Policies & Procedures

Human Subjects Education Policy

Effective: October 1, 2000

Revised:

April 1, 2005
December 1, 2006

Purpose:
Central to Washington University's mission of fostering excellence in research is a commitment to ensuring that all individuals responsible for the design, conduct and reporting of a research study involving human subjects receive adequate education in the protection of those human subjects. This policy defines the educational requirements for the conduct of human subject research at Washington University.

Applicability:
This policy is applicable to all members of the Washington University community who engage in human subject research including: faculty, post-doctoral appointees, residents, fellows, students (graduate and undergraduate) and staff. It is applicable regardless of the research funding source.

An individual is "engaged in human subject research" if s/he has contact or interactions with human research subjects or research data involving human subjects.

This policy is also applicable to all individuals identified by the Principal Investigator on a sponsored research project as "key personnel." Washington University defines key personnel as any individual responsible for the design, conduct or reporting of research.

This policy also applies to non-Washington University employees serving as consultants who contribute to the scientific development or execution of research in a substantive way whether or not they are compensated for their contributions.

Educational Requirements:
Education programs will be selected by the Human Research Protection Office (HRPO) in conjunction with the Vice Chancellor for Research, who retains responsibility for assuring the protection of human research subjects at this organization.

Specific curriculum will be identified based on the type of research conducted (biomedical or social-behavioral). The currently approved educational program is accessible through the Research Administration System at http://aisinfo.wustl.edu/ra.html.

Frequency:
The educational program must be completed only once, not prior to each IRB or grant submission.

The Human Research Protection Office reserves the right to require additional education as it deems appropriate for the proposed research in order to ensure research is conducted by individuals fully educated in the protection of human subjects. Frequently asked questions regarding requirements for training in various situations are available at the HRPO web page http://hrpo.wustl.edu.