Ethical issues of secondary analysis of archived data MedicReS Conference May 4, 2017 Istanbul, Turkey Adil E. Shamoo, Ph.D., CIP University of Maryland School of Medicine

1. Ethical issues of secondary analysis
of archived data
Presentation to:
MedicReS Conference
May 4, 2017
Istanbul, Turkey
Adil E. Shamoo, Ph.D., CIP
University of Maryland School of Medicine
108 N. Greene Street
Baltimore, MD 21201
Tel# 410-706-3327
Cell # 301-538-2599
E-mail: ashamoo@som.umaryland.edu

2. Types of Terminology
of Healthcare Data
 Hospital Healthcare Data (HHD)
 Electronic Medical Records (EMR)
 Electronic Health Records (EHR)
Adil E. Shamoo, Ph.D.

3. Sources of Data Collection
O’Doherty et al, 2016, BMC Medical Ethics
 Population Biobanks, Cohort studies,
and genome data bases
 Multi-site Clinical Trials and Public
Health Data
 Direct to Consumer Genetic Testing
 Social Media
 Fitness Trackers, Health Apps, and
Biometric Data Sensors
Adil E. Shamoo, Ph.D.

4. Types of EHR Archives
 Case reports
 Clinical data
 Genetic data
 From groups
 Large population studies
 Gene sequences
 Drug Prescription data
 Research data
Adil E. Shamoo, Ph.D.

5. Means of attaining data
(for current and future data)
 Stored Blood samples (Biobanking)
 Stored Tissue samples (Biorepositry)
 DNA (Biobanking)
 Big data derived from another set of
data
Adil E. Shamoo, Ph.D.

6. Ethical Issues Of EHR
 Privacy and confidentiality
 Misconduct
 Data Management
 Publication
 Authorship
 Conflict of Interest
 Intellectual Property
 Informed Consent
Adil E. Shamoo, Ph.D.

7. Informed consent
 Informed consent –inform subjects on
methods and devices and how are the
data handled
 Re-use of data – Informed consent
again?
 General (broad) consent
 Dynamic consent
Adil E. Shamoo, Ph.D.

8. Protections of Privacy and
Confidentiality
 Limiting access to data and sources of
data such as tissue samples,…
 Secure storage of data and samples
 Electronic security (Password,
encryption,firewalls), de-identification.
 Limit sharing of data and samples,..
 Public data – social media
Adil E. Shamoo, Ph.D.

9. Benefits of Genetic Data
 Identification of Disease
 Develop an Individualized treatment
plan (Personalized Medicine)
 Better Gene therapy
 Advance Research
Adil E. Shamoo, Ph.D.

10. Ethical Justifications for Use of
EHR - Utilitarianism, Balance of:
 Private good Versus Public good (Improve
health, less cost)
Or
 Privacy Versus Public good
Or
 Privacy Versus Public Interest
Or
 Big data harm Versus Big data benefits
Adil E. Shamoo, Ph.D.

11. Types of Genetic Tests for clinical
practice:
U.S. Secretary’s Advisory Committee on Genetic
Testing:
Influence on clinical practice
Follow highly regulated by CLIA (Clinical
Improvement amendment requiring:
Genetic tests for clinical research need not
follow CLIA (Clinical Laboratory Improvement Amendments of
1988)
Direct to Consumers genetic testing---
Less validity…..
Adil E. Shamoo, Ph.D.

12. Genetic Test Must Be:
 Analytically valid
 Clinically valid
 Benefits the patient
 From: Genetic data and electronic health records: a discussion of ethical, logistical and technological
considerations, By Shoenbill et. Al. 2014.
Adil E. Shamoo, Ph.D.

13. Harm
 In France: It is a crime for the physician to breach confidentiality
under any circumstances such as courts order or even patient’s
permission.
 Prescription drug information ---patients may not give accurate
information or other health records if it becomes public.
e.g. Embarrassing information (ref spouse or ex-spouse, or mental
health record).
 Iceland genetic study…. Identified genes linked to diseases. Court ruled
against it
Adil E. Shamoo, Ph.D.

14. Adil E. Shamoo, Ph.D.
Cases of Harm

15. Potential Harm from Genetic Testing
# 1
(From: Shoenbill K, et al. J Am Med Inform Assoc 2014;21:171–180. doi:10.1136/amiajnl-2013-001694
Personal
Anxiety, depression, confusion, changes in life plans, changes in
reproductive plans, parental guilt about passing on a deleterious
mutation, survivor guilt about not having a deleterious genetic
mutation when other family members do, refusal of recommended
medical care because of false reassurance from an invalid genetic
test
Social
Stigmatization, breach of confidentiality, identification of
misattributed parentage, privacy concerns or desire not to know a
genetic result that may be at odds with family members’ desire to
know a genetic result, misuse of genetic data (surreptitious DNA
testing or transfer of genetic data to third parties after sale of
direct to consumer testing company)
Adil E. Shamoo, Ph.D.

16. U.S. Legislative Acts Relevant to Genetic
Testing # 1
(From: Shoenbill K, et al. J Am Med Inform Assoc 2014;21:171–180. doi:10.1136/amiajnl-2013-
001694)
1996 (HIPAA)73
 Sets standards on how protected health information should be
controlled
 Does not apply to many companies or laboratories that perform
direct to consumer genetic testing and analysis Protects against
genetic discrimination in employer-sponsored group health plans
Patient Protection and Affordable Care Act of 2010
(ACA)75
 Prohibits health insurers from determining eligibility for
coverage based on signs and symptoms of genetic disease
Changes in 2014: prohibits differences in premiums according to
health status and genetic information
Adil E. Shamoo, Ph.D.

17. Genetic Information Nondiscrimination Act of 2008 (GINA)74
Extends HIPAA protections by making it illegal to use genetic information
to underwrite group and individual health insurance
Prohibits employers from making employment decisions based on genetic
information
Does not address life insurance, disability insurance or long-term care
insurance discrimination
Does not apply to health benefits for federal employees, members of the
military, veterans seeking healthcare through the Department of Veterans
Affairs, or the Indian Health Service
Does not apply to athletic programs
Adil E. Shamoo, Ph.D.
Legislative Acts Relevant to Genetic Testing # 2
(From: Shoenbill K, et al. J Am Med Inform Assoc 2014;21:171–180. doi:10.1136/amiajnl-2013-
001694)

18. IRB Requirements
 Research: Systematic investigation…..contribute to
generalizable knowledge.)
 Collection and storage for research purpose …is
research and requires IRB approval.
 However, if biobank is private operation and
tissues are not for clinical trials, no need for
IRB approval.
Adil E. Shamoo, Ph.D.

19. Unforseen Risks
In Biobank,
Genetics …Prospective consent.
Patient advocate object to involuntarily take blood and tissue samples for
future use.
Privacy Issues:
Anonymization (de-identification) becoming impossible as time goes on.
(From: The Ethical use of existing samples for genomic research, Bathe and McGuire, Genetics in Medicine,
11(10), October 2009.)
Adil E. Shamoo, Ph.D.

20. Biobank and Biorepository
Store Human biological material (DNA, blood,
cells, tissue)
Purpose: Conduct research on samples
Informed Consent: broad or narrow
permission, Opt in, opt out
Is there a need for future consent?
From: Prentice and Logsdon, 2013. Monitor (ACRP).
Adil E. Shamoo, Ph.D.

21. Conclusions
 EHR imposes ethical issues
 Requires Data management
 Complications in Informed Consent
 Genetic tests produce new potential
harm
 Informed consent requires more
information
Adil E. Shamoo, Ph.D.

22. The End
Questions?
Adil E. Shamoo, Ph.D.