A child’s parents ask you for advice on whether to enroll their 5-year-old in a phase 3 clinical trial for an agent that might reduce the size of the child’s brain tumor. You’ve heard about this trial in a medical news source recently, and you suspect that the promising results of the phase 2 trials seemed sensationalized. You consider referring the parents to your colleague specialist, but worry that this particular colleague might overemphasize potential benefits and underemphasize potential risks. What will you do?
Which of the following vulnerable population groups is not recognized in the US Department of Health and Human Services Code of Federal Regulations (CFR) sections on human subject research protections?
From the Editor
Enrolling Research Participants in Private Practice: Conflicts of Interest, Consistency, Therapeutic Misconception, and Informed Consent
The National Clinican Scholars Program: Teaching Transformational Leadership and Promoting Health Justice through Community-Engaged Research Ethics
The Code Says
State of the Art and Science
US Federal Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing
Research on Medical Practices and the Patient-Physician Relationship: What Can Regulators Learn from Patients?
History of Medicine
Suggested Readings and Resources
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