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
There is an IRBManager Quick-start guide. More complete instructions on using IRBManager are available in "The Review Process" section of the Procedures and Guidelines. If you encounter accessibility issues, contact email@example.com for assistance.
Optional Protocol Template
We have created an optional Protocol Template to assist you in submitting a protocol that addresses the areas that the IRB most frequently reviews. The use of the template is optional.
Media Release Form
For projects that wish to collect recordings for use in the research and also wish to use recordings for promotions, websites, and other non-research purposes, the Human Subjects Media Release form should be used. This form allows participants to identify if recordings collected for research purposes may also be used for non-research purposes. It is very rare for the IRB to approve a project that required all research participants to agree for their recordings to be used for non-research purposes.
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 IRB staff at firstname.lastname@example.org.
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