1. Cancer 101: A Cancer Education and Training Program for American Indians & Alaska Natives Cancer 101: A Cancer Education and Training Program for American Indians & Alaska Natives Version 2 – Updated October 2011 Date Location Presented by: Presenter 1 Presenter 2

2. Biospecimens & Biobanking Cancer 101 – Version 2 Learning Module 8

3. Learning Objectives At the completion of learning Module 8, you will be able to:  Define what a biospecimen is.  Describe how biospecimens are collected.  Define what a biobank, or biorepository is.  Explain how biobanks protect a donor’s personal and medical information.  Describe why biospecimens are important in research.

4. Learning Objectives (cont’d)  Explain how biospecimens can be used to advance cancer prevention and treatment.  Discuss ethical, legal and social considerations related to tissue donation for research.  Discuss what informed consent is.  Describe the Genetic Information and Nondiscrimination Act.

5. Where can we find clues about cancer?

6. What are biospecimens? TISSUE FLUIDS Photo credit: Romel Jacinto

7. Biospecimen TYPES:  Extra tissue from diagnosis and treatment  Donation for research  Excess normal tissue COLLECTION:  Blood draw  Cheek swab  Urine collection  Biopsy  Surgery

8. Annotation  Personal and medical information associated with a biospecimen. Age Gender Ethnicity Disease Environmental exposures

9. What is a biorepository? Photo credits: Katherine Briant | Source: Fred Hutchinson Cancer Research Center

10. Biospecimen Handling  Specimens are vulnerable  Stresses introduced: Routine handling during collection Processing Storage Transport  Important to keep specimens biologically viable

11. Biospecimen Storage Photo credit: Katherine Briant | Source: Fred Hutchinson Cancer Research Center

12. 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

13. Why are biospecimens important?  Contain lots of information  Can be processed and stored for later research  Can be used to develop new diagnostic tests or treatment drugs Photo credit: Linda Bartlett | Source: NCI

14. Biospecimens for Cancer Research Photo credit: Diane A. Reid | Source: NCI

15. 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?  Develop targeted treatments: Herceptin® (trastuzumab) Gleevec® (imatinib)

16. Personalized Medicine SOURCE: National Cancer Institute

17. Personalized Medicine  Goals: 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 Image Source: National Human Genome Research Institute

18. After Research Is Completed  Research results may not be ready for many years.  Donors receive results of own medical tests, but usually not results of research performed with leftover tissue. Photo credit: Rhoda Baer | Source: NCI

19. Past Research Without Consent SOURCE: Smithsonian.com SOURCE: The New York Times

20. Bioethics & Biospecimens  How do you help people make informed choices about biospecimen donation?  Who owns information discovered as a result of research on the specimen?  How will discoveries be used?  Do research findings affect an individual or minority community? If so, how does that affect society’s perception of that individual or community?

21. Belmont Report  Issued in 1979 by a national commission  Sets forth three principles for the ethical conduct of research: 1. Respect for persons 2. Beneficence 3. Justice

22. What is Informed Consent?  A document  A process  Should: Provide adequate information Ensure participant understands information Include voluntary consent Photo credit: Rhoda Baer | Source: NCI

23. Informed Consent for Biospecimens Informed Consent should cover: 1. Collection of the biospecimen(s) for the intervention. 2. Anticipated use(s) after the intervention. 3. Findings from the research on the biospecimen(s)

24. Benefits & Risks of Donating Biospecimens Benefits:  Help determine prognosis and treatment  Advance knowledge on how to fight diseases  Helps others in the future with medical advances Risks:  Physical Pain Bruising Swelling Infection  Non-physical Loss of privacy Breach of confidentiality

25. GINA  The Genetic Information Nondiscrimination Act of 2008 (aka GINA)  Prohibits discrimination in health coverage and employment based on genetic information.

26. Deciding to donate biospecimens  Entirely voluntary  Talk with your provider, family and friends.  Review resources to become informed.

27. Case Study  When Martha met with her surgeon to discuss her breast surgery, he informed her about a study going on at the cancer center that was collecting blood samples from patients with and without breast cancer.  He explained the purpose of the study, the risks, and benefits and offered her a pamphlet with more information.

28. In Summary  You now have an understanding of: what a biospecimen is and how they are collected. what a biobank, or biorepository is. how biobanks protect a donor’s personal and medical information. why biospecimens are important in research.

29. Summary (cont’d) how biospecimens can be used to advance cancer prevention and treatment. ethical, legal and social considerations related to tissue donation for research. what informed consent is. the Genetic Information and Nondiscrimination Act of 2008.