5.5 Use of Employees or Laboratory Personnel as Research Subjects

Presents guidelines for participation by employees or laboratory personnel as subjects in Stanford research projects.

Authority

Originally issued as a memorandum from James Theodore, Chairman, Administrative Panel on the Use of Human Subjects in Medical Research

Contact

Questions about this policy can be answered by:

Kathy McClelland

Research Compliance Office Director

Vice Provost and Dean of Research - Research Compliance

(650) 723-4697

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1. Overview

The Human Subjects Panel considered and reviewed the above referenced topic at the December 1988, January 1989, August 1995 and October 2001 meetings and requests that you address this important matter when preparing your protocol applications.

  1. Whenever employees or laboratory personnel participate as subjects in a formally approved research project, they should render the same written informed consent as any other participant in the study.
  2. Research directors should understand that, by virtue of their dependent positions, employees or laboratory personnel represent a vulnerable population with regard to acting as research subjects. The directors should be sensitive to the need to avoid even subtle coercion and to ensure that all personnel who participate in even minimal risk research activities do so entirely voluntarily.
  3. In general, studies involving any type of intervention (e.g. the ingestion or injection of a substance, or venipuncture, solely for the sake of the study) should be considered research, subject to the need for written and signed informed consent. The Protocol Director is urged to contact the Human Subjects Office (724-7141) for guidance in questionable cases.
  4. In principle, the Panel feels that if compensation is allowed, it should go to all subjects; however, compensation of individuals who are full-time members of the academic staff or regular exempt staff may not be allowed.
  5. As mentioned above (see #3), if doubt exists as to the appropriateness of having employees or laboratory personnel participate in even minimal risk activities, the Protocol Director is urged to contact the Human Subjects Office (724-7141) for guidance.

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