo Clinic Spirit of Eagles, http://www.NativeAmericanPrograms.org
Contact the Office of Biorepositories and Biospecimen Research
E-mail: [email protected]
Web: http://biospecimens.cancer.gov
55
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 57
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 58
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 59
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 60
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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 61
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 62
Issues Identified through GENA®
Ownership of the specimens / dataMost 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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 63
Issues Identified through GENA®
Storage of data or specimensQUESTION: 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]
http://www.NativeAmericanPrograms.org / http://www.NatAmCancerInitiatives.org 64
Issues Identified through GENA®
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?
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 65
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 66
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
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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)
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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.
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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.”
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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]
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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 fellowship3 years later (2011), another student comes up to Strong Arm and says, “I’m testing your DNA for a specific type of cancer”
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Real Story: Strong Arm
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
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Real Story: Strong Arm
His 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).
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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 benefitsPhysical
PainBruisingSwellingInfectionA risk in poorly conducted research may be
Loss of privacy Breach of confidentiality
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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
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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
Interactive Activity
GENA® Jeopardy
Summary
Take Home Messages
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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]
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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
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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
85Native 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/are TRUE about Biobanks and Biospecimens?
1 2 3 4 5
20% 20% 20%20%20%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
86Native 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 issue do most American Indian and Alaska Native tribal / village communities
object/oppose?
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
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 88E_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 89E-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
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 90E_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
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 91E_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
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Thank you for allowing us to share the current version of this Native
Cancer 101 module with you
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For further information
Judith 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
Linda Burhansstipanov, MSPH, DrPH
Native American Cancer Initiatives, Inc. (NACI)
3022 South Nova Road Pine, CO 80470-7830 Phone: 303-838-9359
http://www.NatAmCancer.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
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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 objective 1, Module 8: Biospecimens and Biobanking