Compliance

Regulatory Partners

This is the intersection point where administrators of other regulations and/or processes can connect with the CPHS about proposed research. Examples: FERPA, Data Security, BioHazard Safety, etc.

Human Subjects Research often requires the research team to gain access to populations or analyze personally identifiable private information (PII data) which are protected by other regulations or institutional processes. As such, human subjects researchers must obtain authorization to access these populations or data prior to conducting their research activities.

Common populations or PII data used by researchers:

  • CSUMB Students
  • CSUMB Faculty and/or Staff
  • Student and/or Alumni PII Data

Common activities that prompt other authorizations:

  • Collection of Protected Level 1 Confidential data (see: 8065.S02 Information Security Data Classification)
  • Collection of biosamples (saliva, sweat, hair, nail, etc.)
  • Collection of Inherent data (biometric information -- physiological and behavioral)

Frequently Asked Questions & Answers

  • Research which meets the federal definition of Human Subjects Research must be processed through the CPHS so the researcher is most likely contacting you while they're developing their CPHS Application. You may read their application and provide access authorization (or not) at any time. Most administrators prefer to provide access based on the final protocol (AKA: approved application). But often it's necessary for a researcher to obtain "authorization in principal" or "conditional authorization" contingent upon the final protocol not deviating (much) from the draft you read and conditionally approved. Work with the researcher and/or the CPHS to negotiate an agreed upon process that works for both of you. The CPHS abides by the wishes of the site/administrator.

    The researcher should be familiar with researcher-guidance on this topic which dovetails with your instructions: Guidance for HSR Data or Population Access Requests.

  • CSUMB doesn't currently have a single mechanism for processing requests which are Not HSR (i.e.: don't require CPHS review). Each administrating office has their own business process. That said, there are some important red-flags regarding Human Subjects Research to watch for:

    • Many researchers don't know that research meeting the federal definition of Human Subjects Research must be reviewed by an IRB (the CPHS is CSUMB's IRB). The researcher should be able to provide you with a concise explanation why their project is Not HSR (and therefore not subject to IRB/CPHS review and approval). If they can't, the project might be HSR, or the researcher might not be qualified to carry out the proposed activities due to lack of knowledge.
    • Many researchers don't know that all research is subject to all applicable regulations, laws and institutional policies, regardless of whether or not it requires CPHS review. For example, a researcher polling students about their grades must abide by FERPA Law and CSUMB's FERPA Policy, even if the research isn't subject to IRB/CPHS review and approval.

Are you an administrator from outside CSUMB, such as another campus and/or agency?

Frequently Asked Questions & Answers

  • The CPHS determines reliance agreements on a case-by-case basis contingent upon the institution's capacity to manage a given protocol. Submit the request via the Single IRB form to start the dialog.

  • Research which meets the federal definition of Human Subjects Research must be processed through the CPHS so the researcher is most likely contacting you while they're developing their CPHS Application. You may read their application and provide access authorization (or not) at any time. Most administrators prefer to provide access based on the final protocol (AKA: approved application). But often it's necessary for a researcher to obtain "authorization in principal" or "conditional authorization" contingent upon the final protocol not deviating (much) from the draft you read and conditionally approved. Work with the researcher and/or the CPHS to negotiate an agreed upon process that works for both of you. The CPHS abides by the wishes of the site/administrator.