INTERNATIONAL RESEARCH

SUBJECT:

International Research

 Policy Number:
10.3.4		 Effective Date:
May 26, 2026
Supersedes:
October 31, 2018
October 9, 2015
October 21, 2011
May 14, 2010		 Page 1 of 5
Responsible Authorities:
Vice President, Research
Associate Vice President, Research Integrity
Institutional Review Board

  1. Background

    ֱ̲ Atlantic University (FAU) faculty and students carry out a wide range of research studies involving human participants, including studies in foreign countries

  2. Purpose

    Describes the requirements and responsibilities of FAU investigators when conducting non-exempt human subjects research in foreign countries and the responsibilities of human research protection program (HRPP) staff reviewing these projects.

  3. General Statement

    Research with human participants in other countries must comply with both U.S. and that country’s legal and ethical standards. The Principal Investigator (PI) should endeavor to design research that is culturally appropriate, and which guarantees, at a minimum, protections equivalent to those accepted in the U.S. All such international human subjects research carried out by FAU investigators must be reviewed by the Institutional Review Board (IRB) prior to initiation.

    Some countries and international institutions have their own institutional review boards and regulations for human subject protections (

  4. Policy

    Human subjects research conducted by FAU investigators is subject to federal and state laws and regulations, in addition to FAU and division policies, regardless of where the research is conducted. Research by FAU investigators must not be conducted in any foreign country that is subject to U.S. Government sanctions or restrictions that limit or prohibit research activities in that country. FAU investigators must comply with university policy on when conducting research outside of the U.S.

    When the FAU IRB is reviewing research conducted collaboratively with foreign investigators or institutions, its oversight responsibilities extend only to the activities of those investigators covered by the FAU Federalwide Assurance (FWA). In those cases in which an appropriate IRB exists at the foreign research site, its review and approval, in addition to approval by FAU’s IRB, must be obtained before research can begin. When conducting non-exempt human subjects research in a foreign country, FAU investigators must comply with all applicable in-country laws and regulations. If U.S. or state law, regulation, or policy (including FAU policy) differs from the foreign requirements, the most restrictive approach should be used - so long as it is not contrary to U.S. or state law, or policy. (For more information, see the .) Non-exempt human subjects research conducted by FAU investigators in a foreign country must be approved by an in-country IRB/EC prior to receiving final approval by the FAU IRB. The FAU IRB can make certain exceptions, if for example, FAU is the prime awardee of a sponsored project and/or a foreign site is added to an existing project.

    When the FAU IRB is the Reviewing IRB, and there is no in-country IRB/EC, the FAU IRB may require a written assessment of the research for its consistency with foreign country laws and regulations, local customs and culture. The written assessment will be obtained from an individual who has appropriate expertise in the foreign country’s culture and who is independent of the research team.

    The FAU IRB will not approve research occurring in a foreign country that has been previously disapproved by, or otherwise conflicts with the determinations of, the in-country IRB/EC. If previously approved by the FAU IRB and a later determination by the in-country IRB/EC disapproves the research, the FAU IRB approval will be rescinded.

  5. Responsibilities

    The Principal Investigator (PI) will be responsible for:

    • Compliance with federal and state law, regulation, and policy, including FAU policy, regardless of whether the research is conducted either domestically or internationally. In addition to these requirements.
    • FAU investigators conducting non-exempt human subjects research in foreign countries, must comply with all applicable foreign country laws and regulations and the requirements of the in-country IRB/EC (if applicable), so long as the requirements are no less restrictive than, and are not counter to the standards and requirements of the U.S.-based reviewing IRB.
    • FAU Investigators must describe in the protocol, the rationale and the plan (e.g., scope of research, facilities) for conducting non-exempt human subjects research at the foreign site(s), and relevant local context information, including but not limited to:
      1. The name of the foreign PI/Lead Site Investigator(s) (if collaborating with a foreign institution);
      2. The rationale for conducting research in the foreign country;
      3. Information about the foreign study population and what is required to enroll them in research (e.g., legal age at which subjects can provide consent to participate in research, capacity to consent standards, legally authorized representative standards, local processes for obtaining research informed consent, local languages or dialects, and vulnerable populations).
    • FAU Investigators must submit the following items to the FAU IRB (including, as applicable, certified translations of any foreign-language documents into English). Local context information that is not described in the protocol, including, but not limited to:
      1. A description of the foreign country laws and regulations or local customs that impact the conduct of the proposed research;
      2. Whether the protocol will require, in addition to any necessary local IRB/EC approval, local review and approval by any other in-country entities (e.g., institutions, offices, departments, Scientific Committees, drug and/or device oversight agencies).
      3. Documentation of in-country IRB/EC (if applicable) review determinations and approvals, or a written assessment of the research for its consistency with foreign country laws and regulations, local customs and culture when there is no in-country IRB/EC; and
      4. Any other materials needed by the FAU IRB to complete its review.

    The IRB will be responsible for:

    • When reviewing international research, the FAU IRB must take local context information into consideration when making its determinations.
    • The FAU IRB must not issue a final approval for research conducted in a foreign country until approved by an in-country IRB/EC, if one exists.
    • If the foreign country does not have an IRB/EC, the IRB will require the submission of an independent assessment of the protocol by an individual with knowledge of the foreign country laws and regulations, or local culture and customs, which must be submitted to the FAU IRB to consider prior to review and approval of the research.

    The FAU IRB must not approve collaborative research occurring a foreign country that has been previously disapproved by, or otherwise conflicts, with the determinations the in-country IRB/EC. If previously approved by the FAU IRB and a later determination by the in-country IRB/EC disapproves the research, the FAU IRB approval will be rescinded.

  6. General Data Privacy Regulation (GDPR)

    The European Economic Area (EEA) and the United Kingdom (UK) have additional requirements regarding data privacy, referred to as the GDPR. When FAU Investigators are working with personal data collected in, or transferred from, any EEA country (any EU member states plus Norway, Iceland, and Liechtenstein) or the UK, GDPR will be relevant. This includes data collected, obtained, or used for research projects. “Personal data” means any information relating to an identified or identifiable person. Data that is coded with links to identifiers, or “pseudonymized” in GDPR terminology, is still subject to GDPR. GDPR does not apply to anonymized data. Whether data is anonymized per GDPR must be determined based on the facts and circumstances, considering all the means reasonably likely to be used to identify the person, directly or indirectly. Failure to follow GDPR if it applies puts FAU at risk of noncompliance, monetary fines, and reputational harm. Additional questions or concerns regarding GDPR should be addressed to the Chief Privacy Officer at privacy@fau.edu.

    GDPR requires a legal basis to collect and process (e.g., analyze) personal data. To use personal data for research, the legal basis that generally will apply is consent from the data subject. Consent must be freely given, specific, informed, and unambiguous as to the data subject’s wishes by a statement or by a clear affirmative action.

    1. Freely given means the individual must have a realistic choice, or the realistic ability to refuse or withdraw consent. Individuals in a position of authority cannot obtain consent, nor can consent be coerced.
    2. Specific means the consent must be explicit and transparent and contain the following information:
      • Identity of the Principal Investigator.
      • Purpose of the data collection.
      • Types of data collected, including listing of any special categories of data. This includes information about a data subject’s health, genetics, race or ethnic origin, biometrics for identification purposes, sex life or sexual orientation, political opinions, religious or philosophical beliefs, or trade union membership.
      • The right to withdraw from the research and the mechanism for withdrawal.
      • Identify who will have access to the data.
      • Time period for which data will be stored (can be indefinite).
      • Information regarding data security, including storage and transfer of data.
      • Information regarding automated process of data for decision making about the individual, including profiling.
      • Whether and under what conditions data may be used for future research, either related or unrelated to the purpose of the current study.
    3. Informed means that subjects are made aware of the risks, how their data will be safeguarded, their rights in relation to the research (as described below), and how to exercise those rights.
    4. Unambiguous means consent is given through a statement or clear affirmative action.
      • This may be by a written or oral statement or other affirmative act demonstrating consent. For instance, checking a box can indicate consent, while silence or pre-ticked boxes that require unchecking (opting out) cannot.
      • Investigators should be able to demonstrate that a particular subject consented to the research.
      • Consent records, including time and date of consent, must be maintained for each data subject.
      • If the consent form serves multiple purposes, the request for consent must be clearly distinguishable within the document.
      • There is no ability for the IRB to waive informed consent under GDPR.

    Additionally, there are certain rights that have:

    • The right of access to their data.
    • The right to request corrections to their data.
    • The right to withdraw and to request erasure of their data. In this case, data may be retained only if it is anonymized or if another legal basis exists to retain the data. This may include:
      • The need to protect scientific research if deletion would render impossible or seriously impair the research objectives; or
      • The need to protect the public health by ensuring the accuracy and quality of data related to medical care or to investigational drugs and devices.
    • The right to request transfer of their personal information to a third party (such as a personal physician) in a format suitable for re-use.

  7. Policy Renewal Date

    As needed

  8. References

    45 CFR 46
    21 CFR 50 and 56

POLICY APPROVAL

Initiating Authority

Gregg B. Fields, Ph.D., Vice President for Research
5/26/2026

Executed signature pages are available in the Initiating Authority Office(s)