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Barbara McGarey serves as the chief counsel for the National Institutes of Health under Alex Azar II, general counsel of the Department of Health and Human Services. Her title is deputy associate general counsel for public health, NIH. She has 10 attorneys on her staff. What does your organization do? NIH conducts and funds biomedical research to help cure disease, from the rarest genetic disorder to the common cold. About 80 percent of its $26 billion budget is used to fund medical research projects at universities and research institutions around the world. The rest supports about 6,000 scientists who work in NIH laboratories and our research hospital. NIH has 27 separate institutes and centers � for example, the National Cancer Institute, the National Human Genome Research Institute (home of the Human Genome Project), and the NIH Clinical Center, the world’s largest hospital dedicated solely to biomedical research. We are located primarily in Bethesda, Md., on a 300-acre campus. How did you come to this job? I’ve been a government lawyer for about 18 years, all of it related to biomedical research and health care, so this job is a fairly natural extension for me. My first legal job was with the Department of Justice (Office of Consumer Litigation), then I went in-house with Health and Human Services’ Office of the General Counsel for about seven years. After HHS, I took a management job at NIH as deputy director of their (then fledgling) Office of Technology Transfer. That job allowed me to gain insight into NIH as a client, which has been very helpful in my current position. What’s top of mind for you in your job at the moment? What’s in those folders piling up on your desk? Well, I’d have to say that issues related to biodefense are requiring lots of time and attention. NIH and HHS have new legal authorities, and are gearing up for new research and public health programs. We are very involved in these programs in terms of legal analysis of authorities, assisting with funding transactions, reviewing policies and procedures, etc. We also have our normal diet of legal issues involving grants and contracts, intellectual property, patient care, facilities � all of the issues one might expect of a large government biomedical research institution. What are the main challenges of your position? I think any in-house position has special challenges because the in-house counsel is called upon to advise on a very wide variety of legal issues. That is definitely the case at NIH, a federal enclave with its own facilities management (including its own fire department and police force). We handle issues ranging from the rights of protestors on campus to emergencies involving consent issues for patients in our hospital, to the legal implications of recombinant DNA research. It’s a challenge to stay on top of such a wide range of issues. Fortunately, our GC at HHS encourages frequent interactions among the various components of his office, and we keep in close contact with other public health attorneys throughout the organization, such as those at the Food and Drug Administration and Centers for Disease Control and Prevention, who can lend expertise as needed. As the head of your group, what are your top administrative issues or challenges? I’m pretty lucky in that my group is part of HHS OGC, which employs about 400 lawyers, so I don’t have to create or maintain an administrative infrastructure. I would say my top administrative challenge is managing client expectations. We have a small legal staff, and by design we do not require formal vetting of the questions presented to us. This is generally a good thing, because NIH officials feel free to run issues by us on an informal basis, allowing us to intervene early if necessary. On the other hand, it also means that hundreds of clients consider us their lawyers and call us directly on a broad spectrum of issues. We are constantly juggling, prioritizing, and managing the clients’ expectations about whether their issue warrants legal advice and the timing of that advice. Diplomacy is a key factor in our environment. What do you like most about your job? I like the public service aspect of the work, and the fact that the issues are interesting and varied. Probably the best part of the job is the interaction with NIH officials and scientists. NIH attracts an amazing pool of talent, so we are working with the world’s experts on some very tough public health problems. It is personally rewarding to be part of the team. Hopefully, we actually help facilitate the NIH mission. What kind of work do you send out? We don’t use outside counsel.

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