Compliance Issues

Programs performed abroad or involving foreign collaborators may need to address local (country) regulatory requirements and the regulations of a variety of U.S. government agencies in addition to UMB and sponsor policies.

Human subjects research overseas

UMB policies apply to all research conducted (and data collected) by UMB faculty, students, and staff, whether the work is done within the United States or overseas.

Subrecipients engaged in human subjects research must provide to Sponsored Programs Administration the local ethics board approval for the study.

In addition to federal requirements and UMB policies, the collaborating organization or the host country for an overseas project may have laws, regulations, and standards applicable to human subjects research. As a general rule, the most stringent policy or regulation must be followed.

Contact the Human Research Protections Office for assistance with determining whether you will need approval from UMB's IRB for the research conducted abroad.

  • Will you need local (country) IRB approval?
  • How do the laws and standards on human subject research of the host country differ from U.S. laws and UMB policies? What applies?
  • Are there local (country) data privacy laws that will apply to or impact your work? Do not assume that data can be transferred to the United States, even with subject consent.
  • Does your research need to comply with HIPAA requirements even though you are overseas?

If your work will involve the collection of specimens, organisms, or other materials, ensure that you and your host-country contacts have identified any local rules or requirements for the activity, and that the team has obtained any necessary permits or licenses. Cross-border biospecimen shipment is sensitive, may be regulated by local country laws, and/or may require USDA, CDC, or Department of Commerce permits.

Resources

Search federal-wide assurances

DHHS Office for Human Research Protections, international activities

World Health Organization: Ethical standards and procedures for research with human beings

International Compilation of Human Research Standards, 2018 Edition

Animal use in research overseas

UMB policies apply to all research conducted (and data collected) by UMB faculty, students, and staff, whether the work is done within the United States or overseas.

Subrecipients performing research involving animals must provide to Sponsored Programs Administration the local ethics board approval for the project/protocol.

In addition to federal requirements and UMB policies, the collaborating organization or the host country for an overseas project may have laws, regulations, and standards applicable to animal research. As a general rule, the most stringent policy or regulation must be followed.

Contact your IACUC to discuss requirements for animal research performed overseas. How do the laws and standards on animal use in research of the host country compare to U.S. requirements and UM polices? What applies?

If your work will involve the collection of specimens, organisms, or other materials, ensure that you and your host-country contacts have identified any local rules or requirements for the activity, and that the team has obtained any necessary permits or licenses. Cross-border biospecimen shipment is sensitive, may be regulated by local country laws, and/or may require USDA, CDC, or Department of Commerce permits.

Resources

The International Guiding Principles for Biomedical Research Involving Animals (2012)

AAALAC International Regulations and Resources