June 2, 2008
IN THIS ISSUE… NEWS AND EVENTS: ANNOUNCEMENTS: FEATURE: ARTICLE: GENERAL INFORMATION:
NIH Funds 14 New CTSA Institutions—Expands Consortium to 38 On May 29, the NIH announced the expansion of the CTSA Consortium to 38 institutions. More information, including the list of new members, can be found in the NIH News Release. Duke University—Ethics in Cellular Therapy Conference This June 16–17 conference, in Durham, N.C., will explore the interface of cell therapy treatments and the regulatory and ethical framework in which they exist. The event will feature experts on each of the therapies followed by comment and discussion. Visit http://www.dtmi.duke.edu, or contact Becky Haley (rebecca.haley@duke.edu), program director for the Cellular Therapies Core, for more information or to register to attend. Mayo Clinic CTSA to Host Upper Midwest Consortium Annual Meeting The Mayo Clinic Center for Translational Science Activities (CTSA) will host the 2008 Upper Midwest Consortium Annual Meeting on June 16–17 in Rochester, Minn. The Upper Midwest Consortium includes nine academic institutions with CTSA/KL2, K12, or IDeA programs. The consortium’s goal is to support faculty and scholars at the participating institutions by sharing curricula, facilities, education technologies, and best practices. This year’s meeting will feature addresses by Dr. Anthony Hayward (NCRR), Dr. Richard Weinshilboum (Mayo Clinic), and Dr. James Neaton (University of Minnesota). Workshops and networking opportunities will be provided for scholars. For more information, visit http://ctsa.mayo.edu/umc.cfm. Enhancing Clinical Investigation by Improved Clinical Research Management Workshop The CTSA Regulatory Knowledge Workgroup, together with NCRR, is sponsoring a workshop in Bethesda Md., on June 23–24, to develop a system of metrics to apply to the processing of clinical research protocols. These metrics would be used as an instrument to measure and promote improved management of clinical research protocol processing. Contact Dan Rosenblum at rosenblumd@mail.nih.gov for more information. Pediatrics Oversight Committee Face-to-Face Meeting The CTSA Pediatrics Oversight Committee is having a face-to-face meeting in Bethesda, Md., on June 23–24. Please contact Gail Pearson, pearsong@mail.nih.gov, for more information. Access to CTSA institutional and consortium news and media coverage is available on the CTSAs in the News page on CTSAweb.org. We want to post your CTSA institutional news items and open events in the CTSA e-Newsletter and on the CTSAweb.org Events page. Please send submissions to Kameha Kidd, kiddka@mail.nih.gov.
NCRR Announces CTSA Administrative Supplements for Consortium Projects NCRR has announced a solicitation for administrative supplements to CTSA grants to support CTSA Consortium projects. The administrative supplements are to support projects of national scope for established CTSA-wide consortia, defined as CTSA Steering Committees, Workgroups, or Taskforces. Proposed projects must contribute to national efforts and relate to the mission of CTSA-wide consortia. The goal of this solicitation is to support projects within the focus areas of the CTSA-wide consortia that facilitate the transformation of 1) performance or 2) training in clinical and translational science on a national level. Additionally, projects are expected to collaboratively engage multiple CTSAs. NCRR Is Hosting Demonstrations for the CTSA Wiki and CTSAweb.org NCRR is offering two online demonstrations of the CTSA Web systems, CTSAweb.org, and CTSA Wiki. Learn where key information is, how to navigate the sites, and basic editing in the Wiki. Due to system limitations, please plan to attend with as many people as possible from a common room or location at your institution. CTSA Web Systems Demonstrations:
NCRR Announces New System for Managing Committee Participants To simplify enrolling and managing the rosters for CTSA committee members and participants, NCRR is implementing a new Web-based interface. Access to this system is through the CTSA Wiki and is restricted to CTSA PIs and administrators who have authority to assign representatives to committees. Guidelines are available on the Wiki—in CTSA Main. Bookmarks to CTSAweb.org Should Be Updated CTSAweb.org has undergone improvements that have resulted in URL changes for its pages. Please update any bookmarks you have to pages within CTSAweb.org. New Helpdesk E-mail for CTSA Web Systems The CTSA Web systems have a new help desk e-mail, help@CTSAweb.org. Please contact the help desk if you have questions regarding the CTSA systems, including CTSA Wiki and password questions.
Clinical Research Ethics Workgroup The Clinical Research Ethics Workgroup created several taskforces to address its priorities, which include identifying best practices of clinical research ethics consultation, exchanging clinical research ethics educational materials, and addressing conflict-of-interest issues. The Clinical Research Ethics Consultation Taskforce, chaired by Laura Beskow, MPH, PhD, of Duke University, is developing a paper for publication to further elucidate what research ethics consultation is, its purpose and scope, and how it differs from and relates to the work of institutional review boards (IRBs). The paper will also discuss what types of requests a consultation service might anticipate, the value of early intervention (i.e., ethics consultation at the time a study is being designed), the nature of the advice provided, and who the customers for such a service would be. This taskforce has also compiled a preliminary table that summarizes what CTSA institutions are doing or planning in terms of research ethics consultation and is considering developing a repository of research ethics consultation cases as a resource for education and identifying best practices. The Conflict of Interest Taskforce focuses on faculty and institutional issues associated with T1 translation, such as technological transfer related to intellectual property. The taskforce is drafting a case-based survey of CTSA institutions to determine how they are addressing conflict-of-interest policies on first-in-human research. The Regulatory and Ethics IRB Taskforce, which is composed of members from the Regulatory Knowledge Workgroup and the Clinical Research Ethics Workgroup, has identified two areas of focus: improving the process of IRB oversight of multicenter studies and collecting data from a subset of CTSA sites on the costs and benefits of the current review system. There is widespread agreement among the members of this taskforce that IRBs often place requirements on research that are not related to protecting human research subjects, and this taskforce hopes to reduce the burden on investigators of such requirements. The Educational Materials Taskforce met during the Office of Research Integrity’s Conference on the Responsible Conduct of Research Education, Instruction, and Training in St. Louis in April to discuss developing standards for the responsible conduct of research. The Clinical Research Ethics Workgroup, which meets monthly via teleconference, will meet in person on October 23 during the American Society for Bioethics and Humanities’ Annual Meeting in Cleveland. Workgroup Chair Paul Applebaum, MD, of Columbia University is soliciting items for the agenda for that meeting.
Update from the April CTSA Consortium Oversight Committee Meeting On April 27–28, the CTSA Consortium Oversight Committee (CCOC) met in Chicago. The following summarizes major announcements and activities that emerged from the meeting:
Consortium Committee Meeting Calendar Key: CTSA Consortium Meeting CTSA Consortium Workshop NIH Staff Meeting
* Please note that the meetings and events listed in this newsletter are provided for your information. If you wish to participate, please contact the NIH coordinator. Updated Information on CTSAweb.org CTSAweb.org was developed to ensure access to CTSA resources, enhance communication, and encourage sharing. The site continues to evolve with the CTSA in promoting this new direction of clinical and translational science. Features and updates:
Reminder—CTSAweb.org has undergone improvements that have resulted in URL changes for its pages. Please update any bookmarks you have to pages within CTSAweb.org. Access archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.
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