Respect for Persons Autonomy

1. Bioethics Café: The Immortal Life if Henrietta Lacks – 13 Nov 2012Sponsored by: New Jersey Association of Biomedical Research, Bioethics Society of Rutgers University, Rutgers University College Avenue Campus Dean, and Rutgers University Undergraduate Education Dr. Chris Asmann-Finch, Medical Humanist, UMDNJ Human Subjects Protection Program, Dr. Paula Bistak, Executive Director, UMDNJ Human Subjects Protection Program, Neil Rajnikant Patel, President, Bioethics Society of Rutgers University, Neil Raju and Julia Xia, Programming Chairs, Bioethics Society of Rutgers University

2. We do not know much about Henrietta Lacks, the woman whose name graces the book’s title. She was born Loretta Pleasant in 1920 and raised in Roanoke, VA. As an adult, she and her husband, David Lacks, moved to Baltimore with their 5 young children. We glean from story details that Ms. Lacks cherished family, good music and dancing. Yet, in her short life, Ms. Lacks was also no stranger to hard work, poverty and racial discrimination. We learn Ms. Lacks died much too young at age 31 from cervical cancer, suffering a death as brutal as cancer can make. She is survived by a loving family.

3. Respect for Persons Autonomy “You know what is a myth?” Bobbette snapped from the recliner. “Everybody always saying Henrietta Lacks donated those cells. She didn’t donate nothing. They took them and didn’t ask.” Excerpt Immortal Life… pg 169

4. Respect for Persons Autonomy Day clenched his three remaining teeth. “I didn’t sign no papers,” he said. “I just told them they could do a topsy. Nothin else. Them doctors never said nuthin about keepin her alive in no tubes or growin no cells. All they told me was they wanted to do a topsy see if they could help my children…. They knew them cells was already growin when I come there after she [Henrietta] died,” Day said, shaking his head. “But they didn’t tell me nuthin bout that. They just asked if they could cut her up see about that cancer.” Excerpt Immortal Life… pp. 164-165

5. Respect for Persons Autonomy “What really would upset Henrietta is the fact that Dr. Gey never told the family anything—we didn’t know nothing about those cells and he didn’t care [Bobbette remarked]. That just rubbed us the wrong way. I just kept asking everybody, ‘Why didn’t they say anything to the family?’ They knew how to contact us? If Dr. Gey wasn’t dead, I think I would have killed him myself.” Excerpt Immortal Life… pg 169

6. Privacy and Confidentiality “I told him [Day Lacks] my name [R. Skloot explains] and started to explain why I was calling, but before I could say much, he let out a deep sigh. “Whanowthis,” he mumbled in a deep Southern accent…. “You got my wife cells?” “Yeah,” I said, thinking he was asking if I was calling about his wife’s cells….. “Well, so let my old lady cells talk to you and leave me alone,” he snapped. “I had enough ‘a you people.” then he hung up. Excerpt, Immortal Life pg 55

7. Fair Dealings and Just Access to the Benefits of Research “Hopkins say they gave them cells away,” Lawrence yelled, “but they made millions! It’s not fair! She’s the most important person in the world and her family living in poverty. If our mother so important to science, why can’t we get health insurance?” Excerpt Immortal Life… pg. 168

8. Trust “Back then they did things,” Sonny said. “Especially to black folks. John Hopkins was known for experimentin on black folks. They’d snatch em off the street…” “You’d be surprised how many people disappeared in East Baltimore when I was girl,” Bobbette said, shaking her head. “I’m telling you, I lived here in the fifties when they got Henrietta, and we weren’t allowed to go anywhere near Hopkins. When it got dark and we were young, we had to be on the steps, or Hopkins might get us.” Excerpt Immortal Life… pg 165

9. Human Dignity Radio Lab…. …take a listen…[excerpt Minute 18:45 to 22:20] http://www.radiolab.org/2010/May/17/henriettas-tumor/

10. Current Collection, Storage and Use of Human Biological Materials and/or Data Where are we today?

11. What protections are currently in place? • Federal Regulations • Department of Health and Human Services (DHHS) Office for Human Research Protection (OHRP) Common Rule • Health Insurance Portability and Accountability Act (HIPAA) • Genetic Information Nondiscrimination Act (GINA) • State Statutes • Patient’s Bill of Rights • Limitations on type of research conducted • Institutional Policies • Departmental Requirements

12. Institutional Review Boards • The administrative body established to protect human research subjects. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction (i.e., research involving a human subject). • Limited • Research funded by DHHS or under the authority of another federal agency (i.e. FDA, DOD) • Must meet the federal definition of a human subject

13. Definition of Human Subject 45 CFR 46.102 (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

14. Definitions • Identifiable: The biological specimen is labeled with personal identifiers • Coded: • Identifying information that would enable the investigator to readily ascertain the identity of the individual has been replaced with a number, letter, symbol (i.e. code); and • A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. • Anonymized: The act of permanently and completely removing personal identifiers from data, such as converting personally identifiable information into aggregated data. Anonymized data is data that can no longer be associated with an individual in any manner. Once this data is stripped of personally identifying elements, those elements can never be re-associated with the data or the underlying individual. --- No link • De-identified: de-identification involves the removal of personally identifying information in order to protect personal privacy. De-identified data may not necessarily be anonymized data. This may mean that the personally identifying information may be able to be re-associated with the data at a later time. In such cases, anonymized data is a particularized subset of de-identified data. --- Link exists

15. Does the Research Involve Human Subjects? • Human Not Involved if: • The private information or specimens were not collected specifically for the currently proposed project through an interaction or intervention with living individuals AND • The investigator(s) cannot readily ascertain it identity of the individual to whom the coded private information or specimens pertain because, for example: • The investigator and the holder of the key enter into an agreement prohibiting the release of the key, until the individuals are deceased • There are IRB-approved written policies and operating procedures for a repository or data management center that prohibits the release of the key, until individuals are deceased • There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased

16. Exempt from Humans Subject Protection Regulations 45CFR106.101 (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

17. Collection, Storage and Use of Human Biological Materials and/or Data • Retrospective • Discarded Tissue • Identifiable • De-identified/Anonymized • Decedent • Prospective • For a Particular Research Study • Future Use • Specifically for a Repository/Registry • Genetic Studies

18. Retrospective • Discarded after clinical care; not collected for research purposes • Anonymized • Usually no consent necessary • Coded or Identifiable • Consent • Waiver • Honest Broker • Agreement not to disclose • Decedent • May need consent if research impacts the living

20. Prospective • Specimen collection for single IRB-approved protocol for defined research • Not considered a research tissue bank/repository • General elements of consent apply • Future Use Provision/Repository/Registry • For use of a single investigator or shared with multiple investigators for future research not yet defined

21. Advanced Notice of Proposed Rule Making Proposed: Reforms would require written consent for research use of biospecimens, even those that have been stripped of identifiers.  Consent could be obtained using a standard, short form by which a person could provide open-ended consent for most research uses of a variety of biospecimens (such as all clinical specimens that might be collected at a particular hospital). This change would only apply to biospecimens collected after the effective date of the new rules.

22. Rationale Changing technology in the field of genomics has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA. Surveys indicate a desire on the part of most respondents to be able to decide whether their specimens can be used in research.  Providing mechanisms for such control should enhance public trust in biomedical research.

23. Ethical, Legal and Social Issues in the Genomic Era • Consent • Privacy & Confidentiality • Fair Dealings & Just Access • Trust

24. Consent (Respect for Persons Autonomy) • Is individual ‘donor’ consent adequate? • When is (re)consent appropriate? • What form of consent is ethically appropriate? • Presumed • Broad • Tiered • To what do ‘donors’ consent? • How do ‘donors’ unconsent?

25. Privacy of Person and Confidentiality of Information • Is there such a thing as ‘anonymized’ tissue? • Can data be protected against loss or theft?

26. Fair Dealings • Property Rights • Who [should] own tissue and the profits from commercially developed products/services derived from them? • What is ‘owed’ to ‘donors’? • Public Engagement/Deliberative Democracy • Who should set [or limit] the research agenda? • Equitable Representation in Research • Who should be represented in research? • Equitable Access to the Benefits of Research • What are ‘benefits’ of research? • Who and how is access assured to them?

27. Trust • Relationships based on Trust • Minimize social stigma • Strengthen equitable representation • Preserve future research relationships • Because it’s the right thing to do

28. The Value of Science • The stunning achievements science have alleviated the suffering of many. We invest our hopes and energies into assuring that trend continues.

29. The Value of Story • Stories of personal experiences in research help us develop moral imagination about what values are important to us in our relations with one another. • Respect for Persons • Protecting Privacy & Confidentiality • Fair Dealings • Relationships based on Trust

30. “We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own treasures, with its own sources of anguish, and with some measure of triumph.” Elie Wiesel From The Nazi Doctors and the Nuremberg Code