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1. How does OCRR support the clinical research careers of senior and junior investigators?
2. How does OCRR maintain a culture of compliance and emphasize the need for clinical researchers to be aware of and in compliance with relevant regulations?
1. How does OCRR support the clinical research careers of senior and junior investigators?
- The MGH Radiology department has made a substantial commitment to expanding its support for clinical research with the introduction of a year-long course for selected faculty members in clinical research methods. The course is taught by senior faculty members, and meets for a full day each month. This course covers biostatistics, epidemiology, decision analysis, and other aspects of clinical research and technology assessment. Visiting speakers include Libby Hohmann, Pearl O'Rourke, Bill Crowley, Jane Weeks, and other leaders in clinical research institutionally and within Boston. Part of the course focuses on grant writing, and each participant in the course is expected to write and submit a grant proposal by the end of the year.
- In recognition of the importance of clinical research, and specifically the important differences between clinical research and basic science research, Scott Gazelle, MD, MPH, PhD was named Director of Clinical Research. Jamien Richardson was recruited as Operations Manager for Clinical Research. Both Dr. Gazelle and Ms. Richardson had been actively involved in the hospital's Clinical Research Program. Jamien currently directs the MGH Clinical Research Support Office and previously was the Clinical Research Specialist in that Office. Ms. Richardson and Dr. Gazelle join Thomas J. Brady, MD, (Vice Chair for Research) a core group, which focuses on supporting the needs of researchers throughout the department. Jamien has also recently been named the Director of the Office of Clinical Research Resources (OCRR) in Radiology; a program developed to provide infrastructure and support specifically addressing the unique needs of radiology clinical researchers.
- OCRR has maintained an active role in the hospital's Clinical Research Program.
- Drs. Brady and Gazelle meet weekly to discuss issues related to research in the department. At these meetings, needs of researchers in the department are discussed.
2. How does OCRR maintain a culture of compliance and emphasize the need for clinical researchers to be aware of and in compliance with relevant regulations?
- Through OCRR, support is provided for investigators who need help or guidance when preparing IRB applications. OCRR endeavors to educate clinical researchers about IRB regulations and other issues related to the responsible conduct of research. Both Libby Hohmann and Pearl O'Rourke speak at the Research Methods Course. Jamien and Dr. Gazelle are available to advise investigators on issues related to the IRB or clinical research in general. Finally, if and when OCRR becomes aware of any problems related to compliance, individual researchers are contacted as needed.
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