Genomics and Privacy Natasha Davis, JD/MBA, Senior Associate General Counsel Legal Department Nikki Pryor, MSN, RN, CNOR, CPN, BH Clinical Risk Manager Legal Department
case involves tiny newborns in our neonatal intensive care unit with a variety of failure-to-thrive related difficulties, including metabolic and developmental problems. The big difference in this procedure is our goal to return information about these babies to our neonatal ICU providers in only 48 hours! This time-to-results goal is a technical and logistical challenge that we are still tackling, yet we have already made significant progress, having returned information on our most recent case in only 4 days. Two other areas of collaborative study have emerged in the past year. One area focuses on the relationship between our health and our microbiome, which is defined as the bacteria and viruses that naturally live in and on our bodies. Research has illustrated that this close relationship between humans and microbes shapes our illness and health in ways that had not previously been appreciated and has sparked further study in the pediatric realm. These studies include gaining a better understanding of the impact of vaccines and antibiotics on the normal gastrointestinal flora, adverse effects on normal flora caused by anti-anxiety medications and how microbes impact childhood neuronal development. Most recently we have opened a collaborative protocol with researchers and care providers in a new focus area at Nationwide Children’s Behavioral Health. Here we will use the body of knowledge emerging from
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psychiatric genomics and autism genomics research to study pediatric patients and their families who have been diagnosed with autism, with depression leading to suicidality and with bipolar disorder. Longterm we anticipate our work in behavioral genomics will transition to the setting of genomic testing as a component of medical diagnosis for these children. While strong progress has been made toward our mission at the Rasmussen Institute, it is clear that additional medical service lines will benefit from the integration of genomics into both research and clinical practice. To better identify and define these opportunities, a critical activity involves education of clinical providers regarding the application of genomics - what it can and cannot address. Similarly, we benefit from understanding the challenges and unanswered questions in these different areas of pediatric medical practice and using this information to shape study design, patient accrual and other important aspects that maximize the yield of information we obtain. With a basic understanding of each other’s vocabulary, strengths and challenges, we can better define the way by which genomics can help answer the difficult questions that clinicians must address when diagnosing and treating their patients. This is the essence of team science in precision medicine and why genomics is an accelerator for our hospital and its important focus on providing the best care possible for our patients.
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for research. The research subject should have a good understanding of what the consent entails and have the opportunity to ask questions.
In the 1950s, cells were used from a cancer patient named Henrietta Lack and were utilized in multiple research projects.
Genomics data has the potential to impact denial of medical treatment, eligibility for healthcare insurance and qualifying for job opportunities. The Genetic Information Non-Discrimination Act (GINA) was developed to protect against discrimination in the workplace and healthcare insurance but there are still unprotected gaps, such as disability, life and long-term care insurance. GINA also does not apply to small employers and the U.S. military. The uncertainty and variability of what privacy protection is available can impact the participation of needed participants.
arge scale data breaches are in the news frequently, hitting many different types of institutions, such as banks, corporate companies and even hospitals. In the digital age, it leads people to wonder about the security of their information and how data remains private. This is especially true in the world of genomics, where this sensitive data has a unique need to be shared for research, public health, clinical interpretation and medical practice support. As this information is shared for current and future research or treatment of genetic conditions, it is more valuable to cybercriminals than traditional protected health information (PHI) because of its ability to illuminate generational family health. The balance to keep it private and secure is paramount while at the same time remaining cognizant of the importance of sharing for advances in genomic research.
It became known as the HeLa cell line. This was done without her or her family’s consent, which was not uncommon at the time. When discovered, this led to discussions about consent, patient privacy, ethics, property rights and others. Those discussions continue today as the boundaries of privacy, patient understandings of consents, and precedence set on regulations or legal outcomes evolve. Informed consent is a large component of research and testing. This consent should be written, clear on the risks and benefits of participation and include whether data or specimens will be used
Privacy concerns with genomics impact not only the initial research subject, but also siblings, current or future children, and other family members. The institutional review board (IRB) and/or privacy board is designed to ensure maximum privacy protection while sharing the minimum amount of data, specimens, etc. Federal law requires adherence to these core procedures established by the Common Rule including the appropriate informed consent and the mandated review by the IRB.
It is imperative that the privacy laws and regulations match the rapid pace of which science and the study of genomics evolve. Typically, deidentified data is absolved of federal and state privacy requirements but as technology advances, even the best deidentified data can be reidentified with accuracy. Future regulations will need to focus on addressing this to meet the needs of scientific advancements and privacy protection.
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