Human Subjects -- Forms and Links
Human Subjects Research Forms on IRBManager
Please access the online system, IRBManager, to submit the appropriate form:
- For new projects, submit a Protocol Approval Form
- For extensions/renewals, submit a Continuing Review Form
- For changes to methodology, personnel, funding, etc., submit a Modification Request Form
- For reporting adverse events, unanticipated problems, or complaints, submit a Reportable Event Form
Instructions are available in "The Review Process" section of the Procedures and Guidelines. If you encounter accessibility issues, contact Trish Brock, (805) 756-1450, hs-irb@calpoly.edu, for assistance.
Optional Protocol Template
Protocol Template To assist you in submitting a protocol that addresses the areas that the IRB most frequently reviews, a template is available. The use of the template is optional.
Templates and Samples for Informed Consent, Parent Permission, and Child Assent
These templates and samples are provided to assist researchers in preparing informed consent forms, and related parent permission forms and child assent statements/forms. If you require any assistance in determining which form to use or in modifying a template to suit your research, please email or call Trish Brock, hs-irb@calpoly.edu, (805) 756-1450.
Note: These templates and samples have been developed in order to comply with new Federal regulations, effective January 21, 2019, which have altered the requirements for informed consent. Failure to use these templates after January 21, 2019, may result in delays in IRB review as forms that are missing information or lacking proper organization will be returned to the researcher for proper formatting and information. (Note that ongoing projects -- those approved prior to January 21, 2019 -- can continue to use the previously approved types of forms, even if modifications are made to them.) More information on the new Federal requirements for informed consent can be found on the OHRP website.
To prepare your project's consent form(s), use the appropriate template, either:
- Informed Consent Form (doc) -- use for most projects; see samples below for how to modify this template for applicability to projects with different levels of complexity and risk.
- Parental Permission Form (doc) -- use for projects in which subjects are under 18 years of age
- Child Assent Statement/Form (doc) -- use for projects in which subjects are under 18 years of age and capable of providing their assent. The assent language should be provided in writing for older adolescents (age 15-17), verbally for those age 7-14; and the assent of younger children should be obtained to the extent that it is possible in a developmentally appropriate way. Assent statements can have many variations because of the different developmental and comprehension levels of the child subjects, and this template should be used as a general guideline.
Review these sample forms for examples of different variations that can be created from the templates:
- Sample Informed Consent Form for Minimal Involvement/Risk Project (doc) -- This brief form is typical for research in which there is no to minimal risk anticipated and there is no intervention, e.g., data is collected via an anonymous/online survey.
- Sample Informed Consent Form for Minimal Intervention/Risk Project (doc) -- This moderate form is typical for research in which there is no more than minimal risk anticipated, but includes, for example, a relatively benign intervention or risk to confidentiality.
- Sample Informed Consent Form for Increased Intervention/Risk Project (doc) -- This complex form is typical for research in which there is minimal to more-than-minimal risk and/or includes, for example, a more invasive intervention or increased risk (probability or magnitude) of physical harm, emotional distress, loss of confidentiality, etc.
- Sample Parental Permission/Child Assent (doc) -- This form and statement are for projects when there are subjects under the age of 18. Child assent statements can have many variations because of the different developmental and comprehension levels of the child subjects. The sample statement provided might need significant revisions to be appropriate for different age subjects.
Cal Poly IRB Documents
Human Subjects Research Decision Chart (pdf) -- does your project require review by the Cal Poly IRB?
Human Subjects Research Process Chart -- summarizes the process for review
Changes to Cal Poly Policy and Procedures for Human Subjects Research
The Cal Poly Institutional Review Board (IRB) has revised the Cal Poly Policy for the Use of Human Subjects in Research (effective July 2017) and has published an extensive document on Procedures and Guidelines for Human Subjects Research (effective October 2017). Please refer to these documents in preparing your submission and related documents, such as protocols and consent forms.
New Regulations. Effective January 21, 2019, the U.S. Office for Human Research Protections will be implementing revisions to 45 CFR 46, the Code for the Protection of Human Subjects, as known as the Common Rule. Starting on January 21, 2019, the Cal Poly IRB will comply with the new regulations, whether or not these procedures and guidelines explicitly state the procedure for compliance. These procedures and guidelines are being reviewed for compliance and will be updated as needed, but publication of changes may be delayed while processes and documents are updated.
