Human Research Protections Program

Announcements

  • Cayuse Human Ethics is live! Use it to prepare or modify, submit, and route human subjects research studies, and to request reliances and determinations of whether activities are human subjects research. See our Cayuse Human Ethics page for more information. 

  • COVID-19 Research Ramp Up: IRB guidance for research ramp up and relevant forms can be found at COVID-19 Research Ramp Up.

  • Contacting ORCA: ORCA is working 100% remotely until further notice. We remain open from 8am - 5pm and all analysts are responding as usual.  Please note that the main phone will send you straight to voicemail. Voicemails are forwarded to the appropriate analyst.

 

Human Research Protections Program

Institutional Review Board (IRB)

Office of Research Compliance Administration (ORCA)

 



Human Research Protections Program

Mission: To safeguard the rights and welfare of human research participants and promote high quality, ethical research. 

UCSC adheres unequivocally to the principles of The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. UCSC has established policies to assure full compliance with all federal regulations, state laws, and University of California policies governing the participation of human subjects in research.

UCSC operates under Federalwide Assurance number, FWA00002797 on file with the U.S. Department of Health and Human Services (DHHS). The UCSC Institutional Review Board (IRB) is registered with DHHS under IORG number IORG0000158.   

For more information about the UCSC FWA please visit the OHRP website, insert the number 0000158 for the IORG number and click Search

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Institutional Review Board (IRB) 

The UCSC IRB is charged with the responsibility of reviewing human subjects research conducted at or sponsored by UCSC, and ensuring compliance with federal regulations, state laws, and UC/UCSC policies. The primary role of the IRB is to protect the safety rights and welfare of human subjects in research conducted by UCSC investigators. The IRB is composed of physicians, scientists, non-scientists, and community members with varying backgrounds to promote complete and adequate review of the research activities conducted at UCSC. Members are appointed by the Vice Chancellor for Research who is the UCSC Institutional Official (IO) responsible for the human research protections program.

Office of Research Compliance Administration

The Office of Research Compliance Administration (ORCA), which is a unit within the Office of Research Administration, is the administrative arm responsible for managing the University's human research protections program. ORCA, in partnership with the UCSC IRB and research community, is responsible for ensuring the safety and welfare of participants in human research studies conducted under the aegis of UCSC. 

All research activities at UCSC involving human subjects must receive IRB approval or be determined exempt from IRB review before any research activities involving human subjects may begin. UCSC investigators engaged in human subjects research activities are expected to conduct human subjects research in an ethical manner adhering to federal regulations, institutional policy, and as described in the IRB approved/exempt certified study.

ORCA ensures human subjects research is conducted ethically and consistent with federal and state regulations and with UC and UC Santa Cruz (UCSC) policies by:

  • Providing guidance and administrative support to the Institutional Review Board (IRB)
  • Facilitating reviews of human subjects research studies
  • Providing regulatory support to the UCSC research community by assisting investigators in navigating federal, state and University policies regarding human subjects research