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.
NIH ExPorter
NIH ExPorter