ARTICLE IN BRIEF
Neurology chairs and an attorney versed in intellectual property law discuss what happens to research programs when a principal investigator leaves one institution for another. The discussion emerges in the context of an ongoing dispute between the University of California, San Diego and the University of Southern California over ownership of the Alzheimer's Disease Cooperative Study grant.
The legal battle between the University of California, San Diego (UCSD) and the University of Southern California (USC) over control of the massive Alzheimer's Disease Cooperative Study (ADCS) underscores for some academic neurologists an uncomfortable fact: The studies they run and the data they generate are not necessarily their own.
When academics seek to switch institutions, their ongoing studies go along only with the consent of the university they are leaving, and getting that consent beforehand is essential to ensuring a smooth transition, according to neurologists and a university attorney who spoke with Neurology Today.
In practice, the institutions being left behind almost always agree to let the research go, but their legal right to say “no” makes it incumbent upon the departing neurologist to exercise caution and diplomacy in managing the transition.
The stark reality of just how badly the switch can go was brought to the fore in June, when Paul Aisen, MD, left UCSD, where he had directed the ADCS since 2007, to become founding director of USC's Alzheimer's Therapeutic Research Institute. His former institution immediately sued to maintain control of the large Alzheimer's study, which it established in 1991 and which receives an estimated $100 million per year in funding. [See the sidebar, “Two Neurologists at the Center of the Dispute Defend Their Positions.”]
A California Superior Court judge ruled in favor of UCSD in July, but a countersuit filed by USC has kept the final disposition of the matter in limbo.
While the California dispute appears to be unprecedented in scale and rancor, the transition from one institution to another is never easy, said Louise D. McCullough, MD, PhD. She spoke with Neurology Today in September, following her first day on the job as the new chair of neurology at the University of Texas Medical Center at Houston, after departing the University of Connecticut Health Center two weeks earlier.
“The transition has been difficult, I'm not going to lie,” said Dr. McCullough. “Not only did I have to be concerned about myself, my husband, and my four kids, I had to be worried about all my lab personnel, graduate students, and three other assistant professors. It's an incredibly stressful experience, but well worth it.”
In all, Dr. McCullough ended up taking 18 of her Connecticut staff with her to Texas, as well as her family. And while the University of Connecticut could have tried to cling to the National Institutes of Health (NIH) grants that were legally awarded to the institution, not to her personally, the university administrators recognized that it was simply unable to manage them without her, she said.
“UConn was great. They said they would release the grants. They could have been incredibly difficult. I went to my dean, and both he and my university president were incredibly supportive. I think they realized they couldn't compete with what Texas was offering,” she said.
“No university is going to love losing a funded investigator,” she said. “It's a financial loss for them, due to the indirect costs associated with any grant. Academic medicine is different now than it was 10 or 20 years ago. Everything is about the indirect costs [related to conducting the research]. UConn lost more than a million dollars in grants when I left. But sometimes a program has to step back and say, ‘What's best for the field?’”
While the process was amicable throughout, Dr. McCullough said it took more than a year to effect the transition, given all the people and studies involved.
CHALLENGING, BUT NOT CONTENTIOUS
Like Dr. McCullough, Merit Cudkowicz, MD, the chief of neurology at Massachusetts General Hospital, said that while negotiating a switch from one institution to another can be complicated and time-consuming, she has never known it to be acrimonious.
“It involves discussions and meetings and negotiating to come to a fair solution for everybody,” said Dr. Cudkowicz, who is also the Julieanne Dorn professor of neurology at Harvard Medical School. “It involves personalities. The grants don't really belong to the PI [principal investigator]. But I've never actually seen anyone not say ‘okay’ to the PI that they can take the grant when they go.”
Typically, Dr. Cudkowicz said, a researcher intending to leave an institution and take grants with her begins the process by speaking with the department chief. “Then there is an IRB [institutional review board] review,” she said. “And there's often a legal counsel who signs off on patent things.”
In most cases, she said, the grants involved are small enough that the university has little at stake in losing them. But, Dr. Cudkowicz added, “There are some grants where in order to get it, the institution has to expend a lot of its own resources. If they put 10 million dollars into building a database, for instance, it might be hard for them to just say, ‘Take it.’”
While few research programs can compare to the size of the ADCS, Dr. Cudkowicz is the principal investigator of the clinical coordinating center for NeuroNEXT, an NIH network for neuroscience clinical trials.
“There aren't many things comparable to the Alzheimer's network, but NeuroNEXT is close,” she said. “I have no plans to leave. But if I did, what would happen? I think I would probably try to stay involved, but the core of it would remain at Massachusetts General Hospital. It wouldn't make sense to go and rebuild it somewhere else. That doesn't mean I couldn't still be the PI, but it would have to be worked out. You'd have to have it all figured out between the two institutions before you leave, so that it's seamless. You do not want to be losing time. You're not talking about mice or worms; it's people who are in these studies. You want to be sure there are no hiccups.”
Dr. Cudkowicz emphasized, however, that for all the many investigators she has seen come and go, she could not recall an instance in which the transition led to a legal dispute, or even the threat of one.
“I've never seen it at my own institution,” she said. “Other investigators I've spoken to haven't seen it either. People change institutions at least once in their career, if not more. We have a whole transfer guideline [document] to fill out when someone leaves that addresses IRB requirements, inventions, equipment, and other parts of the research project, to make sure they're taking care of everything.”
UNIVERSITIES RESPOND WITH FORMAL CONTRACTS
Academic neurologists are not the only ones reacting with dismay to the ongoing dispute between USC and UCSD.
“I am seeing more evidence of explicit, formal university policies related to ownership of data and grants,” said Margaret Foster Riley, a professor of law and public health sciences at the University of Virginia, where she teaches, among other subjects, the regulation of clinical research.
“There is nothing magical about the explicit formal contracts that I see; universities are simply reacting to events, and occasionally to lawsuits. Since this is something that can be clarified contractually, that is what they are doing.”
Sometimes, Riley noted, university investigators will contend that a study and the data generated from it were conducted on their own time, and so is their own property. “When there is an overlap between what a researcher may have done on his or her own time and future use by a former employer/university, Madey v. Duke can shed light,” she said.
The case involved a Duke physicist who had a research lab and held patents on laser technologies. After nearly 10 years of heading up a lab at the institution, Duke alleged that the physicist was not managing his lab effectively. The researcher, Dr. Madey, contended that Duke sought to use the lab's equipment for research areas outside the allocated scope of certain government funding, and that when he objected, Duke sought to remove him as lab director. He was removed as director of the lab in 1997.
Researchers at Duke continued using Dr. Madey's technology to conduct experiments; he sued, and, to the surprise of many in academia, he won.
“Everything seems fine while the researcher is working for the institution because interests are aligned,” Riley said. “But it may become very difficult — as Madey v. Duke shows — after a departure. Even so, individuals and institutions can make these relationships clear contractually, and many institutions are making sure that happens. It can feel like the parties don't trust each other, but it's prudent to do it. The researcher may also be prudent to engage counsel then, so they know what they may be giving up or other consequences.”
The litigation in California remains nearly one of a kind, whereas the utterly unremarkable experience of George Wittenberg, MD, PhD, was business as usual.
“I was at Wake Forest,” recalled Dr. Wittenberg, who is now an associate professor of neurology at the University of Maryland in Baltimore. “I was doing a study on brain maps in cerebral palsy, using transcranial magnetic stimulation. I had an R21 study from the NIH, a two-year grant limited to $175,000 of direct costs — essentially a pilot study. It arose out of a collaborative venture with the orthopedic department at Wake Forest, which had a large cerebral palsy population, whereas Maryland didn't. So in 2006, when I wanted to make the move to Maryland, the data collection really had to stay at Wake Forest. The NIH grant to run the study moved with me, but we did a subcontract back to Wake Forest to continue the data collection there.”
The arrangement required the agreement of NIH, Wake Forest, and Maryland, Dr. Wittenberg said, and an allowance for indirect costs in the subcontract to Wake Forest. “You tell them you're planning the move, and what your plan is for carrying out the work,” he said. “It has to be a credible approach.”
As complicated as working out the subcontracts was, everything was figured out and the study was ultimately published in the journal Clinical Neurophysiology in 2012.
“I realize that my transferred grant was so small compared to the one [the grant for the ADCS trial] at UCSD,” Dr. Wittenberg emphasized. But then, compared to the ADCS and its $100 million in associated grants that the two California universities are fighting over, just about everything in neuroscience is small, he said.
TWO NEUROLOGISTS AT THE CENTER OF THE DISPUTE DEFEND THEIR POSITIONS
Two of the neurologists at the center of the legal dispute between the University of California, San Diego (UCSD) and the University of Southern California (USC) over control of the Alzheimer's Disease Cooperative Study (ADCS) have defended their positions in discussions with Neurology Today, offering strikingly different accounts.
William Mobley, MD, chair of the department of neurosciences and a distinguished professor at UCSD, was directly involved in offering a formal response earlier this year after Paul Aisen, MD, then a professor there and director of the ADCS, informed the university that he was considering leaving for USC.
“I understood well what Paul needed,” Dr. Mobley told Neurology Today in a telephone conversation. “I cosigned a letter that said, ‘Here is everything you asked for. You've got it.’ He didn't accept it. He rejected the offer. And then — which was a big problem — he picked up the ADCS clinical database and moved it with him. He took our database. He literally picked it up and moved it without permission. And this is a database that has 25 years of data. He's in possession of that. We can see the data but we cannot control the system.”
Dr. Mobley continued: “This is by no means a normal transition of a grant from one institution to another. I think Paul really thought that USC was a better place for him. That was his decision. People can make decisions. We didn't respond as quickly as he wanted. People move. But you have to move in a way that doesn't disadvantage you, the research, the accepting institution, or the leaving institution.”
After reviewing Dr. Mobley's statement, Dr. Aisen offered his own account of the dispute via email.
“I began regular meetings with the UCSD leadership in December 2014 to discuss my concerns regarding administrative support (particularly contracting backlogs and difficulties with rigid human resources rules),” he stated. “These issues were impeding the work of the research program, and led me, at the urging of my collaborators, to seek a new academic affiliation. My discussions with UCSD made little progress. After I indicated in late May that I was nearing a decision to leave, UCSD responded with a mix of penalties: I was cut off from email and server access, interfering with my research responsibilities; I was also asked to sign a loyalty oath to UCSD, and incentives (some limited progress on my administrative requests).”
Dr. Aisen continued: “While it is true that Bill Mobley and David Brenner [vice chancellor for health sciences and dean of the school of medicine] presented me with a written response to my requests, it is untrue that it was an adequate response, as I immediately indicated to them. Then, upon submitting my resignation, I was sued, along with members of my staff and USC. I removed nothing from UCSD: no data, no software, no files. I retained some administrative control of our data systems to allow maintenance of ongoing clinical trials (since no one at UCSD has the appropriate training and experience to manage these tasks, a situation that continues to the present day), and I am responsible for maintaining the integrity of the trial datasets under the study agreements.”
Dr. Aisen concluded: “Throughout this time, UCSD has maintained access to the study data and systems, so it is patently false to state that I ‘picked it up and moved it.’ I had wanted to negotiate an orderly transition with UCSD, but UCSD made that impossible. When I announced my intention to leave UCSD, I immediately received a letter from their attorneys, which I found threatening, and was told by David Brenner that my research studies would never leave UCSD. There are procedures in place for determining the disposition of research studies when a faculty member changes institutions; I wanted to rely on these procedures to determine the appropriate outcomes. UCSD chose to sue me instead.”