Please note: All forms submitted must be typed!

New IRB Submission Forms

• IRB Application
• Record Review
• Research Plan Instructions
• Research Plan
• Parent Permission Form (subjects 17 and under)
• Adult Consent Form (subjects 18 and older)
• Adult Addendum Consent (subjects who will turn 18 while on study)
• Adolescent Assent Form (subjects 13-17 years old)
• Child Assent Form (subjects 7-12 years old)
• Parent HIPAA Authorization Form
• Adult HIPAA Authorization Form
• Application for HIPAA Authorization Waiver

Approved Study Forms

• Continuing Review Form
• Final Review Form
• Amendment Request Form
• Principal Investigator Responsibilities and Assurance of Compliance Form
• Adverse Event Report Form
• IND Safety Report Form
• Study Deviation Report Form

Case Report Forms

If you plan to present outside of RCHSD and/or publish a specific case, you must obtain written authorization to do so from the parent/legal guardian if the patient is a minor or from the patient if he/she is 18 or older.

• Instructions regarding Case Reports
• Sample Authorization Form
• Case Report Request Form – when written authorization cannot be obtained (this must be submitted to the RCHSD IRB office for approval)

HIPAA Forms and Guidance

• Preparatory Research Activities
• Research on Deceased Individuals
• De-Identification of Health Information Fact Sheet
• Form to Withdraw Authorization
• HIPAA & Research FAQs

Other Information

• Parent Bill of Rights
• Adult Bill of Rights
• Adolescent Bill of Rights
• Child Bill of Rights
• Assurance Letter (in lieu of IRB Roster)
• Consent/Assent Form Barcode/Header
• IRB De-Identification of Health Information Research Fact Sheet
• IRB Frequently Asked HIPAA Research Questions
• IRB Principal Investigator Compliance

Have Questions?

If you have any questions or if you think your study may qualify for expedited review, please email: research@rchsd.org. Visit our Help Section for more information.

Instructions

• For instructions on submitting to the UCSD HRPP, click here.
• For dual tracking (UCSD/Rady Children’s) review, please refer to the UCSD website at http://irb.ucsd.edu/forms.shtml

How do you know what form to use?

Each form serves to:

• Let the IRB know what action you wish to take.
• Provide the necessary information to allow the IRB to decide if they may approve that action.
• Document that an action took place.

If you have more than just one action taking place (renewing your study approval AND changing the study protocol), you will need to address the actions separately:

• Use the correct form for each action.
• Submit the materials for each action separately. DO NOT attach a study change to your study renewal. These are different processes and must stay separate.
• For each action, submit three full set of copies which will be distributed to the IRB sub-committee reviewing that action.