In this section
- How Do the New Regulations (effective January 21, 2019) Impact My Project?
- Do I Really Need Cal Poly Institutional Review Board (IRB) Approval before I Can Proceed with my Research Project?
- What Kind of IRB Review is Required?
- Do I Need Additional Training Before I Can Submit an Application for Federal Funding for my Research?
- What Do I Need to Submit for Review?
- Where Can I Get the Forms I Need? Where Do I Submit my Proposal Materials?
- What is the Timeframe for Receiving an IRB Decision?
- How Likely am I to Obtain Approval for my Research?
- What Happens If I Conduct Research without Cal Poly IRB Approval?
- If I Have Submitted my Human Subjects Proposal, Can I Start My Research while I’m Waiting for Approval?
- Can I Conduct my Research Online?
- What if I Plan to Work With Subjects Who Do Not Speak English?
- How Will I Know That My Research Proposal Has Been Approved?
- Can the IRB Require Me to Change My Methodology?
- Can IRB Review and Discontinue Research In Progress?
- If My Research Proposal is NOT APPROVED, Can I Appeal This Decision?
- Where Can I Get Answers to Additional Questions?
Human Subjects -- Frequently Asked Questions
How Do the New Regulations (effective January 21, 2019) Impact My Project?
If your project was approved prior to January 21, 2019, it is considered an ongoing project and no adjustments are needed to the approved protocol or other documents, such as the consent form(s), to comply with regulations. If your project was or will be approved on or after January 21, 2019, it will be reviewed under the new regulations and all components of the project must comply with the Federal regulations published in 2018. If your ongoing project’s approval expires after January 21 without a timely continuing review request, the approval is considered lapsed and the project will have to be submitted as a new project and will be reviewed according to the 2018 (new) regulations. This will require all documents, including consent form(s), to be compliant with the new regulations.
Do I Really Need Cal Poly Institutional Review Board (IRB) Approval before I Can Proceed with my Research Project?
- I'm just doing a senior project. Does that need IRB approval? Answer: Yes! Many senior projects are "published" in the Kennedy Library and are available to anyone in the world via the internet or interlibrary loan. The review process is part of your education as a Cal Poly student, and Cal Poly is responsible to oversee the work you do during senior project.
- I'm collecting data from students in my class. Do I need IRB approval? Answer: That depends. Will the results be used for a class project that does not extend beyond the class itself? If so, then you are not expanding the body of knowledge in your discipline to the extent that human subjects approval is required. If you plan to use the results to develop a presentation for a professional meeting or a publication, etc., then approval IS required. Be aware that some kinds of student information are protected by FERPA, the Family Educational Rights and Privacy Act.
- I'm an off-campus researcher employed by a different university, or another separate entity. I plan to collect data from Cal Poly students, staff, faculty, or attendees at a public event on the Cal Poly campus or during a Cal Poly-sponsored event. My own Institutional Review Board (IRB) has already approved my research. Do I also need Cal Poly IRB approval? Answer: Yes! Any research involving Cal Poly students, staff, faculty, or members of the general public at a Cal Poly affiliated-event also must be reviewed and approved by Cal Poly before data or tissue samples are collected.
- I'm a television news reporter surveying students about their opinions of the new registration fees. The interviews will be edited and broadcast on TV this evening. Do I need Cal Poly IRB review and approval? Answer: No, this kind of information gathering is not considered "research" as defined by the Cal Poly Policy on the Use of Human Subjects in Research. However, you may need approval from another university entity such as Police Services or Public Affairs.
What Kind of IRB Review is Required?
This depends on the proposed involvement of your subjects as well as the potential risks to human subjects. See the section in the Procedures and Guidelines on "Determination of Risk Level and Type of Review Required."
Do I Need Additional Training Before I Can Submit an Application for Federal Funding for my Research?
No, not before you submit a proposal to the Federal government. However, approved training will be required before a funding award will be made. You can fulfill the federal requirements for training for research involving human subjects online at the Federal training website.
What Do I Need to Submit for Review?
The IRB needs to know enough about your planned procedures to evaluate the risks and potential benefits to human subjects. See the section on "The Review Process" in the Procedures and Guidelines.
Where Can I Get the Forms I Need? Where Do I Submit my Proposal Materials?
You can access the online forms using IRBManager; instructions on how to use IRBManager are available in "The Review Process" section of the Procedures and Guidelines.
What is the Timeframe for Receiving an IRB Decision?
If you think your project is eligible for minimal review, please allow one to two weeks for review of the proposal. The timing of approval will vary depending on the completeness of the proposal documents, number of submissions currently being processed, and staff availability.
If you anticipate that your project will be subject to an expedited review, please allow about two to four weeks following receipt of the complete submission. Full reviews may require additional time, a month or longer, to provide the researcher with a response from the IRB.
Researchers should expect that there may be delays to expedited or full review proposals submitted during finals week, holidays, or quarter breaks, due to the academic schedules of the IRB members. Projects submitted for minimal review usually can be reviewed without delays during these periods. More often delays occur when submissions to not include complete information; please make sure your submission includes all the information requested per the Procedures and Guidelines.
How Likely am I to Obtain Approval for my Research?
The vast majority of research proposals reviewed by the IRB are approved, usually after minor revisions to procedures, informed consent forms, etc. In rare cases, proposed research is not approved. Usually this is because the prospective risks to human subjects outweigh the potential benefits, or the research is designed in such a way that it is unlikely to answer the research questions or merit the involvement of human subjects.
What Happens If I Conduct Research without Cal Poly IRB Approval?
This depends on the circumstances. See the section on "Noncompliance" in the Procedures and Guidelines. The main purpose of the review is to protect human subjects from harm. Secondary purposes are to protect the researchers and the university. If you conduct research without approval and subjects are harmed as a consequence of their involvement, you may be held solely responsible for the harm even if the research was conducted as part of your professional responsibilities as a Cal Poly employee or as part of student degree requirements. The university has agreed to adhere to the Federal regulations regarding the use of human subjects in research as a condition of receipt of Federal funding. Failure to fulfill the obligations specified in the regulations could result in the loss of millions of dollars of federal funding that the university receives each year. Most professional organizations require human subjects research review and approval for research as part of their ethical codes of conduct.
If I Have Submitted my Human Subjects Proposal, Can I Start My Research while I’m Waiting for Approval?
NO. You must have approval in order to begin work, including recruiting subjects.
Can I Conduct my Research Online?
Yes, as long as your methodology includes obtaining "informed consent" before your other data, and as long as appropriate methods are used to preserve the anonymity or confidentiality of your subjects (as appropriate). Research involving online methods, like any other research involving human subjects, must be approved by the Cal Poly IRB. See the section on "Internet Research" in the Procedures and Guidelines.
What if I Plan to Work With Subjects Who Do Not Speak English?
If you plan to work with individuals who have no or limited ability in English, you will need to provide two versions of the informed consent and other materials that will be given to participants -- one in English and one in the language of the participants. These must be identical in content. Additional review time will be needed for projects of this type; poor translations will delay approval even more. Allow 3 additional weeks or more for approval. See the section on "Informed Consent Guidance" in the Procedures and Guidelines.
How Will I Know That My Research Proposal Has Been Approved?
You will receive an e-mail message and/or a written letter which states that your research proposal has been approved by the IRB. If there are conditions of approval, these also will be stated at this time and you will have to satisfy the conditions before proceeding. The faculty advisors for student research projects will be copied on this correspondence. Approval is valid for a period of one year, after which approval must be renewed if data collection or analysis from human subjects will continue.
Can the IRB Require Me to Change My Methodology?
Yes, the Cal Poly IRB can either recommend or require changes in methodology as conditions of approval. By law, Cal Poly's IRB must weigh the relative benefits of research against the prospective costs, including risks, and must find that the benefits outweigh the risks. See HHS Policy 45 CFR 46.111(a). If regular IRB members lack the expertise to evaluate the methodology of proposed research involving human subjects, they will seek input from those with the appropriate expertise. If the methodology or research design is judged suboptimal, or the risks of research are too great, the IRB may determine that the costs outweigh the benefits as the research is originally proposed. This may lead to recommended or required modifications to either reduce the risks and/or improve the prospective benefits of research such that the costs of the research are justifiable.
Can IRB Review and Discontinue Research In Progress?
Yes, the Cal Poly IRB is charged with monitoring research in progress. The degree and frequency of monitoring is subject to the discretion of the Vice President for Research and Economic Development and the IRB, and depends on the relative risks of research as well as any complaints which may be received. When the Vice President for Research and Economic Development or IRB Chair determine that the costs of research outweigh the prospective benefits, he or she may withdraw IRB approval and call for discontinuation of research in-progress, pending renewal of approval by the IRB. See HHS Policy 45 CFR 46.113.
If My Research Proposal is NOT APPROVED, Can I Appeal This Decision?
If your proposal was disapproved under either “Minimal Review” or “Expedited Review”, then you can appeal to the convened (full) IRB for reconsideration. The decisions of the fully convened IRB are final. Under Federal regulations, researchers cannot attempt to circumvent the decisions of the fully convened Cal Poly IRB by appealing to their Department Chairs, Deans, the University Provost or President, the Academic Senate, an external funding agency, etc. See HHS Policy 45 CFR 46.112. The full IRB may reconsider revised proposals at the discretion of the Vice President for Research and Economic Development or the Chair of the IRB.
Where Can I Get Answers to Additional Questions?
For additional information, you may contact Trish Brock, Director of Research Compliance, firstname.lastname@example.org, (805) 756-1450; or Dr. Michael Black, the Chair of the IRB, email@example.com, (805) 756-2894.