The Gravity of Becoming a Regulatory Robot

One of my favorite parts of attending PRIM&R’s annual Advancing Ethical Research Conference is that it refocuses my efforts on what really matters. In the year since the last conference, I’ve processed countless exempt 2 determinations, requests for waivers of signed consent, and study team member modifications. I have been doing this while also contributing to new institutional policies and procedures, software requirements, and workflows in order to comply with the revised Common Rule. Some days, we all feel drowned in an ocean of regulations and rules—some days, we all get the Regulatory Robot Blues. However, the first keynote speaker at the 2017 Social, Behavioral, and Educational Research Conference reminded me of why human subjects research protection is my passion.

Kimberly Kay Hoang’s keynote presentation titled “Social Black Holes: The Ethics of Research on Illicit or Morally Compromising Market Actors” explored the protections utilized in her research on sex workers and high finance clients in Vietnam’s informal economy. I think we can all think of a dozen ethical and legal concerns that need to be considered after reading a one line summary of her work.

For me, this presentation was a reminder that we need to remain flexible as we approach each new protocol. It is easy to fall into “one size fits all” solutions to human subjects protection, but nearly every project is a unique intersection of risk resulting from the overlap of subject populations, topics, methodologies, legal issues, regional considerations, and participant expectations. Most studies need unique solutions in order to adapt to these intersections and protect the subjects.

Dr. Hoang’s research involved observations of high-profile individuals while interviewing sex workers. She needed a solution that would ensure that some participants knew she was conducting research on illicit activities while other participants could distance themselves from her work. Dr. Hoang employed a deep cover/shallow cover/explicit cover system to protect the various classes of participants and the integrity of the research. This solution was the result of multiple conversations with legal counsel, the IRB, and peers. Research thrives when solutions are developed through collaboration between various resources and stakeholders that protect the participants, comply with rules and regulations, and allow the researcher to obtain the data they need.

While we are busy rewriting policies and procedures in order to comply with the new regulations and requirements, it is easy to overlook or forget that IRBs need to remain flexible and adaptable. We need to ensure that we don’t just become Regulatory Robots. We need to focus on what we are all really here for. ASU, like many peer institutions, is in the process of making changes to software, forms, policies, workflows, and processes. This presentation was an important reminder to include opportunities for flexibility and discourse between the IRB and investigators into these new processes and workflows.

Erik Williams is a compliance specialist at Arizona State University. He has been a staff member at Arizona State University for the last two and a half years. Prior to that, he was a student board member for three years at University of Wisconsin Eau Claire while working on his MA in English Literature. His focus is on SBER research and issues and he is a contributing member of the SBER Network.