Human Studies
Research involving humans must be reviewed by your campus IRB (institutional review board). Key Personnel must complete human subjects education training before CHR approval can be obtained and funds are released. The IRB review process is detailed and takes time, plan accordingly. We highly encourage researchers to register their project in the UCOP system wide registry, to promote collaborative work among our global researchers.
Allow time for local IRB or ethics committee approval at international study sites. The NIH maintains a compendium of compliance information. Partner institutions also have guidelines, these requirements can be in direct conflict with your own IRB, and it may take time to determine the best course of action.
Contact Risk management early to initiate a quote for Clinical Research Insurance.
Materials to gather for submission
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Initial protocol application and associated documents (e.g., surveys, questionnaires, study information). The application must list al the international locations involved in the study, and the research plan must indicate that this is an international protocol.
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Informed consent document(s) in English. Documents translated into the local language will be submitted after IRB approval. (Translated documents should state who performed the translation services)
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Evidence of local approval by an IRB, Ethics Board, or Independent Ethics Committee (IEC) familiar with the local research context and local law, or a letter stating that such review is not possible and explaining why. If no local ethics approval is in place, at a minimum, there must be endorsement of the project by the local authority/institution involved in the research. No research can begin until local approval has been obtained and submitted to the UC IRB.
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All foreign investigators collaborating in the research must be listed on the IRB application. Include any aliases or alternate spellings, and some affiliation information.
Additional Guidance
The Health Insurance Portability and Accountability Act (HIPAA) is a Federal policy designed to protect patients from inappropriate disclosures of their "protected health information" (PHI). It does not directly apply to international work, but it is good practice to complete HIPAA training. The issues addressed are often magnified in international settings. If this is new to you, you may need further guidance in setting up the study.
1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations.
Information stored on your laptop can be at great risk for theft or corruption, or confiscation by authorities. Encryption software is contraband when crossing some borders. If you are encrypting patient information, be sure your software will not alarm border patrol. This may be in direct contrast to your human studies requirements.
The US government requires that clinical trials be registered on ClinicalTrials.gov.
Research ethics have a human and a scientific component, are complex, and you may need advice when you are in remote areas. Work with your CHR, and develop a resource for accessing that ethical perspective when you are abroad.