Genetic information can also include an individuals

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Genetic information can also include: An individual's request for, or receipt of, genetic services Participation in clinical research that includes genetic services by the individual or a family member The genetic information of a fetus carried by an individual who is a family member of the individual The genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology Source : Rebecca Spence, JD, MPH – American Society of Clinical Oncology (ASCO)
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Common Rule: Health Informatio n from Research Baseline standard of ethics that all government-funded and most academic research must adhere to – safeguards individuals who participate in research. Including research collected in a clinical setting. Most research organizations voluntarily comply. Regulated by Internal Review Board for all human subject research. Has specific provisions for vulnerable populations , including minors, prisoners, and pregnant women. Allows biological samples to be stored and used for research indefinitely as long as the sample is de-identified. Significant changes to the Common Rule were made in January 2017 pursuant to public input. **Most provisions will go into effect in 2018** Source : ctions-research-participants-modernizes-oversight-system.html
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Common Rule Changes - 2017 Consent forms have to include information about the project’s risks and benefits (for informed consent) Requirements to use a single IRB for multi-institutional research studies Use of broad consent for future research (for studies on stored identifiable data or biospecimens), rather than seeking IRB approval for a consent waiver New “ exempt ” categories for research – i.e. “secondary research involving identifiable private information if the research is regulated by and participants protected under HIPAA” Public posting of consent forms for certain federally-funded clinical trials
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Research vs. Non- research Uses of Data Research Developing generalizable knowledge Often published or publically available Can be observational, experimental, simulation, compiled, or reference Can include documents, surveys, data files, models, field notes, etc. Source : Non-research Internal business/operational development In healthcare, services/programs to improve overall public health and services Can contribute to general knowledge **Data may not be initially collected for the purpose of generalizable knowledge – instead for clinical care**
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Laws: What is Covered? HIPAA Sets rules for information privacy and data records standards Covered entities Sets data security requirements Common Rule Standard of ethics for government-funded and academic research Safeguard for individuals who participate in research Biological samples can be used for research indefinitely as long as de-identified Everythin g Else
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