RESEARCH INVOLVING INTERNATIONAL SITES

 

 

POLICY

 

It is the policy of UT Houston that researchers conducting research at international sites must adhere to the same high standards of research ethics required for human subjects research conducted in the US while at the same time being sensitive to local cultures and practices.

PROCEDURE

 

Submission: When a researcher is conducting research at international sites, in addition to the materials outlined in the policy on initial review, the researcher should include:

§  A description of the international sites at which the research will take place.

§  Information about the local research context and any conditions of the local culture that might affect the conduct of research.

§  If the researcher has experience conducting research in this region, a description of the experience should be included.

§  Description of the recruitment plan. If the investigator plans to use recruitment materials in the local language these should be submitted when available.

§  Copy of local ethics committee approval or letter of support from local entity if there is no local ethics committee.

§  Description of the consent process. List of local languages the consent discussion will cocur in. If the researcher or research staff are not fluent in this language, the researcher should also include a description of the translation process.

§  Copies of translated consent forms, if any and when available. .

§  If the research is federally funded verification of OHRP FWA of the institution the research is conducted at.

§  If compensation will be offered to research participants, the details of the compensation with some indication of the value of compensation.

 

CPHS Staff Review:  CPHS staff will determine if the international site is engaged in research. If the international site is engaged in research and if the research is federally funded or supported, CPHS will check if the international site has a federal wide assurance.  CPHS staff will verify that appropriate local approval documents have been submitted. If researchers prefer to get CPHS review prior to submitting to the local approval documents, UT Houston CPHS approval will be conditional upon receipt of the local approval documents.

 

CPHS Review: In addition to the criteria listed in the policy Initial Review, CPHS review will involve additional considerations specific to conducting research at international sites:

·         CPHS may seek the advice of a consultant with sufficient knowledge of the local context.

·         CPHS reviewers will review the plan for communication of information between the UT Houston PI and the researchers at the international site.

·         CPHS reviewers will review the investigators plan for quality control and quality assurance at the international site.

·         CPHS will rely on the local approvals as an assurance that local laws have been met but may contact the local IRB or institution for additional information.

·         CPHS may ask the UT Houston PI to submit additional information on the qualifications and experience of local investigators at the international site.

 

 

APPLICABLE REGULATIONS

 

1.       None

 

OTHER REFERENCES

 

1.       Institutional Review Board

 

REFERENCE TO OTHER POLICIES

 

1.       Initial Review

 

ATTACHMENTS

 

2.       None

 

 

 

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

 

Document Number:

101-C17

Document Name:

International Research

Approved by:

ORSC Director

Effective:

1 Nov 2011

Revision History: