1. What is human subjects research? |
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2. What do we mean by ethics and ethical conduct? Why do we have federal guidelines in order to protect research subjects? |
Definition of ethics and discussion of values (personal, community, society, federal)
Federal and institutional structures that regulate research (i.e., Dept. of Health and Human Services, Office for Human Protections Research, other federal agencies, Institutional Review Boards)
History of how rules were developed (e.g., Nazi experiments, Tuskegee Syphilis Study)
Recent tragedies generating distrust of research
Historical documents underlying current guidelines (e.g., Belmont Report)
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What are your experiences with research?
What are your communities’ experiences with research?
What are common perceptions about research?
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3. What are my ethical responsibilities as a community partner? |
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What is the mission of your organization with respect to youth?
In what ways does the research fit/not fit with your mission?
What can we do to ensure that the research conforms to the principles of the Belmont Report and that it does not violate the mission of the organization?
What risks and benefits does the current study pose?
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4. What is an Institutional Review Board (IRB)? |
IRB structure, responsibilities, and membership
Definitions of vulnerable populations and conflicts of interest
Components of an IRB application
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Are there any potential conflicts of interest? How can you manage potential conflicts of interest?
Are the youth in the organization members of vulnerable populations?
What information is required and what design decisions need to be made in order to complete the IRB application?
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5. What is informed consent/assent, and why is it necessary? |
Definitions and distinctions between consent and assent, minors and adults, and initial and ongoing consent
Rationale for components of a consent and assent form
Connections between consent/assent and Belmont Report
Definition of confidentiality
Adverse events and safety plans
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What information is the minimum information required in order to sufficiently obtain informed consent or assent for this study?
Is it possible to obtain waiver of parental consent for this study?
What unique issues regarding confidentiality may be faced by participants in this study?
What are potential adverse events, and what systems are in place to prevent adverse events and support participants if such events occur?
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6. What are special considerations when involving adolescents in research? |
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