Governing secondary research use of health data and specimens
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Governing secondary research use
of health data and specimens
Kayte Spector-Bagdady, JD, MBE
Assistant Professor, Department of Obstetrics and Gynecology
Associate Director, Center for Bioethics & Social Sciences in Medicine
Virtual Grand Rounds, Hall Center for Law & Health
Indiana University
September 28, 2021
Poll #1: Would you sign this broad
informed consent form?
Are you willing to give your broad consent now to the future research
use of your identifiable information and identifiable biospecimens?
If you say “yes,” researchers in the future may use your identifiable
information or identifiable biospecimens in many different research
studies, over a long period of time, without asking your permission again
for any specific study covered by this form. This could help science.
If you say “no,” researchers in most cases will have to ask your
permission to use your identifiable information or identifiable
biospecimens in any future research study. Because this may be difficult
or impossible, it could make scientific studies harder to do.
2
Funding
• National Human Genome Research Institute
(K01HG010496)
• National Cancer Institute (R01CA21482901A1)
• National Center for Advancing Translational
Sciences (UL1TR002240)
3
Acknowledgements
• Thank you to the participants in the Saint
Louis University School of Law Center for
Health Law Studies and the American
Society of Law, Medicine and Ethics’ 2019
Health Law Scholars Workshop
• As well as Professors Sharona Hoffman,
Paul Lombardo, Kirsten Ostherr, Elizabeth
Pendo, W. Nicholson Price II, Tara Sklar,
and Ruqaiijah Yearby for their insightful
comments on a previous draft
4
Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
5
Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
6
HIPAA: (Identified) clinical Common Rule: (Some identified) research (Maybe) FDA/FTC/CMS: Commercial
Not all human subjects research
1. If the investigator is conducting research using federal
funding from a U.S. Department or Agency that has
adopted the Common Rule
2. If an institution voluntarily decides to extend the
regulatory requirements to all of its employees
conducting human subjects research
3. If investigators would like to submit data derived from
their clinical investigations to FDA in support of an
application for research or marketing or needs an
investigational drug/device authorization
8
Only readily identifiable research
• “Human subject” is a living person with whom the
investigator “obtains information through intervention or
interaction” or which involves “identifiable private
information or identifiable biospecimens”
• Under the Common Rule: “identifiable information” is
private information for which the identity of the subject
is or may readily be ascertained by the investigator or
associated with the information
– Different than the HIPAA Safe Harbor
9
Waiver of informed consent
Even if research falls within the scope of federal
regulation and even if participants fall within the
definition of “human subjects,” researchers may still
apply for a waiver of informed consent
10Lack of responsiveness to risks/ benefits of
research
Individual, physical, and profound
11New risks • Dignitary harms: privacy breaches, non- welfare interests, or algorithmic biases • Negative externality: while the risks of secondary research remain individual, the benefits redound to either the entity holding the data or the common good C. Grady et al., “Informed Consent,” New England Journal of Medicine 376 (2017): 856-67; https://www.cnet.com/news/tmi-some-fitbit- users-sex-stats-on-google-search/; De Vries RG, Tomlinson T, Kim HM, Krenz CD, Ryan KA, Lehpamer N, Kim SY6. The moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate. Life Sci Soc Policy. 2016;12:3;l Price WN 2nd, Kaminski ME, 12 Minssen T, Spector-Bagdady K. Shadow health records meet new data privacy laws. Science. 2019;363(6426):448-450.
Poll #2: Would you sign this broad
informed consent form?
Are you willing to give your broad consent now to the future research
use of your identifiable information and identifiable biospecimens?
Examples of past enabled research include improving weapons of mass
destruction to defend the United States and its territories as well as
improving self-managed abortion with misoprostol.
If you say “yes,” researchers in the future may use your identifiable
information or identifiable biospecimens in many different research
studies, over a long period of time, without asking your permission again
for any specific study covered by this form. This could help science.
If you say “no,” researchers in most cases will have to ask your
permission to use your identifiable information or identifiable
biospecimens in any future research study. Because this may be difficult
or impossible, it could make scientific studies harder to do.
13Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
14• Expectation for formal opt-in consent (Jagsi 2017)
– 35% think its necessary to obtain specific research consent
even for secondary research (48% among Black/Hispanic
participants)
• Access to deidentified medical information (Jagsi 2017)
– 9% uncomfortable for university research
– 16% uncomfortable for drug companies
– 48% uncomfortable for insurance companies
• “Non-welfare interests” (De Vries 2016)
– 68% agreed to blanket consent
– But 70.4% unwilling when presented with a specific
controversial research scenario
Jagsi R et al. Perspectives of Patients With Cancer on the Ethics of Rapid-Learning Health Systems. J Clin Oncol. 2017; De Vries RG et al., The
16
moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate. Life Sciences Society and Policy 2016, 12(1): 1-
15 DOI: 10.1186/s40504-016-0036-4;Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
17Patient informed
consent
18Participant informed
consent
“We would also like your permission to keep some of your
biospecimen and medical information collected in the main study,
so that we may study it in future research.
The future research may be similar to this study or may be
completely different… We may share your biospecimen and
medical information with other researchers, so that they can use it
in their research…With appropriate permissions, your samples and
collected information may also be shared with other researchers
here, around the world, and with companies.
Your identifiable private information or identifiable biospecimens
may be stripped of identifiers and used for future research studies
or distributed to another researcher for future research studies
without additional informed consent…Researchers, their
organizations, and other entities, including companies, may
potentially benefit from the use of the data or discoveries. You will
not have rights to these discoveries or any proceeds from them.”
1920
21
22
Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
23Failure of current regulations
• Only intervention found to consistently improve participant
comprehension is a conversation (Beskow 2016)
• Regulations focus on
– What should be included on the form: (risks, benefits,
alternatives, confidentiality, compensation, contact
information, voluntariness, information regarding secondary
research)(45 CFR § 46.166(b))
– Versus included in the conversation: “An investigator shall seek
informed consent only under circumstances that provide the
prospective subject or the legally authorized representative
sufficient opportunity to discuss and consider whether or not to
participate and that minimize the possibility of coercion or
undue influence.” (45 CFR § 46.166(a)(2))
Beskow LM. Lessons from HeLa Cells: The ethics and policy of biospecimens. Annu. Rev. Genom. Hum. Genet. 2016. 17:409. 24§46.1169(c)(7)
• “…the following elements of information, when appropriate shall
also be provided to each subject… A statement that the subject's
biospecimens (even if identifiers are removed) may be used for
commercial profit and whether the subject will or will not share in
this commercial profit”
25Comprehension re commercialization
• “…the following elements of information, when appropriate shall
also be provided to each subject… A statement that the subject's
biospecimens (even if identifiers are removed) may be used for
commercial profit and whether the subject will or will not share in
this commercial profit” §46.1169(c)(7)
• “All of the information collected about you will be preserved and
made available to others for research…This information may
ultimately have significant therapeutic or commercial value. By
agreeing to participate in this study, you consent to such uses…If a
new discovery, diagnostic test, or treatment results [UM] and
collaborators including commercial entities could profit by filing a
patent. Should any product developed from participant samples,
participants will not be responsible for any costs of development,
nor will they obtain any profit from the commercial use.”
26Comprehension re
commercialization
“…I hope you don’t, because I don’t think you said you would, or did
you? I don’t remember the consent form…I’d get my lawyer because
you promised that none of my personal information would be given to
anyone outside the university!” (Patient 04)
“I hope we aren’t selling it to 23 and Me! …[P]atients trusted in us, that
we have a trial where we are the sole people in charge of their
information, and…to then after the fact sell it…I would have a problem
with that. I would think that we would need to have a secondary
approval from patients.” (Clinician 04)
27of
Spector-Bagdady K et al. “My research is their business, but I’m not their business”: Patient and Clinician Perspectives on Commercialization
Precision Oncology Data Oncologist (forthcoming).Dinerstein v. Google
& UChicago
• UChicago shared de-identified EMR data of all
adult UChicago patients over a five year period
– Goal of generating machine learning techniques
• Dinerstein sued for breach of HIPAA (among
other things) because only allowed to share PHI
for research in exchange for a reasonable cost
based fee
– “Whatever a perpetual license for ‘Trained Models
and Predictions’ actually means, it appears to
qualify as direct or indirect remuneration.”
• But dismissed for failure to state a claim upon
which relief can be granted
Dinerstein v. Google, LLC, No. 19 C 4311, 2020 WL 5296920, 1079-1124 (N.D. Ill. Sept. 4, 2020). 28Argument:
1. Biospecimens and health data are
governed by method of procurement
2. What contributors care about is use
3. Biospecimens and health data that are
procured differently end up being used
similarly
4. Legal mechanisms and market forces
have failed to reconcile this tension
5. What are the implications of the failure to
govern this market efficiently?
29Implication #1 - Privatization
• 23andMe
• All of Us research program
• 10 million genetic & phenotypic
• EMR data from 112,000
participants
participants
• 80% white & educated
• 80% “underrepresented in
• Valuation of $2.5 billion
biomedical research”
• $2.16 billion through 2026
30• Homogeneous cohorts:
– Can skew research agendas
(new analyses)
– Lead to misdiagnoses (Manrai
2016)
• In an assessment of the NHGRI-EBI
GWAS Catalog, the most
extensive record of published
genome-wide association studies,
researchers found only 2.4% of
participants were of African
ancestry
Manrai AK, Funke BH, Rehm HL et al. Genetic Misdiagnoses and the Potential for Health
Disparities. N Engl J Med. 2016;375(7):655-65; Popejoy AB and Fullerton SM. Genomics is
failing on diversity. Nature 2016: 538(7624):161-164; Morales, J. et al. A standardized
framework for representation of ancestry data in genomics studies, with application to 31
the NHGRI-EBI GWAS Catalog. Genome Biol. 19, 21 (2018).Implication #3: Access
• Gives industry a gatekeeping function over
what research is enabled
– In 2011, 96.5% of published, industry-sponsored,
head-to-head comparative effectiveness trials
found favorable results (Flacco 2015)
• Limits ability to validate work or build
derivative discoveries
• Decreased future access (e.g., price
increases or change in leadership)
• Myriad
Flacco ME, Manzoli M, Boccia S et al. Head-to-head randomized trials are mostly industry
32
sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015;68(7):811-20.Potential solutions
1. Regulatory/informed consent
2. Hospital standards
3. Journal standards
34• Hospitals have negotiation power
– Receive over $12.5B in NIH funding alone
– Databanks require a diversity of health-related data, easier to collect
when people have a compelling basic interest in sharing it as well as
when insurance is reimbursing to annotate health information in detail
– Industry needs academic collaborators to conduct research, publish
articles, and treat the patients and write the prescriptions that make
the private data valuable in the first place
• U-M Standards
– Review both biospecimens and data
– No grandfathering in of data & specimens collected before updated
regs
– Review even “de-identified” data 35Journal standards
36Poll #3: Which potential solution do
you think is the most promising?
1. Fix informed consent
2. Set hospital standards that are more
protective than the regulations
3. Set journal standards that are more
protective of the regulations
3738
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