Education and Training

Research Management, Investigators and Support Staff

Picture of Nurse Taking Patient's Blood Pressure

In October, 2000 the National Institutes of Health (NIH) released a new policy requiring the documentation of education for all researchers and project key staff submitting NIH applications for grants or proposals or receiving new or noncompeting awards for research involving human subjects. NIH will not award funding until it has received formal documentation of training that is certified by the IRB. It is anticipated that other funding agencies, such as the Department of Defense, will soon enforce the same requirements.

For those who become directly involved in the management or conduct of human subject research, documentation of human subject training is required every two years. Therefore, applications for review will not be accepted by the IRB without documentation of current training for Principal Investigators and key project staff. The NIH training, which satisfies educational requirements for PNNL and for sponsors such as the Department of Energy and National Institutes of Health, provides a certificate of completion.

Principal investigators are responsible for determining which of their key project staff need to complete the training (generally those involved in project management or direct involvement with human subject activities) and must provide certificates of completion to the IRB. Please see the Director's letter April 2, 2007 (.pdf 284kb) which notifies all staff of this requirement.

To register for human subject training, investigators and their primary project staff should go to the NIH Training site for Research Teams.

The IRB will provide group training upon request. A human subject field advocate program is under development. In time it is expected that the field advocates will assist in topic-specific training as it relates to the research being conducted in their particular field or departments.

See the Oregon Health Sciences University (OHSU) "Big Brain" site for tutorials in the Health Insurance Portability and Accountability Act (HIPAA) and RCR 101 (Responsible Conduct of Research), which may, in rare instances, be required by the client or collaborating institutions. (You must register to access.)

IRB Members and Support Staff

IRB members and support staff are required to provide certification of human subject training every two years. The IRB Program Manager is required to maintain national certification as an IRB Professional.

New IRB members are provided with the IRB manual, offered the support of a mentor, and are required to complete human subject training before they are allowed to vote. Continuing education is provided to IRB members during convened meetings, electronically, and by mail. Meetings are also used to disseminate information gleaned from national meetings and conferences attended throughout the year. Presentations, tours and basic tutorials are provided for specific areas of interest such as the Belmont Report, proteomics and oral history research, and researchers are invited to provide overviews of their particular areas of expertise at IRB meetings. Financial support is provided for IRB members who provide presentations in their particular area of interest and attend or participate in national conferences such as those provided by PRIM&R and ARENA. The IRB Administrative Team members are active in the DOE and Battelle Human Subjects Working Groups, both of which provide educational opportunities for IRB members. To register for training, IRB members use the NIH Site for IRB Members.

Local Community

The PNNL IRB participates in local educational activities or provides presentations related to the ethics and review of human subject research as requested by outside institutions and professional groups.

Please see Current News, Other Sites of Interest, and the Library of Reference Materials for additional educational information.