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
VA: VHA Directive 1200.05(3) sections 25 and 36

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.)
When following VA requirements:
1. VA international research is defined as any VA-approved research conducted at international sites (i.e., not within the United States (U.S.), its territories, or Commonwealths), any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data out of the U.S. This definition applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including MOUs, Cooperative Research and Development Agreements (CRADAs), grants, contracts, or other agreements. Research conducted at U.S. military bases, ships, or embassies is not considered international research.
  1. Sending specimens or data to individuals with VA appointments at international sites (e.g., a without compensation (WOC) appointment, a VA researcher on sabbatical at an international site) is considered international research. Remote use of data that is maintained on VA computers within the U.S. or Puerto Rico and U.S. territories accessed via a secure connection is not considered international research.
  2. International research includes multi-site trials involving non-U.S. sites where VA is the study sponsor, a VA researcher is the overall study-wide PI, VA holds the Investigational New Drug (IND), or the VA manages the data collection and the data analyses.
  3. International research does not include studies in which VA is only one of multiple participating sites where the overall study-wide PI is not a VA researcher (i.e., the principal investigator for the study as a whole is not a VA researcher).
2. Before approving international research involving human participants research, the IRB must ensure that human participants outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research participants inside the U.S. if the activity involves human participants research requiring IRB approval or limited IRB review.
3. For VA facilities:
  1. All international research must also be approved explicitly in a document signed by the VA medical facility Director, except for Cooperative Studies Program activities which must be approved by the Chief Research and Development Officer (CRADO).

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