Ethical Treatment of Human Subjects in Research Should be Important to Everyone
On campus ethics seminars and the annual Responsible Research Conference regularly include sessions on the ethical treatment of human research subjects. Unfortunately, when trainees submit summaries for responsible conduct of research (RCR) credit, too many graduate students report disinterest toward education on the welfare of human research subjects. The summaries state that because the student does not engage in research that involves human subjects, this topic is not important to them. When I read these statements, I sigh deeply and shake my head because students are failing to realize that not only is awareness to ethical considerations related to the use of human research participants important to every researcher, but also to every human being on the planet. Ignorance to ethical considerations regarding the treatment of human research subjects facilitates abuse.
A couple years ago, I was struggling to help care for my aging father who was suffering from rudimentary age-related cognitive impairment. My father had begun to struggle with higher cognitive demands, such as managing finances or communicating with medical doctors. He could no longer effectively comprehend medical instructions and thus could not comply with treatment. Yet, he hid his impairment very well. When speaking to his doctor, he would lean back, cross his legs and nod very knowingly. Then, later in the day he would call me confused and frustrated because he did not know what to do with all of his medication.
I started communicating with his physician and nurses. At first they denied that my father suffered from any impairment and assured me that he understood their instructions. After many discussions, they conceded that he had normal age-related impairments of a man his age. In retrospect, I realize that their initial concession was more about appeasing me than attending to my father's impairment because a short time later, my father's physician asked him to participate in a clinical trial for a new medication. Not surprisingly, my father nodded knowingly, and she prescribed him the new medication. Later that night, my father once again called me in confusion as to what he should do with the new medication. He gave me the name of the drug and after a bit of research, I learned that it was a new experimental drug and that one potential side effect was memory impairment, which would only exacerbate his current struggles. The next day I made an exasperated phone call to his physician. She informed me that my dad had given his consent to participate in a clinical trial and I emphatically informed her that he could not give an informed consent because he did not even know he was a research participant. After a follow-up appointment and a detailed consultation, my father's impairment revealed itself and the conflict was resolved. My father was incapable of giving informed consent because he was not able to understand the risks associated with participating in the research study.
I'm not telling this story to place blame on my father's physician nor on my father. Prior to realizing the magnitude of his impairment, his physician was respecting my father's autonomy over what could be perceived as an interfering relative. My father, as would be expected, was doing his best to save face during a challenging time of life. Rather, I tell this story because I think it is a good example of how understanding the rights and responsibilities associated with conducting human research is valuable information for everyone, not merely human subjects researchers. I am very glad that I had rudimentary understanding of patient autonomy, vulnerable populations and informed consent so that I could help my father. Similarly, everyone has family and friends and may one day be in a position to help them make a critical decision about participating in a research study when they are at their most vulnerable.
My father, of course, was vulnerable due to his rudimentary cognitive impairment that hindered his ability to understand the experiment his doctor was proposing. However, even when patients have full use of their faculties, they can be vulnerable to exploitation when they are desperate for a treatment or cure. It is common to hear of patients facing a terminal diagnosis say they feel lucky to be included in an experimental treatment. What many people fail to understand is experimental treatments are seldom beneficial to research participants. Rather, research participants are providing information and data that may benefit future patients that will suffer from the same diagnosis. In fact, research participants can also be putting themselves in a position to be harmed by promising experimental treatments.
A current example of this type of potential for harm is the controversial availability of the experimental Ebola vaccine that was made available to two American health care workers who contracted Ebola while working in West Africa. Their survival after being administered the experimental vaccine has triggered a "humanitarian" response by making the experimental compound available to other health care workers in the Ebola-affected regions. Many people think that this is a good thing. However, there could be serious reservations regarding the irresponsible exploitation of desperate, and thus vulnerable, people.
The initial availability of the experimental vaccine raised many questions and opinions in the media. Why was a vaccine only available to American health care workers when hundreds had died of Ebola in Liberia and Sierra Leone? Why were masses of people being permitted to die when there was an available treatment? Has race, socio-economic class or culture impacted the decision to make the vaccine available when Americans were infected? However, careful examination of news reports covering the Ebola vaccine revealed that it was an experimental compound that had not yet been tested on humans at all. The vaccine had merely shown promise in lab animals. Contrary to the understanding of much of the general public outside the realm of research, promising results in lab animals does not equate a cure in humans. There are many incremental research steps that must be addressed regarding safety and efficacy of experimental compounds in both animals and humans before a drug should ever be administered to humans, let alone a large number of humans. The medical workers took a very big risk when they consented to being administered the experimental vaccine, and they continue to be at risk, since there is no information about the potential for long-term complications.
There have been many assertions that access to the vaccine is worth the risk since Ebola has such a high rate of lethality. However, the latest overall lethality rate according to CNN is 52 percent, which means that patients have roughly a 48 percent chance of surviving. Experimental compounds at this early stage of development could easily decrease the chances of survival, effectively harming an already suffering population. Now that the vaccine is being made available to more health care workers in the region, the more widespread administration of the untested vaccine could kill or harm masses of people even entire families or villages, as the experimental vaccine becomes more widely available in Liberia, Sierra Leone, Guinea and now Senegal. Even if the compound ultimately does not harm but helps the patients, arguably, pharmaceutical companies will be guilty of conducting massive experimental testing on vulnerable human populations without being given appropriate informed consent. This is a huge risk to take and an exploitive experimental practice conducted on populations that are vulnerable due to desperation and unlikely to understand all the risks associated with being a recipient of an untested experimental vaccine. Even for patients with sufficient education and training to enable them to comprehend the risk, arguably, these participants may still be vulnerable due to their desperation for benefit overshadowing their comprehension of risk.
The above addresses how education regarding the responsibility and risk associated with human subject research has application outside the realm of research. From this argument, some students may be inspired to educate themselves to be of service to their families, communities or cultures. However, other students may be better motivated to educate themselves when they comprehend that ignorance to these rules and policies can cost them in the development of their own career. During the early stages of career development, researchers cannot fully predict the trajectory of their career. A research career constantly evolves and includes multiple turns and collaborations as the validity and application of ideas are tested. If researchers fail to educate themselves on the rules associated with conducting research on humans, they may find that they are unable to utilize completed data sets or may have experiments shut down because they failed to get prior approval of research protocols. At Texas Tech and many other institutions, all research involving human subjects must have protocol approval before data is collected. Any data collected prior to getting an Institutional Review Board (IRB) protocol approved cannot be utilized for publication or for submission of research grants. Ignorance of the rules can cause you to make minor or very costly mistakes.
My niece almost made this very mistake recently. She is an undergraduate student studying art. True to the artist stereotype, she vocally protests any type of bureaucracy or compliance. A few weeks ago, she made a post on Facebook announcing her new research project and with the distribution of her survey, she felt like a "real researcher." When I read her post, it dawned on me that I had never read any previous posts complaining about the need to submit a protocol or obtain IRB approval for conducting a human research project. So, I sent her a message to ask if she had an approved protocol. She replied that she did not need one because she was not conducting any biological or medical experiments. I immediately sent her a copy of her university's policy regarding the use of human subjects in research. She absolutely needed to submit a protocol for approval and if she neglected to do so, she would have to forfeit any data that was collected. Even with her voluntary, anonymous survey, if she started to collect data before submitting the protocol, she would have lost all of her work; a costly mistake. Unfortunately, neglecting to inquire whether a protocol is needed is a pretty common mistake and many students and faculty have paid a hefty price for remaining uninformed on the rudimentary policies and procedures associated with utilizing human research participants. Lucky for my niece, I prevented her from neglecting to submit a protocol, and once she realized her mistake she worked with her university's IRB office to complete the process.
However, even when you are informed regarding the policies and regulations of your research, you can make mistakes. When I was a relatively new graduate student, our lab purchased some shiny new equipment. We were all excited to play with our new research toys. So, a fellow student and I wandered down to the animal facility to get some of our rats. Just as we were about to place the rats in our shiny new equipment, our lead technician walked in and asked what we were doing. When she realized that we were about to place the rats in the chamber, she promptly pointed out that we did not yet have an animal protocol in place to utilize the equipment and ordered us to promptly return the rats to their colony. Now, I would love to attribute our error to ignorance, but our lab was very proactive with regard to complying with all the regulations associated with conducting animal research. We knew better. Even though we were fully aware of the regulations associated with conducting animal research, we got excited about a new line of research and shiny new research toys, and our enthusiasm overshadowed our knowledge. Just like my niece, we got lucky because we had a lab mom who corrected our behavior before we made a critical error.
Students who do not currently conduct research with human subjects may not need to be experts on the details associated with human research and the protocol process. However, choosing to remain ignorant regarding the responsibilities and policies associated with utilizing human subjects in research can result in costly mistakes and penalties as your career and research studies evolve. I encourage students to attend educational opportunities that address the ethics associated with conducting human research and raise their awareness so they recognize when questionable practices could injure individuals and even cultures. And remember, when your research questions and methods evolve to include human application, contact your IRB office for guidance to ensure that your plans will not endanger the welfare or autonomy of your research subjects.
Hopefully, I have motivated some students to take the opportunities to increase their awareness of the ethical use of humans in research. Next month, I plan to discuss some of the common mistakes and misconceptions regarding the use of humans and personal data for research purposes.
Marianne Evola is senior administrator in the Responsible Research area of the Office of the Vice President for Research. She is a monthly contributor to Scholarly Messenger. Alice Young, associate vice president for research/research integrity, is a contributing author/editor.