International regulations in the area of research and its ethical conduct largely overlap with national regulations in the areas of human subject research, trial insurance, and data sharing. These are defined somewhat universally and seek to enhance the credibility and integrity of the research being performed in addition to protecting the researchers, subjects, and institutions involved.
Most commonly used regulations internationally {U.S. Code reference}
- Conflict of Interest and Conflict of Commitment {§ 200.112}
- Effort Reporting {§ 200.430}
- Certs and Reps {§ 200.208}
- Allocation & Allowability {§200.4 & § 200.403}
- Cost sharing / Matching {§ 200.209}
- Single Audit / program‐specific audit {§ 200.507}
- HIPAA (1996)
- Intellectual Property and allowable costs {§ 200.448}
- Indemnification {§ 200.447}
- Retention requirement for records {§ 200.333}
- Order of Precedence
- Suspension and Debarment {§ 200.213}
U.S. LAWS ABROAD
In addition to laws in the host country, some U.S. laws govern the conduct of activities in foreign countries. The following list is intended to highlight some of the more significant laws that you need to consider when conducting an activity abroad.
- Foreign Corrupt Practices Act
- Anti-Boycott Laws
- Export Control Statutes
- U.S. Economic Sanctions
- Fly America Act
- Florida CS/HB 7017: Foreign Influence Bill
Resources
- The New EU General Data Protection Regulation: What You Need to Know about It and Why | Webinar slides and accompanying information from the U.S. National Association of College and University Attorneys (NACUA).
- Overview from the European Union on the GDPR.
- International Compilation of Human Research Standards | Compilation of over 1,000 laws, regulations, and guidelines that govern human subjects research organized by region and country.