The US Department of Health & Human Services has developed a series of decision charts to assist Principal Investigators in determining the applicability of Human Subjects regulations to their research. Investigators intending to conduct research involving human subjects should carefully review Sonoma State University’s campus policy on Human Subjects in Research. Researchers are required to submit a protocol describing their proposed research or activity involving human subjects. Student non-collaborative research protocols must first be submitted to the faculty sponsor and to the department review committee, if one exists, for review and approval. It is the responsibility of the individual investigator to ensure that appropriate ethical principles are adhered to in the conduct of research involving human subjects.
Application materials can be downloaded from ORSP's forms page. For questions on the review process, please contact email@example.com or (707) 664-2066.
Download SSU's brochure Working with Human Subjects in Research.
SSU Policy Highlights
There is human subject involvement when human beings are asked to participate:
- Physically in an activity or to donate their tissue, organs, fluids, and other bodily material.
- When information is sought from them directly (as through interview, questionnaire) or indirectly (as through observation).
- When information concerning specific, individually identifiable human beings is asked for from third parties—whether through access to files, data banks, or other means—or through direct inquiry of third parties concerning the individuals in question.
- Research proposals for which the question of human subject involvement is itself uncertain or ambiguous must be submitted for review.
The Provost has appointed the Institutional Review Board for the Rights of Human Subjects, which works under the sponsorship of ORSP to ensure the protection of the rights of human subjects and serves as the University’s Institutional Review Board (IRB) for purposes of local, state, and federal requirements. The Associate Vice President of ORSP serves as the University’s Institutional Signatory Official for purposes of federal regulation.
Sonoma State University and federal IRB regulations require principal investigators to retain IRB relevant records for at least three years after completion of the research. Other regulations may require principal investigators to retain original data for a shorter or longer period of time.
Federal Policy Guidance
Current IRB Membership
- Heather Smith, Psychology, IRB Chair
- Bulent Sokmen, Kinesiology
- Jennifer Mahdavi, Educational Leadership and Special Education
- Gene Nelson, Community Member
- Debora Paterniti, Sociology
- Carol Rathmann, Community Member
- Adele Santana, Business Administration
- Steve Karp, Office of Research & Sponsored Programs
- Mary Ellen Wilkosz, Nursing
- Emily Vieira Asencio, Criminology & Criminal Justice Studies
- Megan McIntyre, English