Human Subjects Research (UIRB)

Impact of COVID-19 on UIRB approved research

Due to social distancing restrictions instituted by the CSU Chancellor’s office, the UIRB will permit currently approved research to change study procedures that implement social distancing without submitting a protocol modification specific to digital versus in-person participant contact. This approval will be in effect for the duration of social distancing measures. Investigators may offer study information sheets electronically, or change a study procedure from in-person interviews/surveys to an online or phone-based method. Investigators do not need prior approval from the UIRB to institute these changes. Investigators must document this change and inform the UIRB at the time of the next modification or renewal. Please note that if the modification results in a significant change to the context of the study, a formal modification request must be submitted to IRBadmin@csustan.edu.

Informed Consent form(s) must be updated to accurately reflect the online study procedures. Investigators must address any video/audio recording, data collection and storage procedures, and confidentiality. For more information, please visit OHRP.

Investigators may use Zoom software to conduct interviews with participants, but should be mindful to store any recordings to their personal computer, not the online cloud storage system, in order to maintain participant/data confidentiality.

Telephone Consent may be used if written consent is required. The consent process can occur over the phone, and should include an audio recording of consent. All expectations of informed consent remain in effect, and participants must be given a copy of the informed consent form via mail, email, or fax.

Secure Tools:

SurveyMonkey – secure consent usage
Microsoft OneDrive – data storage
Zoom – pop up consent box.

 

Best Practices for Working Remotely with Human Subjects Data

Documents

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.

*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 Training - Classroom Visits

Faculty members planning to have student in their classroom submit individual IRB applications for review are welcome to request an IRB presentation for their class. 

An IRB administrator will present helpful information about the IRB, including human research ethics, IRB regulations, and how to prepare an IRB application. 

The IRB office will work with you to schedule a presentation for your classroom; if you are interested in scheduling a presentation, please submit your request a few weeks in advance, to ensure availability.

Request an IRB presentation 

IRB Workshop Slides - Fall 2019

IRB Handout

2019 IRB Common Rule Update Notice

The Stanislaus State documents have been revised following updated federal regulations, and are effective January 21, 2019.  A copy of the new updated Common Rule can be found here.

Brief Summary of Changes

  • Definitions have been revised and updated
  • Exemption categories have been broadened
  • Expedited research no longer requires continuing review (unless required by the IRB)
  • Federal definition of vulnerable populations has changed
  • Informed Consent requirements have changed

Beginning January 21, 2019, investigators must use updated forms to submit for IRB review; these include the IRB application form, informed consent templates, and continuation/renewal form.

 

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.

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.