Texas Tech Staffer Guides Honduran Alumni Through IRB Set-up

May 16, 2023 | By: Karen Michael 

A Texas Tech University staff member spent a week in Honduras last semester as a service to the Zamorano University research community.

To get federal funding for research on human subjects, researchers are often required to submit a human ethics review via an Institutional Review Board, or IRB.

While those processes are known to researchers in the United States, for researchers outside of the U.S., setting up an IRB is a critical yet daunting step towards obtaining funding.

“A lot of international countries will have regulations when it comes to biomedical research or even privacy regulations, but they don't have regulations when it comes to social behavioral research,” said CassiDe Street, director for Texas Tech University's Human Research Protection Program and the direct liaison to the IRB chair and associate chair.

Street assists Texas Tech researchers with constructing and submitting IRBs to gain approval to conduct human subject research.

In Honduras, she assisted her former classmates from Texas Tech to set up an IRB. Those former classmates are now doing human subject research in Honduras at Zamorano University. While studying at Texas Tech, the Zamorano researchers became familiar with how the IRB process works, Street said.

She worked with them for a year via the internet and Zoom calls, but joined them in Honduras for a week this past fall to work out some areas of their implementation of a human ethics review committee.

In certain cases, foreign institutions can apply for U.S. federal funding. Street said the U.S. Department of Agriculture, National Institutes of Health and National Science Foundation all offer grants that can sometimes go to institutions outside of the U.S. She said although her former classmates at Zamorano applied and got funding, they didn't have a way to submit a human ethics review, which is required for the award.

“They had to turn down the money,” Street said. “They can't get the grant if they don't have a human ethics board that says the research will be ethically done.”

Street said U.S. regulations require institutions to follow the federal code of regulations (45 CFR 46) for the protection of human subjects in research.  Texas Tech also applies the Belmont Report that upholds the three basic principles: Respect for Persons, Beneficence, and Justice.  It is the IRB's responsibility to make sure that people who are participating in research are protected.  Participants must be fully informed about the research, data collection procedures, and benefits and risks.

The Institutional Review Board also ensures that all populations have an opportunity to participate in research by volunteering, that participants cannot be forced to participate, and that they can stop participating in the research at any time.  Additionally, the participants' identity must be kept confidential by each research team.

“The board recognizes that some of the participants come from a very small community and could easily be identified based on their demographic information.  We want to make sure that our research does not increase the risk to participants by a breach of confidentiality.  A lot of our research is sensitive and could pose physical, psychological, social, economic, and/or legal risk to the participants.  For example, we have international students belonging to the LBGTQIA+ community and this may be illegal and a criminal offense in their (home) countries. So, when we're collecting or doing research in the LGBTQIA+ community, how can we make sure to protect that population so that their identity is never known,” Street said.

The researchers at Zamorano looked at many institutions in the U.S.  when they decided to create their own human ethics research committee, but Street said they liked how Texas Tech's IRB interprets U.S. regulations.

One of the challenges of working with researchers at Zamorano University was adapting U.S. regulations to an area where laws are different, Street said. For instance, Americans are considered adults at the age of 18, but in Honduras, the age of majority is 21.

The field of human research ethics faces the obstacle of regulations being implemented across the nation as it is, especially with the constant changes in the socio-political climate.

Another challenge was the terminology of the regulations, especially since there was a language difference. There are four different types of research reviews that her office handles, including full board, expedited, limited and exempt, and those cause confusion even in the United States.

An expedited review, Street said, is not necessarily the quickest review.

“It doesn't mean it's a quick review. It's a very thorough review and actually takes longer, but it's just maybe faster than a full board study,” she said.

Another term, exempt, is also misinterpreted by researchers. Even if they believe their research is exempt from review, it still must be submitted to the IRB, who then makes the determination that the research is exempt, Street said.

The Zamorano researchers decided to not use the words ‘expedited' and ‘exempt' in order to make their human ethics review clearer for their researchers.  

“Our job is very simple, we are here to protect the participants,” Street said.  “If we do our job protecting the participants, then we are also protecting the researchers and the institution.”  

Street said she looks forward to collaborating with Zamorano University, and this is a great opportunity for TTU researchers to work with Zamorano as well.