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The purpose of this document is to provide guidance to researchers who wish to conduct or participate in international research. The JHM IRBs recognize the importance of international research projects, but wish to alert investigators to the additional review requirements for such activities. All policies and procedures that are applied to research conducted domestically should be applied to research conducted in other countries, as appropriate.
Local review requirements:
a) International research applications submitted for JHM IRB review should identify whether there is a local IRB, Ethics Committee (EC), or government entity that will perform review in the host country. If local review has been conducted, a copy of the approval letter/notice should be included in the application. If local review has not been initiated or is still in process, this should be made clear in the application. Oversight by the local IRB should include the following activities: i) Initial review, continuing review, and review of modifications. ii) Post-approval monitoring. iii) Handling of complaints, non-compliance and unanticipated problems involving risk to subjects or others. If the local IRB will not perform the required review functions, the JHM IRBs must fulfill the functions.
b) There are countries in which a local review board or government review mechanism is not available. In such cases, the JHM IRB must obtain a consult from an individual who is familiar with the cultural background, local context and community attitudes of the country in which the research will be conducted. This individual may not be associated with conduct of the proposed research.
Please Note: The JHM IRB will not take action to approve an application without either written documentation that local review and approval has been granted in the host country, or the consult requested by the IRB has been received and accepted. (The JHM Organization Policy on Consultants )
Written consent is presumed required for international research. Requests for waiver of written consent, or for use of an oral consent process, will be permitted if the protocol has received local approval. If a consultant is required, the consultant will be asked to comment on the consent process. The JHM IRB reserves the right to make the final decision whether to allow a consent process other than written. The JHM IRB requires consent forms (or oral consent scripts) to be written at a level that will be understandable to the subject population. Submission of copies of consent documents in the local language(s) is required. A sample informed consent template should be used to submit the English version of the consent document for JHM IRB review. In addition, the investigator must submit a Certificate of Translation Form.
Inclusion of the following information will assist the JHM IRB in the review process:
- Proposed payments to participants: The remuneration should be described in terms of both US and local currency. Include a description of payment in relative terms (i.e. payment equates to a day’s work, hourly salary, or another local reference).
- Local contact information: Include a local phone contact number for co-investigators or the local IRB/EC who could answer research related questions. If the project is a clinical trial, include local emergency contact phone numbers for participants.
- Treatment options: For clinical trials, explain if any treatment(s) will be available to participants after study completion. If a placebo arm is included in the trial, explain whether participants will be able to receive the study drug/intervention after study completion.
- Recruitment materials to be used locally in both the language of the host country and in English.
The extent to which HIPAA applies to international research is currently a matter of debate; however, once identifiable health information is received by a covered entity, that information becomes PHI (with a narrow exception for overseas foreign nationals receiving health care from US agencies). This means that when a researcher sends identified health information collected internationally across a JHM network or stores such information on a JHM computer or server, the information becomes PHI.
Because HIPAA concepts can be difficult to translate in international studies, researchers have several options. The first is to ask the IRB to approve a simpler form of the required authorization language either within the body of the written consent itself or separately as the standalone form [HIPAA Statement for International Research” form] and/or request approval to obtain Authorization in oral form. . Another option, where cultural barriers are significant, is to request permission to exclude HIPAA language from the consent form and process. This may be most appropriate where no data will be transferred to the U.S. and subject to HIPAA protection.