University Times

As a national research institution, Pitt boasts annual sponsored research support on the order of $425 million. Of Pitt's six schools of the Health Sciences — Dental Medicine, Health and Rehabilitation Sciences, Medicine, Nursing, Pharmacy and Public Health — four (medicine, nursing, public health and pharmacy) are in the current or recent top 10 of their respective disciplines in attracting National Institutes of Health (NIH) support.

But research isn't just scientists soliciting grant money and poring over data in isolation. Biomedical research, from basic through translational through clinical research is a many-faceted process, requiring the nurturing of research activities both within and across schools, according to the director of the newly reorganized Office of Research, Health Sciences (OORHS).

The mission of the office, which has expanded its core staff in recent months to 11, is to coordinate biomedical research across the schools of the Health Sciences, said director Michelle S. Broido, assistant vice chancellor for basic biomedical research. "It's useful to think of what is necessary for a robust research environment: space, equipment, skilled people, research funding and support services. OORHS is involved in all of these."

According to Susan Manzi, associate professor of medicine, Division of Rheumatology and Clinical Immunology, OORHS offers researchers two important services: matching grant opportunities with appropriate faculty across the Health Sciences and expediting the process of obtaining funding.

"The office is incredibly helpful in identifying grants that are specifically tailored to the individual and matching you with the right collaborators," said Manzi, whose research in Systemic Lupus Erythematosus is done in collaboration with Graduate School of Public Health epidemiologists.

"They also help with a relatively simple thing like doing applications," she said. "At one point I asked, 'How does this particular center treat PIs (principal investigators)? Do they prefer applications listing co-investigators or one principal investigator? Well, the office did all the calling and finding out about that for me, and it turns out [that agency] looks more favorably on applications from one PI. I consider that service 'above and beyond' what one normally expects," Manzi said.

Broido said, "We maintain an extensive list of funding opportunities on our new web site — wwws.oorhs.pitt.edu — and send e-mail messages about almost every announcement that we post to faculty members across the Health Sciences whose interests are targeted at the given subject."

These opportunities include all NIH program announcements, requests for proposals, competitive grant solicitations from foundations that support biomedical research, and requests for nominations for special awards. The web site also serves as a catch-all resource with links to an events calendar, current medical news, the Health Sciences schools and relevant University offices including the OORHS companion office, the Office of Clinical Research (OCR).

OORHS also provides assistance in preparing multi-disciplinary grant applications such as for a specialized research center grant or a training grant, Broido said. "In some cases we'll pull together the scientific team that will serve as the PI and co-PIs on the application. In other cases, the PI will contact us and ask for our assistance in preparing a complex application."

Rather than technical writers, OORHS staff include two scientist-administrators with Ph.D.s to help in the preparation of grant proposals, applications and supporting materials.

The scientists provide background information on Pitt's strengths and resources and serve as editors who convert multiple-author documents into coherent and scientifically detailed presentations.

OORHS also represents Senior Vice Chancellor for the Health Sciences Arthur Levine in the design and construction of new and renovated research facilities and research space, Broido said.

In fiscal year 2000, as an example, OORHS staff were involved in discussions about more than $15 million worth of renovations on 128,000 square feet of research space, she said.

The office relocated displaced faculty, disposed of old equipment, worked with Environmental Health and Safety personnel to ensure that the old labs were decontaminated and that chemical and biological agents were disposed of properly, and coordinated meetings between the new occupants and the architects, Broido said.

"OORHS staff acted as the liaison between the researchers, the architects and Facilities Management," Broido said, coordinating needs of the researchers with re-designed space.

Billy Day, associate professor of pharmaceutical sciences, whose lab moved recently from RIDC Park in Harmarville to Salk Hall, said the office's help was invaluable.

"The entire space in the new lab, which is in an old building, had to be renovated to accommodate our instruments, which are very specialized pieces of equipment," Day said. That equipment included a nuclear magnetic resonance spectrometer that requires properly stored liquid helium and nitrogen.

"The ceiling had to be a certain height to accommodate a long tube, and that required cutting a hole in the ceiling to get it properly installed. We worked very closely with Jaime Cerrilli (OORHS manager of research space and resources) on the design plans. It all went very smoothly."

Day said OORHS currently is helping him establish a new proteomics core lab, where researchers will study proteins and peptides from complex systems, such as tissue, blood and cell culture, using mass spectrometers and other complex and sensitive equipment.

"This involves a huge expenditure, between $1 million and $2 million in equipment and people," Day said. "They've been totally supportive, including helping us obtain some funding from Dr. Levine's office."

Part of the proteomics core lab will be housed in Salk Hall and part in the Biomedical Science Tower (BST), Day said. "Eventually, we'll be in the new BST3 building, and we'll be relying on their support services again," he said.

"We're responsible for identifying the 'flow' of the BST3 building," Broido said, "that is, which research group should be close to what facility or to which other research groups in order to maximize efficiency and collaboration."

While OORHS supports general academic research, the Office of Clinical Research, now housed in the same suite at 401 Scaife Hall, supports human subject research. S. Clifford Schold, assistant vice chancellor for clinical research, heads the OCR.

According to Schold, OCR (which also has a new web site: www.oorhs.pitt.edu/clinicalresearch) offers a number of clinical research related services. "These include: the clinical research informatics service, or CRIS, which protects patients' confidentiality; statistical assistance; an institutional data and safety monitoring board, and guidance in Institutional Review Board (IRB) and other compliance submissions," Schold said.

Marilyn Hravnak, assistant professor of nursing and coordinator of the Acute Care Nurse Practitioner Program, said she worked closely with OCR on her research needs.

Hravnak was designing a clinical study on the prevalence of atrial fibrillation in coronary, post-bypass patients. "I think I was somewhat naive in the beginning about knowing all that was involved in doing retrospective versus prospective research," Hravnak said. "[OCR's staff] will work with you and help you work things through step by step.

"I have learned a lot from their office, for example that you can do certain things with retrospective research to ensure the reliability of the data. I had developed the basic methodology, but they helped with refining the questions and narrowing the focus," she said.

"Then [OCR] helped me through it all: data collection, data screening, evaluation and interpretation of data. I think the secret is to start working with them early on. I'm a very satisfied customer."

Schold said that while there are a number of alliances in place between clinical research programs and statisticians in the Health Sciences schools, "the process of identifying expert statisticians and developing meaningful collaboration is often opaque, particularly to junior investigators. OCR acts as a point of contact for investigators who are seeking statistical input for their projects."

The medical school's Manzi said that OCR not only provides statisticians for data analysis, it connects researchers with other clinical staff, such as research nurses to organize data collection and recruiters of human subjects for clinical trials. "It takes a lot of people to conduct a clinical trial," Manzi said.

She added, "I think Dr. Schold is improving the whole system, creating templates that streamline the process without sacrificing the essential protections of human subjects. After grants have been approved, the execution of a clinical trial begins, and Dr. Schold's office helps to iron out problems and get the wheels rolling," she said.

Schold pointed out that the changing regulatory environment is a challenge to both investigators and the IRB. "One of the principal functions of the OCR is to remain current on regulatory guidelines and policies affecting clinical research. But we also are advocates for the clinical research process and for the faculty engaged in clinical research, while recognizing and communicating the absolute necessity of regulatory compliance," he said.

Unlike the University's central Office of Research, which is authorized to assume the obligations imposed by federal laws, requirements and conditions for grant application, OCR is more a grassroots support office, Schold said.

"The Office of Research reviews grant applications to make sure that all the 'I's have been dotted and the T's have been crossed,' and certifies that the resources [described in a grant application] are available. But that office does not identify or build the resources," Schold pointed out. "We may get involved in the writing of a grant application, and we work with investigators to help them locate or acquire the resources that they need to be productive, something that staff members in the Office of Research do not do."

Broido added that the Office of Clinical Research provides more basic services, such as help with protocol submissions to the IRB, recruitment of patients for clinical trials, training research coordinators and helping with the data safety and monitoring boards that are required for clinical trials.

"The way the Office of Research, Health Sciences interacts with the OCR is that OCR is often involved in helping to meet the research space and research equipment needs for these clinical studies," Broido said. "Biomedical research is a continuum, and the two offices, through a common location and shared personnel, are committed to the goal of working together to ensure that all research disciplines in the Schools of the Health Sciences have the infrastructure necessary to support their activities."

–Peter Hart