Ethics in Research: What is the IRB?

Research with humans and animals is a complex task, requiring scientists to go through an approval process to ensure humane treatment of their participants, no matter the species. This is an introduction to research ethics applications for those interested in doing research with humans and animals. In part 1, we’ll focus on research in humans, which is overseen by something called the Institutional Review Board.

Across many fields, scientific research involving humans has a dark history, and many studies conducted in the past are completely unethical both in their original contexts and now. In America, examples include the Tuskegee Study on syphilis, which ran for over 40 years, and Henrietta Lacks’  ovarian cancer cells which were used in scientific research for decades without her or her family’s knowledge. Because of these and other historical atrocities conducted in the name of science, international standards for conducting ethical research have been established and enforced for the past several decades.

In fact, IU and other institutions like it are required to oversee and ensure that all research adheres to Federal ethical standards laws, called the Common Rule. Institutions do this by the use of a special panel at each facility/institution, composed of scientists and members of the public, known as an Institutional Review Board (or IRB). The IRB reviews all cases of human-based research, from minimally invasive studies utilizing things like online surveys, to more invasive studies like clinical trials and biomedical research. 

A typical process for completing IRB review involves online training in research ethics, a written description detailing all of the intended interactions with participants, a plan for storing, protecting, and reporting scientific data, and a declaration of any conflicts of interest (for instance, being funded by industries to do research on their process or products). The IRB also allows for anyone to report concerns about research studies, and they conduct regular randomized audits to ensure that approved studies are complying with rules and regulations.

My own research is about how handedness relates to brain organization, and how it might have evolved as part of human cognition and technology becoming more complex over the last 3 million years (you can read more about this here!). For my dissertation, I train left- and right-handers to make very simple stone tools, and then I put them in an MRI brain scanner to see which parts of their brain they use for toolmaking, language, and other tasks. There are two particularly dangerous parts of this research: 

1. Stone tool making basically involves banging heavy rocks together to take knife-sharp shards of the rock off, repeatedly. I have injured myself more than once making stone tools, even though I am not a newbie at it (anymore)!
2. The MRI scanner is basically a giant magnet, which means that anyone with magnetic metals in or on their body shouldn’t go anywhere near it! Even non-magnetic metals can be dangerous in the scanner, because they might conduct electricity and heat up during the scan. Moreover, it’s still unclear what the effects of long-term exposure to an MRI scanner are.

Because of these dangers, my research protocol was evaluated by the entire IRB panel, in an in-person meeting, a process known as “Full Board Review.” IU’s IRB meets once a month to conduct full board reviews, but studies with less risk involved may be eligible for less intensive, expedited review, or they may be exempt from review entirely. Regardless of level of review, completing the IRB is a bit stressful, because you need to describe your research fully and clearly for other people, who may have no knowledge of your topic, in order for them to evaluate you fairly. The process can also be frustrating simply because the bureaucracy¹ can be frustrating.

University IRB’s are an early barrier to prevent unethical research, but the IRB process has been integrated throughout the modern model of science, from inception, to implementation, to dissemination. For instance, Research conducted with human participants which does not have the approval of an IRB or similar body cannot be funded by any federal, state, or local agency, nor can it be published in any reputable journal. Before, during, and after the hassle of working with the IRB, it helps me to remember why this process exists, and to think about why it’s worth the effort to conduct ethical research. Scientists are people too, and so we all have an obligation to be humanistic first, scientific second.

Want to learn more about the IRB? Check out this article by IU’s own Amy Waltz, JD, or visit IU’s IRB page for practical guidance. 

Footnotes:
¹ For instance, I submitted my IRB application February 2nd, 2018, but it didn’t get approved until 2 months later, after being sent back to me seven different times and after two full board meetings. Each IRB must be renewed if the data collection isn’t completed within 1 year, and my renewal process also involved six rejections and 2 months of review.

Edited by Chloe Holden and Riddhi Sood