Ethical Dilemmas in Clinical Research

Before coming to graduate school, I worked as a clinical research coordinator with a large hospital system in Greenville, SC. Ethical research was central to my job. I submitted and oversaw intuitional review board (IRB) applications, patient enrollment, data collection, and adverse events related to the study. So naturally, I picked a case study that related back to the work I did in clinical research. The case study, Taking Advantage of Patient Trust, presented interesting details and a conversation I witnessed many times in my previous job.

Earning a patient’s trust is pivotal to the doctor patient relationship. Patients want to trust their doctor and the recommendations they provide. They see them as the expert. Patients I worked with would ask their doctor whether they should be in the study. Their opinion mattered most. The case of Dr. Joanna and Duncan is a similar situation. Duncan trusts that Joanna will put his medical interest ahead of her research interest, which there in lies the ethical dilemma. Doctors want to discover new treatments and push medicine forward, however it can’t be done at the sacrifice of current patient needs.

What I find interesting about the case study is the placebo is less than the standard of care. I am curious how this study even got approved by the IRB. When I worked in orthopaedics, the placebo had to be the standard of care or something equivalent. The study could not put patients at risk of receiving less than the standard. This protected patients and helped minimize risk. If I were Dr. Joanna, the study would only be an option if all standard treatments had failed and the patient could safety be off of medicine if in the placebo group.

While I am not pursuing a research career in medicine, this case study represents ethical challenges with human subjects research. My future research involves minimal risk to human participants, however this does not negate the importance of proper consenting and considerations for their health and wellbeing. I think we as researchers need to be open about ethical issues and discuss remedies that balance participant and researcher interests.

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Going Back to My Roots in South Carolina

Growing up in Charleston , SC, I took for granted the rich history of the city and all it has to offer. Amazing beaches, restaurants ,and a college in the middle of the city all make Charleston a pretty unique place. Even though my brother went to the College of Charleston, I knew I wanted a different experience. I chose Clemson University in upstate SC. The setting, size, sports focus, and curriculum were all quite different then the experience my brother had at College of Charleston. So I thought it would be neat to compare and contrast the mission of two universities from a state I called home for 25 years. Before I go into to detail about the mission statements, here is a brief run down of both schools.

Clemson University

  • Land grant state university
  • Focus on engineering and science
  • Around 20,000 undergraduate
  • Located in the small college town of Clemson, SC

College of Charleston

  • State college
  • Focus on liberal arts
  • Around 10,000 undergraduate
  • Located in downtown Charleston, SC

Clemson University prides itself on being a top 20 public university. Their mission traces back to its roots as a land grant university. Meaning the university was set up by the state and focuses teaching on agriculture, science, and engineering. Additionally, their mission is grounded in pursuing innovative research to solve global challenges.

This is in slight contrast to the mission of the College of Charleston. Their focus is on a liberal arts education. This includes an emphasis on intellectual creativity and curiosity within the arts. This is not to say that Clemson doesn’t foster an environment of creativity, it just that their emphasis is more STEM oriented. College of Charleston is also strongly tied to the history of Charleston, SC and being located in Lowcountry.

The missions do however share similarities, which I would expect given they are both state schools residing in South Carolina. Both clearly prioritize the educational needs of the area around them and the state. Students living in South Carolina are given priority with acceptance. Secondly, both schools place an emphasis on personal growth and the development of good citizens. A culture of respect, support, and responsibility are characteristics indicated by both missions.

While there may be difference is the type of education (science vs. liberal arts), size, and setting, there is a shared goal to provide students an intellectually challenging education, and graduate students that can serve their communities in meaningful ways.

Shifting Norms

Each morning I drop my son off at daycare. He sees familiar faces of his little friends playing on the floor, parents dropping off other kids, and the teachers moving about the room. When I toured the center, of course I had my first impression about whether a person seemed friendly or approachable, but I never really stopped to think what judgments the children may be making about who these people are. You expect them to have their favorite friend or a teacher they are drawn too, but a bias toward race? How can this idea of bias settle into toddlers?

The NPR article, How the Hidden Brain Does the Thinking for Us, describes how bias against race can be seen in three years olds! As a parent that is alarming. We try to teach our children kindness and acceptance for others, but societal norms seem to be shaping what is “okay” or “bad” in a questionable direction. If children learn what seems safe or normal by watching the world around them, then we need to inject more diversity. Easier said then done.

As children move up in education, it’s not like this bias goes away. Societal norms become even more prominent, further shaping the bias toward others. The challenge is this bias of the hidden brain is not intentional. It not like we go out of our way to group people into buckets of good or bad. Like the NPR article said, the brain is wired to form associations. However, associations described about context come from society, and society gravitates toward what is common, not what is different.

Embracing diversity and having an inclusive mindset has the potential to bring immense benefit to society, workplaces, and the classroom. In the article, How Diversity Makes Us Smarter, socially diverse groups are the ones that bring innovation and creativity. Those are characteristics we all want in the classroom setting, from preschool to college. Somehow as a society thought we have to find ways to integrate more diversity into our everyday. If starting at a young age we were exposed to more races, ethnicities, etc, then bias might be reduced. We can also be more aware and cognoscente of our own biases. These are small changes, but they have the potential to nudge us in a less biased way of thinking.

Self-Assigned Grades

I can remember my first day of creative writing as a freshman at Clemson University. For such an entry-level class, I felt so anxious. I should have been worried about the chemistry or biology class, but no I was worried about writing. It felt so much more abstract, and then on top of that my work was going to be picked apart and graded.

To my surprise, the professor said she would not be giving any grades on any of our writing. I was floored. How can this be? At that moment, I could feel some weight lifted and the anxiety ease. All of a sudden the pressure to write for a grade was gone. There was a caveat though; she still had to submit a grade to the University at the end of the semester. So she told us all we would assign a grade to ourselves. We had to argue for our grade in the form of a persuasive paper based on how well we improved throughout the semester. As long as we provided a legitimate argument with supporting information, we would get the grade we proposed. What a cool way to approach grading. By removing the pressure of grading, the professor gave us the freedom to explore writing with a focus on improvement. I’ll admit, I was pretty grade focused. I knew I wanted to argue for an A, which I did, and the professor accepted my argument. While I still had the thought of grades in my head, I was not as motivated or concerned about it. I could write more freely. I can honestly say I have never encountered another class like this in terms of grading structure.

As I read “The Case Against Grades” by Alfie Kohn, I kept coming back to my experience as a freshman in creative writing. He says, “What matters is whether a given practice is in the best interest of the student”. At least for me, changing the typical practice of grading allowed me to write without additional pressure. I would still receive feedback from the professor, but a value was not assigned. This qualitative assessment described by Kohn offers an alternative to numerical grades. Embracing a more democratic classroom as Kohn describes can be done. I experienced it first hand and 12 years later still remember the positive impact it had on me.

Let Them Be Children!

I am finding a common theme across many of these talks. Our children and youth set an example for learning. They are unique, curious, and active learners if provided with the right conditions. Sir Ken Robinson’s talk, “How to Escape Education’s Death Valley” describes what learning could be like if we leveraged the diverse talents they possess vs. pushing conformity across a narrow field of study.

While we are not Finland, we can certainly learn from a system that has a vastly lower drop out rate. They must be doing something to foster a unique learning environment where children thrive and enjoy learning. And the result is they want to keep going and finish, not drop out. Finland sees teaching as an esteemed profession, doesn’t require standardized test, and offers individualized learning, but it’s the embracement of play that I see immense opportunity.

Play can be an outlet for fun and exercise, but can also be an avenue to discovery and sparking curiosity, which we need in American classrooms. Play lets children learn in a more natural way. If classroom environments where a place for play then maybe kids wouldn’t be so eager to go to recess. It would be learning through play that kept them engaged. I think this is where the value we place on teachers comes in. Ensuring that teachers have access to resources, continuing education, and are properly supported will help further alternative ways to learn through play in the classroom.

I also found many takeaways from Robinson’s talk including his proverb like messages about learning. The ones below I personally found to be powerful. What were your takeaways?

“Curiosity is the engine to achievement”

“No learning means no education”

“Human life is inherently creative”

“Education is not a mechanical system it’s a human one”

 

 

What Do A’s Really Mean?

As I watch my 8-month-old son learn to crawl, the notion that learning is about persistent, self-love, failure, and triumph resonates with me. Michael Wesch, provided a perspective that embraces the idea that learning doesn’t happen in one moment nor does it end once you succeed. Everyday, my son tries to get on all fours, unsuccessfully. One leg keeps getting stuck, just like Wesch’s son George kept falling on the last stair step. This failure doesn’t stop them from trying though. So why is it in academia we become so paralyzed by the fear of failure vs. celebrating the process of learning?

I have thought about this many times in my academic career. I think the consequences of not succeeding on the first try and being stuck with a bad grade are partly to blame. So while an “A” may mean mastery, it doesn’t mean that the learning experience sparked passion, curiosity, or deepened the exploration.

This notion that learning is based on a grade has lessened as I have continued into my graduate education, and especially now as a PhD student. My success has become about the development of my ideas and research, not a letter grade. As I progress through academic milestones, it drives me to learn more, not stop and find something new to study. My success is no longer based solely on a grade, but on scholarly contributions. In the article, “Twitter and Blogs are Not Just Add-ons to Academic Research” Tim Hitchcock said, “The best and most successful academics are the ones who are so caught up in the importance of their work, so caught up in their simple passion for a subject, that they publicize it with every breadth.” That passion for learning and sharing seems to get overshadowed by grades in many academic settings. And while grades aren’t going anywhere, we could benefit from incorporating the fearless learning style of children and the passion of researchers into more facets of academic learning.