Do I Need Approval?

Buena Vista University is committed to safeguarding and respecting the rights and welfare of human subjects and vertebrate animals involved in research. In order to carry out this obligation, the University, through its Institutional Review Board/Institutional Animal Care and Use Committee (IRB/IACUC), is responsible for conducting initial and continuing review of all research that involves human subjects and vertebrate animals. Investigators cannot begin research with human subjects and vertebrate animals until a complete application has been submitted to the IRB/IACUC, reviewed and approved.

What is considered Human Subjects or Vertebrate Animal Research?

One of the most challenging aspects of Human Subjects and Vertebrate Animal Protection is determining what constitutes "human subjects and vertebrate animal research" in order to determine what requires IRB/IACUC review. Trying to decide, for example, whether a faculty member needs IRB/IACUC approval in order to conduct a classroom assessment or a student needs IRB/IACUC approval to conduct a survey for a course project can be confusing. Fortunately, we can help!

To determine what constitutes research, consider:

1. Is it Research?

For purposes of IRB/IACUC review, "research" is defined as "a systematic investigation designed to develop or contribute to generalizable knowledge." (45.CFR 46.102).

Activities that meet this definition constitute "research" whether or not they are supported or funded by an external agency. Some "programs" and "projects" may also include research activities, particularly if there will be an assessment or evaluation. Projects at the undergraduate or graduate level such as thesis, honors, or seminar projects may also be considered "research."

2. Are Human Subjects Involved?

For purposes of IRB review, a "human subject" is defined as "a living individual about whom an investigator conducting research obtains (1) data through interaction or intervention with the individual or (2) identifiable private information." (45.CFR 46.102)

3. Are Vertebrate Animals Involved?

For purposes of the IACUC review, Buena Vista University references The Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals, which is based on the United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. This policy covers all vertebrate species of animals including birds, mice and rats and it covers all research that is funded by the National Institutes of Health (NIH).

What else should I consider?

Determining whether something is research that involves human subjects or vertebrate animals can be surprisingly complicated and depends on a variety of factors. There are a number of questions to think about as you determine whether you will need IRB/IACUC approval:

• Do you intend to collect information and then present it to a public audience or at a conference?
• Do you intend to publish findings or disseminate information based upon your work?
• Will you be conducting interviews, surveys or focus groups?
• Will you need access to sensitive data or records?
• Is there any way to link the data you plan to collect with identifying information?
• Are you seeking grant funding?

If the answer to any of these questions is "yes" your work may require IRB review.

If you suspect that your research might constitute human subject or vertebrate animal research, please contact the IRB/IACUC Chair, to discuss the specific circumstances of your project. The IRB/IACUC Chair is happy to help you determine whether or not your work will require IRB/IACUC review. It is usually better to err on the side of caution if you will be working with human subjects or vertebrate animals to ensure both their protection and your own.

See Frequently Asked Questions about the Review Board (IRB/IACUC).

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