• New/Re-submission Forms for UCSD Biomedical Research
• New/Re-submission Forms for Rady Children's Hospital — San Diego

New/Re-submission Forms for UCSD Biomedical Research

• Standard Facesheets for UCSD Biomedical Research (updated 2/6/2018)

• Application instructions (updated 1/19/2019)

• Research Plan Template for UCSD - MS Word (updated 10/1/2013)
• Sample Informed Consents/Permissions/Assents:

• Experimental Subjects' Bill of Rights
• UCSD (English) (updated 9/28/2016)
• UCSD (Spanish) (Spanish Translation Certificate ) (updated 9/28/2016)
• UCSD research HIPAA authorization forms
  • UCSD research HIPAA authorization forms can be found on the Research Compliance Program (RCP) intranet site at https://pulse.ucsd.edu/departments/research-compliance/study/Pages/Forms.aspx . The HIPAA authorization form is available in the following languages with copies of the translation certificates, as provided by UCOP: English, Cambodian, Farsi, Mandarin, Russian, Spanish, and Vietnamese. For additional information, please contact RCP at rcp@ucsd.edu.
• Investigational Drug Fact Sheet — MS Word (updated 10/19/2011)
• Supplements to the Research Plan
  • Research involving an IND exemption — required for research requesting an IND exemption for the use of a drug, bioavailability or bioequivalence studies, studies involving radioactive or cold isotopes, or foods including dietary supplements and conventional/medical foods (released 1/28/2014)
  • Research involving pregnant women, neonates, and/or human placenta or fetal material — required for research that involves pregnant women, neonates, and/or human placenta, the dead fetus, or fetal material obtained after delivery (updated 1/11/2013)
  • Research involving prisoners — required for research that involves prisoners (updated 10/2/2014)
  • Research funded through the DoD — required for research supported by or in collaboration with the Department of Defense (updated 11/8/2010)

New/Re-submission Forms for Rady Children's Hospital — San Diego

• These forms are for UCSD salaried faculty, staff and students who are planning research where RCHSD is a site of performance.
• Standard Facesheets for combined UCSD and RCHSD application (updated 6/14/2017)
• Application Instructions (updated 2/3/2014)
• Research Plan Template for UCSD - RCHSD projects (updated 10/1/2013)
• Investigational Drug Fact Sheet - MS Word (updated 10/19/2011)
• Informed Consent/Assent resources for UCSD-RCHSD projects:

Note: Commercial companies sponsoring research often request their own language be used for subject injury or harm clause wording or that minor changes be made to this wording. Such requests cannot be honored. The wording was formulated with the intent of adhering to the requirements of federal regulations and University of California and RCHSD policy and conveying the basic, necessary information to the subject.
	Revised Common Rule version (federally funded only)
Adult* (updated 3/22/2016)	Adult* (released 1/24/2019)
Parent* (updated 10/1/2013)	Parent* (released 1/24/2019)
Adolescent* (updated 10/1/2013)	Adolescent* (released 1/24/2019)
Child Assent
Experimental Subjects' Bill of Rights
*Includes Experimental Subjects' Bill of Rights

• Note: Commercial companies sponsoring research often request their own language be used or that minor changes be made to the HIPAA authorization. Such requests cannot be honored. The wording and formatting used in the authorization was formulated on University of California and RCHSD policy and with the intent of adhering to the requirements of federal and state regulations.
• RCHSD-UCSD HIPAA Authorization Form (English) - MS Word (updated 12/21/2015)
• RCHSD-UCSD HIPAA Authorization Form (Spanish) - MS Word (released 12/21/2015) (HIPAA Translation Certificate )
• Application for Waiver of HIPAA Authorization for projects such as chart reviews that will access medical records information.
  • Note: In addition to IRB review and approval, all research or related activities conducted on the Rady Children's campus or involving Rady Children's patients, data, or resources requires Rady Children's Research Administration review and approval (Ready-to-Accrue Letter) before the project can start. To initiate the process, a Project Initiation Form must be submitted to research@rchsd.org. You may access the form at http://intranet.rchsd.org/categories/departmentsesearch/forms-resources-research (click on Project Initiation Form to open the form — requires RCHSD intranet access). If the form cannot be accessed through this link, please contact research@rchsd.org to request the form.