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International Research

IRBMED

| Approval Date:

February 19, 2016 10:30 am

In order for UM researchers to conduct a project outside of the U.S., the foreign host hospital/research center must negotiate an International Assurance Agreement with the Office of International Activities (OIA) in the in the federal Department of Health and Human Services (DHHS). Consult the following OHRP website to see if your host institution already has an agreement on file: http://ohrp.cit.nih.gov/efile/Default.aspx 

The OIA will require the foreign host hospital/research center have or set up an or similar committee to review the research project. In some situations, the local health ministry or institutional ethics committee serves in this capacity.

IRBMED Guidelines

In addition to the local review at the location the is conducted, the must also review the project. The onus is on the to provide IRBMED with the same level of information that would be required for an investigation conducted here at UM, and provide information regarding the local research context. The extent of the information to be provided depends upon the of the project to subjects.

Required for All International Studies

  • Foreign host /ethics committee’s approval letter
    • Copy of the original (electronic version is acceptable) and, if not in English, an English translation of the approval letter
  • in local language and English translation (indicate the language expertise of writer(s)/translator(s))
  • General information regarding local context
    • EXAMPLES:
      • Local laws/customs (e.g. proxy, minor consent, age of majority)
      • Racial/ethnic/socio-economic demographics
      • Literacy rates among potential subjects
      • Healthcare status of community/subjects
      • Relevant political issues (e.g. war, civil unrest)
      • Religious/Cultural customs
  • Allow 10 weeks for review

 

Recommended for Studies Involving Greater than

  • information: size of hospital or clinic
  • Supervision and training of research personnel
  • English translations of particularly relevant policies and procedures of local site (safety monitoring/data security)
  • IRBMED may also request contact information for on-site investigators, or local authorities, or other additional information.
  • Contact IRBMED prior to submission of application (email irbmed@umich.edu)

Web Resources

 

 

Created 4/17/2012; Last Updated 2/19/2016

UNIT: Institutional Review Boards (IRBMED)

TOPICS: International Research

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: May 10, 2018 1:00 PM