Background
On June 5, 2000, NIH published a new policy requiring education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects.  A set of Frequently Asked Questions (http://grants.nih.gov/grants/policy/hs_educ_faq.htm) has been posted on the NIH web site to explain the new requirements.

To help UW�Madison investigators satisfy the training requirement, we have adapted the computer-based training program developed by the NIH.  The tutorial provides information about federal regulations and UW�Madison�s human subjects protection program (http://www.grad.wisc.edu/research/compliance/humansubjects/tutorial/). All investigators and key personnel who are conducting research on human subject are now required to complete the tutorial.  Key personnel include all individuals responsible for the design and conduct of the study.  Graduate students may be included as key personnel.  The principal investigator is responsible for assuring that key personnel are informed of this policy and comply with the training requirement.

UW�Madison Implementation
To assure that all UW�Madison investigators comply with the NIH requirement, UW�Madison will implement the following procedures beginning October 1, 2000.

For investigators submitting new applications, competing applications or contract proposals to NIH

 UW�Madison will use Just-in-Time procedures for monitoring the education requirement of investigators applying to NIH for new funding.  NIH�s current Just-in-Time procedures require that IRB protocol approval be certified by the institution before an award is made.  UW�Madison protocol forms will be modified to include a list of key personnel and a date field for verification of completion of the tutorial.  Investigators must verify that they have completed the UW�Madison training program prior to submission of a protocol application to the campus IRBs.   Protocol applications will not be processed until all key personnel have completed the training.  Consistent with our current policy, RSP will not activate NIH awards unless the investigator has current IRB approval for involvement of human subjects.

For investigators submitting non-competing continuation applications for grants or annual reports for research and development contracts

Investigators submitting non-competing renewal applications for grants or annual reports for research and development contracts that involves human subjects research must include a description of such education in their annual progress reports.  The description of education will be submitted in a cover letter that accompanies the description of Other Support, IRB approval, and other information in accordance with Just-in-Time procedures.  The use of a cover letter is also acceptable for contract proposals.  RSP will supply investigators with a standard cover letter modeled after the current proposal submission cover letter.  The cover letter at https://rsp.wisc.edu/forms/files/NIHcover_letter.pdf may be used when submitting applications or reports.  This letter must be signed by the PI and co-signed by RSP.  The RSP signature will be obtained when the transmittal form is processed through RSP.  RSP will not forward non-competing renewal applications to the NIH until the PI has verified completion of the tutorial.
 

Note:  This NIH policy will eventually be superceded by the DHHS Office of Research Integrity�s institutional assurance on the responsible conduct of research.

c:  School/College Pre-Award Research Administrators for Distribution to new PIs and Project Administrators
 

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