Research performed outside the United States or involving foreign collaborators may be subject to local (country) laws and regulations, U.S. federal requirements, UMB policies, and sponsor-specific rules. Investigators are responsible for ensuring compliance with all applicable requirements. When multiple standards apply, the most stringent requirement must be followed.
Human Subjects and Animal Research
UMB policies apply to all research and data collection conducted by UMB faculty, students, and staff, regardless of where the research takes place.
Key Requirements
- Subrecipients engaged in human subjects research must provide local ethics board or IRB approval to Sponsored Programs Administration.
- In addition to UMB and federal requirements, the host country or collaborating organization may have laws, regulations, or ethical standards that apply.
- Local approval requirements do not replace the need for UMB IRB review when applicable.
Investigators should consider:
- Will local (country) IRB or ethics approval be required?
- How do host-country human subjects laws differ from U.S. regulations and UMB policies, and which standards apply?
- Are there local data privacy or data protection laws that affect data collection, storage, or transfer? Do not assume data may be transferred to the United States, even with participant consent.
- Does the research remain subject to HIPAA requirements while conducted overseas?
- Will the study involve specimen, organism, or material collection or shipment? Cross-border biospecimen transfer may be regulated by local law and may require USDA, CDC, or Department of Commerce permits.
For assistance in determining whether UMB IRB approval is required for research conducted abroad, contact the Human Research Protections Office.
Resources
UMB policies apply to all animal research and data collection conducted by UMB faculty, students, and staff, regardless of research location.
Key Requirements
- Subrecipients performing animal research must provide local ethics board approval for the project or protocol to Sponsored Programs Administration.
- Host-country laws and institutional standards may impose additional requirements beyond UMB and federal regulations.
- When multiple standards apply, the most stringent requirements must be followed.
Investigators must consult with their Institutional Animal Care and Use Committee (IACUC) to determine applicable requirements for animal research conducted abroad, including:
- How host-country animal research standards compare to U.S. regulations and UMB policies
- Whether permits or licenses are required for specimen or material collection
- Whether cross-border shipment of specimens or organisms requires USDA, CDC, or Department of Commerce authorization
Resources
Contact
Office of Research and Development
620 W. Lexington St.
Fourth Floor
Baltimore, MD 21201