Ethical Training for Student Researchers Working with Human Research Subjects

By Marianna Evola

Happy New Year!

I spent some time during my holiday break pondering the topic for my first responsible research column of the New Year. I finally decided that I would start the year promoting the need for students to pursue more education on the ethics associated with utilizing human participants for research. My last presentation of 2016 was to a group of fresh young undergraduate researchers. During my responsible research presentation, I presented a bit of research regulation history so that students understand that the modern day regulatory environment of research stems from the misdeeds of our academic ancestors. More specifically, I like to point out that there were regulations to protect animals in research before there were notable regulations to protect humans. And surprisingly still to this day, the regulations and oversight involved in approving and monitoring animal research are more stringent than the regulations and oversight involved in conducting research on humans. While thinking about this over break, I realized that a couple decades (or so) ago when I entered graduate school, I was required to complete mandatory training on the responsible use of animals in research before I was given approval to engage in my research. Similarly, when my research moved to Texas Tech Health Sciences Center, I was required to complete mandatory training in responsible research with animals before the animal facility staff would issue me keys to the animal colony. However, currently unless student researchers are working on a select type of sponsored research, TTU has no institutionally mandated training in responsible research with human research subjects.

One of the biggest concerns regarding a lack of mandatory training is that students often work with vulnerable populations but are unfamiliar with the vulnerabilities associated with their subject population. Sometimes the vulnerabilities are obvious. It is easy to comprehend that children, especially disabled children, are vulnerable. It would be very difficult for anyone to argue against the vulnerability of children. And in fact, if anyone tried to argue against the vulnerability of children, their colleagues would likely perceive them as callous, unethical and perhaps even immoral. In contrast, it is very difficult for many people to understand the vulnerability of prisoners. Most people cannot grasp that the nature of incarceration creates vulnerabilities in even tough hardened criminals. Specifically, incarceration is structured to create a power hierarchy so that prison officials can control the difficult population. This power differential naturally creates serious concerns that prisoners can be subject to coercion by researchers, which would be a violation of subject autonomy.

As I thought about this, I vaguely remembered a conversation that I had with senior research colleagues when I was a new graduate student. I say vaguely remember, because as I thought about this conversation, I had a bit of difficulty remembering the details so I'll qualify that my recreation may be flawed. Anyway, I was being introduced to the controversies and challenges of conducting research on animals and the need to be vigilant about facility security. Now, at the time I was not naïve regarding the existence of animal rights organizations nor their emotional propaganda and irksome interference with animal research. However, at that time my stereotype of their membership was one of undergrads with too much free time. As such, while my senior colleagues were trying to educate me to be serious about security, I cavalierly asserted that I was not highly concerned about bored undergrads. Immediately, one of my faculty mentors corrected my assumptions and informed me that animal rights supporters were not limited to undergrads but could also be found among the faculty. She told me a story about first describing her research to colleagues as a new faculty member. Her research examined the abuse potential of narcotics in animal behavioral models of substance abuse. Upon hearing the description of her research, one of her faculty colleagues asserted that it would be more ethical to conduct the research in human prisoners rather than in animal models. When I heard the story I was stunned that a member of the faculty would be so callous regarding the use of humans in research by rationalizing that they were just prisoners. At the time, and for years later, I thought that this type of bias was isolated and that in academic populations I would be unlikely to again encounter the belief that animals had more rights than human prisoners. However, a few years later when I was a postdoc, I was describing my drug abuse research to three first year medical students and was again shocked when one of the students similarly asserted that she felt that type of research should be conducted on prisoners and not animals. Then surprisingly, the other two students nodded in agreement. Medical students had asserted that animal welfare was more important than the welfare of prisoners.

Now, my research did not notably involve humans. However my research focus was drug abuse, so many of my colleagues did considerable research in human populations. Furthermore, because of the legal issues related to substance abuse, many of my colleagues also worked with prisoners or persons that sought treatment under the direction of the court. Thus, my graduate training, and even a considerable amount of my undergraduate training, focused on the ethics associated with conducting research on humans. Because of my well versed background in research ethics with humans, I was appropriately shocked that medical students would assert such an unethical research agenda. However, what I failed to realize at that time is that not all disciplines provide students with notable training on ethics. In fact, there are marked differences in the ethical training that students receive depending on their chosen discipline. Thus, if those three medical students had received little or no training on research ethics, they may have no inclination that the prison population is a very vulnerable research population. Nor would they be aware that vulnerable populations are provided special protections by research regulations associated with conducting human subject research.

It is the differential training backgrounds in research ethics that leads to flawed assumptions that students "know the rules". Too many academics assume that the ethics associated with research are common sense and of course, student researchers know that they should not violate the rights, welfare and privacy of human research subjects. However, these assumptions probably contributed to the opinions of the three medical students that I encountered when I was a postdoc. They did not think that there was anything wrong with coercing prisoners to serve as test subjects for experimental drug treatments. Nor did they question that utilizing prisoners would be unethical, or less ethical that utilizing animals to examine the experimental compounds. When we assume that students "know the rules", without mandating some minimal standardized education, we are not ensuring that they have been exposed to adequate ethical training. Furthermore, this failing may contribute to students making ethical mistakes in their future research which could damage their careers, the careers of their collaborators, or much worse harm human research participants.

Many faculty have already realized that students need more training in responsible research. In the few years that I have worked in responsible research education, I have observed more and more mentors and even entire departments begin to mandate training in responsible research. Furthermore, a few departments that focus on human subject research now require students to participate in a defined ethics training. This cultural evolution has been inspiring to witness and I look forward to watching more departments implement mandatory training for their student researchers. The interesting thing is that although faculty can be reluctant to impose training mandates, most students embrace responsible research training. In my opinion, I think that the training helps students fend off cynicism and preserve an element of the optimistic ivory tower ideal of academic training and research.

So, if mentors want to provide more training for their students that are conducting research on human subjects, what resources can our office (the HRPP office and the OR&I) provide?

1. Thorough training on ethical research with human subjects is available on the Collaborative Institutional Training Initiative (CITI website). Students can log in, affiliate with Texas Tech University and complete any course listed on the training site. As most of us know, online training has limitations regarding students internalizing information. However, the training provides broad exposure to complex regulations and ethical practices and it is a great reference when students have questions in the future.
2. If mentors would like students to receive face-to-face training, please contact the Human Research Protection Program Office and we will work with you to arrange a training seminar with our HRPP staff.

Finally, a couple months ago, I attended my first Public Responsibility in Medicine & Research (PRIM&R) Conference which focused on the protection of human research subjects. I came home with a realization that most major research institutions mandate some ethics training for all students that conduct research with human research participants. I think that it will be important for our institution to consider implementing similar training requirements in the future so that we can best serve our students and protect human research participants.

 

Marianne Evola is the director of the Human Research Protection Program in the Office of Research & Innovation. She is a monthly contributor to Scholarly Messenger.

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