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Application Form

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Consent Form

Policy

Steps for Obtaining IRB Approval

Complete the IRB Application

  1. Complete and sign the IRB 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 guides, etc.)
  5. Attach letters of support from outside agencies (if necessary)
  6. Sign and submit a PDF of the entire application to IRBAdmin@csustan.edu

Obtain Approval for the Research

Upon submission your protocol will be reviewed for completeness and then forwarded to an IRB member for review.  One of the following reviews will be conducted: 

Full Board:  The research requires a full board review before approval can be given
Expedited:   The research is approved and is authroized to proceed for one year
Exempt:       The research is exempt from further review and is authorized to proceed
Beyond the Purview:  The research does not require IRB review

Following the review the IRB will either issue an approval letter or will ask for modifications to the protocol prior to the determination of final approval.

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 start your data collection.

Required Elements of an IRB Protocol

Application Certification and Signature

  • Principal Investigator Signature
  • Faculty Sponsor’s Signature (if required)

Application Document:

  • Hypothesis Statement and Purpose of Research (Statement of study hypothesis, background information)
  • Methods (detail procedures and materials to be used; clearly explain research procedures; define study endpoints)
  • Informed Consent Procedure (clearly outline consent process, where and how consent will be obtained, describe process to allow for questions; if study involves minors describe parental consent and participant assent procedures)
  • Selection and Recruitment of Participants (list inclusion/exclusion criteria; describe recruitment methods and materials to be used; give rationale for number of participants to be used)
    • Describe the targeted participants (do they fit with the research being conducted)
    • Do they include protected populations? (prisoners, children, pregnant women, cognitively impaired)
    • How will they be recruited? (describe methods, setting, recruitment materials to be used)
    • Confidentiality/anonymity of data (describe privacy protection measures; data in locked files/password protected files, who will have access)
    • What kind of data will be collected? (what identifying information will be collected, will participants be audio or videotaped)
    • How will the confidentiality/privacy of the data be protected? (secure servers/computers, encrypted files, de-identified, how long will data be kept)
    • Description of risks to participant and how risks will be minimized (describe all risks to the participants; describe how risks are reasonable in relation to potential benefits)
    • Description of benefits to participant (describe all benefits the participant will receive)

Informed Consent (Ensure process is appropriate for the population; process minimizes opportunity for coercion or undue influence; process allows sufficient time.)

  • Language of consent is appropriate/understandable            Yes ___ No ___
  • Statement that this is research                                             Yes ___ No ___
  • Explanation of purpose of the research                                Yes ___ No ___
  • Expected duration of the participant’s participation               Yes ___ No ___
  • Description of procedures involved                                       Yes ___ No ___
  • Description of risks/discomforts                                           Yes ___ No ___
  • Description of benefits to participant or others                     Yes ___ No ___
  • Description of alternatives to participation                            Yes ___ No ___
  • Statement regarding confidentiality of records                     Yes ___ No ___
  • Provide contact information for investigators                       Yes ___ No ___
  • Provide contact information for UIRB                                   Yes ___ No ___
  • Invite participants to ask questions                                       Yes ___ No ___
  • Describe any costs to participants                                       Yes ___ No ___
  • Describe any payments to participants                                Yes ___ No ___
  • Provide a place for the participant’s signature
    and the date (if online survey include a statement that clicking
    on “agree” indicates that the participant has read and understood
    the information and chooses to participate)
                             Yes ___ No ___
  • Statement that participation is voluntary                               Yes ___ No ___
  • Statement that the participant does not give up
    any legal rights by signing form                                            Yes ___ No ___

Attach all Materials:

  • Informed Consent Document
  • Recruitment information (flyers, advertisements, emails of solicitation, Facebook event page descriptions, etc.)
  • Letters of support from outside agencies (where study/recruitment of participants will be conducted)