Full disclosure – I work in compliance. It’s not the sexiest work – a lot of T crossing and I dotting – but the foundation of what I do is ethics; specifically, research ethics. A good chunk of my day is spent reading through the studies that researchers have planned, thinking about risk and benefit, thinking about justice, community, and unintended consequences. I guess that’s maybe a little sexy.
I work in Fenway Health’s research department, The Fenway Institute (TFI). I was recently tasked with helping to clean out some of our long-term file storage. Thirty plus years of “we might need this”a; “do I need to keep this?”; and “I’ll deal with this later.” It included research etcetera since before there was a TFI. As the person-in-charge of our research document retention policy, I was given the power to say “we’ll never need this”; “we are not legally required to keep this”; and “I’ll deal with this now.”
Research at Fenway Health has an incredible history. It was not born of some huge endowment to a university or prestigious hospital. It began when a tiny student-run health clinic that served a lot of gay men realized it needed to confront a pandemic. I’m sure there were detractors – people who wondered why a small facility staffed mainly by volunteers wanted to provide experimental treatments and ultimately conduct HIV research – but those trying to survive in the chaos of those early days understood even then what would become public health doctrine. Commitment to community is essential to building trust. Connection to community is fundamental to understanding need. Because of this, Fenway Community Health Center was the IDEAL place to conduct HIV/AIDS research. This work, born of necessity, transformed Fenway into a world-class research destination, and in 2001, The Fenway Institute was founded.
But back to those files – those mountains of paper growing old in long-term storage.
In compliance speak – they were all non-essential, non-source documents, no identifiable patient or participant data. Instead, it was a lot of the day-to-day detritus of research administration: strategy notes; Call logs; Request letters; Early drafts; Mailing labels; Warning labels; Flyers. That’s all to say, it was wildly compelling.
I saw extra copies of letters from sponsoring pharmaceutical companies letting Fenway know that a trial was closing due to inefficacy. That seems so mundane – a letter from a sponsor. But what I read wasn’t on the page – I was reading the dashing of hopes, the endless hours of work, the awful calls that volunteers had to make to each participant. “Thank you for your participation. They reviewed the preliminary data. It’s not helping. They are stopping the trial.”
I read the notes of Fenway’s early research ethics review board. How should a research ethicist weigh risk and benefit for a population clamoring for any chance at life when facing what was an almost universally fatal disease? What risk would I and my board have deemed too great? What side-effect too harsh?
I saw descriptions of cutting-edge treatments for debilitating opportunistic infections, some which went nowhere and some which bought participants precious days, months, or even years. Reading these totally dry administrative files was….devastating.
But, I then got to watch something wonderful happen. Drugs getting through Phase II (seems to work well enough for large scale trials) and then Phase III (large scale clinical trials). Drugs getting approved! Suddenly (for me – years of meticulous work for the research teams), we were looking at non-inferiority! We weren’t looking for just ANY treatment – but if this new treatment would work BETTER. And then, hallelujah, studies on medication to prevent infection, both before and after exposure. Participants with good long-term outcomes, studies not looking only at survival but long-term quality of life. Vaccine research! Pregnancy! Exercise! Smoking! Old age!
As a lifelong AIDS activist, it’s hard to express what it meant to me to follow that paper trail into the past, back to what our fearless leader refers to as “the bad old days” and back again. Those numbers on the page were lives – so many lost, and then so many saved.
But what am I trying to tell you? I want you to know that TFI is special and the work we do today comes from a profound history of struggle and strength. Today, we work at a world class research, evaluation, training, education, policy and advocacy center dedicated to optimizing health and well-being for sexual and gender minorities and those affected by HIV. Honestly, I’m sure I missed a couple of key verbs – the scope of the incredible work now done at TFI is truly mind-boggling. The luminary faculty are committed to addressing the needs of our diverse LGBTQIA+ community from birth through end of life. They train the next generation of researchers focused on the needs of the LGBTQIA+ community and people living with HIV. Each day is just an incremental step, but what a gift to be able to support transformative work, work that strives to heal this broken world.
Me and my tiny but mighty compliance team? We help keep everyone accountable. Let me assure you, it’s my great honor. And TFI-ers? Take good notes and, for the love of all that’s holy, please label your files!
Want to learn more about the history of Fenway Health?
Want to learn more about early trials? Take a trip in this time machine. Fenway participated in the aerosolized pentamidine trial.
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/612418
https://www.latimes.com/archives/la-xpm-1993-06-20-tm-10183-story.html
https://www.ncbi.nlm.nih.gov/books/NBK234129/
Recent groundbreaking studies where TFI was a site that are changing the face of HIV prevention: