Human Participant Research
|Paula Garcia McAllister, PhD|
What is the IRB, and Who Needs It?
Research helps us answer questions about life, humanity, and the world around us. It is one of the most important elements in graduate education. Researchers see their research activities as very important to their field, to the world, and to their own professional advancement. Because research can be such a powerful thing, researchers hold a great responsibility to the people who are involved in their research; this responsibility is the cornerstone of ethical research conduct. This article provides some nuts and bolts information for graduate students who have human participant research in their future.
Who regulates human participant research and why?
The Institutional Review Board (IRB) is charged with reviewing research that involves human participants. Such research is regulated because of past abuses in research such as the Tuskegee Syphilis Study, the Stanford Prison Experiment, and the Monster Study. The Office of Human Research Protections, part of the U.S. Department of Health and Human Services, is the federal agency that regulates human participant research. Various state laws also contribute to human participant research regulation, such as the state law on minors.
What types of research require IRB review?
The federal guidelines state that all research that involves living human participants must be reviewed by an IRB. By “research,” they mean a systematic investigation designed to develop or contribute to generalizable knowledge. By “living human participants,” they mean a living individual about whom an investigator obtains data or identifiable private information. For more information on these definitions, see What Projects Need IRB Review.
Usually, all dissertations and master’s theses that involve interaction with human participants require IRB review because they are, by design, meant to contribute to generalizable knowledge within their academic field. Projects that include surveys, interviews, focus groups, videotaping or audiotaping of participants, or treatment groups usually require IRB review. Also, projects that involve records review or the analysis of previously collected data may also require IRB review if the data originated from living human beings. Projects that involve historical records of the deceased or ancient artifacts, for example, do not require IRB approval. Also, projects that involve the analysis of de-identified products, such as collections of published writing, also do not require IRB review. If you are unsure about whether your project requires IRB approval, call the IRB office at (928) 523-4236 and describe your project.
What is the process for obtaining IRB approval?
Once you have formulated your research plan and determined that your project requires IRB review, go to the IRB website and take the CITI tutorial, which is an internationally known and widely accepted tutorial about ethics and responsibilities in human participant research. Your faculty sponsor and any other researchers working on your project, such as research assistants, also need to take the tutorial or may have already taken it. The tutorial is good for two years, after which researchers need to take it again.
After taking the tutorial, fill out the IRB application, which is an online form called NAIRBe and available on the IRB website. There are additional tools available to assist you with this, such as the Worksheet for Drafting Responses and pop-up help boxes that appear when you click on a question within NAIRBe.
Once you have completed your online application, your faculty sponsor receives an e-mail directing them to your online application for their approval. At this point, your faculty sponsor will approve it or send the application back to you with a request that you make changes. Once your faculty sponsor approves the application, it is directed to the IRB for review.
In review, your IRB application is checked for completeness, reviewed for the methodology, and placed is a category of review (see below). If anything is incomplete or unclear, you will hear back from the IRB within 10 working days of the submission of your application. The IRB will work with you until your project is approved.
What are the review categories?
Projects that require IRB approval are placed into one of three categories:
Exempt – These studies involve minimal risk to participants and conventional methodologies. Projects that involve the assessment of normal educational practices, non-threatening surveys, or the analysis of existing data are often classified as exempt. These projects are approved indefinitely.
Expedited – Minimal risk projects that include the audio or videotaping of participants, focus groups, a treatment/control group design, or mildly invasive procedures such as the placing of electrodes often classify as expedited review. These projects are approved for a period of one year or less; they can be renewed by filing an Application for Continuing Review available on the Forms page of the IRB website.
Full Board Review – These projects may present greater than minimal risk, involve vulnerable participant groups, or involve novel methodologies. Vulnerable groups include children, pregnant women and their fetuses, and prisoners. Other participant groups that may send a project to full board review are the cognitively or mentally impaired, at-risk youth, undocumented individuals, and Native Americans. Research involving Native Americans must be reviewed by tribal governments prior to being reviewed by the NAU IRB.
What is the timeline for attaining IRB approval?
This depends on how complete and clearly written your IRB application is. If your project falls under exempt or expedited review and there are no requests for additional information or documents, your project can be approved within two weeks of submitting your application. If there are revisions or missing documents, then the timeline for your approval is based on how quickly you can get the revisions or missing documents back to the IRB.
If your project is reviewed by the full board, you will be informed at least one week before the board meeting at which your application is discussed. You will be invited to attend a question/answer session with the board. The board meets on the second Monday of each month without break year-round (see the calendar). The timeline for approval of applications requiring full board review depends on when the application is submitted in relation to the date of the next board meeting, how many revisions or additional documents are required, and how quickly you respond to the board’s requests.
Are there other IRBs?
Most hospitals, such as Flagstaff Medical Center, and universities have IRBs, and most Native American tribes have an IRB-equivalent body, such as the Navajo Nation Human Research Review Board. If you are collaborating with an outside entity that has an IRB or equivalent, you will likely need to secure IRB approval from that entity either before or shortly after receiving NAU IRB approval. The exception is research involving Native Americans, which must be approved by the tribe prior to applying for NAU IRB approval.
Please note that if you are involving an entity that does not have an IRB, you will still need to get a letter of support from that entity prior to applying for NAU IRB approval. This includes local entities such as the Flagstaff Unified School District or any other school district, the Peaks Nursing Home, the Summit Center, the Museum of Northern Arizona, etc.
What are the consequences of NOT obtaining IRB approval?
Unapproved research is inadmissible as a dissertation or master’s thesis because the results are unusable. Without IRB review, it is unknown if the data were collected within the guidelines of federal regulations and therefore cannot be published, as dissertations and master’s theses are. Your faculty advisor should inform you about obtaining IRB approval. Failure to comply could subject you and your faculty sponsor to sanctions such as suspension of all research. If you are unsure if your project requires IRB review, call the IRB office at (928) 523-4236.
What other resources can I access?
Many professional organizations have established guidelines on the ethical conduct of research. The American Educational Research Association has a policy on research ethics with information on human research protections. So does the American Psychological Association. Official government policy can be found at the U.S. Department of Health and Human Services website. And IRB professional websites include the IRB Forum and PRIM&R. Of course, you can find virtually everything you’ll need as an NAU graduate student on the NAU IRB website.
—Paula Garcia McAllister, IRB Director