Human Subjects -- Frequently Asked Questions

Do I Really Need Cal Poly Institutional Review Board (IRB) Approval before I Can Proceed with my Research Project?

If the answer to the following 3 questions is "YES", then you need approval from the IRB before you can recruit human subjects and collect data:

  • Question #1: Am I collecting/using data or tissue samples about or directly from human subjects?
  • Question #2: Will I use the data or tissue samples as part of a systematic investigation that is designed to expand the body of knowledge in an academic or professional field of study ? (e.g. through a publication in a peer-reviewed journal, or a presentation at an academic or professional meeting, etc.)
  • Question #3: Am I a member of the Cal Poly faculty, staff or student body collecting data or tissue samples as an official part of my work or degree program at the university, or am I employed by another entity but collecting data or tissue samples from Cal Poly employees, students or members of the general public in a Cal Poly facility or during a Cal Poly-sponsored event/activity?

Examples:

  1. 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.
  2. 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.
  3. 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.
  4. 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 Human Subjects Policy. 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.

There are 3 levels of review:

  1. "Minimal Review" (also known as "Exempt from further Review"). Minimal review is usually only done by one IRB member and is acceptable for most forms of observational or survey research, etc., involving minimal or no risks to subjects. The review is conducted by the Chair of the IRB, the Compliance/Information Officer, the Dean for Research, or specific members of the IRB. Minimal review can take 1 to 2 weeks.
  2. "Expedited Review." Expedited review is conducted by at least two members of the IRB, usually the Chair, the Compliance/Information Officer, or the Dean for Research and at least one other member of the IRB. This type of review is for research involving no more than minimal risk to human subjects, and defined by the Federal regulations as falling into one of seven categories of research allowed for expedited review.  Examples include audio or film recordings, projects in which subjects are asked to disclose sensitive information, moderate or maximal exercise protocols, and noninvasive procedures such as weighing and testing of sensory acuity. Expedited reviews generally take 3-4 weeks.
  3. "Full Review." Full review is conducted by the convened IRB and is appropriate for any research involving more than minimal risk to human subjects or for when exemption is not allowed (all research involving prisoners and some involving children), and the research does not qualify as one of the "Expedited Review" categories. Examples include research involving the use of experimental drugs, invasive surgery, stimulus deprivation, threat of significant financial loss to subjects, etc. Full reviews can take a 1-2 months or longer, depending on the complexity and risks involved.

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. You should prepare the following materials for review:

1.  Human Subjects Protocol Approval Form

2.  Research Protocol, a description of your planned procedures including:

  1. Who your subjects will be (are minors or other vulnerable populations involved?)
  2. Recruitment methods
  3. Data collection methods
  4. Classification of data (anonymous? confidential? non-confidential?)
  5. Methods to preserve anonymity or confidentiality of the data (if applicable)
  6. Potential risks to human subjects and methods to minimize these risks
  7. Potential benefits of research; either direct benefits to the subjects and/or benefits to your field of study and humankind if the research is conducted.

Where Can I Get the Forms I Need?

You can download forms from the Forms and Links page, or obtain paper copies from the Office of Research and Economic Development, Bldg. 38, Room 154.

Where Do I Submit my Proposal Materials?

Proposals may be submitted electronically or as printed copies to the Compliance/Information Officer, Debbie Hart, at dahart@calpoly.edu and located in Building 38, Room 154.

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. 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. Most peer-reviewed journals will not publish research that was not reviewed and approved by an appropriate IRB before it was conducted. Students who do not obtain IRB approval before conducting research, e.g. for senior project, masters thesis, or dissertation work, could risk not receiving course credit for these endeavors or fulfilling graduation requirements contingent on this work.

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.

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.

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. 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 Dean for Research and the IRB, and depends on the relative risks of research as well as any complaints which may be received. When the Dean of Research 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 (Exempt from Further) 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 Dean of Research or the Chair of the IRB.

Where Can I Get Answers to Additional Questions?

For additional information, you may contact Debbie Hart, Compliance/Information Officer, dahart@calpoly.edu, (805) 756-1508; Dr. Michael Black, the Chair of the IRB, mblack@calpoly.edu, (805) 756-2894; or Dr. Dean Wendt, Dean of Research, dwendt@calpoly.edu, (805) 756-1508.

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