Compliance

Checklists, Forms & Policy

Paper/PDF form submissions will be delayed for unspecified amount of time due to the physical nature of the document. Kuali Protocols are reviewed and approved online. Should you have questions, contact the CPHS.

  • What kind of protocol are you preparing?

    Regular Protocol

    Not HSR Verification

    Regular Protocol

    1. Protocol (application form)

    • Kuali Protocols: Our online, cloud-hosted, development and submission system. Complete the entire application for a Regular Protocol review:
      • Section 1: General Information
      • Section 2: Is it "Human Subjects Research"?
      • Section 3: Funding Source
      • Section 4: About the Researcher(s)
      • Section 5: Research Summary
      • Section 6: Subject Population
      • Section 7: Recruitment, Enrollment & Compensation
      • Section 8: Consent Procedures
      • Section 9: Activity Site & Data Source
      • Section 10: Anticipated Risks & Benefits
      • Section 11: Safety & Privacy Monitoring
    • Other applicable laws, policies, and "standards of professional conduct" approvals

    Companion guide to Kuali Protocols. This is the closest possible reproduction of sections and questions in static form -- so it is lengthier than what you will see in Kuali Protocols.

    Need Help? Kuali Protocols vendor guidance and SPO Tech Help - Kuali.

    2. Attachments

    Forms and guidance in: CPHS Applicant Materials.

    Training Certifications

    PDF of all applicable training certifications.

    • HSR certification from CITI, NIH, or Other for all "engaged" researchers.
    • Additional optional/applicable training should be completed in advance of protocol submission or you may be required to complete it prior to protocol approval.

    Instruments or Diagrams

    PDF of instrument (survey, questionnaire, etc.), or equipment diagrams (photos, illustrations, etc.).

    Recruitment Documentation

    PDF of document (i.e.: flyer), online announcement, post or dedicated project website.

    Consent Documentation

    PDFs of all applicable consent documents (i.e.: letters), online consent posts or dedicated project website.

    • NOTE: IF your subjects do not fully understand English, you must also provide translated PDF versions in the language(s) understood by subjects.

    Site Authorization

    PDFs of all applicable authorizations required to conduct the research per Guidance for Obtaining Site Authorization.

    • IF your project involves physically recruiting participants or conducting research at another institution, on private property, at K-12 school(s), or another location requiring site authorization.
    • IF your project involves recruiting or conducting research on a social media site or other internet platform AND the vendor's terms of service or user agreement requires pre-authorization.
    • IF your project involves use of existing data at CSUMB, another institution, from a private company, at K-12 school(s) or district(s), or another "owner" requiring access authorization.

    Safety & Privacy Monitoring Plan

    See Safety & Monitoring Monitoring Plan guidance.

    Need to request a safety/security consultation with Risk Management? Contact them at: https://csumb.edu/risk.

    Need to request a data security consultation with IT? Submit a Help Desk ticket > Information Security & Compliance. Until Research Data Security Consultation is available as a SERVICE, select Accessible Technology Initiative (ATI) and in the subject line enter "Research Data Security Consultation".

    Other (if applicable)

    PDF of all other applicable documentation.

    Not HSR Verification

    1. Protocol (application form)

    Companion guide to Kuali Protocols. This is the closest possible reproduction of sections and questions in static form -- so it is lengthier than what you will see in Kuali Protocols.

    Need Help? Kuali Protocols vendor guidance and SPO Tech Help - Kuali.

    2. Attachments

    Forms and guidance in: CPHS Applicant Materials.

    Training Certifications

    PDF of all applicable training certifications.

    • HSR certifications from for all "engaged" researchers.
    • Additional optional/applicable training should be completed in advance of protocol submission or you may be required to complete it prior to protocol approval.

    Instruments or Diagrams

    PDF of instrument (survey, questionnaire, etc.), or equipment diagrams (photos, illustrations, etc.).

    Other (if applicable)

    The CPHS has the right to request other documentation, clarifications, and full protocol materials commensurate with the protocol.

    Student Researchers

    Lead researchers who are students (vs. Student Assistants on a faculty/staff protocol) must confirm your faculty (or MPP staff) advisor is prepared to serve as Lead Researcher on the submission.

  • Amendments & Renewals

    Risk-reducing Modification Requests

    Due to the State of California's Executive Order N-33-20, the CPHS is currently accepting requests which REDUCE the risk to subjects on any active, approved, protocol via: Risk Lowering Change to Approved Protocol.

    Approved requests are valid upon confirmation of receipt from the CPHS. Complete the form and the CPHS will take it from there.

    Modifications, Changes, and Extension Requests

    For CSUMB researchers (student, staff and faculty) requesting amendments (modifications, changes) or renewals (extensions) to an approved, active, protocol.

    How did you submit the original protocol?

    As we transition to Kuali Protocols, you will need to recall which system you used to submit your initial protocol, and submit your request accordingly.

    Periodic Status Reports

    Continuing Reviews, Close-out Reports, and other periodic reports

    For CSUMB researchers with an Expedited/Level II or Full Board Review/Level III protocol approved PRIOR to January 21, 2019, AND researchers with protocols approved ON or AFTER January 21, 2019

    How did you submit the original protocol?

    Unanticipated Problem and/or Adverse Event Reports

    For anyone to use to reporting subject's complaints, problems, or other adverse effects of the research.

  • Single IRB (sIRB)

    (AKA: Collaborative/Cooperative Agreement for Engaged Human Subjects Research)

    For two or more IRBs who wish to rely on a single protocol (review) and researchers at both institutions are "engaged".

    Refer to the definition of "engaged" in OHRP’s Guidance on Engagement of Institutions in Human Subjects Research (October 16, 2008).

    Transfer a Protocol, Data or Materials

    For CSUMB researchers who want to transfer a protocol, data or materials from a prior institution to continue the research at CSUMB.

  • The CPHS has temporarily suspended External Researcher requests due to State of California Executive Order N-33-20.

    External Researchers wishing to conduct research at CSUMB, with CSUMB subject populations (students, staff, or faculty), or with CSUMB subject's data (personally identifiable private information), must submit their home-IRB approved protocols for CPHS validation prior to contacting any CSUMB persons.

    The CPHS validates the home-IRB approved protocol meets minimal requisites derived from NIH's Guidelines for the Review of Human Subjects, and the FWA and IRB statuses are both active.

    Some research designs are subject to other/additional regulations and/or policies pertaining to accessing CSUMB property, populations and/or personally identifiable private information (PII data). It is the responsibility of the researcher to understand all applicable regulations to their research design.

    The CPHS has temporarily suspended External Researcher requests due to State of California Executive Order N-33-20.