SOCRA CCRP Practice Exam

Which federal regulations govern financial disclosure by researchers?

1. 21 CFR 54

2. 18 US Code 2331

3. 42 CFR Part 2

4. HIPAA Regulations

The correct answer is: 21 CFR 54

21 CFR 54 is the FDA's regulations governing financial disclosure by researchers. It is important for researchers who work with federal funding or participate in FDA-regulated clinical trials to understand and comply with these regulations. Option B, 18 US Code 2331, pertains to terrorism and is not related to financial disclosure by researchers. Therefore, it is not the correct answer. Option C, 42 CFR Part 2, is the federal regulation that protects the confidentiality of substance use disorder patient records. While this is an important regulation for healthcare providers, it is not directly related to financial disclosure by researchers. Option D, HIPAA regulations, is the federal regulation governing the protection of personal health information. While it does require certain disclosures related to research, it does not specifically govern financial disclosures by researchers. Therefore, it is not the correct answer.