POLICY ON INSTITUTIONAL REVIEW BOARD (IRB) AND INSTITUTIONAL ANIMAL CARE AND USE (IACUC)
APPROVAL FOR RESEARCH

All research activity associated with the UCSF School of Medicine Office of Student Research or the Office of International Programs must comply with academic and governmental standards regarding the ethical principles and guidelines for the conduct of research involving human or non-human subjects. (A definition of what constitutes “research” is included at the end of this page.) To this end, students receiving financial support or any other form of sponsorship by our Office must ensure that their work has been fully approved by a qualified Institutional Review Board (IRB) in the case of studies involving humans, or an Institutional Animal Care and Use Committee (IACUC), as specified below. The IRB at UCSF is called the Committee on Human Research (CHR). Failure to meet these requirements will lead to a suspension of all sponsorship and possible further actions that could ultimately affect the academic or professional standing of the student or faculty sponsor.

For all research sponsored by a UCSF Principal Investigator (either based at UCSF or one of its affiliated institutions):

• Approval must be obtained from the UCSF CHR or UCSF IACUC.
• Students may list their affiliation with UCSF in publications, poster presentations, and any other form of communication regarding their work.

For all research sponsored by non-UCSF Investigators or sponsored by other institutions within the United States:

• Approval must be obtained from an accredited IRB or IACUC of a sponsoring institution which operates under accepted Federal regulations, State laws, and institutional policy.
• Students may list their affiliation with UCSF along with their affiliation with their sponsoring institution in publications, poster presentations, and any other form of communication regarding their work.

For all research sponsored by non-UCSF Investigators or sponsored by other institutions outside the United States:

• Approval must be obtained by an accredited IRB or IACUC of a sponsoring institution which operates under accepted regulations and laws established by the country or region. In addition, IRB approval must also be obtained from a US institution which operates under accepted Federal regulations.
• Students may list their affiliation with UCSF along with their affiliation with the US- approving and sponsoring institutions in publications, poster presentations, and any other form of communication regarding their work.
• Approval from the UCSF or another accredited IRB must be obtained before any data or human biological specimens are obtained.
• If an international project develops data for analysis (i.e., interviews, biological specimens, or evaluation of existing data bases) and later publication in any public journals or sites, documentation of UCSF or other IRB approval must be provided.

DEFINITIONS INVOLVING HUMAN RESEARCH

For the purposes of programs and activities that are supported by the Office of Student Research and the Office of International Programs, “research” is defined by the following
(originally developed by the federal government to manage federally-funded research):

A systematic investigation that includes testing and evaluation and is designed to develop or contribute to generalizable knowledge.

The UCSF Office of Research provides the following additional guidelines:

1. The intent to publish usually indicates that a project is research.
2. Examples of projects on the edge of the definition of research include:
   1. A retrospective report of a single case typically is not considered research, but a report of five cases involves more systematic organization of knowledge and is considered research.
   2. A “pilot study of a proposed intervention or survey instrument is part of research development and is considered research under the Federal definition.
3. Does this project involve human subjects?
   1. Federal regulations define a human subject as a living individual about whom a researcher obtains:
      1. data through an intervention or interaction with the individual or
      2. identifiable private information
   2. Analyzing previously gathered tissue involves human subjects because almost all tissues are associated with potentially identifiable private information, either through linked information, codes, or DNA analysis.
   3. Educational interventions (e.g. randomly providing pamphlets to increase compliance with medication regiments and testing for effectiveness of the program) involve human subjects because there is an intervention with a living individual.
   4. Blood draws and finger sticks for research purposes involve human subjects because there is an interaction with a living individual.

For more information, please refer to the UCSF Office of Research website at: http://www.research.ucsf.edu/