Dr. Brownley is Associate Director of Policy & Initiatives in the OHRE and Adjunct Professor of Psychiatry, where she has been a faculty member since 1999. She is a Certified IRB Professional, has served as Chair of two UNC IRB committees (C and F) since 2014, is a founding member of the UNC Scientific Review Committee, and previously was co-Director of the NC TraCS Regulatory Services. Dr. Brownley began her research career over 35 years ago while completing her graduate degrees in Exercise Sciences and Experimental Psychology at UNC and her postdoctoral research fellowship and clinical training in Behavioral Medicine at the University of Miami, FL.
As a Principal Investigator, her research encompassed various aspects of human psychology, physiology, and behavior and focused on stress, mental health, and the psychobiology of appetite regulation. In her current role in the OHRE, Dr. Brownley contributes her knowledge of the regulatory framework governing human subjects research, her experience as a PI, and her love of mentoring and teaching to help others move their research from concept to completion with as few regulatory bumps in the road as possible.
Why were you interested in joining the IRB?
I absolutely loved being a PI, but I also found it somewhat isolating; so, I saw the IRB as a place I could put my research skills to work in other ways that involved a wider range of interaction and collaboration with trainees, colleagues, and staff across campus. I thought I could be helpful.
What was your first IRB meeting like?
I don’t remember much detail except the mounds of paper strewn across the tables in the boardroom😊. If I had to guess, I was probably a bit overwhelmed!
What is your favorite part of serving on the IRB at UNC?
After serving in a part-time role as chair for many years, I joined the OHRE full-time in 2023 as an Associate Director to help with board member and workforce development, policy, and outreach to our research community. This gives me more time to teach, mentor, and advise – things I love to do. I really enjoy reasoning through complicated ethical principles and regulations to help researchers, IRB members, and OHRE staff accomplish their professional goals.
What is the most common reason your boards defer a study?
It comes down to missing some piece of information the board members believe they need to determine that risks to participants are reasonable and minimized to the extent possible.
Is there a common problem in research applications that drives you crazy?
Consent forms that are not written in plain language that the average individual can understand. Common blind spots are the use of highly technical and medical terms, and inconsistencies across the protocol, application, and consent form.
What is the most interesting ethical dilemma you’ve encountered while serving on the IRB?
That’s a tough question! When I think back over some of the lengthier and more contentious board discussions, a couple come to mind.
The board was asked to grant a waiver of parental permission for research that involved asking minors about sensitive topics that they may not be transparent about with their guardian. The dilemma was in satisfying two separate approval criteria: 1) the risks are reasonable and minimized, and 2) the research is based in sound research design. Some members felt uneasy waiving parental permission because it would remove a layer of protection that otherwise is recognized as ethically important to protect minors. Other members focused on the fact that requiring parental permission could lead to disclosure; this would introduce added risk to participants and bias the study sample toward youth who had already disclosed to their families, leading to study outcomes that had limited generalizability.
Our charge is to protect participants, but there have been a few situations where the IRB had to deliberate about physical harm and the threat of physical harm experienced by study personnel conducting field-based research in remote areas. The dilemma was in balancing the weight of the harms, their probability of recurring, and the value in allowing the research to continue for societal benefit.
What advice do you have for researchers submitting to the IRB for the first time?
Remember, you are the content and context expert for your research. When the IRB reviewers ask questions about your IRB application, it is because we need more information to understand that which is second nature to you. IRB members and staff rely on you to communicate your intentions, plans, rationales and justifications clearly so that they can weigh in on the adequacy of protections for the participants in your study. Be proactive, reach out for support and consultation if you are unclear about any aspect of the IRB submission process. If you are completing the application and find yourself cutting and pasting the same answer in multiple places, this may be a signal that a consult would be helpful. Whether you delegate writing the application and consent form to a team member is a personal choice, but you should always carefully review and edit before submitting.