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Located Inside: Research Policy Handbook

Summary:

Presents requirements for training in the protection of human subjects for any individuals at Stanford University who are involved in research using human subjects in either medical or nonmedical research

Related Research Policy Handbook Documents:

1.4    Administrative Panels for Research Compliance
7.1    Federalwide Assurance of Protection for Human Subjects

SEE ALSO:  Research Compliance Office Home Page
                      Administrative Panels on Human Subjects
                       Human Subjects Manual
                      Protection of Human Subjects in Research,
                               a required tutorial

Authority:

Vice Provost and Dean of Research

Contact Person:

Research Compliance Director

NOTE: This policy will be enforced for NIH awards made on or after October 1, 2000. For all other research involving human subjects, this requirement was effective on January 1, 2001.

   A. POLICY

Stanford University requires that all individuals working with human subjects in either medical or nonmedical research complete an instructional program in the protection of human subjects. Training must be completed before the University will approve a project protocol or release project funds. This requirement reflects the University's commitment to the protection of the rights and welfare of human subjects in research, and incorporates the requirements of the National Institutes of Health (NIH).

At Stanford University, the required tutorial is provided through the Collaborative IRB Training Initiative (CITI) at the web site:

http://humansubjects.stanford.edu/resources/req_tutorial.html

Upon review of the information presented at this site, individuals must identify themselves and certify their completion of the tutorial. Falsification in this regard is a violation of Stanford policy subject to appropriate corrective action.

   B. APPLICABILITY

1. This policy applies to all individuals working with human subjects under the auspices of Stanford University, whether at Stanford facilities or at another location, and regardless of their institutional affiliation or source of funding. In the event that individuals from other institutions conduct research under the auspices of Stanford University, they must complete the necessary training, but may do so at their home institution.

2. The training requirement applies to all faculty, staff, students, visitors or any other individuals who work with human subjects in research. Some examples include: individuals who obtain informed consent, administer surveys, or collect private or personal information from individuals. It is applicable for both medical and nonmedical research.

   C. IMPLEMENTATION

1. When preparing a proposal for a project involving human subjects, the Principal Investigator (PI) identifies key project personnel who are responsible for the design and conduct of the study. The PI is responsible for assuring these key personnel and all others working with human subjects on the project complete the necessary training. An award will not be made unless all identified key personnel have completed the training.

2. The Certification of Human Subjects Training is required for all research projects involving human subjects being conducted under the auspices of Stanford University regardless of the source of funding for the project. Where required by sponsoring agencies, the PI will need to obtain a Certification of Human Subjects Training form for the institutional representative to endorse and forward to the sponsor. For projects funded by the NIH, the Certification of Human Subjects Training form must be provided to the agency before awarded funds will be released to Stanford University. For all other projects involving human subjects, verification that the PI and other key personnel have completed the human subjects training will be retained in the file.

3. Subcontractors, consultants and other non-Stanford personnel must also complete this training. Key non-Stanford personnel must be listed on the Stanford University Certification of Human Subjects Training. They may satisfy this requirement at their home institutions, providing that Stanford be assured of completion of the necessary training. A letter or certificate countersigned by a representative from the home institution will satisfy this requirement.

4. Members of Stanford's Administrative Panels for Human Subjects in either Medical or Nonmedical Research, appointed after October 1999, have completed this requirement by virtue of their training as Panel members.

5. Stanford University reserves the right to require additional training for researchers working with human subjects where that it is deemed to be necessary.