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Trial Experience: Participating in a Clinical Trial for a Covid-19 Vaccine

by Robyn Ice
Program Director, Professor of Practice, General Legal and Applied Business Studies.

Despite practicing law for over two decades before joining Tulane,  I’ve always tried to avoid what I perceive as lawyer stereotypes.  I prefer to leave the expected behaviors to the characters depicted in lawyer jokes and TV shows, while I slip around in disguise and simply do my job.  Clients seemed to like that approach, too.

Nonetheless, my legal education and experience have not left me unscathed.  I must admit to ongoing obsessions with research, facts, deadlines, rules and procedures, structure, and task execution.  Also, thanks to my childhood among engineers and science teachers and my career in environmental law, I have a strong faith in science.  In addition, I prefer action over lethargy, although this may stem more from my background in theatre than law.  Fortunately, these vestiges of past lives translate pretty smoothly to my work at SoPA.

When the Covid-19 pandemic hit, I was proud that Tulane and SoPA followed the science and took action.  On Friday, March 13, we shut down and prepared to move all classes online. After a week off, classes resumed and I returned to work “at” SoPA, teaching and working from my dining room, performing Tulane’s symptom check each day and taking regular Covid-19 tests.  My students’ law office internships went remote. Our faculty taxed the limits of their residential wi-fi systems.  Everyone rose to the challenge heroically.

Still, the realities of the virus hit.  One of my faculty members fell ill while setting up remote medical care facilities in Chicago. In late March, a musician/songwriter friend in NYC died of Covid-19, alone in a hospital and on a respirator. A friend lost her husband.  Family members in New York and WV fell ill and recovered.

Life outside work assumed a new structure.  We celebrated St. Patrick’s Day at home with my granddaughter, whose school had closed.  We baked Irish soda bread and did puzzles.  We did not know it then, but we would celebrate her mom’s birthday, Easter, my birthday, commencement, Memorial Day, Independence Day, my son’s birthday on 7/11, Labor Day, my husband’s birthday on 9/11, Hallowe’en, Thanksgiving and, almost certainly, Christmas, in much the same way.   Despite random shortages of whole wheat flour and other staples, we baked as if carrot cake were a proven antidote to the virus.  Our presentation skills improved, though frosting and decorating remain mysterious.

Now, we are nine months in.  We are offering our SoPA classes online, in-person/distanced, and via Zoom.  We are very skilled at camera angles, lighting, and unmuting.  If we ever go out, we have masks to match our outfits.  Uncharted waters are mapped.  The election happened and provided a longer list of “unprecedented” events.  As the pandemic continues, most of us mask up and persevere, some refuse to protect themselves or others, and ridiculous numbers of our fellow citizens die.

As the bizarre normalized, I occasionally felt frustrated and helpless, wondering how a detail-oriented non-scientist with legal experience and lawyer-traits could take direct and productive action against the virus.  Then, on November 4, the day after the election, I read a Tulane Today notice about a Covid-19 vaccine trial.  I immediately submitted the screening survey and called the contact number.  Because I do not have any of the health issues of concern, I was deemed a candidate for consideration.

By 8 the next morning I was in a medical  office in Metairie, where I completed a more in-depth screening, read and signed consent forms, spoke with the supervising physician, and gave blood samples.   By 9 AM, I had been injected with either the vaccine or a saline solution placebo.  It is a double-blind study, so I do not know.  After observing me for 30 minutes after the shot, the nursing staff gave me a tote bag containing a thermometer, a pulse oximeter, Covid-19 self-test kits, and other materials and released me.

My primary obligations include recording my symptoms daily in the e-diary of an app, returning for monthly visits, and notifying the company of any changes.  For the first few days, I felt nothing except a sore arm and a great sense of relief at having found an avenue for active participation.  Then, on November 11, I awoke with a slight fever, stuffy nose, and a feeling of overall weariness.

I reported my symptoms in the app and received a call from the nurse the next day.  As instructed, I began taking my temperature, pulse, and oxygen levels three times per day.  I also completed two types of Covid-19 self-tests, refrigerating the tubes in biomed bags until a courier retrieved them for analysis.  By November 13, I was feeling fine, and the test results were negative.  For the next two weeks, I continued taking my temperature and recording the pulse oximeter readings thrice daily.

The nurse scheduled me for an office visit just after Thanksgiving.  When I arrived, she praised me for my ongoing diligence and accuracy in recording my data.  At a distance, she introduced me to all the other staff members as “Robyn, the one who always submits her data.”   I asked why this was surprising or even noteworthy, in a clinical trial. “Well,” she said, “people get tired of recording their symptoms, or using the app, or they forget the rules, or it just seems like too much.”   She then asked me to sign some updated consent forms which, of course, I first read closely.

Wow, I thought, my legal background prepared me perfectly for the role of vaccine test subject.  It may be a limited engagement, but I am pleased to perform.   I have recruited my husband and two sons to participate, as well.  I know they will do well but, of course, I will do better.  I forgot to admit that I am also competitive.

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