Office of Research, Innovation, and Economic Development

Policies & Procedures

In accordance with federal guidelines for the protection of human subjects, research involving human subjects is defined as any systematic investigation of living human subjects or human materials that is designed to develop or contribute to generalizable knowledge.   Human subjects research which requires review by the IRB includes faculty research, master's theses, doctoral dissertations, and senior projects as well as research conducted on campus by parties not directly affiliated with the University. While the ethical principles for research are often applicable to classroom activities, demonstrations, and assignments, the IRB does not review classroom activities unless data will be collected and used in a systematic investigation (fulfilling part of the criteria of the federal regulation defining human subjects research, HSR).

An example of when IRB oversight is not needed or required is the following.  A faculty member collects data from students to study possible means of improving graduation rates with the intention of sharing the results only within the department or college.  The operative word is "only" because the study is not contributing to generalize knowledge (often interpreted as a publication or a conference presentation, but there are other ways).  The data are being kept and used within Cal Poly.  The IRB would still recommend utilizing IRB concepts, e.g., informing the participants of what the internal study is about.  Further, the data cannot later be used in a publication except in a general way (e.g., based upon a pilot study, we learned X about Y) because the IRB did not have the opportunity to ethically review the proposed study in a protocol.  IRBs are prohibited by federal regulation from retroactively approving human studies.

The policies of Cal Poly’s IRB are fully described in the document "Policies and Procedures of the Institutional Review Board (IRB) (aka Policies and Procedures for Human Research Protection)" (PDF) originally published on September 11, 2007, it continued to be updated periodically with a date notation in applicable sections - the current version is November 2020. Please bring issues (typographical errors, questions, suggestions for inclusion, etc.) to the attention of any member of the IRB, or email us at irb-office@cpp.edu .

Section 14 contains specific and focused guidelines relating to, for example:

  • (14.14) request by unaffiliated PIs to do HSR at Cal Poly Pomona
  • (14.17) clarifying the differences in "engagement" roles between PIs and research assistants
  • (14.12 and 14.15) exempt reviews like PEIP (Policy on Education Improvement Protocols) and SAE (Studies of Assessment and Evaluation).

For student research guidance - Review the Faculty Information Sheet 

Do contact the IRB members ( irb@cpp.edu)  and the compliance associate (irb-office@cpp.edu) with other questions, interpretations of federal regulations, and information about Cal Poly Pomona guidelines and policies.

 Unaffiliated investigators

The CPP IRB is supportive of research by others who want to collect data from human subjects at Cal Poly Pomona, while at the same time being mindful of the impact on resources and implications for the campus. Individuals may of course collaborate with members of the CPP faculty and staff to conduct investigations of mutual interest. Please submit your documents through the unaffiliated researcher access request form

The documents will be reviewed for consideration by the IRB, once approved the unaffiliated investigator will be notified via email and/or direct approval memo from the Cayuse IRB system. the approximate turnaround time is 2-3 weeks. 

*The IRB will not approve unaffiliated research requests involving minors.

INSTITUTIONAL AUTHORIZATION AGREEMENTS (RELIANCE AGREEMENT)

DEFINITIONS / ROLES AND RESPONSIBILITIES   

What is a Reliance Agreement?

A reliance agreement (also called an IRB Authorization Agreement): is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.

Single IRB (sIRB): One IRB of record (or Reviewing IRB), selected on a study-by-study basis, provides the ethical review for all sites participating in a specific multisite study.

 Relying IRB: IRB that relies on the reviewing IRB for the regulatory reviews. The relying IRB is still responsible for institutional reviews (COI, Radiation, Biosafety, Privacy, and others).

 Reviewing IRB: The selected IRB of record that conducts the ethical review for participating sites of the multi-site study, including initial reviews, modifications, continuing reviews, and reportable events.

Lead PI: Responsible for the communication and overall conduct of the study and regulatory compliance. The Lead PI will be submitting the regulatory IRB submissions on behalf of all the sites relying on the reviewing IRB. (Note: The Lead PI may not always be associated with the reviewing IRB, but the Lead PI’s responsibilities nevertheless remain the same.)

Relying PI: Responsible for providing the Lead PI with necessary information according to the reviewing IRB’s policies and procedures so the reviewing IRB can conduct an IRB review. The relying PI must know what is also required from their local relying IRB. Relying PI responsibilities

An IRB Authorization Agreement (IAA) assigns the responsibility for the review of research required under a Federal Wide Assurance (FWA)* to one or more IRBs. This IRB can assume this responsibility for another institution, or can cede this responsibility to another IRB.

*An FWA is an agreement between an institution and the U. S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) which requires IRB review of human subjects research as a condition of eligibility for federal grants.

An IAA is put in place when the collaborating institution has an FWA, although it might not have a registered IRB if ceding review to Cal Poly Pomona. An IAA can also be put in place if both institutions have registered IRBs, but it makes more sense for one IRB to take on oversight. Please refer to the OHRP website for more information about IAAs. If the Cal Poly Pomona PI is requesting our IRB to be the reviewing institution, an IRB protocol must be created within the Cayuse IRB system and the CPP PI must contact the collaborating PI and/or IRB request guidance on proper procedures for that institution. Please email irb-office@cpp.edu to inform the IRB of your desire to collaborate with another institution to ensure appropriate resources are available and additional information is provided in a timely manner.

CPP Investigator requesting reliance agreements ( IAA's) for unaffilaited lead PI's must :

  1.  Email (irb-office@cpp.edu) a summary of the research related activities along with:

a. Collaborating institution name, PI name and contact information  

b. Collaborating IRB contact information

c. If available approved protocol, it's attachments and approval letter

*Ensure all human subject research protection training for research assistants has or will be completed prior to research engagement ( leading PI's and co-pi's must have completed their training prior to IRB approval).

2. Once the IRB reviews the request, an email acknowledgement will follow with additional guidance and/or questions (or reasons for disapproval to participate in the project). 

3. The IRB office will create a submission within the cayuse IRB system ( called a "legacy") to incorporate all documents related to the request (including approved protocol).

4. The IRB Chair and Institutional Official will approve the collaboration and execute the IAA between institutions. 

* Whether the CPP affiliate is a leading or relying PI they are encouraged to be in communication with both IRB's to ensure understanding of proper procedures and that the IRB is aware of details which can impact the approval timeline.

When Cal Poly Pomona IRB is not the IRB of record, the relying PI must follow the Cal Poly Pomona IRB Obligations listed in the IRB Cayuse application/ IRB policies and procedures, as well as the reviewing IRB’s Policies and Procedures.

Requests for IAAs are considered by the IRB on a case-by-case basis subject to the approval of the IRB Chair and the designated Institutional Official ( Associate Vice President for Research at Cal Poly Pomona University).

 

SPECIAL CONSIDERATIONS REGARDING ONLINE SURVEYS

  • Online surveys should allow “no response” as an option for every question. That is, a survey design where one cannot proceed without answering the question is in violation of the respondent’s right to withhold information.
  • Sensitive data must be protected as it moves along communication pathways between computers. If using a commercial site (e.g., Zoomerang, Qualtrics) the researcher should review the site’s security measures for protecting respondent privacy and data confidentiality.
  • The researcher’s agreement with the commercial site should include specific provisions about how, and for how long, it will store the data.

International Research with Human Subjects Checklist (*Adopted from Tufts university) Use this checklist when developing your protocol and other study documents for international research projects. 

 

 Assessment "not regulated by the IRB": When You Don’t Need an IRB Application at All

If your project involves data collection with human subjects and the only goal is to use the data to inform/improve internal practices, then you do not need to submit an IRB application (this includes an application for exemption).  This is a category of data collection referred to as not regulated. The IRB only reviews activity that has a research goal. Internally-focused assessments do not have a research aim, as defined by the IRB*. 

Not submitting an IRB application -- means that you have no plans to present or publish the data you collect. If you plan from the outset to present or publish your data, you must submit an IRB application. When submitting an IRB application, there are conditions under which you may be able to submit an application for ‘exemption’ (described below).  If you are conducting internally-focused data collection without a research goal (i.e., without an IRB application) and you later decide to present or publish those existing data, you must submit an IRB application for the ‘secondary use’ of those data.

Student based assessments

Before collecting assessment data, ask yourself whether you intend to disseminate findings or
would disseminate if the findings are interesting / valuable. If the answer to either of these
questions is 'yes', IRB approval is required PRIOR TO the data collection.

Students should be provided advanced notice of the classroom-related research project within
the class syllabus, if the research is to assess the entire course. In addition, IRB approval is required PRIOR TO the analysis of previously collected (e.g., past semesters) data (e.g., coursework, grades, attendance rates, etc.) for research / dissemination purposes. If decisions are made later to disseminate results or analyze data for research / dissemination purposes, IRB approval for the analysis / use of existing data is required as soon as there is intent to analyze the existing data for research / dissemination purposes.

*Determination Decision Tree 

Exempt category criteria

  • poses no more than minimal risk
  • does not involve vulnerable populations (e.g., prisoners, children, pregnant women)
  • does not involve deception
  • does not involve access to student education records under FERPA ( if you must collect this information, the review category will be expedited or fullboard)

* Per HHS Regulations (46.102) research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” In other words, research activity involves a goal of publishing or presenting data in order to advance knowledge in a field or discipline.  If there is any element of research in an activity, that activity should undergo review for the protection of human subjects.