INSTRUCTIONS: CPHS Application Cover Sheet

Part I: Project Information:

• Read Definition of CPHS Researcher Titles and Related Responsibilities before designating Lead Investigator, Faculty Advisor, Key Personnel, and/or Principal Investigator.
• If this is a completely new application, leave “CPHS #” field blank. (Your application will be logged in and assigned a CPHS number once it is received in the OPHS).
• Check appropriate box(es) for the Application Type you are submitting. For more information on application types, see Process for Submission and Review of Applications - Types of Review. For more information on MOUs and the Notice of Intent to Rely form (e.g., when a new project involves multiple UC campuses), see Regulations, Policies, and Guidelines - Relying on Another IRB for Review via Memorandum of Understanding (MOU).

Part II: Key Personnel

• Read Definitions (as above). Lead Investigator need not be included in this list.

Part III: Funding

• Check “Yes” for question #1 if project will be self-funded by the Lead Investigator or will not require any funding.
• If “Yes” to question #3a, the Principal Investigator named on the grant must sign in #3b.

Part IV: Collaborating Institutions or Individuals

• If a collaborating institution/individual is involved in the project, check “Yes” to question #1 and complete information in chart below. Attach copy of any non-UCB IRB approval needed.

Part V: Special Considerations

• If any ionizing radioactive materials or ionizing radiation-producing devices (e.g., injectable, oral, x-rays, etc.) will be used in the research, the RUA (Radiation User Authorization) number(s) must be noted here. See UCB Radiation Safety for more information.

• If any non-ionizing radiation (laser or magnetic) sources will be used in the research, the Laser Use Registration number and/or Magnetic Inventory number must be noted here. See UCB Radiation Safety for more information.

• If any human blood, body fluids, tissues, or cells (including cell lines)* will be used in the research, the lab location and BUA (Biological Use Authorization) number(s) as appropriate must be noted here. See UCB Biosafety Program for more information.
  
  *NOTE: If research involves human stem cells (adult or embryonic), see UC Berkeley policy issued 2/15/07.

• If any substance or device requiring approval from or notification to the FDA (U.S. Food and Drug Administration) will be used in the research, an Investigational New Drug (IND) number or Investigational Device Exemption (IDE) number must be noted here.

• If the research constitutes a clinical trial, a Clinical Trial Agreement must be negotiated through the UC Berkeley Industry Alliances Office, and a copy submitted with the CPHS application.

• If the research involves testing of a proprietary drug or device (i.e., a drug or device owned by a private entity under a trademark or patent), this should be explained in the protocol.

• If any vulnerable subject populations will be involved (e.g., children, prisoners, pregnant women, fetuses, neonates, cognitively impaired persons, economically or educationally disadvantaged persons), this must be addressed in both the protocol and consent document(s). The study will need to satisfy certain additional federal, state, and/or University requirements (see CPHS Regulations, Policies, and Guidelines) as applicable.

• If consent by a surrogate or legally authorized representative will be sought, first consult applicable regulations and UC policy (see Surrogate Consent). Note that consent/ assent issues as pertain to research involving children (minors) are considered separately.

• If the research will take place outside of the U.S., indicate location, and consult CPHS Guidelines on Conducting Research Abroad.

• If the research involves creating, accessing, using or disclosing protected health information (PHI) as defined by the Health Insurance Portability and Accountability Act (HIPAA), consult CPHS website for further details on HIPAA.

Part VI: Human Subjects Education and Training Documentation

• Note requirements for student researchers to complete CITI training (Collaborative IRB Training Initiative), effective since September 1, 2005.

Part VII: Financial Conflict of Interest

• Investigators must declare any potential conflict of interest by completing and submitting the CPHS Checklist for Human Subjects Financial Conflict of Interest. This form is required with all CPHS applications.

• As indicated on the Checklist, any individual who responds affirmatively to certain questions on the Checklist must then complete the UCB Human Subjects Financial Conflict of Interest Form and submit copies to the UCB Conflict of Interest (COI) Committee as well as to the OPHS. This form is required only if applicable.

Part VIII: Investigator Assurance

• In this section, the Lead Investigator, and the Faculty Advisor if applicable, sign agreement to take responsibility for the ethical conduct of this study involving human subjects.

• At least one copy of this agreement should bear the original signature of the Lead Investigator, and the Faculty Advisor if applicable. Signatures should be legible.

Checklist for Complete Applications

• Use this list to make sure all necessary items are included in your submission.

Number of Copies to Submit

• See CPHS Cover Sheet for numbers of copies to submit according to type of application.