Theodore O. Poehler - US grants

This proposal requests fund for renovation of laboratory facilities in Krieger Hall, a primary research laboratory building. The renovation and remodeling will provide the resources to locate more members of the Department of Biomedical Engineering in proximity to other engineering departments with a greater opportunity for joint research in areas including biomedical sensors, biomaterial and biomedical imaging systems. Funds will also be used for renovating an interdisciplinary, interdepartmental microfabrication facility for researchers in the G.W.C. Whiting School of Engineering. The development of such a facility will require major renovation or replacement of an existing clean room to add exhaust systems for safe use of chemicals and gases needed in microfabrication, and an improved air filtration systems to reduce particle counts. The facility will be used by faculty throughout the engineering school including faculty in biomedical, electrical, chemical engineering, and materials science in the conduct of sponsored research. Ongoing projects in diverse areas such as microfabricated biomedical sensors, compound semiconductors lasers, microwave devices, analog integrated circuits, electoractive polymers, porous silicon studies, barrier properties of polyamide layers, would benefit from this facility. Use of this common facility by the participants and their trainees (postdocs, graduate and undergraduate students) will improve the interdisciplinary interactions in this technical area.

This award is made under the high performance connections portion of NCRI's "Connections to the Internet" announcement, NSF 96-64. It provides partial support for two years for a OC-3 connection to the vBNS. Applications include projects in physics, astronomy, computer science, speech processing, earth sciences, library technology and distance education. Collaborating institutions include the University of Wisconsin at Madison, University of Chicago, Princeton University, University of Washington, Fermi National Accelerator Laboratory, Pittsburgh Supercomputing Center and the San Diego Supercomputing Center.

The Johns Hopkins University is deeply committed to the protection of human research subjects. We have a total of 8 IRB's that oversee approximately 3,500 protocols that directly involve about 50,000 human participants. The goal of this proposal is to develop a comprehensive ethics program to support the chairs, members and staff of our institutional review boards as well as all investigators involved in human subjects research. This program, as well as the education/training of our researchers, will be realized by utilizing the faculty and expertise of our University's Phoebe R. Berman Bioethics Institute and by implementation of the following specific aims: 1. To enhance the capacity of our IRBs to address the ethical dimensions of research involving human subjects. Ethicists will be recruited to sit on all 8 of the Johns Hopkins IRBS. 2. To develop a research ethics consultation service to provide advice to investigators regarding ethical issues. This service will be independent of the IRB process and will be available to investigators in both the planning and the implementation phases of human subject research projects. 3. To improve the competency of investigators to protect the rights and interests of human subjects by developing opportunities for investigators to examine intellectually engaging issues in research ethics that are specific to their areas of investigation. These opportunities will supplement our existing on-line courses and classroom teaching and go beyond that required by federal regulations. Three different programs will be developed: 1) a one-day course, tailored to specific research communities. This course will contain lectures that address issues common to all human subject research. Five versions of the afternoon workshops will be developed that will be tailored to specific areas of human subject research; 2) a two-hour, on-line course that provides a more in-depth introduction to research ethics; and 3) eight two hour seminars on topics in research ethics that arise in different types of research. All faculty, fellows and students engaged in human subjects research will be required to participate in at least one of the above three activities. After the period of grant funding is over, these activities will be supported by the University. The Ethics consultation service will also be continued through consultation fees. The programs outlined in this proposal will greatly strengthen our ability to protect human research subjects.

The Johns Hopkins University is deeply committed to the protection of human research subjects. This commitment begins with comprehensive compulsory education and training of our faculty, student, and staff researchers who conduct human subjects research. It continues with the development of a comprehensive program to support our institutional review boards (IRBs) and our investigators involved in human subjects research. The University has a total of eight IRBs which will be expanded to nine in September 2003: five in the School of Medicine, two in the School of Public Health (becoming three in September 2003) and one in the School of Arts and Sciences. These boards oversee approximately 3,500 protocols that directly involve more than 50,000 human participants. During the past year, we have continued an intensive review of our entire human subjects protection program, including the policies, procedures, practices and support systems of our IRBs. Based on the insights that we have gained, and our intent to apply for accreditation, we have formulated the goal of continuing the development of improved electronic work process and data systems needed to support our protection of human subjects. Accordingly, we wish to focus this grant on the following specific aims: 1. To convert the IRB protocol submission and review processes to paperless electronic work process systems that will enhance the timeliness and consistency of the protocol submission and review process, be a source of protocol status communication, assure consistent human subjects protection program compliance with federal regulations and institutional procedures and policies, improve the monitoring of approved studies and assure accurate records for our IRBs. 2. To plan and begin development of an interactive research subject registry that could provide investigators, clinicians, IRBs and compliance staff with information about the subjects, protocols and non-study clinical events experienced by the subjects; thereby improving clinical care, assuring investigator and IRB knowledge of potential adverse events, providing data on what research patient care is funded by the research study and what privacy authorization has been specified by the subject.