The downloadable forms below are in Word document or pdf formats. If you are unable to access, print, or use these forms, please contact the IRB for alternatives. Please proofread and edit all documents carefully before submitting them. Spelling, typographical, and grammatical errors are unprofessional, distracting, and can convey unintended meanings.
For all questions about IRB forms, procedures, or related issues, you are welcome and encouraged to contact the IRB before submitting your application. Students in the Joint PhD Program in Education between CGU and SDSU must include the JPPE Cover sheet with their application.
Signature submissions and approvals may be provided by scan of hand-signed pages, by e-signature, or via electronic affirmations from official CGU email addresses.
If instead of a scanned signature page, an applicant Principal Investigator (PI) or coPI transmits an electronic affirmation via email, the message from the PI or coPI must attach or clearly identify the application and state the following:
(1)All procedures performed during this project will be conducted by individuals legally and responsibly entitled to do so, and any significant systematic deviation from the submitted protocol (for example, a change in principal investigator, sponsorship, research purposes, participant recruitment procedures, research methodology, risks and benefits, or consent procedures) will be submitted to the IRB for approval prior to its implementation.
(2)I/we will comply with all federal, state, and institutional policies and procedures to protect human subjects in research;
(3)I/we understand the ethical responsibilities of research investigators and have received the required training in human research participant protection as specified at www.cgu.edu/irb;
(4)I/we will assure that the consent process and research procedures as described herein are followed with every participant in the research; and
(5)I/we will promptly report any deviations or adverse events to the IRB.
Applications from student Principal Investigators are required to include an endorsement from their faculty advisor. If instead of a scanned or ink signature, the advisor transmits an endorsement via email, the message from the faculty advisor must either attach the application or clearly identify the application by author and title, and state the following:
As faculty advisor, I have reviewed and approved this complete application and its attachments and I accept responsibility to supervise the work described herein in accordance with applicable institutional policies.
IRB Application, Amendment, Renewal, and Closure Forms
Most form are available as fillable Word templates or flat pdf files. Each form includes embedded instructions. The main application form may be downloaded from the link below; the abbreviated form maybe used only for MTURK studies:
Exempt projects do not need to seek further IRB review at a standard interval; follow the instructions provided in the determination-of-exemption letter. Approvals of expedited and board-discussed protocols remain in effect for the period specified in the letter of approval, generally for one year. If data collection from human subjects has been completed and if personally identifying information that has been collected (if any) is no longer in active use, then CLOSURE rather than RENEWAL of the IRB review may be sought; see more detailed instructions on the CLOSURE form.
IRB Consent and Assent Forms--Instructions and Samples
Every research project has one or more unique features and requires a suitably customized informed consent form. The documents below are meant to assist applicants in developing an appropriate consent form. The Form with Embedded Instructions covers most of the typical variations in project characteristics. The sample forms are for two different types of fictional studies and are meant to illustrate how the forms would appear for such studies. We recommend that adult informed consent forms for general populations be written at an 8th grade level to the extent possible, so that all prospective participants can understand the elements of the research well enough to give truly informed consent to participate. For specially selected research populations who may be educationally disadvantaged or cognitively impaired--or uniformly well educated--different assumptions about the right level of complexity may be appropriate. Assent forms for minors (under 18 years of age) should be written in language that is developmentally appropriate to the age of the children. High school students should be able to understand the adult version.