October 2000  Volume 2   Number 2

Enhancing the Safety Net for Human Subjects Research The landscape of human research protections is changing in response to public concerns about whether an adequate safety net exists. Highly publicized events, such as the death of teenager Jesse Gelsinger at the University of Pennsylvania from his participation in a clinical trial, and the temporary closure of several prominent university research programs, have galvanized reforms. These include the elevation the Office for Human Research Protections (OHRP, formerly OPRR) to departmental status and increased expectations and requirements implemented by OHRP and the National Institutes of Health (NIH). Conducting research that is ethical and safe requires a safety net that is woven out of the fabric of investigator knowledge and integrity, and institutional safe-guards. At the core of this fabric is the integrity of the individual investigator, whose high ethical, scientific, and medical standards and knowledge of research principles are essential. Supporting this capacity are the Institutional Review Board (IRB) and the newly opened Center for Clinical Trials (CCT). To strengthen this safety net and meet federal requirements, the School of Medicine will implement additional safe guards in the coming weeks and months. • Augmenting Institutional Review Capacity: Ethical review of scientific research is a complex and demanding enterprise. Not only must the research be ethical, it also must be scientifically valid. Bad science is unethical. To facilitate the scientific and ethical review undertaken by the IRB, senior investigators from the multiple disciplines represented on our diverse campus have recently agreed to join the IRB, and both the size and scope of scientific expertise of the committee have been greatly augmented. Such service is critical to the ongoing and increasing success of the School’s investigators to gain research funding. Additional faculty are needed to serve on the IRB, so please speak with your Departmental Chair so that he/she can communicate your name to the Office of the Dean. • Revisions to the Research Project Notification Form: The Research Project Notification (RPN) form has been revised and formatted to enhance human subjects protections. Moreover, it will be available electronically on the School of Medicine Website (medschool.umaryland.edu/research.html) to simplify the process. • Scientific Protocol Development: The scientific research protocol is a road map for defining exactly what will take place in the context of a research project. To insure uniformity in research review, detailed scientific protocols will be required for all high risk research projects submitted for IRB review. The CCT has proposed a format for these protocols and CCT personnel will be available to provide guidance in protocol development. In addition to precise description of all procedures, personnel and their qualifications and a statistically justified sample size will be required. This template will be posted in the near future on the Website. • Scientific Peer Review: As detailed in the Standards of Good Clinical Practice, rigorous scientific review of proposed research is fundamental to ethical research. In the near future, documentation of peer scientific review will be required of all projects submitted to the IRB. While the nature of this review will need to be defined at the level of the Department, Research Program, or Center, a description of the review process (e.g. departmental scientific review committee) will be provided to the Office of Research Subjects (ORS) in the Office of the Dean. The revised RPN form will include a field for certifying review of each submission. • Research Investigator Certification: The School of Medicine is implementing a certification process for all researchers on the principles of ethical research, good clinical practice, and related FDA regulatory requirements of human subjects research. A three-pronged approach will involve a four-hour self-directed CME-based program developed by the University of Rochester, an NIH-based online training module, and the ORS website (medschool.umaryland.edu/research.html), which will continue to serve as a resource for investigators to keep up with this unfolding scenario. • Monitoring Research Practice: The federal government requires that all IRB-approved research be monitored, and that quality assurance techniques be in place. The ORS will continue to require ongoing semi-annual reporting, 4th year renewals, reporting of protocol deviations, protocol modifications, and adverse event reporting. In addition, a quality assurance officer will audit all phases of research by performing on-site evaluations. Where deficiencies are identified, investigators will be assisted in developing improved procedures. We acknowledge that these innovations, aimed at strengthening the research safety net and satisfying federal requirements, will add to the burdens of investigators. But the benefits in safety and quality of the research are outcomes that justify this sacrifice. Howard B. Dickler, MD		VA Medical Center Ranked #1 for Nationally Funded Research Grants The Baltimore Veterans Affairs (VA) Medical Center, a division of the VA Maryland Health Care System, has achieved the distinction of being ranked number one for nationally funded research grants from VA Headquarters in Washington, DC. Researchers at the VA Medical Center have been awarded $11.7 million to conduct 100 research projects this year alone. In addition to being the top-funded facility in the nation for VA research dollars, the Baltimore VA Medical Center is also ranked number four in overall research funding nationally for grants provided by the National Institutes of Health, Veterans Affairs and other government and private agencies. Noting that VA research has made improvements not only in the veteran population, but for all Americans, Barbara White, MD, associate chief of staff for research & development for the VA Maryland Health Care System, believes that this research plays a major role in affecting society as a whole. “All of the work we do through our research is for the single purpose of improving the quality of life for everyone,” she said. “What we learn through our work with veterans and other community members is then passed on to citizens around the world.” With 162 investigators throughout the VA Maryland Health Care System and 451 active projects, researchers are addressing the medical concerns that veterans are facing by finding solutions to their needs. These research projects are making significant efforts to study the cause, prevention and treatment of some of today’s most prevalent medical problems, including Alzheimer’s and Parkinson’s disease, cardiovascular disease, prostate cancer, mental illness, diabetes, obesity, bacterial infections, pfisteria, AIDS and Persian Gulf illnesses. “Research that is conducted in each of our medical centers throughout the state is an asset that directly benefits veteran patients and touches the lives of every family in Maryland and in this nation,” said Dennis H. Smith, director of the VA Maryland Health Care System. “People will be surprised to learn that medical researchers with the VA Maryland Health Care System have played a key role in the development of rehabilitative devices and the prevention and treatment of certain illnesses.” Many of the research projects being conducted at the Baltimore VA Medical Center are in collaboration with the University of Maryland School of Medicine.   New Director Named For National Study Center Colin F. Mackenzie, MD, has been named director of the Charles “McC.” Mathias, Jr., National Study Center for Trauma and Emergency Medical Systems by Donald E. Wilson, MD, MACP, vice president for medical affairs and dean of the University of Maryland School of Medicine. Dr. Mackenzie, who has served as interim chair of the National Study Center since 1996, is also professor and vice chairman of the Department of Anesthesiology at the University of Maryland School of Medicine, and director of Anesthesiology at the R Adams Cowley Shock Trauma Center. “I am pleased to appoint Dr. Mackenzie to this important position,” said Dr. Wilson. “Not only does he have the experience and necessary skills, but his drive for excellence matches the mission of the National Study Center, which is to continuously improve the understanding of trauma and the delivery of lifesaving care.” The National Study Center is the primary research center for the Maryland Institute for Emergency Medical Services Systems (MIEMSS) and is involved in a variety of research projects, including: • Crash reconstruction for motor vehicle–related injuries: improving crash survival rates by analyzing vehicle protection systems and the injuries sustained by drivers and passengers • Substance abuse treatment for trauma victims: reducing the number of repeat drug and alcohol-related injuries through intensive bedside counseling at the University of Maryland Shock Trauma Center • Telemedicine: building on established audio/video links between Shock Trauma doctors and patients, community doctors and EMS providers to enable faster treatment for stroke, trauma and other emergencies • Pedestrian safety: establishing new safety measures to curb pedestrian injuries, such as a new pedestrian safety campaign The National Study Center was established by Congress in 1986 and named for former US Senator Charles “McC.” Mathias, Jr., in honor of his support of Maryland’s trauma care system. The Center investigates the causes and treatment of traumatic injuries. The National Study Center is staffed by nationally known epidemiologists, physicians, statisticians, and database coordinators. These professionals work in teams to develop and conduct research, as well as provide analysis and publish results. The research teams also collaborate with government agencies, professional associations, university affiliates, and private enterprises on projects designed to increase understanding of and improve trauma care.