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Classic Historical Cases

Special Populations and Cultural Competence

• Community or consumer representation
• Institutionalized populations
• International research
• Linguistic barriers
• Mental health disorders, participants with
• Minors (children, adolescents)
• Racial and ethnic minorities
• Other special population issues

Informed Consent: Disclosure and Deception

• Deception (debriefing, illusions)
• Obstacles to informed consent
• Passive consent
• Waiver of informed consent
• Waiver of written consent form
• Other informed consent issues

Decision-making Capacity, Assent, and Surrogate Permission

• Advanced directives
• Assent
• Decision-making capacity (competence), determination of
• Surrogate decision makers
• Waiver of parental permission
• Other decision-making issues

Voluntariness and Undue Influence in Recruitment

• Deference to authority
• Financial incentives
• Therapeutic misconception
• Other voluntariness or recruitment issues

Study Design and Risk-Benefit Analysis

• Existing data (epidemiology, services research)
• Experimental designs (randomization, clinical trials)
• Observational
• Placebo
• Risks and benefits
• Safety monitoring / safety arms
• Survey and qualitative research (behavioral, social science)
• Other study design or risk/benefit issues

Privacy and Confidentiality

• Analysis of data
• Anonymous / de-identified data
• Authorization of data usage
• Certificate of confidentiality
• Collection of data
• Mandatory reporting
• Storage of data
• Other privacy or confidentiality issues

Identifying and Managing Conflicts of Interest

• Dual roles of researchers
• Financial conflicts of interest
• Other conflict of interest issues