21st Century Vax
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 contracted 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 in order to attend our family ski trip in Vail.
This presented challenges: while I had no doubt of scientific integrity in the process, my immune system had overcome the virus twice pre-vax, and I hadn’t identified a compelling reason for adding one 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. The CRO industry is unique in that we are not connected to the outcome of any specific trial, thus removing conflict-of-interest for the end consumer while remaining focused on data integrity throughout the process. 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?
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Additional reading and references:
ARPA H. (Accessed 27JUL2025). https://arpa-h.gov
International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. (2025, 06JAN). Guideline for Good Clinical Practice E6(R3). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
National Institutes of Health. (Accessed 27JUL2025). The 21st Century Cures Act. https://www.nih.gov/21st-century-cures-act
Tucker, Luke. (Accessed 27JUL2025). Rousseau’s Social Contract Theory. OSU Library on Philosophical Thought. https://open.library.okstate.edu/introphilosophy/chapter/rousseaus_social_contract-theory/
Planned Parenthood. (Accessed 27JUL2025). The History of Planned Parenthood. https://www.plannedparenthood.org/about-us/who-we-are/our-history
UNC Research. (Accessed 27JUL2025). Nuremberg Code. https://research.unc.edu/human-research-ethics/resources/ccm3_019064/
U.S. Food & Drug Administration. (Accessed 29JUL2025). Informed Consent Guidance Document: Guidance for IRBs, Clinical Investigators, and Sponsors. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent
Wen, B., Zhang, G., Zhan, C., Chen, C., & Yi, H. (2025). The 2024 Revision of the Declaration of Helsinki: A Modern Ethical Framework for Medical Research. Oxford Postgraduate Medical Journal. Vol. 101 (Issue 1194), pages 371-382. https://doi.org/10.1093/postmj/qgae181