The StarNet Case Control Study

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´╗┐The StarNet Case Control Study Investigating the Effects of Genes and Environment on Smoking Behavior

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Overview of Research Study Phase 1: Designing the StarNet Case Control Study Phase 2: Recruiting subjects; gathering DNA and survey information from them; genotyping subjects' DNA; entering information into a database Phase 3: Analyzing data

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The StarNet Study Phase 1: Designing the Study plan incorporates: Research address Outcome and exposures Study populace Research poll

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Cases are individuals who started smoking and got to be smokers. Controls are individuals who started smoking yet never got to be smokers. Examine Question: What hereditary and natural exposures are connected with individuals moving from smoking start to upkeep? Phases of Smoking 1. Start Experimental smokers Non-smokers never smoked, or had a go at smoking yet did not proceed with Controls Cases 2. Upkeep 3. Suspension Former smokers effective slackers Regular smokers 4. Backslide

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Outcome and Exposures Subjects will finish a poll that gets some information about ecological components Subjects will be genotyped for a couple hopeful qualities Outcome: Moving from smoking start to support Exposures: Several natural elements and a couple of qualities required in the reward pathway or nicotine digestion system

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Our Study Population 300-400 subjects Both men and ladies Different ethnicities Age 25 to 54

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Questionnaire Design What would we like to know? Demographic inquiries Smoking propensity Environmental exposures

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Progress on Phase 1 Study plan was finished in 2007 Study has been affirmed by UW IRB What is the UW IRB? Why do we require endorsement?

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Protection of Human Subjects The Belmont Report: Ethical standards and rules for research on human subjects The Common Rule: Federal directions for human subjects investigate (in light of the Belmont Report)

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The Belmont Report Autonomy (regard for people) Beneficence/non-wrathfulness (Do great; expand benefits and minimize hurts) Justice (Be reasonable)

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Autonomy Research subjects have the privilege to choose whether to take an interest in a study Minors or individuals with constrained limit spoke to by a mindful gatekeeper educated assent/consent People ought not be forced into taking part and ought not get undue impact

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Beneficence/Non-perniciousness For every study, scientists need to minimize dangers to research subjects while boosting advantages of the study As a group, analysts needs to consider the long haul advantages and dangers from a field of study or from the advancement of a restorative system

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Justice Benefits and weights of the study are genuinely appropriated Vulnerable populaces don't bear an out of line weight of research

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The Common Rule Federal controls for leading exploration with human subjects Adopted by 17 government organizations in 1991 Research foundations must give confirmation that they will authorize security of human subjects in research done at their establishment Research organizations must have an Institutional Review Board (IRB) to survey governmentally financed inquire about studies with human subjects Research with human subjects requires educated assent

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How Does the StarNet Study Meet the Ethical Guidelines of the Belmont Report? Self-governance Competent grown-ups Give educated assent Small money pay Beneficence/Non-wrathfulness Potential dangers: inconvenience with a few inquiries, blood draw, or uncovering hereditary data Benefits: enhancing instruction and our comprehension of elements influencing smoking conduct Justice Diverse subject populace Competent grown-up subjects who volunteer

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The StarNet Study Phase 2: Recruitment and Genotyping Subjects are being enlisted from around Puget Sound Subjects call the study facilitator, who screens every guest to figure out if they are qualified for the study as a case or a control

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Meeting a Subject Eligible subjects: meet the study organizer in a private office read assent frame, have chance to make inquiries sign assent shape if inspired by partaking in study Fill out survey, give blood test

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DNA Preparation and Genotyping Lab filters DNA from the subjects' blood tests StarNet lab utilizes PCR to open up areas of subjects' DNA StarNet group sends hardware, reagents, and PCR-intensified DNA to classrooms for genotyping High school understudies genotype the subjects' DNA and send comes about back to StarNet The StarNet group enter genotyping information and ecological information from poll into a queriable database.

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The StarNet Study Phase 3: Data Analysis The database will be a wellspring of information for unique research Students will propose speculations about smoking conduct, and utilize the database to test them Students will impart their disclosures to the StarNet group and with different classrooms

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Case Studies Read one of the four contextual investigations. Choose whether a human subjects infringement has happened. Provided that this is true, prescribe what ought to be done to enhance the study or choose whether the study ought to be ended.