Selected Policies / Guidelines
Research Involving Human Subjects  


Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to general knowledge.  Human subjects are defined as living individual(s), about whom an investigator (whether professional or student) conducting research, obtains (1) data through intervention or interaction with the individual, or (2) identifies private information.

Policy

In accordance with the Federal Policy on the Protection of Human Subjects (DHHS Policy 45 CFR Part 46, FDA Policy 21 CFR Parts 50 and 56), UCSC is responsible for the protection of the rights and welfare of human subjects in research conducted by, or under the supervision of faculty, staff, or students.  To effectively assume this responsibility, the University maintains an Institutional Review Board (IRB) to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.

UCSC, as part of its Multiple Project Assurance (the license from the NIH to function as an IRB), has agreed to protect the welfare of all human subjects involved in research, whether or not the research is conducted or supported by a federal department or agency.  Therefore, the UCSC IRB has jurisdiction over all human subject research conducted at this institution and does not recognize any exemptions.

Responsibilities
Institutional Review Board

The IRB is responsible for:

A.	determining and certifying that all projects reviewed by the IRB conform to the regulations and policies set forth by DHHS and FDS regarding the health, welfare, safety, rights, and privileges of human subjects
B.	assisting investigators in complying with federal and state regulations

Responsibilities
UCSC Institutional Review Board

The UCSC IRB is responsible for reviewing all human subject research if any of the following situations apply:

A.	human subject research uses UCSC facilities
B.	human subject research is paid for by the campus or with funds administered by the campus
C.	human subject research is conducted as part of a researcher's progress toward a campus degree
D.	human subject research is conducted by a campus faculty member or employee in the course of employment by the UCSC campus
E.	human subject research uses UCSC students as subjects

RESOURCES

REFERENCES