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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
International Research
IRBMED
| Approval Date:
February 19, 2016 10:30 am
In order for UM researchers to conduct a research 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 Office of Human Research Protections (OHRP) in the federal Department of Health and Human Services (DHHS). Consult the following OHRP website to see if your host institution already has an assurance 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 IRB 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 research is conducted, the IRBMED must also review the project. The onus is on the investigator 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 risks of the project to subjects.
Required for All International Studies
- Foreign host IRB/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
- Informed consent documents in local language and English translation (indicate the language expertise of writer(s)/translator(s))
- General information regarding local research 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
- EXAMPLES:
- Allow 10 weeks for review
Recommended for Studies Involving Greater than Minimal Risk
- Site 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 [email protected])
Web Resources
- Assurances and IRB Registration
- Declaration of Helsinki
- International Ethical Guidelines for Human Subject Research – Council for International Organizations of Medical Sciences
- ICH E6 Good Clinical Practice: Consolidated Guidance (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
- Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP) (including the International Compliation of Human Research Standards, a document listing relevant laws, regulations, and guidelines for many countries)
- Operational Guidelines for Ethics Committees – World Health Organization
- NIAID ClinRegs: aggregating clinical research regulations from around the globe (selected countries only)
Created 4/17/2012; Last Updated 2/19/2016
Questions?
Contact us at [email protected] 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: [email protected]
Last Updated: May 10, 2018 1:00 PM