Human Subjects Research (UIRB)

 

Mission Statement

The goal of the University Institutional Review Board (UIRB) and all University-sanctioned IRBs at Stanislaus State are 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.

*The UIRB does not review human subjects research protocols from psychology students; these protocols should be submitted to the Psychology Institutional Review Board for review and approval.

Impact of COVID-19 on Human Subjects Research

In-Person Human Subjects Research: If a study cannot be conducted in a virtual format, investigators may apply to the IRB to conduct an in-person study. In addition to securing IRB approval, the investigator would also be required to secure university approval for in-person research. This approval is secured by applying for an RSCA Resumption Request on InfoReady.

Best Practices for Working Remotely with Human Subjects Data

Documents

Coming Soon 

All investigators, including student investigators and co-investigators will soon be required to have completed the CITI training course for human subjects research at the time of submission to the IRB. Once completed, the training is good for three (3) years. 

The new training requirement will be enforced starting in Fall 2022. Instructions on how to register for the HSR module may be found here

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 of 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.

Some human subjects research studies may require additional review and approval by the University. It is the responsibility of the Principal Investigator (PI) to determine whether additional approvals are required with Safety & Risk Management. Some examples of research that may require approval from Safety & Risk include: medical procedures with sharps, medical procedures where public vital signs are documented, physical activities, and food preparation for public consumption. If your human subjects research will involve these activities or others that would rise to the level of requiring Safety & Risk review, please contact Safety & Risk Management to obtain approval prior to applying for IRB approval.

Safety & Risk

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. 

International Research

Investigators planning to conduct international research should begin the IRB review process early to avoid delays. Investigators may reach out to the IRB Coordinator while developing the IRB application for any specific guidance or questions related to their project.

For studies that are determined to be exempt by the IRB, federal regulations do not require review by another IRB at the foreign site where the research will be conducted.

Studies that are designated expedited or that require a full board approval may require local IRB approval. Investigators should address the IRB requirements of the foreign country in the IRB application, and clearly state whether local IRB approval is not needed (based on the regulations of the country), or how the investigator plans to obtain local IRB approval. The Stan State IRB does not require that local IRB approval be obtained prior to the investigator receiving approval from Stan State.

The Office of Human Research Protections (OHRP) has published a list of over 100 countries and related international human research standards. Investigators should consult this list during the planning phase.