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Frequently Asked Questions

  1. Administration
    1. What is CPHS and what do we do?

      CPHS (Committee for the Protection of Human Subjects) is the Institutional Review Board (IRB) for all of the departments under the California Health and Human Services Agency. As such, the IRB is required to review all research-related requests for state personal identifiable information from the University of California and non-profit educational institutions.

    2. What is defined as research?

      According to CFR 46.102, research is defined as a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Therefore, this project will require CPHS' review.

      If a project falls under any of these parameters, it will require CPHS' review and approval.

    3. What is defined as non-research?
      An exemption for non-research can be approved based on the following:

      • FDA evaluation
      • Public health practice/surveillance
      • Program evaluation
      • Resource utilization review
    4. What is defined as Exempt Research?

      An Exemption for Research can be approved based on the following:

      • Research involving analysis/study of existing data
      • Research involving data which is publicly available
      • No identifiable data is being requested from any of the CHHSA departments
  2. General
    1. I have submitted my IRBManager application. What is the next step?

      CPHS staff screens all protocols before assigning it to a Reviewer(s). If the protocol is incomplete or missing documents, CPHS staff returns the protocol to the Primary Investigator (PI) using the "Notes" feature. Once the protocol is received with the correction, staff will re-screen and assign to a Reviewer(s). If the Reviewer(s) needs any clarifications on the information provided, the Reviewer uses the "Notes" feature to communicate with the Primary Investigator (PI). Once the Primary Investigator (PI) receives the note in IRBManager, the Researcher is able to edit the protocol.

  3. Approval Letters
    1. How do I receive the data once my protocol has been approved?

      The Researcher provides a copy of CPHS' approval letter and submits it to the department that holds the data. CPHS is not responsible for notifying individual departments.

  4. Adverse Event/Unanticipated Problems
    1. When will I be notified that my Adverse Event Review has been approved?

      The Committee Chair, Vice Chair and the Reviewer review each Adverse Event Report as soon as it is received. Once it has been reviewed and recommended for approval, the Report is scheduled onto the next Committee's public meeting date. At the meeting, the Reviewer provides a brief summary of the event report and the corrective steps taken by the Primary Investigator (PI). The Committee votes to approve or disapprove the report. Upon the Committee's decision of the report, CPHS staff releases the appropriate letter via IRBManager within ten business days after the meeting.

  5. Types of Reviews
    1. What is an Expedited Review?

      Expedited Review protocols are reviewed on an expedited basis by one or two Reviewers, as opposed to the entire committee at the next scheduled CPHS public meeting.

    2. What is a Full Committee Review?

      Projects that have any contact with human subjects, such as a survey or specimen collection, must initially be presented and approved at the next scheduled CPHS public meeting.

      Also, if a Reviewer determines a project must be reviewed by additional members beyond the two assigned Reviewers, the project is scheduled for the next CPHS public meeting.

    3. What is an Exempt Review?

      Exempt Review protocols are reviewed on an expedited basis by one or two Reviewers to determine if protocol falls under its purview.

  6. IRBManager Accounts/Personnel
    1. How do I add staff to my protocol on IRBManager?

      Initiate an Amendment to the protocol and attach the PIs and Co-PIs curriculum vitae.

    2. How can I update my account information?

      Once your account is created, you will be required to contact CPHS staff for any changes except for your password. If the need arises, to change/reset passwords, go to the "IRBManager page" and click on the "Forgot Password" option at the lower right of the screen.

      For other account information changes, (i.e., address, phone, organization) contact CPHS staff.

    3. How can I update personnel changes for my project on IRBManager?

      If the personnel or email address associated with your project have changed, an amendment must be initiated and submitted to CPHS via IRBManager. These types of changes will be reviewed on an Expedited basis. For these types of revisions, an Expedited basis is reviewed within ten business days after submission.

  7. Timeline
    1. What is the time line for projects to be reviewed?

      If projects are submitted by the submission deadline, they are approved on that cycles' meeting date. (Note: All projects are reviewed for quality and completeness of the application).

      Special considerations: Determination requests and amendments can be approved at any time. New Expedited projects can be approved within five to ten business days after the CPHS public meeting. Projects presented to the CPHS Committee receive approval or deferred approval letters within five to ten business days after the CPHS public meeting. Deferred projects will not receive an approval letter until all revisions are approved by a subcommittee. The subcommittee also determines if the project requires to be re-evaluated by all the members.

    2. I have submitted my IRBManager application. What is the next step?

      CPHS staff screens all protocols before it is assigned to a Reviewer(s). If the protocol is incomplete or it has missing documents, CPHS staff returns the protocol to the Primary Investigator (PI) using the "Notes" feature in IRBManager. The Primary Investigator (PI) addresses the concerns and returns the protocol using the "Notes" feature. Once the protocol has successfully passed screening, it is assigned to a Reviewer(s). Should the Reviewer require any clarifications, he/she will send a note via IRBManager to the Primary Investigator (PI). The Primary Investigator (PI) and all personnel listed on the protocol receive a system generated email message. Once this message is received, the protocol can be edited. Once the revisions are completed, the Primary Investigator (PI) returns a note on IRBManager and returns the protocol to CPHS by clicking "Save" and "Done". If the application meets all the requirements, the Reviewer recommends approval. All approval letters are released after the CPHS public meeting dates. For meeting dates and submittal dates, visit the CPHS homepage

    3. What is the renewal window period for Continuing Renewals?

      Continuing Renewal reviews can be started and submitted for protocols 60 days prior to the project's Primary Investigator (PI) expiration date. Once the protocol's expiration date is reached, Researchers can no longer start or submit Continuing Renewal reviews.

    4. What is a submission deadline?

      Submission deadlines are set one month prior to the CPHS public meeting date. During this time period, CPHS staff screens and processes and assigns all protocols to the Reviewers before the public meeting date.

    5. What is an expiration date?

      Expiration dates are set a year from the project's current approval date. Most projects are approved for one year.

  8. Data Security
    1. When should the Data Security letter be submitted?

      All data security questions must be answered on Cal Protects. If a question does not apply to your protocol, indicate your response as "N/A." Do not leave any questions blank.

      The Data Security Letter must be signed by your organization/department's Chief Information Officer, Privacy Officer, Security Officer or an equivalent position. This letter is required to be attached to your online protocol prior to its approval. If there is a delay in obtaining this document, you will need to contact CPHS staff for assistance.

    2. How often do I have to update my Data Security letter?

      The Data Security Letter must be updated whenever there is an amendment that led to the change of personnel. This includes Primary Investigator (PI) RO, Chief Information Officer, Privacy Officer, Security Officer, or an equivalent position.

    3. Who can sign the Data Security Letter?

      The Data Security Letter MUST be signed by your organization/departments Chief Information Officer, Privacy Officer, Security Officer or an equivalent position.

      (Note: The Primary Investigator (PI) CANNOT sign the Data Security Letter. All letters that are not signed by the appropriate officer will not be valid.)

  9. Reminder Emails/Notifications
    1. Why am I not receiving any email notifications?

      Only personnel registered with Cal Protects User accounts linked to a protocol receive emails regarding said protocol. If your account is listed in a protocol's Personnel Information section, but you are not receiving any email notifications, check the Spam folder of your email address and/or check with your organization's IT department to inquire if your firewall is blocking the email from being received. If you are still not receiving notifications, please contact CPHS Staff at (916) 326-3660 or by email to request access to the project.

  10. Protocol Track Changes/Revisions
    1. I submitted the revised language within the protocol and I am unable to view the track changes/revisions?

      Once you have submitted the revisions, a side by side comparison screen appears for CPHS staff and Reviewers for comparison and review. The system does not allow the Researcher to view this screen.

    2. Do I need to attach documents with track changes?
      Yes, if changes are being proposed for attached documents, include the track changes version and a clean copy version with the changes. DO NOT delete any original documents.
  11. Registration
    1. Who needs to register an account for IRBManager?

      It is mandatory for the Principal Investigator (PI) and Responsible Official (RO) to register on IRBManager prior to creating a protocol. If the project has other contacts, such as the Co-Principal Investigator (Co-PI), Administrative Contact and Other Contact, each individual must also register on IRBManager. This allows them to access and receive emails on the protocol.

  12. General
    1. Who is the Responsible Official?

      The Responsible Official is an individual who is above the Principal Investigator in the line of authority.

    2. How do I know if I need CPHS' approval on my project?

      If you are not certain whether or not the project requires CPHS' review/approval, please select the "Determination of Not Research/Exempt Research" category.

    3. How do I make changes to my project once it has been submitted to CPHS?
  13. Determination Requests
    1. What should I expect after submitting a Determination Request?

      After you have submitted a Determination Request, CPHS staff screens for completeness and assigns the protocol to a CPHS Reviewer. If the CPHS Reviewer determines that the project is exempt, an approval for Exemption letter is released via IRBManager. An automatic system email notifying all personnel listed in the protocol is also released. However, if the project is determined to be Not Exempt the Determination Request is denied in IRBManager. (In addition, a detailed email stating the reason(s) and instructions on how to obtain CPHS approval is sent to the personnel listed in the protocol.)

    2. What is the process to request a Determination of Non- Research/Exempt Research?

      The registration process must be completed. Once you have registered, you will have access to complete a request for Determination of Non-Research/Exempt Research.

  14. New Projects
    1. My project was determined to be presented at a CPHS Full Committee meeting, what are the next steps?

      If a protocol requires Full Committee presentation, CPHS notifies the Researcher(s) that 14 hardcopies need to be mailed to CPHS, two to three weeks prior to the upcoming public meeting date. CPHS staff coordinates all the logistics with the Primary Investigator (PI), i.e., time, place, etc. The Primary Investigator (PI) is provided with an option to make a personal appearance or attend by teleconference on the day of the meeting.

    2. How do I create a new project/protocol on IRBManager?

      Once all the required individuals (at a minimum the Primary Investigator (PI) and the Responsible Official) have successfully registered, you are able to create a protocol.

      In addition to providing the responses, the following documents must be uploaded under the "Attachments Section":

      1. Curriculum Vitae of the Principal Investigator, Co-Principal Investigator(s), and Translator (if applicable)
      2. Complete the New Project Application and Review Checklist.
      3. Project Budget Document
      4. Cover letter summarizing the project
      5. Attach the signed Data Security Letter/statement from your Internet/Data Security Officer. For additional information on the requirements of the Data Security Letter, please click here.
      6. Any and all other project documents related to the project. You may also view a sample of the required letters.
  15. Continuing Renewals
    1. How do I renew my project's approval or file for a Continuing Renewal Review?

      You are only able to renew the project within 60 days of the project's expiration date.

    2. I did not renew my project in time and now it is expired. What steps do I need to take to obtain approval?

      Contact CPHS Staff. Expired projects are reviewed on a case by case basis.

    3. Do I have to create a new protocol to renew my project?

      No. New protocols are only created when a new project is submitted to CPHS for the first time. Existing projects that require renewals will appear on the Researcher Dashboard.

    4. Can I make changes to my protocol while filing for a Continuing Renewal Review?

      Yes. Changes are strongly encouraged to be included and must be provided in the Continuing Renewal section of the project.

    5. What do I need to attach when filing for a Continuing Renewal Review?

      All documents being added or altered to the project must be attached when Continuing Renewal Review is filed. Do not delete previously attached documents unless instructed by CPHS staff.

    6. How can CPHS distinguish what has been changed within my protocol?

      All tracked changes made to the protocol are automatically saved on the IRBManager system.

    7. By what date do I need to submit my project for a Continuing Renewal Review?

      A project's deadline date for renewal is one month before the CPHS' meeting date. The dates can be found on the CPHS homepage under CPHS Meetings.

  16. Amendments
    1. How do I make changes to my approved protocol before it is due for renewal?

      To make any changes on your protocol, an Amendment Review must be completed via IRBManager.

    2. By what date do I need to submit my project for an Amendment Review?

      Amendments can be submitted at any time and are not subject to Deadline Dates.

  17. Completing and Withdrawing Projects
    1. I want to withdraw a project which has not been entered into IRBManager. What am I required to do?

      Projects that are withdrawn from CPHS require the submission of the following documents:

      • A cover letter clearly summarizing the reasons for withdrawal of the project.
      • Include a description of the plan for the destruction or return of any data used in the study. If the data will be retained, include a justification.
      • Appropriate Project Forms: (Continuing Periodic Review Data Only or Human Subject Contact, Annual Report Form for Information Practices Act, or Death Data Only) found here. The box next to "Withdrawn" must be checked.
    2. I completed a project which has not been entered into IRBManager. What am I required to do?

      For completed projects, you are required to submit of the following documents:

      • A cover letter clearly summarizing any results and knowledge gained from the research project. Also include a description of the plan for the destruction or return of any data used in the study. If the data will be retained and include a justification.
      • Appropriate Project Forms: (Continuing Periodic Review Data Only or Human Subject Contact, Annual Report Form for Information Practices Act or Death Data Only) found here. The box next to "Completed" must be checked.
      • Copies of any reports or publications related to the research.
  18. Notes
    1. I received an email stating I have "Notes" on my project. What are Notes?

      CPHS staff uses the "Notes" feature to communicate with the Primary Investigator (PI) or Co-Primary Investigator (Co- PI) to obtain clarification or obtain missing information/documents during the initial screening of the project. All documents and/or comments requested must be addressed before resubmitting to CPHS.

    2. I received an email stating that the Reviewer has left a Note on my project.  What are notes?

      Once your project has successfully passed the screening process, the project is assigned to a Reviewer(s). The "Note" feature is used as the communication tool between the Reviewer and the Researcher. The Reviewer will initiate the "Note" feature to obtain clarifications on the projects.

      (Note: Not all projects will receive Return Notes and/or Comments.)

  19. Approval Letters
    1. When will I be notified that my Amendment Review has been approved?

      Upon the Reviewer's approval of your amendment, CPHS staff will release the approval via IRBManager. The email notification will contain the approval and instructions on how to obtain the project's approval letter. The email is sent to all personnel listed on the project.

    2. When will I be notified that my Continuing Renewal Review has been approved?

      Researchers are notified of their Continuing Renewal Review approval on their project's cycle meeting date.

    3. Why do I have to wait until the CPHS meeting date to get my Approval Letter?

      All projects are officially approved on IRBManager ten business days after the CPHS public meeting. This allows all projects from that cycle to have a consistent renewal date.

  20. Adverse Event/Unanticipated Problems Forms
    1. What is an Adverse Event/Unanticipated Problems? How do I report it to CPHS?

      An Adverse Event/Unanticipated Problems entails unanticipated problems (including breach of data security) or adverse events involving risks to human subjects while the research is being conducted. A "Report Form" must be completed and submitted via IRBManager within 48 hours of the event. To file a report, you must log into IRBManager. Additionally, you must call CPHS staff at (916)326-3660 to notify them of the report submission.

    2. A breach of data security occurred on my project, is this reportable?

      A breach of data security is considered an unanticipated problem during the research. A "Report Form" must be completed and submitted via IRBManager within 48 hours of the event. To file a report, you first log into IRBManager. Select report form andn it will open a separate screen. Once the form has been submitted, you must call CPHS staff at (916)326-3660 to notify them of the report submission.


This page was last updated on Monday, January 23, 2017.