“Personnel engaged in human subjects research,” for purposes of this training requirement, means all individuals, including students, subcontractors and consultants, who:
The required UW-Madison training consists of certain CITI human subjects protection training modules designated by UW-Madison. All personnel engaged in human subjects research must retake human subjects training every three years and must achieve an 85% pass rate each time they take the training.
Investigators can also apply to the IRB Offices for approval to substitute other training programs for research personnel not otherwise affiliated with the UW-Madison if circumstances warrant. For example, a different substitute training program might be approved if other personnel would have difficulty accessing one of the training programs listed above because they are not located in the U.S.
Certification of Training
It is no longer necessary to fill out an electronic form to certify completion of human subjects training. Instead, researchers’ training completion information is automatically loaded into the UW-Madison CITI training database four times a day: https://my.gradsch.wisc.edu/lookups/citi/trainingStatus.html. Once your information is loaded, you can search the database by last name, first name, click on the “details” link and pull up your certificate.
You can also obtain a certificate of completion of CITI human subjects training directly from the CITI webpages. After you have PASSED the course, the Main Menu page in the CITI training website provides an active link to a completion report.
In each case, the certificate/completion report can be printed off and faxed or saved to your desktop and then emailed to who ever needs verification of your training.
When preparing a protocol for submission to an IRB, the principal investigator is required to certify that all investigators and key personnel have completed human research training.
If you are using a paper protocol application form, the form includes instructions explaining how to do this.
If you are using WebKit for electronic submission, all persons listed on the protocol application must have a current human subjects training date entered into WebKit before you can submit the protocol to the IRB office using WebKit.
WebKit is automatically populated with the CITI training dates (with some exceptions) for all personnel taking the UW-Madison CITI training. For each non-UW-Madison personnel who does not take the UW-Madison CITI training, you will have to provide the IRB office with a certificate of completion of one of the alternative human subjects training programs described on page 1 of this guidance document. The IRB office must review the alternative training and manually enter the training date into WebKit before you can submit the protocol.
The National Institutes of Health (NIH) requires that all “key personnel” on NIH funded research complete training in the protection of human research participants prior to release of NIH funds. For purposes of NIH grants, “key personnel” are individuals involved with the design and conduct of research involving human participants supported by an NIH award, including third party key personnel and consultants, whether or not they receive compensation from the award.
RSP must certify to the NIH that all investigators who are identified as key personnel and are involved in the design and conduct of research involving human participants have completed their training in the protection of human research participants. Investigators must prepare a certification letter using the available template and submit it to RSP with all NIH proposals.
All grant and contract types (Research Grants, Fellowship Grants, Career Awards, Training Grants, Program Project Grants, Clinical Trials, Cooperative Agreements, etc.) must adhere to protocol approval and educational requirements. All personnel engaged in human subjects research on all grants, subgrants, and other agreements must complete the UW-Madison CITI human subjects protection training.
UW-Madison is the Grantee: The UW-Madison is responsible for all projects, regardless of performance site, for which UW-Madison is the prime grantee. All subgrantees at which human subject activities are involved must obtain protocol approval and complete the required human subjects training. If a training program is not available to the subgrantee, RSP will work with the subgrantee to ensure satisfaction of educational requirements. The subgrantee may complete the UW-Madison CITI human subjects protection training.
UW-Madison is the Subgrantee: The UW-Madison is responsible for all activities taking place on its campus and for all activities performed by its employees within the scope of their duties. Therefore, even if UW-Madison is not the prime grantee, protocol approval by a UW-Madison IRB and certification of completion of human research training is necessary.