Human subjects research: When and why to consult the ASU IRB

Learn everything you need to know about obtaining IRB approval for your human subjects research in upcoming sessions hosted by the Research Academy.

Who is the ASU IRB?

If you are a student, faculty or staff whose research involves people (referred to as human subjects), you need to get approval first. At Arizona State University, this approval comes from the ASU Institutional Review Board. The ASU IRB checks and approves research plans to make sure they follow ethical guidelines and legal requirements. They review the procedures and materials you plan to use to ensure that they protect the people participating in your research. The IRB is part of the Office of Research Integrity and Assurance, which helps create and enforce university research policies and supports researchers in following these guidelines.

You might wonder why the ASU IRB is important if you’re not in a STEM field. Here’s why: if your research involves interacting with people (such as conducting surveys to gather opinions), collecting and analyzing their information (like survey responses), and using the results for publication or to contribute to general knowledge, it falls under human subjects research as defined by The Common Rule (45 CFR 46). The ASU IRB reviews research proposals from various departments and colleges across the university, including the College of Liberal Arts and Sciences, W.P. Carey School of Business and Mary Lou Fulton Teacher’s College, to name a few.

What does the ASU IRB do?

When you submit an IRB application through the Enterprise Research Administration system, it undergoes an initial review process. This review may be conducted by ORIA IRB staff, a few individual board members, or by the entire IRB board. During convened board meetings, the board decides whether your submission is approved, needs changes, or is not approved at all. Most research submissions don’t require a full board review. However, if your research is considered "greater than minimal risk," it will need to be reviewed by the full board.

The ORIA IRB staff work closely with two specialized IRB boards: the Social Behavioral IRB and the Bioscience IRB. Both boards include a range of members as required by regulations. A current list of members is available for both boards. Additionally, ORIA IRB staff work with other research compliance experts to handle specific issues, such as financial conflicts of interest related to the proposed research.

Why is the ASU IRB so important?

To ensure your human subject research gets reviewed quickly, it’s a good idea to work closely with the ASU IRB and make use of the resources they offer. The ORIA IRB staff are available to help you with every step, from protocol development, preparation of additional required materials, initial submission through ERA and managing your study after you’ve received approval.

How can I learn more about the ASU IRB?

The ASU IRB Office is offering various sessions in the fall 2024 semester via Research Academy, ranging from protocol submission processes to special topics such as research considerations when using emerging technologies. The sessions are open to all ASU faculty, staff and students who are interested in learning more about human subjects research. To sign up, please review the sessions on the ASU IRB’s Research Academy landing page. 

If you’re interested but unable to attend the sessions, you can schedule a one-on-one consultation with ASU IRB staff to address your needs. The ASU IRB also provides outreach presentations to departments as well as specific classes that discuss human subjects research in their curriculum. 

How do you know if your research falls under the “human subjects” definition?

To understand what is meant by human subjects research, we must first understand the federal definitions of "research" and "human subjects" as defined by 45 CFR 46.102. 

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. To determine if your project is "research," let's break down the definition into two parts:

1. Systemic investigation: generally, refers to a methodical approach to the activity. It likely involves a hypothesis, a research question, and a plan to systematically collect and analyze data.
2. Generalizable knowledge: If the proposed study develops or contributes to generalizable knowledge, the systematic investigation adds information and contributes to generalizable knowledge in the field. This can be in the form of a thesis, dissertation, publication, etc.

The main concept here is that if the proposed study’s results will be shared outside of ASU with peers at other institutions and with the general public, then the ASU IRB would consider this contributing to generalizable knowledge and, therefore, warrant ASU IRB review.

A Human Subject is a living individual about whom an investigator conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

Though the key component of this definition is that the individual must be a living person, it is important to understand the other components (which can be reviewed under 45 CFR 46.102). 

It can not be overstated that “human subjects research” is research with people. 

Contact

ContactASUIRB@asu.edu for more information and register for upcoming sessions via Research Academy.