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Mandatory Training in the Protection of Human Subjects

Date: August 28, 2000

Sender: Joseph Cerny, Vice Chancellor for Research

To: Deans, Directors, Department Chairs, and Administrative Officers

Subject: Mandatory Training in the Protection of Human Subjects

In response to the increasing pressure from Congress to tighten oversight of research on humans, the National Institutes of Health (NIH) has announced that effective October 1, 2000, all investigators and key personnel conducting clinical research on NIH grants or contracts will be required to undergo training in the protection of human subjects in research. Please note that the definition of clinical research, found on the attached Berkeley Campus Procedures document, is quite broad and will impact a large fraction of our NIH research involving human subjects.

Principal Investigators (PIs) on projects involving human subjects research and all personnel who are directly responsible for the design and conduct of the human subjects part of the project must be trained prior to working with human subjects. This includes key foreign and domestic personnel on subcontracts and consultants and applies whether or not these individuals are compensated from the award. Training is required only once during the project period.

As the Procedures document outlines, beginning October 1, 2000, all new proposals for competing grants or contracts require a statement from the PI describing and certifying completion of the required training. To accomplish this, a Human Subjects Training Certification form has been developed, which must be submitted to the Sponsored Projects Office (SPO) along with the proposal. This form may be found on the SPO website, www.spo.berkeley.edu.

NIH does not require a specific course of study, and has allowed institutions to use their on-line tutorial "Protection of Human Subjects: Computer-based Training for Researchers." This computer-training module may be found on the SPO website as well as the NIH website: http://ohsr.od.nih.gov/cbt. NIH also provides links to other useful training sites at http://www.nih.gov/sigs/bioethics/casestudies.html.

The new regulation and frequently asked questions can be found at http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. We hope that you will find the attached Procedures document informative and useful. However, if you have any questions about the regulation or the campus implementation, please contact SPO Director Joyce Freedman at 642-8110 or jbfreed@uclink.berkeley.edu.

Joseph Cerny
Vice Chancellor for Research


Current link:
NIH Requirements on Education in the Protection of Human Subjects

Current contact:
SPO Director Pam Miller, 642-2925, plfmiller@berkeley.edu