What to Submit - Forms Required for CPHS Submission

New Exempt | New Non-Exempt | Amendment | Continuation/Renewal | UC Institutions Memorandum of Understanding (MOU) | Response to Conditions

New Exempt

Submit 2 copies, typed and collated (one with original signatures)

  • CPHS Application Cover Sheet (Word)
  • CPHS Checklist for Financial Conflict of Interest: Human Subject Studies (Word / PDF)
  • Request for Determination of Exempt Status Form (Word)*
  • Protocol Narrative Form (Word)
  • Informed consent materials for all adult subjects (written form and/or verbal script, if seeking waiver of documented/written consent) (CPHS Informed Consent Guidelines 10/05)
  • Assent materials for minors (written form and/or verbal script) and parental consent/permission form
  • Surveys, interview guides, and any other data collection instruments
  • Certificate of Completion of CITI Training (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)
  • Recruitment materials (e.g., advertisements, letters, flyers, scripts for verbal recruitment).

Additional Documents (if applicable):

  • Letters of permission from off-site institutions/participating data collection sites (e.g., permission from school administrator, data sharing agreement, etc.)
  • IRB approvals from collaborating institutions
  • UCB Human Subjects Financial Conflict of Interest Form (If answered “yes” to questions 1, 2, or 3 on page 1 of COI Checklist) (Word / PDF)
  • Copy of grant proposal (for funding received through the UCB Sponsored Projects Office (SPO)).

*NOTE: Regarding Exemption Category #4 (Existing Data): Applications for exempt research involving the use of de-identified and pre-existing data generally do not need to include a protocol narrative or consent materials; instead, a description of the dataset(s) and content, where/from whom it will be obtained, data security/storage measures, and other information as requested on this form should be provided.

New Non-Exempt (Expedited or Full Board review level is determined by OPHS after submission)

Submit 3 copies, typed and collated (one with original signatures)

  • CPHS Application Cover Sheet (Word)
  • CPHS Checklist for Financial Conflict of Interest: Human Subject Studies (Word / PDF)
  • Protocol Narrative Form (Word)
  • Informed consent materials for all adult subjects (written form and/or verbal script, if seeking waiver of documented/written consent) (CPHS Informed Consent Guidelines 10/05)
  • Assent materials for minors (written form and/or verbal script) with parental consent/permission form, and any other subjects who do not have the capacity to provide consent for themselves
  • Surveys, interview guides, and any other data collection instruments
  • Certificate of Completion of CITI Training (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)
  • Recruitment materials (e.g., advertisements, letters, flyers, scripts for verbal recruitment).

Additional Documents (if applicable):

  • Letters of permission from off-site institutions/participating data collection sites (e.g., permission from school administrator, data sharing agreement, etc.)
  • IRB approval(s) from collaborating institution(s)
  • UCB Human Subjects Financial Conflict of Interest Form (If answered “yes” to questions 1, 2, or 3 on page 1 of COI Checklist) (Word / PDF)
  • Copy of grant proposal (for funding received through the UCB Sponsored Projects Office (SPO))
  • Documentation of FDA approval for an Investigational New Drug (IND)/Investigational Device Exemption (IDE), or sponsor evaluation of risk level of the investigational drug or device
  • Medical Research Subject’s Bill of Rights
  • HIPAA Waiver Documentation or Form if use of PHI (protected health information) is involved. See HIPAA and Human Subjects Research for more information.

Amendment (Applies to all proposed changes to currently approved protocols and to projects previously granted Exempt status by CPHS)

Submit 2 copies with the following materials:

  • CPHS Application Cover Sheet (Word)
  • Study Amendment Form (Word)

Additional Documents (if applicable):

  • CPHS Checklist for Financial Conflict of Interest (needed only for changes in Key Personnel or Funding) (Word / PDF)
  • Copy of previous CPHS Determination of Exempt Status letter (if applying for revision/amendment of Exempt protocol)
  • Copy of grant proposal (if adding funding source received through the UCB Sponsored Projects Office (SPO))
  • Two (2) updated copies of all new or revised documents and materials (e.g., protocol, informed consent materials, etc.): one copy with changes highlighted and one “clean” copy without highlights.

Continuation/Renewal (For all previously approved Expedited and Full Board level research projects that are continuing with subject enrollment or data collection, as well as studies that have completed all data collection but are still in data analysis. Reminder: Exempt protocols do not need to be renewed.)

Submit one copy with the following materials:

  • CPHS Application Cover Sheet (Word)
  • CPHS Checklist for Financial Conflict of Interest (Word / PDF)
  • Study Renewal/Continuation Form (Word)
  • Summary of study findings from the past year
  • Current copy of Protocol Narrative (Word) (9/05 version or newer)*
  • Current copies of all consent/assent materials*
  • Current copies of all recruitment materials*

*NOTE: The Protocol Narrative does not need to be submitted IF:
1) No Changes to the approved protocol on file with OPHS are proposed, and the protocol is written in the 9/05 version or newer of the CPHS Protocol Narrative Form; OR
2) The study is moving into a “data analysis-only” stage, with no data collection or subject interaction planned for the coming year. (An updated protocol will not be required in this case, nor will consent or recruitment materials.)

Additional Documents (if applicable):

  • Any findings/ literature/ other relevant information outside of your study (especially about risks associated with the research) since last approval received
  • Current IRB approval(s) from off-site institutions/participating data collection sites or collaborating institutions, if applicable.
  • Certificate of Completion of CITI Training if not previously submitted (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)
  • If “yes” to any questions under point 9 of the Study Renewal/Continuation Form (Proposed Study Amendments), submit a Study Amendment Form, with two (2) copies of any revised documents: one copy with changes highlighted and one “clean” copy without highlights.

Core Grant/Training Program

NOTE: CPHS/OPHS no longer reviews and approves release of funds for these research activities. Contact your SPO Research Administrator for assistance.

UC Institutions Memorandum of Understanding (MOU) (For new projects initiated after 3/21/2006. Exempt and Expedited under UC System-Wide MOU or Exempt, Expedited and Full Board under UCSF-UC Davis-UC Berkeley-LBNL MOU)

See the UCSF web site for instructions, forms, and guidance: http://www.research.ucsf.edu/chr/Inst/chrInst.asp, under the “Relying on Other IRBs” section.

Response to Conditions (Investigator response to specific, minor revisions requested by the Full Committee)

Submit the following materials:

  • One copy of a memo with a point-by-point response to the Committee’s concerns
  • For any protocol, consent materials, or other document(s) for which revisions were required, include two (2) copies with your response, one with changes highlighted and one “clean” copy without highlights.

Return to Main Page