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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 starnet case control study

The StarNetCase Control Study

Investigating the Effects of Genes and Environment on Smoking Behavior

overview of research study
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
The StarNet Study Phase 1:Designing the Study
  • Study design includes:
    • Research question
    • Outcome and exposures
    • Study population
    • Research questionnaire
slide4
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
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
Our Study Population
  • 300-400 subjects
  • Both men and women
  • Different ethnicities
  • Age 25 to 54
questionnaire design
Questionnaire Design

What do we want to know?

  • Demographic questions
  • Smoking habit
  • Environmental exposures
progress on phase 1
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
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
The Belmont Report
  • Autonomy (respect for persons)
  • Beneficence/non-maleficence (Do good; maximize benefits and minimize harms)
  • Justice (Be fair)
autonomy
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
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
Justice
  • Benefits and burdens of the study are fairly distributed
  • Vulnerable populations do not bear an unfair burden of research
the common rule
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
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
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
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
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 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
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.