Human Subjects Research (UIRB)

Mission Statement

The goal of the University Institutional Review Board (UIRB) and all University-sanctioned IRBs at Stanislaus State is to promote the ethical conduct of student, staff, and faculty research involving human subjects through safeguarding their rights and welfare.

What is the UIRB?

The UIRB is a committee responsible for reviewing human subjects research protocols submitted by Stan State students, staff, and faculty. The UIRB is composed of Stan State faculty members from a variety of academic disciplines, as well as a community member. The committee reviews research protocols to ensure that the rights of human subjects are protected, and that the level of risk to subjects is managed.

Documents

Does my research require UIRB review?

If you plan of pursuing research with human subjects either through direct interaction (interviews, surveys, observation, etc.) or through the use of private records about individuals, a protocol must be submitted to and approved by the UIRB prior to the start of research. UIRB approval is also needed for human subjects research that is conducted to develop student research projects, honors theses, and graduate theses/dissertations.

If you will be conducting research with publicly available information (databases, archives, public use data files, etc.), you do not need UIRB approval. However, if these records have identifiable information regarding individuals, or if the individuals had a reasonable expectation to privacy (or an expectation that their information would not be made public) UIRB approval would be required. Classroom activities involving data collection for the purpose of program evaluation/assessment, quality improvement, or quality assessment usually do not require UIRB approval. Please feel free to contact the IRB Administrator with questions.

Please consult the IRB decision tree to help determine if your project meets the federal definitions of “research” and “human subjects” to find out if UIRB approval is required. For a complete description of research that requires UIRB approval, please consult the UIRB policy.

Getting Started

  1. Once you have determined that your project is human subjects research, it is recommended that you complete the CITI training modules related to the responsible conduct of human subjects research. This is not a requirement, but it is strongly recommended.
  2. Complete the IRB application form.
    1. Complete and sign the application form
    2. Complete the protocol summary template
    3. Attach all informed consent documents
    4. Attach copies of any instruments to be used (survey, interview questions, recruitment materials, etc.)
    5. Attach letters of support/permission from outside agencies (if necessary)
    6. Sign and submit a PDF of the entire application to IRBadmin@csustan.edu
  3. After your IRB application has been received by the UIRB Administrator, your protocol will be reviewed for completeness and then forwarded to an IRB member for review.
    1. Please see UIRB Review for more information.

Modifications and Renewals

Modifications: to report significant changes to your research methods, design, personnel, type or number of subjects, consent process, recruitment of participants, or location, please submit a revised protocol (highlighting the revisions) to IRBadmin@csustan.edu.

Renewals: to conduct research beyond the one year approval period, you must submit an IRB renewal form. If there have been no changes to your protocol, you need only submit the first page of the renewal form. However, if there have been modifications to your protocol, you must submit a revised protocol for review prior to the expiration date.