Foreign Research

Conducting Foreign or International Research

U.S. regulations recognize that the procedures followed in a foreign country where research will be taking place may differ from those set forth by the U.S. federal policy. Therefore, research may be approved by a U.S.-based Institutional Review Board (IRB) if the procedures prescribed by the foreign institution afford Equivalent Protections to those provided in the U.S. federal policy. In such cases, the foreign country's procedures may be substituted for the procedures required by the federal regulations.

Note that the provision described in the previous paragraph does NOT apply to FDA regulated research. The FDA regulations were revised in 2008 (21CFR Part 312.120) to require that Investigational New Drug studies in foreign countries be conducted in accordance with Good Clinical Practice (GCP) rather than in accordance with the Helsinki Declaration or with the regulations of the country. GCP standards MUST be met before the FDA will accept the study in support of an IND or a marketing application.

Click on a topic below to quickly jump to specific information regarding foreign research.

Review Requirements and Procedures

All policies and procedures that are applied to research conducted domestically will be applied to research conducted internationally, as appropriate, including oversight of the following: initial review, continuing review, and review of modifications; post-approval monitoring; and handling of complaints, noncompliance, and FCOIs.

Students may only conduct Minimal Risk studies in foreign countries unless the Faculty Principal Investigator is present and supervising research activities.

In order to fulfill its responsibilities under its Federalwide Assurance (FWA) and to comply with all applicable required standards, the Mercer University Institutional Review Board (IRB) must obtain sufficient knowledge of the local research context when reviewing research protocols that will be conducted internationally or at other non-Mercer University study sites.

Monitoring of Approved International or Foreign Research: The Mercer University IRB is responsible for the ongoing review of international research conducted under its jurisdiction. Documentation of regular correspondence between the investigator and the foreign institution may be required. In certain cases, the IRB may require verification from sources other than the investigator that there have been no substantial changes in the research since its last review.

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Requirements of Federal Regulations

Federal Regulations require that IRBs be knowledgeable about the local research context as demonstrated by fulfillment of the following criteria:

The IRB's composition must be adequate in light of the scope of the institution's research activities, types of subject populations, appropriateness of proposed review procedures in light of probable risks, and the size and complexity of the institution [45 CFR 46.103(d)].

The IRB's members must be sufficiently qualified through the experience and expertise and diversity, including race, gender, cultural background, and sensitivity to such issues as community attitudes to promote respect for the IRB's advice and counsel [45 CFR 46.107(a)].

The IRB must be able to evaluate research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice [45 CFR 46.107(a)].

The IRB must also be capable of ensuring that the selection of subjects is equitable, privacy and confidentiality of subjects is maintained, informed consent is sought in language understandable to the subject and in circumstances that minimize the possibility of coercion, and that there are appropriate safeguards protecting vulnerable subjects [45 CFR 46.111(a)(3), (a)(4), (a)(7), (b) and 46.116].

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Requirements of FDA Regulations

For the purposes of research that may be subject to regulation by the FDA, FDA regulations contain essentially the same requirements as those set forth above in the provision entitled, Requirements of HHS Regulations [21 CFR 561.07, 56.111(a)(3), (a)(7), and (b)]. Both HHS and FDA regulations, as well as other Federal regulations may apply to the same research protocol. Alternatively, either HHS or FDA regulations may apply to a research protocol.

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HIPAA Requirements

The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. regulation and does not apply to international research. If protected health information is brought back to the U.S. and used with data here, then HIPAA will apply.

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OHRP Local Research Standards

In accordance with the OHRP Guidance Document: Knowledge of Local Research Context, July 21, 2000 (Adobe PDF), the Mercer University IRB must demonstrate that it has obtained sufficient knowledge about the local research context to review any research that is to be conducted in that geographic location. The level of local knowledge required is based on the degree of risk associated with the research. The OHRP standards include the following:

Minimal Risk: When the research poses minimal risk to participants, the IRB should obtain the necessary information about the research context through written materials or discussion with appropriate consultants.

Greater than Minimal Risk: When the research poses greater than minimal risk to the participants and the investigator and/or study personnel will have interaction or intervention with the participants, the IRB should obtain the necessary information about the local research context through one or more of the following mechanisms or through other mechanisms deemed appropriate by OHRP for the proposed research and local research context:

  • Personal knowledge of the local research context on the part of one or more IRB members;
  • Participation (physically or by telephone conference) by one or more appropriate consultants in a convened IRB meeting. Such consultant(s) should have personal knowledge of the local research context;
  • Prior written review of proposed research by one or more appropriate consultant(s), in conjunction with participation (physically or by telephone conference) by the consultant(s) in convened IRB meetings;
  • Systematic, reciprocal, and documented interchange between the IRB and elements of the local research context.

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Local Research Considerations

Listed below are other factors that may be considered by the Mercer University IRB when reviewing your research under consideration of local research context:

The extent of training in human subjects research ethics of study staff; if local study staff are under local ethics committee oversight, then that committee's requirements take precedence - study staff includes all personnel engaged in human subjects research, even non-Mercer University local study staff;

The qualifications of the researchers and research staff for conducting research in the country or area;

Coordination and communication with local IRBs when appropriate;

The economic prosperity of the area in which the research is to take place;

The influence of local officials on the population;

If the research is conducted in a foreign country, whether the country or area allows foreign visitors;

The nature of the procedures conducted;

The literacy rate of the area;

Local laws, including the local legal rights of the population (such as legal age of adult consent, any mandatory reporting issues, and laws relevant to sub-populations such as women in general, unmarried versus married women, children, etc.);

How complaints will be reported and to whom;

The relevance of the research to the local population's needs and interests;

The possibility of including officials from the area in the monitoring of the research;

The likelihood for the subject population to benefit from the results of the research; and

The local standards of care for relevant medical conditions.

The Mercer University IRB must also assure that adequate provisions are made for data and safety monitoring in addition to taking into consideration that some foreign IRBs or Ethics Committees may not require Continuing Review of approved research. The Mercer University IRB, however, should ascertain that the local IRB's approval period is consistent with all applicable regulations.

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Equivalent Protections

The Common Rule regulations governing research with human subjects, at 45 CFR 46.101(h), include a provision that would allow the U.S. government to determine whether the procedures adopted by a research institution in a foreign country provide protections for human subjects that are at least equivalent to those provided by the U.S. regulations.

Although this authority has not been formally utilized by the U.S. government, [The Department of Health and Human Services (DHHS) believes] that equivalent protections is a feasible strategy for ensuring the protection of human subjects in research conducted in, or through, foreign research institutions and financed by U.S. public funds. Read more about equivalent protections in the report below.

The Framework for Equivalent Protections is a table that provides a framework for identifying potential differences in protections between the practices normally followed at an institution seeking a finding of equivalent protections and the procedures described in 45 CFR 46. In the table the specific procedures described in 45 CFR 46 have been matched with the protections they are thought to provide.

The DHHS has identified 7 specific protections afforded by 45 CFR 46 that should figure in the determination of equivalence:

  1. Establish expectations of ethical conduct and due diligence in review and performance of research within the institution
  2. Ensure adequate authority and independence of the IRB/Research Ethics Committee
  3. Protection from biased and arbitrary decisions in research ethics review
  4. Ensure sufficient quality and comprehensiveness of research ethics review
  5. Ensure review and oversight are commensurate with risk and vulnerability of study population
  6. Protection from unnecessary or unjustified risk throughout the course of the study
  7. Protection from inadequate disclosure and non-voluntary participation

Each of these protections is necessary for a determination of equivalent protections.

Determinations of equivalent protections would offer an important symbolic gesture on the part of the United States to foreign countries, namely the recognition that the same ethical goals can be met through procedures different from those in 45 CFR 46. Permitting foreign country institutions to use their own procedures (if found equivalent) would amount to recognition, not just of the procedures themselves, but also of the moral authority of the institutions and/or the national agencies that promulgate the local procedures and guidelines.

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Informed Consent Issues

The fundamental purpose of IRB review and approval of the consent document is to protect the rights and welfare of human subjects. The informed consent document is the written summary of the information provided to the subject.

In order to meet the regulatory requirements for informed consent, the information must be presented in a language understandable to the subject [45 CFR 46.117(b)(1) and/or 21 CFR 50.27(b)(1)]. In addition, no consent may contain exculpatory language through which the subject or subject's legally authorized representative is made to or appear to waive any of their legal rights, releases or appears to release the investigator, sponsor, institution or its agents from liability for negligence.

Investigators may not involve a human subject in clinical research without the legally effective informed consent of the subject or the subject's legally authorized representative. Investigators may seek consent only under circumstances that provide the subject sufficient opportunity to consider whether or not to volunteer for the study and in an atmosphere/presentation that minimizes possible coercion or undue influence.

Mercer University's IRB has the authority to audit investigators and/or observe the informed consent process to assure that written consent is obtained, documented, and maintained in accordance with IRB SOP 028.3.

As customs differ from country to country, investigators must be sensitive to local cultural and religious norms when recruiting and enrolling human subjects. For example, signing a consent document for a study collecting opinions about government policy may put subjects at risk in some locales.

In addition to ensuring the regulatory elements of informed consent are met, the Mercer University IRB will consider the following issues when reviewing research to be conducted in a foreign country or other non-Mercer study site:

  • Disclosure of information to individuals who may be unfamiliar with and distrustful of the concepts;
  • Differences in societal and cultural norms;
  • Differences in the role of women in society;
  • Differences in the role of family and community in the consent process;
  • Multiple local languages;
  • Literacy level; and
  • Assent requirements for the enrollment of children or other vulnerable populations.

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Non-English Consent Requirements

When informed consent procedures are used with subjects who do not speak English, a Foreign Language consent may be requested, reviewed, and approved by Mercer University's IRB.

To obtain consent from non-English speaking subjects,

  • The informed consent information must be provided in a language understandable to the subject and contain all elements necessary for legally effective informed consent
  • The consent documents and any related questionnaires or forms for the participants must be clearly translated into the targeted population's language
  • A certified translation of the IRB-approved informed consent must be provided for review and approval - Mercer University's IRB may also require a back translation of the consent to verify accuracy of the translation
  • A qualified interpreter must be available during the consent process and to answer questions and conduct procedures during the study - this may be a researcher or member(s) of the research team fluent in the targeted subject population's language

If necessary, the Mercer University IRB staff will assist sites with resources regarding translation.

 

 

If a non-certified translator is used during the consent process, then a statement verifying the translator's credentials and/or expertise must be submitted to the IRB. A statement from the translator attesting to the translator's proficiency in English and the other language (e.g., he or she is a native born speaker of the other language and has completed at least 4-5 years of education in English or other evidence that he or she speaks and reads both languages fluently) meets this requirement.

 

OHRP requires that the consent be documented in writing.

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Short Form

In accordance with 45 CFR 46.117(b), it may be appropriate to orally present informed consent information in conjunction with a short form written consent document. This method involves use of an IRB-approved English language consent form, an IRB-approved short consent form written in the non-English language, and a witness fluent in both English and the language of the subject.

A witness to this process is required and the subject must be given copies of the short form document and a written summary of what was presented orally.

For more information on Informed Consents for Non-English Speaking Subjects and the Short Form, see SOP IRB 028.3 (Adobe PDF).

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Other Issues to Consider

Researchers proposing international or foreign research should allow additional time for the IRB review process.

Data Protection, Storage, and Transportation

When collecting data in a foreign country, the researcher should consider methods of recording collected data, data protection, storage issues, and safe transport of data. While HIPAA does not apply to international research, it will apply if protected health information is brought back to the U.S. and used with data here.

It is recommended that personal identifiers not be collected unless essential to the research.

Special IRB Considerations for Federally Funded International Research

Approval of federally funded research at foreign institutions engaged in research is only permitted if the foreign institution holds an Assurance with the federal Office for Human Research Protections (OHRP) and if local IRB review and approval is obtained.

Review of Research at Foreign Institutions Engaged in Research

When the foreign institution is a performance site engaged in research, the IRB will review the proposed protocol to ensure that adequate provisions are in place to protect the rights and welfare of the participants. Mercer University IRB approval to conduct research at the foreign institution is contingent upon the Mercer University IRB receiving a copy of the performance site's IRB (or equivalent) letter of approval.

Review of Research at Foreign Institutions Not Engaged in Research

When the foreign institution is a performance site not engaged in research and the foreign institution has an established IRB (or equivalent), the investigator must obtain from the site's IRB (or equivalent) approval to conduct the research at the site or the Mercer University IRB must have, on record, a signed IRB Authorization Agreement (IAA) recognizing Mercer University as the IRB of record.

When the foreign institution does not have an established IRB (or equivalent), a letter of cooperation must be obtained. This letter must state that the appropriate institutional or oversight officials are permitting the research to be conducted at the performance site. Mercer University IRB's approval to conduct research at the foreign institution is also contingent upon receiving a copy of the performance site's IRB (or equivalent) letter of cooperation.

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Additional Resources

Compilation of National Policies

Created by the Office for Human Research Protection (OHRP), The International Compilation of Human Research Standards is a listing of the laws, regulations, and guidelines that govern human subjects research in various foreign countries around the world.

 

 

OHRP Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.

 

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Contact Information

For questions regarding foreign research review and requirements, please contact

Ava Chambliss-Richardson, Ph.D., CIP, CIM

Associate Director of Human Research Protection Programs (HRPP)

Email: Chambliss_A@Mercer.edu

Phone: (478) 301-2327

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