STANDARD I-3

standard i-3: The organization’s transnational research activities are consistent with the ethical principles set forth in its Human Research Protection Program and meet equivalent levels of participant protection as research conducted in the organization’s principal location while complying with local laws and taking into account cultural context.

Researchers often conduct studies in other countries as well as in their own country. IRBs or ECs that review such research must be knowledgeable about the laws, regulations, codes, and guidance that govern such research in addition to the cultural context in which the research will be conducted.

Both researchers and the IRB or EC have the responsibility to ensure the research performed in other countries meets equivalent levels of protection that would be required in the organization’s principal location, taking into account local laws and cultural context.

When research is sponsored by a U.S. federal agency, the regulations of that agency apply. Providing equivalent protections is unacceptable in lieu of providing the required federal protections.

Regulatory and guidance references

DHHS: 71 Fed Reg 10511 (July 7, 2006)

DoD: Instruction 3216.02 6 para. 3.6.; SECNAVINST 3900.39D, para. 6i

Required written materials

Essential requirements:
1. The organization has policies and procedures for reviewing transnational research including:
  1. Ensuring appropriate expertise and knowledge of the country either through IRB membership or consultants.
  2. Confirming the qualifications of the researchers and research staff for conducting research in that country.
  3. Initial review, continuing review, and review of modifications.
  4. Knowledge of local laws.
  5. Post-approval monitoring.
  6. Handling of complaints, non-compliance, and unanticipated problems involving risk to participants or others.
  7. Consent process and other language issues.
  8. Communication and coordination with local IRBs or ECs when appropriate.
2. All policies and procedures that are applied to research conducted domestically should be applied to research conducted in other countries, as appropriate.
When following DoD requirements:
1. Policies describe the process to confirm approval by the appropriate DoD component prior to research starting when human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens. (See Standard I-2 for Component-level review requirements.)

Common types of materials that may be used to meet the element

Applications
Checklists
Copies or summaries of local laws

Outcomes

Researchers provide the same or equivalent protections to human participants in research conducted in other countries.
When conducting transnational research, researchers are aware of local laws and cultural context in all locations where the research is conducted and comply with local laws and adhere to cultural norms.
When reviewing transnational research, IRBs or ECs ensure that equivalent protections are provided to research participants enrolled in research in other countries.
IRBs or ECs make determinations and decisions based on laws and knowledge of the country in which the research will be conducted.

Proceed To: STANDARD I-4

Evaluation Instrument for Accreditation

INTERNATIONAL ADDENDA

INTRODUCTION

TABLES

DOMAIN III: RESEARCHER AND RESEARCH STAFF

DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE

DOMAIN I: ORGANIZATION

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

STANDARD I-3