Tania Hossain Caravella is the director of the UNC Institute for Global Health & Infectious Diseases Regulatory Affairs Office. She discusses the role of this office in the Institute’s clinical trials around the world as well as how she unwinds outside of work.

Q. What is your title and how long have you held this position?

A. I have served as the Director for Regulatory Affairs within the UNC Institute for Global Health & Infectious Diseases (IGHID) for the last 12 years and the Ethics Consultant for the UNC Center for AIDS Research (CFAR).

Q. How do you and your team support the research being conducted by IGHID and CFAR investigators?

A. I was hired in 2006 to create a central regulatory affairs office for the Division of Infectious Diseases. We started with one regulatory coordinator, Nazneen Howerton, and myself. Over time, we have added four additional regulatory coordinator positions and 1.5 regulatory documents specialists. We manage more than 400 research projects in 10 countries. We also work very closely with regulatory staff around the world, including one key point person in Vietnam and two in Malawi. The mission behind our work is to provide protections to all of the individual volunteers who choose to participate in our research.

We work closely with study teams around the world to assist and provide information to participants in the most meaningful and complete way. It is so important that we present information clearly and concisely, in language that is understandable to the participant. We always have to walk the line between what is truly useful and what we are required to include in an informed consent to meet legal requirements. At the end of the day, we want to ensure we are doing our part in regulatory to help research participant volunteers to feel they are informed, respected and appreciated for their service to research; and, of course, ensure we are maximizing benefits and minimizing harms. We are advocates for study participants and we take this role very seriously.

In addition to serving research participants, we are an integral part of the study team. We work closely with them on any regulatory or ethics concerns. For example, if a study participant is facing stigma at work or in the community because people have discovered they are in an HIV research study, we would work with the team to gather all pertinent information, and report this to the proper institutional and federal authorities. We also work with the team to develop a corrective action plan to help prevent this problem from happening in the future.

We work with study teams before, after and during a research trial. For example, each country has strict guidelines on how study results can be disseminated. We can work with study teams to decide the best way to share these results and ensure clinicaltrials.gov submissions are up to date as required.

We interact with many different regulatory authorities around the globe, most often with IRBs. IRBs or Institutional Review Boards are a part of all studies that involve human subjects to ensure studies are ethical. In the United States, we work with multiple Institutional Review Boards, like the one at UNC, as well as central IRBs such as WIRB. Now with the single IRB mandate, we are doing more work than ever in helping to set up deferral or reliance agreements between domestic IRBs, for example where Duke will rely on UNC or vice versa for a shared project. In some ways, it adds a new level of complexity to work with so many other institutional IRBs, each of which is trying to determine the best way to interpret the regulations. That is always the rub in regulatory, the regulations are anything but black and white. We deal with the gray on a daily basis.

In addition to IRBs, my team works with the Food and Drug Administration (FDA), the National Institutes of Health (NIH) reviewing bodies, biosafety committees, international ministries of health and the international equivalents of the FDA. Incidentally in Malawi, the “FDA” is affectionately called the Poisons Board.

Q. What do you enjoy the most about your job?

A. I love working with different study teams in the United States and all over the world. It is gratifying to work with so many different individuals for a common cause. Sometimes the ethical issues that come up in Africa are completely different than the ones that come up in the US, and sometimes they are exactly the same. It’s always interesting to examine the differences and similarities.

The other thing is that I came to UNC after working in private industry. There, it was all about the data, and hitting that next milestone for the company. I didn’t hear much about actual study participants even though I was looking at their data. I really love being at an academic institution where you are always learning something new, and we are much closer to the faces behind the disease. You can actually see the impact behind your work and the individuals you affect.

Q. When you are not at work, how do you spend your time?

A. I love to travel, capture images and write. I now design and offer jewelry made with gorgeous, natural stones. Regulatory Affairs can definitely be creative, but these are the other things that let me stretch my brain in completely different and fulfilling ways. It’s great to experience the beauty our world offers, whether that means connecting with an artist painting murals in the clinic in Malawi or being able to make something inspired by an incredibly vibrant market in Vietnam. It all ties together for me.