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Office of
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Scientific Affairs
47 College Street,
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Phone: 785-4689
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Policies > Clarification of NIH Requirements on Human Subjects Training
Clarification of NIH Requirements on Human Subjects Training
(updated 10/11/00)
The following information provides a summary of the new NIH requirements and is based on additional clarification provided by NIH on September 14, 2000. If you have any additional questions on this issue, please contact Grants & Contracts Administration at 785-4689.
NIH Human Subjects Training Requirements
Who has to obtain training?
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All people identified as "key personnel" in the application who are involved in the design and/or conduct of research involving human subjects.
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Requirement extends to all funding mechanisms: grants, contracts, fellowships, training grants, etc., as well as to subcontractors on any such awards.
How can this training requirement be met?
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Complete the Yale web-based training program that can be accessed at http://info.med.yale.edu/irbtraining.
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Complete the NIH web-based training program that can be found at http://ohsr.od.nih.gov/cbt/.
If you choose this option, please provide a copy of the NIH completion certificate to the G&C Office (fax to: 785-4159).
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Attend one of the training programs ("IRB 101") presented by the School of Medicine. In conjunction with the Learning Center, two courses have been offered focusing on behavioral and biomedical research. The Learning Center suggests that investigators send an e-mail indicating their interest in attending either course in the future.
Course information for the biomedical sciences can be found at: http://edserv03.its.yale.edu/lcweb/courses/classinfo.asp?CourseID=167
Course information for the behavioral sciences can be found at: http://edserv03.its.yale.edu/lcweb/courses/classinfo.asp?CourseID=168
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Receive certification from some other provider (i.e., another University's training program). Please provide documentation to the G&C Office (fax to: 785-4159).
What documentation is required and when is it to be submitted?
For new applications:
- PI is to provide a letter, co-signed by Grants & Contracts, that includes the includes the names of the key personnel who are responsible for the design and conduct of the study; the title of the education program completed by each named personnel plus a one sentence description of the program.
- Letter is to be provided along with other "Just In Time" materials (updated other support, HIC and YACUC information, etc.) when requested by NIH just prior to the issuance of an award.
For non-competing (renewal) applications:
- PI must include a description of the training received by their key personnel in the text of their progress reports.
References:
Further information on this topic can be obtained from the following materials:
Yale School of Medicine Grants & Contracts Administration
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