Human Studies Regulations

Human Studies

Research involving humans at must be reviewed by UCSF's IRB (institutional review board), called the Committee on Human Research (CHR). Submissions are processed through iRIS (IMedRIS). Key Personnel must complete human subjects education training before CHR approval can be obtained and funds are released from UCSF. 

Allow time for local IRB or ethics committee approval at international study sites. The US Office for Human Research Protections keeps a database of international IRBs.  Find governing bodies for each country compiled here. Partner institutions also have guidelines. Working with established partners can facilitate the process. Contact Risk management early to initiate a quote for Clinical Research Insurance.

Materials for UCSF iMedRIS Submission

  1. Initial protocol application and associated documents (e.g., surveys, questionnaires, study information).  The application must list the international locations involved in the study, and the research plan must indicate that this is an international protocol.

  2. Informed consent document(s) in English. Documents translated into the local language must be submitted after UCSF IRB approval.  (Translated documents should state who performed the translation services)

  3. 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 UCSF IRB.

  4. All foreign investigators collaborating in the research must be listed on the IRB application. Investigators should review the CHR website for additional information.

Additional Guidance

HIPAA

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. UCSF has its own set of ethical compliance regulations regarding confidentiality and privacy that closely parallel the federal requirements. If this is new to you, you may need further guidance in setting up the study.

Data Security

Information stored on your laptop can be at great risk for theft or corruption. 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. Global Research can help to resolve the conflict. The CHR (IRB) also has information about data security.

Clinical Trials

The government requires that clinical trials be registered on ClinicalTrials.gov. See the UCSF Clinical Resource Research HUB for guidance about ClinicalTrials.gov registration and results reporting.

Field Ethics

Research ethics have a human and a scientific component, are complex, and you may need advice when you are in remote areas. Our CHR is a great source for input on ethical issues.

Last updated: March 12, 2018