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The StarNet Case Control Study. Investigating the Effects of Genes and Environment on Smoking Behavior. Overview of Research Study. Phase 1: Designing the StarNet Case Control Study
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The StarNetCase Control Study Investigating the Effects of Genes and Environment on Smoking Behavior
Overview of Research Study • Phase 1: Designing the StarNet Case Control Study • Phase 2: Recruiting subjects; collecting DNA and questionnaire data from them; genotyping subjects’ DNA; entering data into a database • Phase 3: Analyzing data
The StarNet Study Phase 1:Designing the Study • Study design includes: • Research question • Outcome and exposures • Study population • Research questionnaire
Cases are people who initiated smoking and became smokers. Controls are people who initiated smoking but never became smokers. Research Question: What genetic and environmental exposures are associated with people moving from smoking initiation to maintenance? Stages of Smoking 1. Initiation Experimental smokers Non-smokers never smoked, or tried smoking but did not continue Controls Cases 2. Maintenance 3. Cessation Former smokers successful quitters Regular smokers 4. Relapse
Outcome and Exposures Subjects will complete a questionnaire that asks about environmental factors Subjects will be genotyped for a few candidate genes Outcome: Moving from smoking initiation to maintenance Exposures:Several environmental factors and a few genes involved in the reward pathway or nicotine metabolism
Our Study Population • 300-400 subjects • Both men and women • Different ethnicities • Age 25 to 54
Questionnaire Design What do we want to know? • Demographic questions • Smoking habit • Environmental exposures
Progress on Phase 1 • Study design was completed in 2007 • Study has been approved by UW IRB • What is the UW IRB? • Why do we need approval?
Protection of Human Subjects • The Belmont Report: Ethical principles and guidelines for research on human subjects • The Common Rule: Federal regulations for human subjects research (based on the Belmont Report)
The Belmont Report • Autonomy (respect for persons) • Beneficence/non-maleficence (Do good; maximize benefits and minimize harms) • Justice (Be fair)
Autonomy • Research subjects have the right to decide whether to participate in a study • Minors or people with limited capacity represented by a responsible guardian • informed consent/assent • People should not be coerced into participating and should not receive undue influence
Beneficence/Non-maleficence • For each study, researchers need to minimize risks to research subjects while maximizing benefits of the study • As a community, researchers needs to consider the long term benefits and risks from a field of study or from the development of a medical procedure
Justice • Benefits and burdens of the study are fairly distributed • Vulnerable populations do not bear an unfair burden of research
The Common Rule • Federal regulations for conducting research with human subjects • Adopted by 17 federal agencies in 1991 • Research institutes must give assurance that they will enforce protection of human subjects in research done at their institution • Research institutes must have an Institutional Review Board (IRB) to review federally funded research studies with human subjects • Research with human subjects requires informed consent
How Does the StarNet Study Meet the Ethical Guidelines of the Belmont Report? • Autonomy • Competent adults • Give informed consent • Small cash compensation • Beneficence/Non-maleficence • Potential risks: discomfort with some questions, blood draw, or revealing genetic information • Benefits: improving education and our understanding of factors affecting smoking behavior • Justice • Diverse subject population • Competent adult subjects who volunteer
The StarNet Study Phase 2:Recruitment and Genotyping • Subjects are being recruited from around Puget Sound • Subjects call the study coordinator, who screens each caller to determine whether they are eligible for the study as a case or a control
Meeting a Subject Eligible subjects: • meet the study coordinator in a private office • read consent form, have opportunity to ask questions • sign consent form if interested in participating in study • Fill out questionnaire, give blood sample
DNA Preparation and Genotyping • Lab purifies DNA from the subjects’ blood samples • StarNet lab uses PCR to amplify regions of subjects’ DNA • StarNet team sends equipment, reagents, and PCR-amplified DNA to classrooms for genotyping • High school students genotype the subjects’ DNA and send results back to StarNet • The StarNet team enter genotyping data and environmental data from questionnaire into a queriable database.
The StarNet Study Phase 3:Data Analysis • The database will be a source of data for original research • Students will propose hypotheses about smoking behavior, and use the database to test them • Students will share their discoveries with the StarNet team and with other classrooms
Case Studies • Read one of the four case studies. • Decide whether a human subjects violation has occurred. • If so, recommend what should be done to improve the study or decide whether the study should be terminated.