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Committee For the Protection of Human Subjects

International Research


POLICY

Research conducted by UTHealth faculty at international sites must meet equivalent levels of protection that would be required of research conducted in Houston, taking into account local laws and cultural context. . When research is sponsored by a US federal agency, the regulations of that agency apply.


PROCEDURE

Submission: When a researcher proposes 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 IRB or 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 occur 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 where the research will be conducted.
  • If compensation will be offered to research participants, the details of the compensation with some indication of the value of compensation.

IRB staff Review:  IRB 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, the IRB will check if the international site has a federal wide assurance.  IRB staff will verify that appropriate local approval documents have been submitted. If researchers prefer to get IRB review prior to submitting to the local approval documents, UT Houston IRB approval will be conditional upon receipt of the local approval documents.

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

  • If the IRB membership does not have the expertise or knowledge of the country where the research will be done, the IRB may seek the advice of a consultant with sufficient knowledge of the local context.
  • IRB reviewers will review the plan for communication of information between the UT Houston PI and the researchers at the international site for dealing with complaints, non-compliance and other unanticipated problems involving risks to participants or others.
  • IRB reviewers will review the investigators’ plan for quality control and quality assurance, including post approval monitoring, at the international site.
  • IRB 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.
  • IRB will confirm the qualifications of the researchers and research staff for conducting research in that country.
  • IRB may ask the UT Houston PI to submit additional information on the qualifications and experience of local investigators at the international site.
  • If needed, IRB staff or reviewers may communicate directly with the local IRBs or local ethics committees.

APPLICABLE REGULATIONS

  1. 45 CFR 46 Protection of Human Subjects

OTHER REFERENCES

  1. None

REFERENCE TO OTHER POLICIES

  1. Initial Review

ATTACHMENTS

  1. None

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

Document Number:

101-C17

Document Name:

International Research

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Nov 2011

Revision History:

1 Jun 2016, 21 Jan 2019, 1 Jun 2021

 

 

 




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