IRB Forms & Templates

You must submit a protocol using Cayuse Human Ethics , including a copy of your planned Consent Forms, as well as supporting documentation for your research project.


Informed Consent/Assent Templates and Requirements

Section 46.116 of the Common Rule (Post 2018) describes Consent Form Requirements

 

Parental Consent

A Parental Consent Form is used when human subjects are under the age of 18. If subjects are between the ages of 6-18, a Minor Assent Form is also needed.

NOTE: Before downloading this form, read the Guidelines for Obtaining Minor Assent.

 

Minor Assent to Participate in Research

A Minor Assent form is used when human subjects are between the ages of 6 and 18. Read the Guidelines for Obtaining Minor Assent which include samples. A  Parental Permission to Participate in Research with forms is also required.

 

Implied Consent for Surveys

Because of advances in technology over the years, written consent can usually now be obtained by embedded the written consent information and acceptance in the beginning of an online survey.  In rare situations, when federal regulations warrant or allow a consent alteration, an alteration or waiver or implied consent approval for surveys may be requested when conducting a non-sensitive survey of non-vulnerable adults or when a survey will be administered online.

This process requires a request for a waiver of federal requirement to document consent in writing, requested through a section of the Cayuse Protocol Submittal.

 

Verbal Consent Form

Because of advances in technology over the years, in almost all instances some form of written consent or acknowledgement (with alteration approval) can be obtained from study participants. In the rare cases when a verbal consent form is allowed by federal regulations, the investigator will read a scripted consent form  aloud to the subject. This process requires waiver of federal requirement to document consent in writing, requested through a section of the Cayuse Protocol Submittal.

 

Witness/Translator Consent Form

This type of Consent form is used for subjects who do not speak or read English (the alternative, and preferred method, is to translate an Informed Consent form into the subjects' native language). The Investigator or designated witness/translator will read it aloud to the subject and the witness/translator will verify that the subject understands.

 

Focus Group Consent Form

Add this paragraph under “Risks” in the informed consent when conducting research where subjects will be involved in group discussions or focus groups and where they may be discussing sensitive topics.

 

Recruiting:

When recruiting subjects through a teacher, department, organization or agency, or if you are conducting research in the classroom, or at a business, organization or agency, you are required to provide the IRB office with a letter of permission to recruit and/or conduct research. Please make sure the letters are signed and on the organization’s letterhead, if possible. Emailed versions are accepted on a case-by case basis.  The letter must be attached to the Cayuse Protocol Submittal.

 

Recruiting Script

 

Photo Release

Use only the elements that apply to your research.

 

Video Release

Use only the elements that apply to your research.

 

Continuing Research:

A non-exempt IRB approval typically expires in 1 year. Continuation requests must be submitted prior to the expiration date. To request a continuation PRIOR to your protocol expiration date, log onto to Cayuse, choose your original protocol, and request a modification to update your protocol and extend the end date. Submit your Continuation/Renewal Request through Cayuse at least 14-30 days prior to protocol expiration to allow enough time for IRB review and approval.

 

Modifications of Research Study Protocol

If you need to modify you original protocol, which is required with any substantial changes, and with changes to investigators or methodology, log on to Cayuse and follow the steps to Modify your original protocol. You must submit your Modification Request and receive IRB approval before you collect Human Subject data or perform actions on Human Subjects with the new personnel or methodology.

 

Completion of Research

When you have completed your research, log on to your Study in Cayuse and follow the steps to initiate the Close out of your Protocol.

 

Adverse Events & Protocol Deviation/Violation:

Serious and Significant adverse events must be reported to the IRB as soon as possible for the protection of the participant, but within at least 5 working days. Please use Cayuse to submit your information. 

 

Deviation Report 

Deviations from the approved protocol that have already occurred and breaches of scientific integrity and ethics on the part of the researchers should be reported using the Cayuse website. If you are the PI or on the research team please use Cayuse to report the deviation. 

If you are not part of the research team and need to make a deviation report, please use the Deviation/Violation Report form, available in Word. After you complete the form please email it to irb@csueastbay.edu.