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BBRB Newsletter: Spring 2001Frequently Asked Questions of Scientific Review Administrators (SRAs) at the Center for Scientific Review (CSR) Q: How can I access study section rosters?A: CSR study section membership rosters are available on the CSR web page: http://www.csr.nih.gov/ASPDocs/Committees/rosterindex.asp. Click first on the study section of interest. Then click on the acronym (left column) of the study section to view its chartered membership roster, if available. For meeting rosters (right column), click on the current roster, if available, or either of two prior meeting rosters for each study section. Current rosters are posted four weeks before the meeting date and are tentative only, pending any last minute changes. These rosters list all members present, whether permanent or temporary, and provide the total scope of expertise that may be present at the meeting. Q: After my application is reviewed, when should I expect to receive my priority score and summary statement? A: CSR makes every effort to provide investigators with priority scores within 10 days of the review meeting. Summary statements should be available 4-8 weeks following the meeting. Q: Does CSR really care about font size? A: Absolutely. NIH is now paying close attention to font size and character spacing regulations. Font size should not be less than 10-point and there should be no more than 15 characters per inch of text. The CSR Office of Receipt and Referral will return applications, without review, that do not adhere to these guidelines. Q: Who at NIH should I contact if I have questions about my application once it has been submitted? A: Investigators should be aware of the proper NIH official to contact at various stages of the review process. Prior to submission of the application, contact should be made with Program offices. While the application is under review – from the date of submission until the review meeting – investigators with questions should contact the SRA handling the review. Once the review has occurred, questions and requests for information should be directed to Program officials at the institute to which the application has been assigned. Q: How much detail do I need to provide regarding gender, minority, and inclusion of children in study populations? A: Investigators should pay close attention to NIH requirements for gender, minority, and inclusion of children in study populations. Procedures to ensure inclusion must be stated explicitly. Decisions to exclude women, minorities, or children (defined by NIH as persons less than 21 years of age) must be justified. For example, it would not be sufficient to simply state that there are few minorities available in the geographic area in which the research is to be conducted. Investigators must make every effort to adhere to NIH guidelines for coverage of human subjects. Moreover, investigators must now include in their data analysis plan examination of outcomes variables by gender, minority status, and age. It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. For more details about this policy see http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. It is the policy of NIH that children must be included in all human subjects research conducted or supported by NIH unless there are scientific and ethical reasons not to include them. If children will be excluded from the research, the application must present an acceptable justification for the exclusion. For more details about this policy see http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Q: Do I need to include a Data and Safety Monitoring Plan if I will be conducting a behavioral clinical trial? A: As of the October 2000 receipt date, all clinical trial applications must include a Data and Safety Monitoring Plan. The principles of data and safety monitoring require that all biomedical and behavioral clinical trials be monitored to ensure the safe and effective conduct of human subjects research, and to recommend conclusion of the trial when significant benefits or risks are identified, or when it appears unlikely that the trial can be successfully completed. Risks associated with participation in the research must be minimized to the extent practical, and the method and degree of monitoring should be commensurate with risk. For further guidance on data and safety monitoring for phase I and phase II trials, see http://grants.nih.gov/grants/guide/notice-files/not-od-00-038.html. The essential elements of an adequate plan for data and safety monitoring of clinical trials funded by NCI can be found at http://cancertrials.nci.nih.gov/researchers/dsm/index.html. Q: When do I need to submit Institutional Review Board (IRB) approval of human subjects plans? A: NIH policy no longer requires documentation of IRB approval at the time of the initial peer review. IRB approval of human subjects plans is now submitted on a "just in time" basis. NIH will request approval for those applications that receive priority scores that fall within the "fundable range." Note that a "fundable range" is not to be confused with an Institute's pay line. The "fundable range" includes all applications that fall within an Institute's pay line and also applications that extend a number of priority score/percentile points beyond. This range may vary from year to year or round to round. For further details about IRB review of human subjects protocols see http://grants.nih.gov/grants/guide/notice-files/not-od-00-031.html. Back to Top |
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