What to Submit - Forms Required for CPHS Submission

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

New Exempt

As of July 1, 2009, all new applications for Exempt Status must be submitted online via Berkeley eProtocol; no paper applications will be accepted.

SEE Berkeley eProtocol.

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

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

  • CPHS Application Cover Sheet (Word) (5/08 version or newer)
  • CPHS Checklist for Financial Conflict of Interest: Human Subject Studies (Word / PDF)
  • Protocol Narrative Form (Word) (2/08 version or newer)
  • Informed consent materials for all adult subjects (written form and/or verbal script, if seeking waiver of documented/written consent) (CPHS Informed Consent Guidelines – November 2008)
  • Assent materials for minors (written form and/or verbal script) with parental 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 (1 copy only)
  • 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 CPHS COI Checklist)
  • 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)

See Berkeley eProtocol concerning amendments to projects granted exempt status via eProtocol. Beginning January 1, 2010, all amendments to projects previously granted exempt status must be submitted as new exempt applications via eProtocol; no paper submissions will be accepted.

The below requirements apply to all proposed changes to currently approved, non-exempt protocols and exempt protocols not submitted via eProtocol:

Submit two (2) copies of the following materials:

  • CPHS Application Cover Sheet (Word) (5/08 version or newer)
  • Study Amendment Form (Word) (11/08 version or newer)

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) (one copy only)
  • Two 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.

Renewal/Continuation (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.)

See CPHS Renewal/Continuation Requirements: Quick Reference Chart below for assistance.

FOR ONGOING SUBJECT RECRUITMENT/ DATA COLLECTION
Submit two (2) copies with the following materials:

  • CPHS Application Cover Sheet (Word) (5/08 version or newer)
  • CPHS Checklist for Financial Conflict of Interest (Word / PDF)
  • Study Renewal/Continuation Form (Word) (11/08 version or newer)
  • Summary of study findings from the past year
  • Protocol Narrative (Word) (2/08 version or newer) – ONLY IF AMENDING PROTOCOL
  • Current copies of all consent/assent materials (unstamped)
  • Current copies of all recruitment materials

FOR DATA ANALYSIS ONLY
Submit two (2) copies with the following materials:

  • CPHS Application Cover Sheet (Word) (5/08 version or newer)
  • CPHS Checklist for Financial Conflict of Interest (Word / PDF)
  • Study Renewal/Continuation Form (Word) (11/08 version or newer)
  • Summary of study findings from the past year
  • Protocol Narrative (Word) (2/08 version or newer) – ONLY IF AMENDING PROTOCOL

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 10 of the Study Renewal/Continuation Form (Proposed Study Amendments), submit a Study Amendment Form, with two copies of any revised documents: one copy with changes highlighted and one “clean” copy without highlights.

NOTE: If you are planning to submit an amendment request as part of your Renewal/ Continuation application, please be aware that the renewal (with amendment) may not be approved until close to the time that the previous approval expires.  If you need to have the amendment approved sooner than this, contact OPHS (642-7461) to discuss and receive advice on how to proceed.

CPHS RENEWAL/ CONTINUATION REQUIREMENTS – QUICK REFERENCE CHART
What to Submit for Renewal/Continuation CPHS Application Renewal/Continuation with Amendment(s)
IF: subject recruitment/data collection ongoing AND proposed changes to previously approved protocol		 Renewal/Continuation
IF: subject recruitment/ data collection ongoing AND no proposed changes to previously approved protocol		 Renewal/Continuation-DATA ANALYSIS ONLY
IF: subject recruitment/ data collection has ended AND proposed changes to previously approved protocol		 Renewal/Continuation - DATA ANALYSIS ONLY
IF: subject recruitment/ data collection has ended AND no proposed changes to previously approved protocol
CPHS Application Cover Sheet YES YES YES YES
CPHS Checklist for Financial Conflict of Interest: Human Subject Studies YES YES YES YES
Study Renewal / Continuation Form YES YES YES YES
Summary of study findings from the past year YES YES YES YES
Consent / assent materials YES YES NO NO
Recruitment materials YES YES NO NO
Current IRB approval(s) from off-site institutions / participating data collection sites or collaborating institutions, if applicable. YES YES YES YES
Study Amendment Form YES NO YES NO
Protocol Narrative YES NO YES NO
Certificate of Completion of CITI Training YES
(if adding UCB student as personnel)		 NO YES
(if adding UCB student as personnel)		 NO

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 Systemwide MOU or Exempt, Expedited, and Full Board under UC Berkeley, UC Davis, UC San Francisco, and LBNL MOU)

See Relying on Another UC IRB for Review via Memorandum of Understanding (MOU) for instructions, forms, and guidance.

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 copies with your response, one with changes highlighted and one “clean” copy without highlights.

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