21st Century VAX (Remaster)
The worldwide pandemic known as COVID-19 shed light on the clinical research industry, as highly industrialized (often referred to as “developed”) nations anxiously awaited the release of three vaccines that would loose Americans once again from their homes into the commercial sphere. Although my entire professional career has been spent working in this field - for Contract Research Organizations (CRO) that are outsourced* to perform various responsibilities of the trial “Sponsor” (typically a pharmaceutical or biotech client, also government entities) in clinical research studies, I also found myself in the collective predicament: I was required to vaccinate to attend our family ski trip in Vail.
This presented challenges: while I had no doubt of scientific integrity in the process*, I had overcome the virus twice pre-vax**, and I hadn’t identified a compelling reason for adding another vaccine to my records. I stalled, I bargained, I considered abandoning the trip altogether, but eventually I made a simple call to my Nana - whichever vaccine had preserved her precious life, I wanted. So I vaxxed and we skied and I’ve never once been required to show my badge of entry for Vail or elsewhere. I’ve considered stapling it to my expired Passport.
This was of course the final mini-drama in the wreckage the novel Corona virus had in my life and relationships: extraverts vs. introverts, vaxxers vs. anti-vaxxers, to Thanksgiving with family or dine in solitary? My marriage ended, many friends were lost, breakdowns and breakthroughs were had. For Americans, this may have been the first time each individual was required to consider bodily autonomy: John & Norma from all backgrounds and walks of life decided whether to mask, when, where, and for how long. This pivotal decision (along with the subsequent options to vaccinate) redefined principles, politics, and our closest relationships while many passed away perilously in hospitals and institutions lacking the resources to manage such a crisis.
The Nuremberg Code was established following WWII crimes performing experimentation in Jewish captives to define the ethical requirements for experimentation in humans, and this; along with the Declaration of Helsinki (established in 1964, revised 2024) provide the basis for modern research ethics along with informed consent of trial subjects. From a regulatory standpoint, companies like those I’ve spent my career working for are bound by the same ethical standards as the Sponsor/clients, regardless of contractual assignments.
In contrast, sleeping around in my college days typically required 2 drinks and a good joke - no medical history or contracts required for pre-marital sex. As a woman, my idea of consent has greatly evolved since committing to living in sobriety. As an imperfect person walking with Christ, it’s taken me a long while to reconcile my past abortion. As an American, I will never understand how these topics continue to be confused within our legal system which expressly requires separation of Church and State. If consent were honored in this context - that is a binding agreement to consequences regardless of intentions; then perhaps our society would reflect more judicious outcomes for both partners.
In research, outcomes are exploratory, so the highest precautions are taken in qualifying and informing participants. A medical person is required to authorize and supervise study conduct - a grown-up doctor making life-preserving decisions. With history bearing witness, special care is taken to avoid any prospect of coercion, with risks carefully explained and an independent review performed before administration of any study procedures. A trial participant provides one of two answers - “yes” or “no” documented for both parties to share. No middle ground here. I experimented a lot in college - mostly yes, if memory serves.
So here we are in the hyper-competitive future, one less offspring of mine short, trying to remember what we did last quarantine. Was it good for you? Maybe if we have a few more drinks, do you think we should try again soon? Could we maybe get together and talk it out?
*Outsourcing is intended to prevent conflict of interest between drug developers and consumers, protecting patient safety, data integrity, and regulatory compliance outcomes
**I received Ivermectin off-label prior to release of vaccines
***Additional information on global governance of clinical trials can be sourced from the International Council for Harmonization for Better Health (ICH) Guideline for Good Clinical Practice (GCP), also referred to as ICH-GCP current revision E6 (R3) dated 06JAN2025
ORIGINAL WORK COPYRIGHTED TO HYPE GIRL MEDIA