Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 141
AAHRPP Element: I-3
UIC HSPP applies the same ethical standards to the review and approval of international and US-based research.
- IRB Review of International Research.
- If a foreign institution or site is engaged in research:
- The UIC IRB reviews all human subjects international research to ensure that adequate procedures are in place to protect the rights and welfare of the subjects.
- For FDA regulated trials, non-IND studies must follow Good Clinical Practice guidelines rather than the Declaration of Helsinki.
- The UIC IRB may approve the research if “the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.” (45 CFR 46.101(h)).
- The UIC IRB must approve each research study before research can begin at the foreign institution or site. The foreign institution or site must obtain local IRB/IEC review and approval (or appropriate equivalent) for each research study being added to the research. The investigator must submit an amendment to the UIC OPRS adding the foreign institution or site and provide a copy of the foreign institution approval and/or review before the UIC IRB can approve the study for conduct at the foreign institution or site as a performance site.
- If the necessary cultural expertise is not on the UIC IRB, the UIC IRB may utilize an ad hoc consultant in accordance with UIC HSPP policy Identification and Use of Ad Hoc Consultants.
- The UIC OPRS may consult with OHRP to ensure equivalent protections are in place, including the identification of an equivalent IRB/IEC for the site.
- If the foreign institution or site is not engaged in research. (Refer to Determining Whether a Performance Site or an Institution is Engaged or Not in Research for more information as to the “engaged or not” determination).
- If the foreign institution or site has an IRB/IEC, the investigator must obtain approval to conduct the research at the “not engaged” site from the site’s IRB/IEC or provide documentation that the site’s IRB/IEC has determined that approval is not necessary for the PI to conduct the proposed research at the site.
- When the foreign institution or site does not have an established IRB/IEC, a letter of cooperation must be obtained detailing that the institutional or oversight officials are allowing the research to be conducted at the performance site.
- The UIC IRB must receive documentation of the foreign institution or site’s IRB/IEC determination, or letter of cooperation (as applicable), prior to the approval of the research.
- The investigator and the foreign institution or site is responsible for ensuring that the resources and facilities are appropriate for the research.
- If the necessary cultural expertise is not on the Board, the UIC IRB may utilize an ad hoc consultant in accordance with the UIC HSPP policy Identification and Use of Ad Hoc Consultants.
- UIC IRB Role.
- The UIC IRB considers local research context when reviewing international studies. In most cases, the UIC IRB relies on the review of the foreign institution or site’s IRB/IEC to assess local research context issues and to assess whether the PI is providing adequate protections in place to protect the rights and welfare of the participants. (See UIC HSPP policy UIC IRB Review of Domestic Research Involving Non-UIC Sites, Agencies, Organizations, or Institutions for discussion of local research context).
- The informed consent documents must be in a language that is understandable to the potential subjects. The investigator must provide a written translation of the exact content of the foreign language informed consent document, as well as the credentials of the translator. The UIC IRB reviews the informed consent documents.
- Monitoring of Approved International Research.
- The UIC IRB may require:
- Documentation of regular correspondence between the PI and the foreign institution or site;
- Documentation of continuing IRB/IEC approval from the foreign institution or site;
- Documentation of continuing cooperation from the foreign institution or site if the institution or site is not engaged in the research;
- Documentation from other sources than the PI that there have not been any substantial changes in the research since the last continuing review; and/or
- The inclusion of an independent monitor/body as part of the data safety monitoring plan.
- International Research Involving JBVAMC
- Definition of VA International Research: any VA-approved research conducted at international sites (not within the U.S., its territories, or Commonwealths); any VA-approved research using either human biological specimens (identified, de-identified, or coded) or human data (identified, de-identified, or coded) originating from international sites; or any VA-approved research that entails sending such specimens or data out of the U.S.
- Multi-Site International Trials are covered under this definition if any of the following apply:
- VA is a sponsor;
- VA functions as the coordinating center; VA subcontracts to a foreign site;
- PI for the total study is a VA investigator; or
- VA investigator is specifically collaborating with an international investigator and the VA investigator sends data or human biological specimens outside the U.S., or receives them from outside the U.S.
- VA does not consider their involvement to encompass international research when JBVAMC is only one of the participating sites and the trial does not meet the conditions in A or B.
- Permission must be obtained from the CRADO, or designee, prior to initiating any VA-approved international research. This applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including agreements, MOU, Cooperative Research and Development Agreements (CRADA), grants, or contracts.
- CRADO, or designee, will not grant permission for an international research study involving prisoners as research subjects.
- All international sites must hold an international FWA, and the research must be approved by the IRB or Research Ethics Board of the participating site(s) that are listed on the international FWA.
- JBVAMC facility Director is responsible for:
- Approving the request for permission to conduct international research prior to forwarding it to the CRADO for action.
- Ensuring permission has been obtained from the CRADO, or designee, for the international research prior to its initiation by an investigator at the facility.
- PI is responsible for:
- Obtaining approval from the facility Director.
- Obtaining permission from the CRADO, or designee, in writing before initiating an international research study.
- Conducting research in compliance with this Handbook, and all other applicable VA and other Federal requirements including those for protecting human subjects, tissue banking, use of databases, Federal criminal laws, and the Standards of Ethical Conduct for Employees of the Executive Branch.
- Department of Defense Supported International Research
- Refer to UIC HSPP Policy Research Involving Department of Defense Components.
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Added information regarding research at the VA (section I.A.7). Added link to UIC HSPP policy Determining Whether a Performance Site or an Institution is Engaged or Not in Research.
||Added a Policy section that establishes requirements for a formal agreement between institutions that specifies the roles and responsibilities of each party when conducting multi-site research.
||Updated policy section to remove reference to DoD multi-site research and add UIC HSPP ethical review standards for international research and VA requirements