Transcript Bioethics Café - Rutgers Biomedical and Health Sciences

Bioethics Café: The Immortal Life if Henrietta
Lacks – 13 Nov 2012
Sponsored 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
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.
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
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
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
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
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
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
Human Dignity
Radio Lab….
…take a listen…[excerpt Minute 18:45 to 22:20]
http://www.radiolab.org/2010/May/17/henriett
as-tumor/
Where are we today?
Current Collection, Storage and Use of
Human Biological Materials and/or
Data
What protections are currently in place?
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Federal Regulations
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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
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Patient’s Bill of Rights
Limitations on type of research conducted
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Institutional Policies
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Departmental Requirements
Institutional Review Boards
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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
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.
Definitions
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Identifiable: The biological specimen is labeled with personal identifiers
Coded:
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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
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:
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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
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.
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
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Retrospective
 Discarded after clinical care; not collected for research purposes

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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

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Prospective
 Specimen collection for single IRB-approved
protocol for defined research
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Not considered a research tissue bank/repository
General elements of consent apply
 Future Use Provision/Repository/Registry
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For use of a single investigator or shared with
multiple investigators for future research not yet
defined
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.
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.
Ethical, Legal and Social Issues in the
Genomic Era
 Consent
 Privacy & Confidentiality
 Fair Dealings & Just Access
 Trust
Consent (Respect for Persons Autonomy)
 Is individual ‘donor’ consent adequate?
 When is (re)consent appropriate?
 What form of consent is ethically appropriate?
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Presumed
Broad
Tiered
 To what do ‘donors’ consent?
 How do ‘donors’ unconsent?
Privacy of Person and Confidentiality of Information
 Is there such a thing as ‘anonymized’ tissue?
 Can data be protected against loss or theft?
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?
Trust
 Relationships based on Trust
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Minimize social stigma
Strengthen equitable representation
Preserve future research relationships
Because it’s the right thing to do
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.
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.
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Respect for Persons
Protecting Privacy & Confidentiality
Fair Dealings
Relationships based on Trust
“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