International Research

Introduction

All human subjects research conducted in foreign countries, in which American investigators are involved, and which would be subject to the federal regulations if it were conducted wholly within the United States, must comply with the federal regulations for the protection of human subjects in all material respects. Research may be approved, therefore, if "the procedures prescribed by the [foreign] institution afford protections that are at least equivalent to those provided in this policy (45CFR46)." International standards, such as the Declaration of Helsinki or the Nuremberg Code, are a starting place, but are not alone sufficient, and thus written descriptions of the specific procedural implementation of such policies should be provided.

Cultural Differences

Research conducted in foreign countries may raise special issues related to cultural differences (i.e., reluctance to sign Informed Consent documents, politically repressive/coercive environments, proper social interactions when communicating with subjects, gender issues) which should be considered and addressed in the protocol submission package.

The requirements for documenting informed consent vary among cultures. The IRB does not exempt projects conducted in foreign countries from the consent requirement, but it can waive the requirement for written documentation of consent. In some settings, the process of signing the form is very intimidating and is thought to be riskier than the research itself. Researchers planning to conduct research in another country should justify their proposed method of documenting consent. The justification should include a description of local customs if they constrain the typical informed consent process. Subjects in foreign sites should be given local contacts for any questions they may have about the research or about their rights.

2007 International Compilation of Human Research Protections

The 2007 International Compilation of Human Research Protections, provided by the Office of Human Research Protections, is available:

http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

The compilation lists the human subjects research legislation, regulations, or guidelines for 79 countries, two confederations, and several international organizations.

Its purpose is to assist IRBs, researchers, funding agencies, and others who are involved in international research familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure that those standards are followed appropriately.