Compliance

Standard HSR Protocol vs. a Not HSR Verification

To learn more about whether or not your protocol requires standard IRB review, check out our guidance on: When is CSUMB IRB review required?

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 IRB 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)

• Cayuse Human Ethics: Our online, cloud-hosted, development and submission system.
  
  
• Other applicable laws, policies, and "standards of professional conduct" approvals

Need Help? Contact us at irb@csumb.edu

2. Attachments

Forms and guidance are available in this Google Drive.

Training Certifications

• HSR certification from CITI will be stored in your Cayuse profile.
• Attach a PDF of any additional optional/applicable training. This should be completed in advance of protocol submission or you may be required to complete it prior to protocol approval.

Instruments or Diagrams

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

Recruitment Documentation

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

• 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 IRB 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

Required for Greater Than Minimal Risk studies

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.

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. CSUMB students will need to request access to utilize Cayuse. Please utilize this form and allow up to 5 business days for processing.

Not HSR Verification

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

• Cayuse Human Ethics: Our online, cloud-hosted, development and submission system.
• Other applicable laws, policies, and "standards of professional conduct" approvals

Need Help? Contact us at irb@csumb.edu

2. Attachments

Forms and guidance are available in this Google Drive.

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

Amendments & Renewals

Modifications, Changes, and Extension Requests

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

• • Submit via Cayuse Human Ethics

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 Cayuse Human Ethics

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 Cayuse Human Ethics

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, contact IRB at irb@csumb.edu.