Compliance

Standard HSR Protocol vs. a Not HSR Verification

To learn more about whether or not your protocol requires standard CPHS (IRB) review, check out our guidance on: Do I need to submit a CPHS application?

If you have ascertained that the research you are preparing to engage in meets the federal definition of Human Subjects Research, you will submit a Standard HSR Protocol (see below).

If you are not sure, or you need an official letter from the CPHS determining the study is Not Human Subjects Research (i.e.: your publisher or conference requires official documentation of IRB review), you will submit a Not HSR Verification (scroll down below Standard HSR Protocol).

Standard HSR 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.

• AND: IF participants are recruited in person by someone with real or perceived authority over them (i.e.: teacher, professor, health care provider), PDF of script to be followed during recruitment.
• NOTE: IF you're offering gift card compensation or incentive to subjects, CSUMB's Gift Cards Used as Payments to Research Participants or Event Awards Procedures. If your research is externally funded, refer to UCorp's guidelines.
• NOTE: IF you're conducting a raffle for a prize, the CPHS follows precedent set by UC Irvine and their Lotteries, Raffles or Drawings guidelines (XII).

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

(when you are unsure or need an official letter from the CPHS determining the study is Not Human Subjects Research)

1. Protocol (application form)

• Kuali Protocols: Our online, cloud-hosted, development and submission system. Complete AT LEAST the following sections for a Not HSR verification review:
  
  • Section 1: General Information
  • Section 2: Is it "Human Subjects Research"?
  • Section 4: About the Researcher(s)
  • Section 5: Research Summary
  • Section 6: Subject Population
• 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 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.

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.

• Was your initial submission via Google Doc?
  • Submit amendment requests via the Modification (change) Request form or Exempt+Minor Express form AND follow-up email all applicable supporting documentation to cphs@csumb.edu.
    
  • Submit renewal (extension) requests via the Continuing Review form AND follow-up email all applicable documentation to cphs@csumb.edu.
• Was your initial submission via Kuali Protocols?
  • Submit amendment (modification/change) and/or renewal (extension) requests via Kuali Protocols. Search for your initial protocol in Kuali, then follow these instructions.

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?

• Was your initial submission via Google Doc?
  • Submit via Continuing Review AND follow-up email all applicable documentation to cphs@csumb.edu.
    
• Was your initial submission via Kuali Protocols?
  • Submit via Continuing Review AND follow-up email all applicable documentation to cphs@csumb.edu.

Unanticipated Problem and/or Adverse Event Reports

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

• Submit via Unanticipated Problem and/or Adverse Event Report

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).

• Submit via Single IRB (sIRB) Authorization Agreement

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.

• Submit via Transfer Agreement for Protocols, Data or Materials