Human Subjects Training Requirement

New NIH Requirement: A notice regarding required education in the protection of human research participants appeared in the June 5, 2000 NIH Guide. It states that: "Beginning on October 1, 2000 the NIH will require 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." The effective date of this new requirement has been clarified by NIH to include all projects scheduled for new or continuing funding in federal fiscal year 2001 (beginning October 1, 2000) or beyond. This training requirement covers not only principal investigators, but also all individuals identified as "key personnel" in the proposal and who are involved with the human subjects portion of the project.

Effective immediately, non-competing proposals for research involving human subjects must include in the progress report a statement indicating that key personnel have completed mandatory training; the required statement is noted below. For new or competitive renewal awards, the principal investigator must prepare and submit a letter that includes this same statement regarding the education completed by key personnel in the protection of human subjects. This letter must be countersigned by the Office of Sponsored Research (OSR).

Initial Implementation: In order to ensure that Northwestern University investigators are in compliance with this new mandate, we are instituting the following requirement. You and all individuals identified as key personnel on current and pending NIH projects who are involved in the human subjects portion of the research, will be required to take the University of Miami's on-line tutorial "Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Research Subjects". Registration for this tutorial is located at: http://www.miami.edu/citireg/. It is the principal investigator's responsibility to ensure that all key personnel have taken the tutorial.

Non-competing Proposals: Effective immediately, the progress reports incorporated in non-competing proposals must include the following statement: "All key personnel identified in this proposal who are involved in the human subjects portion of the project have successfully completed the University of Misami's on-line tutorial entitled 'Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Research Subjects.'" The progress report and all other non-competing application materials must be submitted to OSR for review and institutional endorsement. OSR will not endorse proposals without first verifying that the training statement has been included in the progress report.

New and Competitive Renewal Proposals: Before funds are awarded, the principal investigator will be asked by NIH staff to prepare and submit a letter describing the education in human subject protection completed by each person listed as "key personnel" in the proposal. The following statement must be included in the letter: "All key personnel identified in this proposal who are involved in the human subjects portion of the project have successfully completed the NIH on-line tutorial entitled Protection of Human Research Subjects: Computer Based Training for Researchers." Institutional endorsement is required on the letters so they must be sent to OSR for review and counter signature.

Related Training Requirement: Within the next few months, The Office of Research Integrity, Department of Health and Human Services (DHHS), will be introducing expanded mandatory training requirements on the responsible conduct of research to all persons involved in research supported by DHHS. This will include not only the protection of human subjects, but also conflict of interest, ethical conduct of research, and the financial stewardship of federal funds. We have already begun planning for these additional educational mandates.

Summary: In order to continue receiving research funding from the NIH, we must all comply with the new educational requirement. As principal investigator on at least one NIH project, it is your responsibility to verify that each person identified as "key personnel" has taken the mandated training tutorial. If you have questions about training programs, please contact Carol Nielsen at 503-1805. If you have questions about training information included in progress reports or letters to NIH, please contact Bruce Elliott, OSR Director, Chicago Campus, at 847/491-3003.

Helpful websites: To help clarify key points about the training requirement, NIH created questions and answers at http://grants.nih.gov/grants/policy/hs_educ_faq.htm

The Guide announcement for the new policy is located at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

University of Miami on-line tutorial "Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Research Subjects." The tutorial is located at: http://www.miami.edu/citireg/

For other information about human subjects research, try the OHSR homepage: http://ohsr.od.nih.gov/