Procedure on International Research
- Applicability: This procedure defines the standards and parameters for the conduct of behavioral and social science research and biomedical research done outside the United States.
- Procedure Statement: Grand Canyon University (GCU) is committed to upholding the standards for ethical research and informed consent expectations articulated in the Belmont Report for all research conducted outside the United States. Research conducted outside the United States will conform to the same ethical and regulatory standards to which domestic research is held and will be conducted in accordance with US Federal regulations for the protection of human research subjects (45 CFR 46, et seq.) regardless of the funding source.
- Research conducted outside the United States must comply with the relevant laws of the host country. Researchers will collaborate whenever possible with a research or educational institution familiar with the local culture and research-related issues. It will be incumbent upon all researchers to ensure that the cultural caveats of the host country are respected and that the participants will not be subjected to retaliation from local authorities or the local community. No research involving humans shall be initiated prior to obtaining appropriate IRB approval(s).
- GCU IRB must review and approve all international research involving human subjects. An international institution or site considered engaged in research must obtain IRB approval from an institution that holds a Federal Wide Assurance in the country where the research is taking place (if the research is supported by federal funding). Review by a local IRB or Ethics Board must be sought whenever possible. The local IRB or Ethics Board must be knowledgeable about and sensitive to, local community composition, mores and standards of conduct. In the event that no such local IRB or Ethics Board exists in the immediate local where the research is to take place, steps will be taken either to identify such a review board within the general region or to identify a local institution that could serve in a comparable capacity (i.e., a tribal council, school board, town committee, hospital board, etc.). Copies of the local IRB approval will be maintained by the GCU’s IRB Director with other pertinent research documentation.
- The informed consent discussion, as well as all consent documents, will be in the subjects' native language, per GCU Procedure on Participation of Non-English Speaking Subjects.
- A translation certification and back certification form must be present in the IRB protocol.
- All consent and recruiting materials must be in the appropriate language of non-English speaking subject.
- Family members will not be asked to provide such translation because they may not be able to fully explain the study's risks and benefits to the potential subjects.
If subjects are likely unable to provide written consent, the researcher(s) will provide justification in the protocol submitted to the IRB for a waiver of written consent. As well as an acceptable alternative method of obtaining oral consent that is appropriate to both the subjects and their culture.
DEPARTMENT: Office of Academic Research
PROCEDURE NUMBER: 1.4
SECTION: 1.0 IRB Policies for Human Subjects Protections
REVIEW RESPONSIBILITY: IRB Director
ORIGINAL CREATION DATE: December 19, 2010
APPROVAL DATE: February 2, 2011
REVISION DATES: March 4, 2015
Adapted with permission from Yale University, Office of Research Administration and Human Research Protection Program, Research Affiliates Policies (2011).