Barbara McGarey’s career has come full circle. After starting as a cardiac surgery intensive care nurse at the National Institutes of Health’s (NIH) Clinical Center in Bethesda, Maryland, she has found herself, many years and many professional turns later, back at NIH, this time serving as the agency’s legal head.
Her transition into law actually began while she was working at the Clinical Center, the largest hospital in the world devoted to biomedical research. She attended Catholic University law school while continuing to work nights and weekends as a Clinical Center nurse. After graduation, she landed a spot in the Honors Program at the Department of Justice, where she worked in the Civil Division Office of Consumer Litigation.
“DOJ was a great experience, but it was clear to me litigation was not going to be my professional path” McGarey says. “I wanted to do more advice work, which is what agency counsels typically do.”
She spent the next seven years at the Department of Health and Human Services’ (HHS) Office of the General Counsel before landing back where she started. This time, though, the NIH hired her as deputy director of its fledgling Office of Technology Transfer. At the time, the agency was building a program to implement the Federal Technology Transfer Act of 1986, which improved private-sector access to discoveries generated by federal laboratories.
“Agencies were starting to aggressively patent inventions arising from federal research and license those patents to companies for commercialization,” McGarey says. Because so much of her role involved managing patents, she sat for the patent bar and became a patent attorney. Working in a nonlegal program position during this time also gave her the management chops to continue rising within HHS. She then spent a year with the NIH Foundation, focusing on public-private partnerships before applying for her current position at NIH in 2001.
She admits her professional path has been unconventional, but she’s grateful for the “amazing public-service” opportunities that have arisen along the path to her dream job. “I see the legal department as a partner and facilitator for the great work of the NIH doctors, researchers, and administrators,” she says.
Her team’s work on recent landmark legislation symbolizes the kind of symbiotic relationship she describes.
The 21st Century Cures Act
The 21st Century Cures Act, signed into law in 2016, was sweeping bipartisan legislation passed to advance research and development of new therapies and diagnostics by providing substantial federal investments. The act established new research programs such as the Precision Medicine Initiative; created an Innovation Fund to carry out brain, regenerative medicine, and cancer research; and provided many new authorities such as those strengthening privacy protections for human research subjects. “Cures is a very large piece of legislation that contains nearly 40 new NIH provisions, programs, and legal authorities,” McGarey says.
This added up to a lot of new language in the law, which McGarey and her legal team labored to ensure remained just right as the legislation evolved. “Legislation like this requires sustained attention and a significant amount of technical assistance to make sure the new language articulates with the current law to support Congressional intent while avoiding unintended consequences—and to ensure at the end of the day that the agency has the authorities it needs to carry out its mission,” McGarey says. “It’s detailed work, but it’s incredibly exciting because it is so important to the success of the NIH and its mission.”
All of Us Research Program
Part of the 21st Century Cures Act was the Precision Medicine Initiative, which includes the All of Us research program, a landmark effort to gather data from a million or more Americans as a tool to accelerate research and improve health. Taking into account individual differences in lifestyle, environment, and biology, the resulting database of baseline information will be used for research projects across multiple platforms by generations of scientists to come. The goal is to extend precision medicine to all diseases.
“The NIH will be collecting data in ways that haven’t been collected before—and on a much broader scale” McGarey says. “For instance, some participants will wear devices that may monitor environmental exposures or collect real-time activity and biometric data.”
Naturally, a number of legal questions have arisen. NIH administrators are accustomed to using grants and contracts to fund their research projects. For a project so novel and complex, however, Congress gave the NIH the authority to use Other Transactions (OTs), legally binding funding instruments that provide much more flexibility than standard procurement contracts, grants, or cooperative agreements.
As McGarey and her team helped the NIH develop OTs for All of Us, they were also deeply involved in ensuring the highest level of privacy protections for the more than one million participants. There are even issues about how much of their own data participants get to see.
“We’re also trying to work through all the legal issues involved in operating a novel research project where participants will be able to access an internet portal and sign up without intervening medical providers,” McGarey says. “Typically, research participants find the NIH through their doctors.”
For McGarey, it’s a thrill to be involved with such projects. In her long history with the NIH, she has learned that projects such as these are often models for future healthcare breakthroughs.
“It’s always exciting to be at the forefront of biomedical research.”
Photo by Chia Chi Chang