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FOR RESEARCHERS

Human Studies Regulations

UCSF is attempting to unify compliance issues.

Human studies

The New Investigator Quick Guide is a good resource that contains practical information about doing research at UCSF, including obtaining regulatory committee approvals and finding and managing research funds.

Research involving humans at UCSF must be reviewed by UCSF's IRB (institutional review board), which is called the CHR (Committee on Human Research). Their protocol submission process must be completed before funds are released from UCSF. The review process is detailed and takes time, so plan accordingly. The CHR has provided some suggestions for speeding up your study approval.

Individuals who have a major role in the study (Key Personnel) must complete the required human subjects education training. The CHR will withhold approval until training is done.The CHR maintains a list of individuals who have completed this training.

Allow time for local IRB or ethics committee approval at international study sites. The Office for Human Research Protections keeps a database of international IRBs. Keep in mind the laws, regulations, and guidelines that govern human subjects in other countries. Partnered institutions also have guidelines. G-RES recognizes the difficulty in coordinating these multilevel regulatory committees, and we are available to help you negotiate these arrangements.

Email the International Database team
contact list

You also should familiarize yourself with the ethical guidelines established by the Council for International Organizations of Medical Sciences.

HIPAA

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 undergo 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. G-RES (contact list) can help to resolve the conflict. The CHR also has information about data security.

Clinical Trials

The government requires that clinical trials be registered on ClinicalTrials.gov. The UCSF Office of Research has guidance about what constitutes a clinical trial and needs to be registered.

Field Ethics

The ethical issues that can arise are impossible to foretell. Here is the experience of one researcher from UCSF. The important point here is that the ethics have a human and a scientific component. Our IRB is also a great source for input on ethical issues.