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Informed Consent 2.0: How Big Data Changes the Game
Transcript of Informed Consent 2.0: How Big Data Changes the Game
How Big Data Changes the Game Informed Consent: A Timeline 1940 1950 1960 1980 1990 2010 2000 1970 1947 1964 1974 1979 1996 The Nuremberg Code Participants
Able to consent
Free from coercion
Comprehend risks/benefits Declaration of Helsinki Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research. *A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available. 12 Principles to guide physicians on ethical considerations related to biomedical research The well-being of the human subject should take precedence over the interests of science and society
Consent should be in writing
Use caution if participant is in a dependent relationship with researcher
Participants benefit from research National Research Act (US) Charged with submitting reports about protecting humans involved in research National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Makes recommendations to Congress for developing laws to protect research subjects, especially:
The "institutionally mentally infirm"
Prisoners Congress identified informed consent as the locus of ethical concern and directed the commission to three components of informed consent
the nature of the consent
the adequacy of information given
the competence and freedom of prisoners to make a choice National Research Act: Title II Identifies basic ethical principles to govern medical research Recommends steps to improve regulations for Protection of Human Subjects NCPHSBBR Henrietta Lacks
1920 - 1951 In the beginning... 5th C BC - The Hippocratic Oath 1803 - Thomas Percival 1947 - AMA Code of Ethics Beneficence Model Benevolent Deception Doctor Knows Best 1962 Kefauver-Harris Drug Amendment (US) Result of Thalidomide incident
Informed Consent became a participation requirement Researchers want to forge ahead into the 21st century using all the data they can get their hands on Regulations are in place to protect the privacy of patients and data are kept under lock and key Edward Jenner
1796 Albert Neisser
1892 Dr. Arthur Wentworth
1896 Dr. Richard Strong
1906 Tuskegee Syphilis Experiment
1932 - 1972 Walter Reed
1900 Tuskegee Syphilis Experiment
1932 - 1972 Cancer Study HPV Study Diabetes Study Asthma Study Alzheimers Study BIG DATA Idea of Privacy Idea of Being Informed Creates a Drag on Innovation The tool to protect us from harm is protecting us from innovation Prevents the reuse of data without extensive permissions
Makes it hard to donate your data to science The Belmont Report Ethical principles and and guidelines for the protection for human subject research Respect for Persons
Participants comprehend information
Consent is given voluntarily HIPAA Health Insurance Portability and Accountability Act 2003 HIPAA Privacy Rule Regulates the use and disclosure of Protected Health Information On July 8, 2010 HHS Secretary Sebelius announced a new “administration-wide commitment to make sure no one has access to your personal information unless you want them to.”
Deborah Peel MD founder of Patient Privacy Rights states "Americans care deeply about their privacy." Privacy Rights ...the right of the individual to control who sees their health information BIG DATA ZIP
Date Voted Medical Data Voter List Re-identifying Data Human Genome Sequencing Ethical and Legal Challenges
of Large Scale Genome Sequencing IC discussion must address
Personal and Social Significance
Security Protections for the DNA
Types of Data Misuse 2008 Genetic Information Nondiscrimination Act Prohibits use of genetic information in health insurance and employment matters Informed Consent 2.0 Consent to Research: An Open Data Project Proposes a "Medical Commons"
Introduces "Portable Legal Consent"
Built on informed consent
Untangles consent from privacy a. Health and molecular data collected from clinical trials & routine health visits
b. Legal framework protects privacy and ensures appropriate downstream uses
c. Data from individuals
d. ...are de-identified
e. ...and made available for academic and industry research "Radical Honesty"