Purpose
Central to Washington University in St. Louis’ mission of fostering excellence in research is a commitment to ensure that all individuals responsible for the design, conduct and reporting of research involving human participants receive education in the protection of those participants that is appropriate and adequate to assure the ethical conduct of the research. This should include education around protecting the rights, safety, and privacy of human participants in accordance with federal regulations and university policy.
Policy
All members of the research community engaged in the design, conduct and reporting of research with human participants will complete education pertinent to the type of research being conducted.
Applicability
An individual is “engaged in human subject research” if s/he has contact or interactions with human research participants or research data involving human participants.
This policy is applicable to all members of the Washington University community who engage in research with human participants. This includes faculty, postdoctoral appointees, residents, fellows, students (graduate and undergraduate) and staff. The policy also applies to any other institution and its employees whose human research is reviewed under the aegis of the university Human Research Protection Office. It is applicable regardless of the research funding source.
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. Nonuniversity employees who are subject to oversight by an outside Institutional Review Board (IRB) will complete education requirements mandated by that IRB. Nonemployees who are not subject to oversight by an IRB will complete education as dictated by this policy.
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) and the research setting. The currently approved educational programs are accessible via WashU ONE. Log in to ONE and search for “Human Subjects Education”.
Frequency
The educational program must be completed only once, not prior to each IRB or grant submission.
The Human Research Protection Office (HRPO) 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 participants. Frequently asked questions regarding requirements for training in various situations are available at the HRPO website.
Sanctions
Final protocol approval by the university Human Research Protection Office will be held until all educational requirements are met.
Research funding awards will not be processed until all educational requirements are met.
Effective October 1, 2000
Revised:
- April 1, 2005
- December 1, 2006
- April 24, 2009