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Washington State University

HRPP policies & procedures manual

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411: International research

1. Purpose

This policy describes the standards and parameters for the review of international research.

2. Policy

The University is committed to upholding the same standards for ethical research and informed consent for all research conducted outside the United States. Research conducted outside the U.S. creates areas of concern for both the investigator and IRB. Cultural, economic, or political conditions of the host country may alter the risk for subjects compared to the same research conducted within the U.S. Other countries and institutions within foreign countries may have IRB or ethics committees that require review of the research before research can be conducted in that country.

The IRB shall require the investigator to provide to the IRB, the local applicable laws, regulations, customs, and practices for the country where the proposed study will occur, along with an outline of how the investigator will follow those laws, regulations, customs, and practices. The IRB will require the investigator to provide to the IRB evidence of the qualifications of the researchers and the research staff for conducting research in the country.

All policies and procedures that are applied to research conducted domestically should be applied to research conducted in other countries as appropriate even if the governing laws of the other country are less stringent.

3. Specific policies

3.1 Review of the research by the foreign ethics committee

Approval by the foreign local IRB or ethics committee where the research is taking place prior to WSU IRB approval is optimal. If there is no equivalent board or group, investigators must rely on local experts or community leaders to provide insight into local context.

It is important that all research with living human beings adequately protects the rights and welfare of the research subjects, irrespective of whether the research is conducted in the United States or at foreign sites. In the international setting, special attention should be given to the involvement of local subjects in the design and conduct of the research to ensure respect for differences in language, education, cultural and social history, and social mores, as well as compliance with local law. In addition, national policies such as the availability of national health insurance, philosophically different legal systems, and social policies distinguish international research from U.S. research and must be considered carefully by investigators and the WSU IRB when contemplating conducting and reviewing such research.

3.3 Exempt and expedited review

International studies that are minimal risk, do not ask sensitive questions, and fall under the exempt or expedited categories may be reviewed by the IRB coordinator. A consultant familiar with local context may be sought out to provide guidance to the reviewer.

3.4 Institutional Review Board considerations

For an international protocol the PI must seek review of his/her human subject research protocol by a local IRB, ethics board or independent ethics committee (IEC) whenever possible. The local IRB, ethics board, or IEC must be knowledgeable about and sensitive to local community composition, mores, laws, and standards of conduct. In the event that no such local IRB, ethics board, or IEC exists or when such a local ethics board is unable or unwilling to review the research, the PI should seek to identify a review board within the general region or to identify a local institution that can serve in a comparable capacity (e.g., a tribal council, school board, town committee, or hospital board). A copy of the local IRB or IEC approval must be submitted to the IRB.  The IRB should have contact information of this organization and work with this committee via e-mail for regular updates.  This committee should also be listed in the protocol as an area reference for subjects to communicate problems and complaints.

If WSU IRB approval is required before the foreign IRB approval can be obtained the IRB may either:

  1. Require an expert consultant to address issues of local context.
  2. Review the study and make a motion, “Defer, pending review and approval of the foreign IRB.” The investigator will be required to submit to the WSU IRB all correspondence and approval documents.

The protocol must provide evidence of sufficient local resources and facilities to support the proposed human subject protocol in compliance with this policy and local law. The PI is responsible for ensuring the resources and facilities are appropriate for the nature of the research and the PI is responsible for ongoing monitoring of the research, including the ability to submit the initial review, continuing reviews, amendments, all unanticipated events as well as regular communication with the WSU IRB.

In order to approve a protocol being carried out at a foreign site and to make an informed judgment about the level of risk to potential research subjects, the IRB must demonstrate that it has sufficient information about the local research context and local law by its review of written material, or through discussions with either IRB members knowledgeable about the local context or appropriate expert consultants. The level of knowledge about the local context and local law required for approval is based on the degree of risk to potential research subjects. Higher risk studies require more thorough considerations of local context and inclusion of strategies to mitigate harm than do minimal risk studies.

3.5 Informed consent

The informed consent process, as well as the document, must be in the subjects’ native language or they must be fluent enough in English to fully understand the information and ask appropriate questions.

4. Applicable regulations and guidelines

Office for Human Research Protections (OHRP) – International Issues

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

Who Task
IRB coordinator, IRB members Determine if local context consultant is needed.

Review IRB application and all associated documents.