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Carley Emerson is the director of the Office of Human Research Ethics (OHRE) within the Office of the Vice Chancellor for Research.

Carley Emerson
Carley Emerson, director of the Office of Human Research Ethics

Carley Emerson is a human subjects research professional with over 20 years of experience in many capacities. Most recently, she served as the director of the human research protections office and IRB at the Carillion Clinic in Roanoke, Virginia. As director of OHRE, Emerson will help ensure ethical and regulatory oversight of research at Carolina that involves human subjects, as well as support and oversee the work of the institutional review boards (IRBs).

UNC Research recently spoke to Emerson about her role and what’s to come for OHRE.

Tell us a little about yourself and your background in human subjects research?

After getting my bachelor’s in biology, I worked in a basic science lab in the Johns Hopkins School of Medicine for a few years. I was then hired within the Johns Hopkins Center for Clinical Trials as a clinical trials project coordinator to support numerous multi-site research studies and serve as a main point of contact within the coordinating center. I conducted monitoring visits for these sites and traveled to them to meet research teams across the country.

I immediately loved the field and started taking some public health and epidemiology classes. After a few years, I was looking to expand on my knowledge, and started a new role at the University of Maryland, Baltimore in their Human Research Protections Office. I have been working in the field of human subjects research ever since. Research by nature is innovative so the knowledge needed is always changing, and within the past few years, there have been significant revisions or additions to the regulations. It keeps things very interesting, and I love that I am always learning!

I am also a proud mom of two children. I love to attend music festivals, hike, and camp with my family, and cheer on my children on at their many activities. I am involved as a coach and board member with Girls on the Run, serve as an assistant troop leader in Girl Scouts, and am very active in the PTA. I love to read, although recently, audiobooks and podcasts have become a little easier to squeeze in.

What role do you and OHRE play in the UNC-Chapel Hill Human Research Protection Program?

The Human Research Protection Program (HRPP) is an institution-wide program that provides oversight, administrative support, and educational training to ensure that Carolina research complies with federal and state regulations, university policy, and the highest ethical standards. The protection of human subjects participating in research is a shared responsibility of researchers and the institution.

I am really proud and excited to be a part of the OHRE team and UNC-Chapel Hill. The OHRE office is an important component of the HRPP and houses the six IRB committees. The primary purpose of the OHRE office within the HRPP is to review research to assure the protection of the rights and welfare of the human subjects taking part in the research.

My role as director is to work with the other components of the HRPP to ensure we are protecting research participants across the many different facets of research. In addition, my role entails providing leadership and education to OHRE staff and the research community, ensuring the IRB committees have appropriate expertise and processes, providing resources to the IRB members, and partnering with researchers to improve the IRB process.

Why is it crucial to protect the rights and welfare of people participating in research?

Very simply, research makes lives better. Research leads to new knowledge. This new knowledge is then utilized to make medical advancements, help get new drugs or devices approved for use, identify new ways to detect or diagnose disease, or teach us more about human behavior and how people interact with each other.

Research participants all take on some level of risk, and some participants take on significant risk. Participants spend their valuable time to help generate knowledge that will benefit society and often receive no direct benefit for their participation. Protection of research participants must be a primary focus for all researchers.

Unfortunately, there are many examples in history when research participants, many in already marginalized communities, were not treated ethically. This led to direct harm to many individuals. The implications of mistrust are that we have a lack of diversity in research participants. Lack of diversity results in research findings that may not be generalizable to broader segments of the population, and downstream, may lead to greater heath disparities.

Are there new initiatives or opportunities you are excited about?

I am excited to be part of the ONE UNC Clinical Research Core Design Group. This important initiative will help me get to know the research community and will fast-track my understanding of the UNC-Chapel Hill and UNC Health research processes across the many different research support offices.

I am also excited about our AHHRPP accreditation process, which is now underway and will continue into 2023. This process will help us identify where our HRPP has gaps and allow us to strengthen it, and demonstrates our commitment to scientifically and ethically sound research.

Lastly, I am really looking forward to getting to know the OHRE team. We have a very dedicated group, and I am looking forward to learning how best to support them and streamline some of our processes within the OHRE office.

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