1. Y OU M AY W ANT TO A SK Y OUR G ENETICIST before you take that drug. Why? G ENETICS A FFECT Y OUR D RUG R ESPONSE Medications work as intended between 50 and 60% of the time That number is closer to 20% for cancer therapies Over 700,000 people in the U.S. suffer or die as a result of an adverse drug reaction every year. S TEPS TO R EJECTING O NE -S IZE -F ITS - A LL S TEPS TO R EJECTING O NE -S IZE -F ITS - A LL Need a new type of informed consent because current types do not cover using old samples for new research, and there is no coherent process for ongoing access to medical records Look for Single Nucleotide Polymorphisms (SNPs) in DNA using microarrays or whole-genome sequencing Record data for hundreds of thousands of people Use statistics to correlate disease states with SNPs B Y I NVITATION O NLY : P RESERVING P RIVACY AND C ONSENT IN P HARMACOGENOMICS K RISTIAN B OROFKA, A MANDA D EWEY & J ULIE H ERMAN A B ETRAYAL OF T RUST A B ETRAYAL OF T RUST The Havasupai people of Arizona were desperate. Nearly 50% of tribe members were affected by Type II diabetes, and tribal leaders wanted to understand if the disease had a genetic basis so that predisposed individuals could take preventative measures. They asked two professors at Arizona State University to help them, consenting specifically to experiments about diabetes. Unfortunately, one of the professors had other ideas. She conducted experiments on schizophrenia and shared the data with post-docs and even professors at other schools. The Havasupai then brought a lawsuit against the university, claiming that tribe members [feared] going to the health clinic, seeking medical attention, or providing blood samples for medical diagnosis or treatment. T HESIS : T HESIS : Expanding GINA to define and require a more robust system of informed consent procedures for patients in pharmacogenomics studies and expand discrimination protection to all insurance will preserve human dignity and autonomy during the advancement of personalized medicine because it protects against potential discrimination and dehumanization on the basis of medical and genetic information. K ANTIAN A RGUMENTS FOR P OLICY Autonomy: Rational beings have a right to self-determination. If an individual cannot control choices about who uses their genetic information and how, their autonomy is removed If an individual does not have enough information to make an informed decision, their autonomy is constrained Proper informed consent, which is a way to ensure patients make free, uncoerced, informed choices, is necessary for autonomy Privacy: An individuals right to privacy is the right to freedom from unauthorized intrusion into medical and genetic information by others. Third Party Transfer violates privacy because individuals have a right to noninterference Dignity: Innate human worth. Personal and cultural beliefs are important extensions of persons, and violating them through unauthorized use of DNA is dehumanizing Preventing discrimination with regard to insurance is important to dignity Discrimination intrinsically frames some humans as worth less than others Access to insurance is critical to maintaining a dignified life Convince hundreds of thousands of people to allow ongoing access to their DNA and medical records so both early- and late- onset disease can be documented A N EW P OLICY FOR A N EW W ORLD Reform GINA Privacy or usage of nonmedical genetic information Third-party transfer of genetic information without consent Expand GINA to include: Non-discrimination for life insurance and long-term care insurance Ban unauthorized third-party transfer of genetic information like HIPAA does for medical information Ongoing informed consent as outlined below Ongoing Consent Ongoing need for updated medical information require ongoing informed consent Implement fines for enforcement Participants have the right to opt out at any point, but it is their responsibility to do so Reciprocal system of contact and consent: Yearly contact with the database participants informing them of the categories of studies being done Allow the researchers to update participant medical information, incentivizing researchers to keep track of the participants Strikes a prudent balance between research needs and ethical concerns Currently: Bans discrimination by health insurance companies and employers on the basis of genetic predisposition to disease Bans insurers and employers from requiring individuals to undergo genetic testing It does not cover Discrimination by long-term care and life insurance providers Participants Information About Types of Studies *Updated Medical Records *Ability to Opt Out Researchers Variability in Drug response Bad responders No toxicity of drug metabolites Bad responders Toxicity of drug metabolites Good responders Toxicity of drug metabolites Cytochrome P450: Liver enzyme Same Medication, Same Dose, Different SNPs Good responders No toxicity of drug metabolites Whole-Genome Sequencing Methods Proposed Reciprocal System of Informed Consent