Federal ethics rules may limit NIH in biomed endeavors
Johns Hopkins interested in federal collaboration at its Life Sciences Center expansion
County officials and Johns Hopkins University are seeking to loosen or alter ethics restrictions on federal research scientists, such as those at the National Institutes of Health in Bethesda, to make it easier for them to collaborate with private companies.
The university's plan to bring together private industry, federal scientists and academic researchers in the forthcoming Gaithersburg West Master Plan could run afoul of the ethics rules at NIH, updated in 2005, that prohibit its scientists from "outside consulting" with pharmaceutical, biotechnical and medical device manufacturing companies, according to an NIH summary of its ethics policy.
Johns Hopkins plans to build a cutting-edge biotech center on 107 acres of open space that is part of the Gaithersburg West Master Plan, which calls for the creation of 40,000 new medical and research jobs at the Shady Grove Life Sciences Center. The Planning Board's current version of Gaithersburg West would allow 20 million square feet of research and commercial space and triple the current size of the Life Sciences Center, which includes Shady Grove Adventist Hospital and the county's biotech corridor.
Johns Hopkins has said one of its goals is to attract a federal research agency, such as NIH, to collaborate at its Life Sciences Center facilities. It is seeking to clarify to what extent the current NIH regulations could impede collaboration between John Hopkins and NIH and other federal agencies, and how these regulations could be changed or eliminated entirely.
"If I am a federal employee, and I am working on a project, and if I want to collaborate with someone in the private sector or in a university, and one result of that collaboration may be the development of a new business that makes profits, is there a conflict?" said David McDonough, senior director of development oversight for Johns Hopkins Real Estate, summarizing the main question about NIH's ethics rules.
Montgomery County's Department of Economic Development is also creating a new position in its office for a liaison with the federal government and academic institutions on conflict of interest issues. The department in general is investigating the flexibility of rules governing NIH employees, said the department's director Steve Silverman.
"The goal is to provide more flexibility for NIH research to become commercialized," Silverman said.
But Silverman also said this goal applies to biotechnical and medical companies in Montgomery County generally and was not specifically directed at Johns Hopkins' expansion efforts.
Current NIH regulations permit scientists, with prior approval, to engage in outside academic efforts such as teaching university courses, writing textbooks and lectures. They can also engage in practicing medicine and other "health professions" with prior approval.
NIH's ethics regulations are developed through the Department of Health and Human Services, which oversees NIH, as well as the federal Office of Government Ethics, which prescribes ethical standards across the executive branch. They were created after input by NIH staff, the public and scientific organizations.
"We are not aware at this time of any plans to alter the ethics rules," said Holli Beckerman Jaffe, a senior policy officer for ethics at NIH.
In fiscal 2009, NIH provided $709 million in financial assistance to Johns Hopkins University, according to federal statistics. Some of the largest Johns Hopkins research programs receiving assistance from NIH include allergy, immunology and transplantation research ($73 million), global AIDS research ($53 million), and cardiovascular diseases research ($44 million).
Johns Hopkins is still investigating how to deal with federal regulations and has not decided on a course of action as to how to further involve NIH in the Life Sciences Center expansion, McDonough said.
"Everyone is very sensitive to ethics in government," McDonough said. "The counterpoint is, how do we accelerate discoveries and the commercialization of discoveries in a global marketplace?"
Asked if county officials had contacted U.S. Rep. Chris Van Hollen Jr. (D-Dist.8) of Kensington to investigate whether NIH ethics rules could be changed, spokeswoman Bridgett Frey did not address the issue directly, stating: "Congressman Van Hollen is committed to supporting the federal agencies and federal employees located in his district. This is an ongoing effort carried out in collaboration with the Maryland delegation, our local government partners, and other stakeholders."
"We've talked with our congressional delegation. They get it. But this is a national effort, this isn't just a Montgomery County issue," Silverman said.
In a 2006 survey of its employees, NIH found 37 percent believed the ethics rules governing outside activities were too restrictive, while 61 believed they were appropriate. Prior to the update to the ethics rules in 2005, the same survey found 55 percent of employees believed NIH needed to clarify its rules on outside activities.