NIDCD CLINICAL RESEARCH CENTER GRANTS (P50) Release Date: November 30, 2000 (see NOT-DC-03-004) NOTICE: DC-01-001 National Institute on Deafness and Other Communication Disorders The National Institute on Deafness and Other Communication Disorders (NIDCD) announces a new Clinical Research Center Grant (P50) program. These guidelines supercede all prior guidelines for the NIDCD Multiple Project Center/Program Project/Clinical Center Grants (P50/P01). The NIDCD made substantive revisions to their program project (P50/P01) programs in 1999, as well as adding the Core Center (P30) grant mechanism. After experience with these changes, the NIDCD has made additional changes to the way it supports multiple project center grants. In summary, the main changes include: 1) the requirement that the research conducted on a P50 be clinical in nature, and 2) the removal of the requirement that subprojects must be interdependent. The NIDCD will use Clinical Research Center grants (P50) to support clinical research (i.e., research involving individuals with disorders or data/tissues derived from individuals with disorders to study a disorder of human communication; examples of such research include, but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language). Non-human research is precluded on an NIDCD P50 grant and humans without communication disorders may participate in the research only when normal controls are needed. The four essential criteria for the new P50 are: 1. The research to be conducted must be clinical (see above for definition). 2. The P50 must have a well-defined central unifying theme consisting of three or more subprojects with supporting cores as appropriate. 3. Each subproject must be unambiguously related to the central unifying theme. 4. The P50 must be multidisciplinary. The NIDCD believes that most research within its mission areas can be best accomplished via the investigator-initiated individual research grant (R01) and the research core center grant (P30) mechanisms. There are special circumstances in clinical research, however, that warrant the use of the P50 mechanism. Additional information may be obtained from NIDCD staff listed below or may be found on the NIDCD web site: http://www.nidcd.nih.gov/funding/types/p30_2003.pdf. SUBMISSION OF APPLICATIONS Applications will be accepted under these new guidelines beginning with the February 1, 2001 application receipt date. New (Type 1) applications prepared using the previous NIDCD Multiple Project Center (P50) Grant Guidelines (http://www.nidcd.nih.gov/funding/types/p50/table_b.asp) will be accepted only through the February 1, 2001 deadline. Applications that have already been submitted under the previous guidelines will continue through initial and secondary review and revisions will be allowed. All applications received after the February 1, 2001 submission deadline must be responsive to the new guidelines. Applicants with pending applications are urged to contact the Program Administrator with whom they have been working for more information. STAFF CONSULTATION Inquiries about P50 applications should be directed to one of the NIDCD Program Administrators listed below. HEARING: Dr. Amy Donahue E-mail: amy_donahue@nih.gov Dr. Nancy Freeman E-mail: nancy_freeman@nih.gov Dr. Thomas Johnson E-mail: thomas_johnson@nih.gov Dr. Lynn Luethke E-mail: lynn_luethke@nih.gov BALANCE: Dr. Daniel Sklare E-mail: daniel_sklare@nih.gov SMELL/TASTE: Dr. Barry Davis E-mail: barry_davis@nih.gov VOICE/SPEECH/LANGUAGE Dr. Judith Cooper E-mail: judith_cooper@nih.gov
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