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Purpose Technology

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Purpose Technology has changed clinical practice in many ways, and has altered the manner in which we view and assess life states. Even the definition of death has changed with the influx of artificial hydration, nutrition, and pulmonary systems. Genomics is creating new waves and it is not fully clear where they will break. When genomic data is coupled with electronic medical records, there are ethical and legal issues for informaticians to attend to. Objectives By the completion of this unit, the student will be able to identify, discuss, and analyze issues related to ethical, legal, and social implications of including genomic data in electronic records. case study University General Hospital (UGH) is a large, urban, teaching hospital in Illinois conducting a newborn screening research study. The hospital serves a minority population that is largely and historically under-served in the community. Researchers there are studying a genetic condition that causes developmental and behavioral problems. The syndrome affects 1 in 100,000 babies, is found across all ethnic and racial groups but mainly impacts caucasians, and causes more severe problems in boys than in girls. There is neither a cure for this condition, nor is there a treatment protocol for early onset; however, early intervention may treat some symptoms if they manifest. This screening is separate from that required by the state of Illinois. Most states require samples to be collected from all newborns to screen for certain genetic, metabolic and/or endocrine disorders of body chemistry, unless the parent or guardian opts out of the process in writing. Ideally, newborn screening samples are collected from the infant between 24 hours and 7 days after birth. No consent is required for the Illinois state sanctioned newborn screenings. Max is a one-day-old male born at UGH. At the time of his state sanctioned newborn screening, a nurse entered the room and said, "I'm here to take samples for the Illinois screening." No consent was obtained and no explanation was given to the parents prior to the sample intake. The nurse pricked Max’s heel, smeared blood from his heel into five circles on one form, and then one more on a separate form. No consent was obtained and no further explanation was given to the parents immediately after the extra sample was taken. The following day a medical student researcher approached Max’s parents and explained the newborn screening research study to them. She explained that when the nurse came in for the Illinois screening one extra sample was taken for the study and immediately deidentified. The researcher then presented the parents with a consent form for the sample that was taken the previous day. The researcher explained that if the parents did not wish to participate then the sample would be destroyed. If the parents decided to participate, Max would receive five years of free treatment for any symptoms if he tested positive for the condition. Additionally, the genetic data would be retained in the child's health record and in a separate, deidentified DNA data bank -- the latter of which could be accessed by future researchers without additional consent. Max’s father was upset that the sample was taken without consent. The researcher explained that the delayed timing of consent was due to logistical issues, and that the protocol was justified to avoid a second heel prick. Max’s father immediately contacted the IRB of the institution to determine if the correct protocol was being followed. The IRB director stated that consent was obtained in compliance with the protocol, which was approved by the NIH. The father demands the return of the sample and that the protocol be changed. Identify and explain three ethical issues attendant to this case. Is the protocol ethical? Use the ethical theories and principles to justify your answer. What should the IRB director do?

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Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst vestibulum rhoncus est pellentesque. Amet dictum sit amet justo donec enim diam vulputate ut. Neque convallis a cras semper auctor neque vitae. Elit at imperdiet dui accumsan. Nisl condimentum id venenatis a condimentum vitae sapien pellentesque. Imperdiet massa tincidunt nunc pulvinar sapien et ligula. Malesuada fames ac turpis egestas maecenas pharetra convallis posuere. Et ultrices neque ornare aenean euismod. Suscipit tellus mauris a diam maecenas sed enim. Potenti nullam ac tortor vitae purus faucibus ornare. Morbi tristique senectus et netus et malesuada. Morbi tristique senectus et netus et malesuada. Tellus pellentesque eu tincidunt tortor aliquam. Sit amet purus gravida quis blandit. Nec feugiat in fermentum posuere urna. Vel orci porta non pulvinar neque laoreet suspendisse interdum. Ultricies tristique nulla aliquet enim tortor at auctor urna. Orci sagittis eu volutpat odio facilisis mauris sit amet.

Tellus molestie nunc non blandit massa enim nec dui. Tellus molestie nunc non blandit massa enim nec dui. Ac tortor vitae purus faucibus ornare suspendisse sed nisi. Pharetra et ultrices neque ornare aenean euismod. Pretium viverra suspendisse potenti nullam ac tortor vitae. Morbi quis commodo odio aenean sed. At consectetur lorem donec massa sapien faucibus et. Nisi quis eleifend quam adipiscing vitae proin sagittis nisl rhoncus. Duis at tellus at urna condimentum mattis pellentesque. Vivamus at augue eget arcu dictum varius duis at. Justo donec enim diam vulputate ut. Blandit libero volutpat sed cras ornare arcu. Ac felis donec et odio pellentesque diam volutpat commodo. Convallis a cras semper auctor neque. Tempus iaculis urna id volutpat lacus. Tortor consequat id porta nibh.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst vestibulum rhoncus est pellentesque. Amet dictum sit amet justo donec enim diam vulputate ut. Neque convallis a cras semper auctor neque vitae. Elit at imperdiet dui accumsan. Nisl condimentum id venenatis a condimentum vitae sapien pellentesque. Imperdiet massa tincidunt nunc pulvinar sapien et ligula. Malesuada fames ac turpis egestas maecenas pharetra convallis posuere. Et ultrices neque ornare aenean euismod. Suscipit tellus mauris a diam maecenas sed enim. Potenti nullam ac tortor vitae purus faucibus ornare. Morbi tristique senectus et netus et malesuada. Morbi tristique senectus et netus et malesuada. Tellus pellentesque eu tincidunt tortor aliquam. Sit amet purus gravida quis blandit. Nec feugiat in fermentum posuere urna. Vel orci porta non pulvinar neque laoreet suspendisse interdum. Ultricies tristique nulla aliquet enim tortor at auctor urna. Orci sagittis eu volutpat odio facilisis mauris sit amet.

Tellus molestie nunc non blandit massa enim nec dui. Tellus molestie nunc non blandit massa enim nec dui. Ac tortor vitae purus faucibus ornare suspendisse sed nisi. Pharetra et ultrices neque ornare aenean euismod. Pretium viverra suspendisse potenti nullam ac tortor vitae. Morbi quis commodo odio aenean sed. At consectetur lorem donec massa sapien faucibus et. Nisi quis eleifend quam adipiscing vitae proin sagittis nisl rhoncus. Duis at tellus at urna condimentum mattis pellentesque. Vivamus at augue eget arcu dictum varius duis at. Justo donec enim diam vulputate ut. Blandit libero volutpat sed cras ornare arcu. Ac felis donec et odio pellentesque diam volutpat commodo. Convallis a cras semper auctor neque. Tempus iaculis urna id volutpat lacus. Tortor consequat id porta nibh.

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