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.
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.
- IRB Application Form.docx
- Informed Consent - Standard - Template.doc
- Informed Consent - Online - Template.doc
- Informed Consent - Parental - Template.doc
- Informed Consent - Example.doc
- Minor Assent Templates.docx
- IRB Renewal Form.docx
- IRB Study Status Form.docx
- UIRB Policy.pdf
- UIRB Procedures.pdf
- Best Practices for Working Remotely with Human Subjects Data.pdf
Mandatory CITI Training
All investigators, including student investigators and co-investigators, are 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.
- 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.
- Complete the IRB application form.
- Complete and sign the application form
- Complete the protocol summary template
- Attach all informed consent documents
- Attach copies of any instruments to be used (survey, interview questions, recruitment materials, etc.)
- Attach letters of support/permission from outside agencies (if necessary)
- Sign and submit a PDF of the entire application to IRBadmin@csustan.edu
- 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.
- 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 (docx). 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.
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 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 International Compilation of Human Research Standards list (pdf) during the planning phase.
UIRB Review FAQs
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.
- After you have submitted your completed IRB application form to the UIRB Administrator, your protocol will be forwarded to an IRB member for review.
- The IRB reviewer will conduct one of the following reviews, depending on your individual protocol:
- Exempt: The research is exempt from further review and is authorized to proceed.
- Expedited: The research is approved and is authorized to proceed for one year.
- Full Board: The research requires a full board review before approval can be given.
NOTE: If your research involves vulnerable populations, including prisoners, individuals with impaired decision-making capacity, or minors, your protocol will be subject to a full board review.
- An approval letter will be sent to you detailing the category of review and approval. This letter will include the IRB assigned protocol number. Once you are in possession of this letter you may begin your data collection.
The review process may take up to 30 days, and if you will be conducting research with vulnerable populations (listed above), the review process may take even longer.
UIRB members are full-time faculty members, and you should not expect your protocol to be reviewed and approved in a shorter time period. Always plan to submit your protocol a full month in advance of when you would like to start conducting research.
If a project involves more than minimal risk to human subjects, the protocol requires full board review. In preparation for the full board review, the IRB member that initially reviewed the protocol will work with the researcher to suggest any revisions necessary to protect the human subjects.
The researcher (and faculty sponsor if the researcher is a student) will be invited to attend the next full board meeting. At this meeting, all UIRB members will review the protocol to assure that the design and safeguards of the research meet the requirements. The IRB will then rule on the protocol to determine if further revisions or approval is appropriate.
The UIRB holds regular meetings throughout the academic year to review protocols as necessary. There are no full board reviews during the summer and winter terms.
In the event that the regularly scheduled IRB meetings are not adequate to provide a timely review of the protocols received, the IRB Administrator will make every effort to schedule additional meetings as needed.
Spring 2022 Full Board Schedule - virtual
|February 10, 2022||9 - 10:30 a.m.|
|March 10, 2022||9 - 10:30 a.m.|
|April 14, 2022||9 - 10:30 a.m.|
|May 12, 2022||9 - 10:30 a.m.|
Research Participant Rights
The role of the research participant will vary in each study, but some examples of common participant activities are to:
- Take part in interviews (individual or group)
- Complete questionnaires or surveys
- Allow researchers to observe behavior
- Complete physical or psychological exams
- Give samples of blood, saliva, or other materials.
If you have been asked to participate in research, you may decide whether or not you want to participate. You have the right to make this decision without any pressure, and there will not be any consequences if you refuse.
You have the right to receive information about the study, in order to make an informed decision regarding participation. This information will be provided to you in writing, and is usually marked as an “informed consent form.” The information must be in a language that you can understand. You have the right to ask questions at any time and to have your questions answered.
You may stop participating in the research study at any time, for any reason. You do not have to justify your decision to leave the study.
You can also contact the Stan State IRB office with questions about your rights related to research.
Si tiene alguna pregunta referente a sus derechos como participante in la investigación, favor dirigirse a los recursos enumerados aquí.
Minors can participate in research studies, but there are some additional protections for children that must be observed by researchers. For example, the parent(s) or legal guardian(s) must provide permission for the child to participate. If the child is old enough to understand the study, the child may also be asked to give agreement or assent to participate in the research.
If you would like to report a violation of your rights as a research participant, please contact the IRB administrator.
|Steven Drouin, Ed.D., Chair||Advanced Studiesfirstname.lastname@example.org|
|Arya Alami, Ph.D., Vice-Chair||Kinesiologyemail@example.com|
|Kilolo Brodie, Ph.D.||Social Work||667-3796||Kbrodie1@csustan.edu|
|William Foreman, Ph.D.||Englishfirstname.lastname@example.org|
|John Garcia, Ph.D.||Social Workemail@example.com|
|Jarrett Kotrozo, Ph.D.||Business Administrationfirstname.lastname@example.org|
|Paul Morgan, Ph.D.||Sociology||667-3404||Pmorgan1@csustan.edu|
|Susan Neufeld, Ed.D.||Advanced Studiesemail@example.com|
|Sherry Roper, Ph.D.||Nursingfirstname.lastname@example.org|
|Steven Wood, Ph.D.||Criminal Justiceemail@example.com|
|Melinda Vargo||Community Member|
Updated: May 17, 2022