BILL ANALYSIS
SENATE COMMITTEE ON EDUCATION
Gloria Romero, Chair
2009-2010 Regular Session
BILL NO: AB 70
AUTHOR: Norby
AMENDED: August 2, 2010
FISCAL COMM: Yes HEARING DATE: August 11,
2010
URGENCY: Yes CONSULTANT:Kathleen Chavira
NOTE : This bill has been amended to replace its contents
and this is the first time the bill is being heard in its
current form.
SUBJECT : Genetic Testing
KEY POLICY ISSUES
Should the educational and research activities of the
California State University (CSU) and the University of
California (UC) be statutorily restricted?
Should the CSU and UC be required to "pay back" funds
expended pursuant to legal judgments or settlements
resulting from specified research activities?
SUMMARY
This bill, until January 1, 2015, requests that California
State University (CSU) and the University of California
(UC) refrain from making "unsolicited requests" of DNA
samples from enrolled or prospective students and requires
the reversion of unexpended appropriations from the General
Fund (GF) in an amount equal to amounts expended for
judgments or settlements resulting from informed consent
violations related to these "unsolicited requests."
BACKGROUND
Current law authorizes persons conducting or operating a
clinical laboratory to accept assignments for tests, and
report results for such tests only to persons licensed
under healing arts provisions of law or their
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representatives.
(Business and Professions Code 1288)
Protection of Human Subjects in Medical Experimentation Act
(Health and Safety Code 24170-24179.5)
Current law requires a list of rights of a subject in a
medical experiment. This list is required to include,
among other things, the right to:
Be informed of the nature and purpose of the
experiment.
Be given an explanation of the
procedures/drugs/devices to be followed/used.
Be given a description of discomforts and risks.
Be given an explanation of any benefits to the
subject.
Be given a disclosure of any alternative
procedures, drugs or devices, and their relative risks
and benefits.
Be informed of the avenues of medical treatment, if
any, available to the subject afterwards if
complications should arise.
Be given a chance to ask any questions about
experiments/procedures.
Be instructed that consent may be withdrawn at any
time and participation discontinued without prejudice.
Be given a copy of the signed and dated written
consent form.
Be given the opportunity to determine whether to
consent without any element of force, fraud, deceit,
duress, coercion, or undue influence on the decision.
(Health and Safety Code 24170 & 24172)
Current law also defines "informed consent" as
authorization for a medical experiment after the following
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conditions have been satisfied:
The subject or subject's conservator or guardian,
or other representative is provided with a copy of the
experimental subject's bill of rights, as specified.
A written consent form is signed and dated by the
subject or the subject's conservator or guardian, or
other representative.
The subject or subject's conservator or guardian,
or other representative, is informed both verbally and
within the written consent form of the following:
o An explanation of the procedures to be
followed, as specified.
o A description of any discomfort and risks
to be expected.
o An explanation of any benefits to be
expected, if applicable.
o A disclosure of any alternative
procedures, drugs, or devices and their relative
risks and benefits.
o An estimate of the expected recovery
time.
o An offer to answer any inquiries
concerning the experiment or the procedures.
o An instruction to the subject that
consent may be withdrawn at any time, without
prejudice to the subject.
o The name, institutional affiliation, if
any, and address of the person(s) performing and
responsible for the experiment.
o The name of the sponsor or funding
source, or manufacturer if the experiment
involves a drug or device, and any organization
under which the experiment is being conducted.
o The name, address, and phone number of an
impartial third party, to whom complaints may be
addressed.
o The material (as defined) financial stake
or interest that the investigator or research
institution has in the outcome of the medical
experiment.
o The written consent form is signed and
dated by any person other than the subject or the
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conservator or guardian, or other representative
of the subject, as specified in Section 24175,
who can attest that the requirements for informed
consent to the medical experiment have been
satisfied.
o Consent must be voluntary and freely
given without any element of force, fraud,
deceit, duress, coercion, or undue influence.
(Health and Safety Code 24170 & 24172)
ANALYSIS
This bill, an urgency measure, until January 1, 2015 :
1) Requests the CSU and the UC to refrain from making an
"unsolicited request" to students (enrolled or
prospective) for a DNA sample for genetic testing
purposes.
2) Defines an "unsolicited request" as transmittal of
materials designed to collect DNA to any person or
entity without their prior invitation or permission.
3) Requires the UC and the CSU to report to the
Controller, Governor and Legislature in writing, on a
quarterly basis, on the total amount of expenditures
(irrespective of source), to satisfy legal judgments
resulting from informed consent violations related to
"unsolicited requests" for DNA samples. More
specifically it:
a) Requires the first of these
reports be submitted on or before January 1,
2011.
b) Requires subsequent quarterly
reports be submitted in January, April, July, and
October of each year.
4) Requires the Controller to revert to the GF any
unencumbered moneys previously appropriated from the
GF to the UC and CSU in an amount equal to the amount
of expenditures reported by each, respectively, under
#3.
5) Clarifies that the bill's provisions do not prohibit
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the performance of genetic testing and counseling in
the course of a patient's medical care by a licensed
health care provider in a university facility.
6) Repeals these provisions as of January 1, 2015.
STAFF COMMENTS
1) Need for the bill . According to the author, this bill
prevents taxpayers from incurring financial liability
resulting from UC and CSU violation of state and
federal genetic testing laws. The author asserts that
the activities being conducted under the UC Berkeley
2010 On the Same Page program violate California laws
that require that a physician order related clinical
laboratory tests and that outline the procedures for
securing informed consent under the Protection of
Human Subjects in Medical Experimentation Act.
2) Overly broad ? This bill prohibits any unsolicited
request of students for DNA samples for the purposes
of genetic testing. As drafted, the bill's
prohibition could be broadly applied and could
restrict the ability of the UC and CSU to engage in
educational and research activity beyond the specific
UC Berkeley project it is intended to address.
According to the CSU, thousands of students in
introductory life science courses routinely take DNA
samples from their cheeks to learn about blood type.
Genetic testing is also a necessary part of many
degree program curricula offered. Is it the intent of
the Legislature to limit these types of educational
and research activities?
3) Compromises funding for direct instruction . This bill
requires the "payback" to the state of any GF funds
appropriated to each segment in an amount equal to the
amount of any settlements or judgments relative to
violations of "informed consent" irrespective of
source . Is this reasonable? Staff notes that GF
appropriations typically support student enrollment
and instruction. Why should funding provided for
instructional purposes be used to "offset" costs
related to research activity? Should students be
penalized for research activities undertaken at the
University's discretion?
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4) UC Berkeley On the Same Page program . According to
the UC, On the Same Page is an annual program for all
transfer and freshmen students entering the UC
Berkeley College of Letters and Sciences. Its purpose
is to engage students and faculty in meaningful
discussion about important societal issues. This
year, the program asked students to voluntarily submit
a DNA sample (provided) via mail for purposes of
testing for three genetic traits as a component of the
program's selected topic of study, Personalized
Medicine. Participation is voluntary and students
were informed that aggregated results and their
interpretation would be presented at a program lecture
to be held early in fall semester. The "study" was
reviewed and approved by the UC Berkeley Institutional
Review Board. Analysis of DNA samples are to be
performed at an on-campus laboratory. Students were
asked to submit the DNA sample postmarked by August 6,
2010. According to the UC, approximately 350-400
student samples have been received. The 2010 On the
Same Page project and its implementation raises a
number of questions, including:
Is this an educational or research activity?
Do provisions of the Clinical Laboratory Improvement
Act (which requires that laboratories doing this
type of laboratory work meet specific state
standards) apply?
Does the design and process of the On the Same
Page project provide sufficient structure for
ensuring student's understanding of the implications
of providing their DNA or the implications of the
test results? Does the nature of the information
gathered and its implication require a higher
standard for informed consent than what was used to
solicit participation by students?
Does this scheme provide sufficient privacy
protections? According to the informed consent
document provided to students, once analysis of the
three genes is complete, the DNA sample will be
destroyed by incineration. However, a faculty
member conducting research study in the area of
personalized medicine will save the submitted data
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for future teaching purposes and for possible
publication of the aggregated data and its analysis.
The document notes the possibility that the data
will be unaggregated for the purposes of
publication, but asserts that it will be
identifiable only by a barcode which only the
student would be provided. Should data provided for
a specific class project be available for future
research and publication? Were students
sufficiently informed of any potential compromising
of their confidentiality?
1) Related informational hearing . The Assembly Higher
Education Committee held an oversight hearing on
Tuesday, August 10, 2010, on the subject of the
University of California at Berkeley's "Bring Your
Genes to Cal" Freshman Orientation Project. The
issues and concerns raised and discussed included the
following:
What is genetic testing and how are genetic
tests generally used?
Is the UC Berkeley project an educational
exercise or research?
Were students provided adequate information
regarding the project and was legal informed consent
obtained from the students?
What are California's laboratory requirements
for this type of genetic testing and why are these
requirements in place?
What are the privacy risks to students?
How do students perceive privacy and the
sharing of personal information?
It is unclear what outcome is expected as a result of
this hearing.
1) Does this bill address the problem ? Although a number
of legitimate questions can (and have) been raised
regarding the UC Berkeley On the Same Page program for
2010, it does not appear that this bill specifically
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addresses these issues. Rather than penalize the
unsolicited collection of DNA samples, it may be more
appropriate to outline appropriate procedures to be
followed and clarify applicable statutes relative to
the solicitation of student DNA samples for purposes
of genetic testing. Staff notes that the author is
expected to offer amendments that more directly
address the issues raised by the UC Berkeley
situation.
SUPPORT
None received.
OPPOSITION
University of California
California State University