I was working at my first “real” full-time job after college as a research assistant on clinical trials for Alzheimer’s disease when the HIPAA Privacy Rule first rolled onto the scene (let’s not do the math on this, it makes me feel old). I remember many in the research community having one of two immediate reactions to the new requirements: either “Oh my gosh, this is going to bring research to a screeching halt” or “This is completely unnecessary; we already get informed consent from participants so why do we need HIPAA?” While this is all ancient history now, and we obviously know that neither was research in the U.S. hobbled nor was HIPAA abandoned, it was the beginning of my love affair with research ethics (I even have a favorite Belmont Report principle- don’t judge) and a career that has spanned over 20 years and myriad roles.
Like many, I came to research administration and compliance somewhat by accident.
Inspired by what I’d learned about research ethics from my job as a research assistant, I went to law school full-time while continuing to work part-time. Once I graduated, I knew I wanted to become more involved in administration and compliance work, and took a position as the compliance manager at the same institution’s Institutional Review Board (IRB). Several years later, I branched out from human subjects research to research in general when I accepted a role as the research compliance officer.
Though in my most recent roles as general counsel and privacy officer for a large federally qualified health center, I may have strayed from research administration, but I cannot seem to stay away for long. While at that organization, I consulted for the IRB and instantly knew I was still hooked on research- the love affair is not over!
It became clear to me that my next move must bring me back to my roots in research. So here I am, ready to take full advantage of all the knowledge on offer at the PRIMR&R 2022 Annual Conference. It’s hard to decide what I’m looking forward to the most, whether it’s the opportunity to engage in discussions with others who share my passion for advancing the goal of ethical, responsible, and quality research or attending virtual sessions about emerging issues and hot topics. I know that no matter what, I always learn something new and look forward to hearing other perspectives and experiences.
Maybe that’s why I can’t stay away from research: the entire enterprise is based on a thirst for knowledge and the idea that while we know some things, we can always know more. And I believe the best way to know more is to dive in, ask questions, encourage dialogue, and never stop learning. I guess that means what interests me the most about this conference is learning. And the opportunity to share what I’ve learned.
So, stay tuned after the conference for additional blog posts where I’ll discuss specific sessions I attended and how I plan to apply what I’ve learned to my everyday work, things that surprised me, and what may have helped me solidify my own ideas about certain issues. I hope you’ll share your thoughts and comments with me about what I write. Because while I will have a lot to share, I know I also have a lot to learn, and I cannot wait to learn from all of you!
Tracy Guarnieri, JD, has over 20 years of research administration and research compliance experience including work with sponsored projects, human and animal research, and conflicts of interest. She started her career as a research assistant on clinical trials for Alzheimer’s disease and has served as a consultant to several IRBs. Tracy received her JD from Quinnipiac University with a concentration in Health Law.