3.   Protection of
        Research Subjects

IRBs and IACUCs   


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Stanford Policy

* Administrative
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Chapter 7
     Human Subjects
     in Research

Chapter 8
     Lab Animals
     in Research


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* Human Subjects


* Lab Animals
Resource Page


Research involving either human subjects or laboratory animals is regulated by Government agencies and by University policy. Stanford extends regulatory requirements in this regard to ANY research activity, regardless of the source of funding for the activity, that involves the use of human subjects or laboratory animals. As is also the case when research will involve either biohazards or radiation, protocol approval by the appropriate Administrative Panel is required BEFORE research can begin.


There are several Institutional Review Boards (IRBs) at Stanford charged with the review of protocols involving the use of human subjects. Some review medical research; others review social science and other nonmedical research involving human subjects.

In determining whether or not your research involves human subjects, consider that the regulations define "HUMAN SUBJECT" as a living individual about whom an investigator (faculty, staff or student) obtains either
  1. data through intervention or interaction with the individual; or
  2. identifiable private information, e.g., school transcripts or medical records.

Before any project involving human subjects (in either medical or nonmedical research) can begin, Stanford requires that all researchers who will work with human subjects complete an online tutorial.

Protecting Human Subjects
[ Required tutorial ]

In addition, any research involving human stem cells, human embryos, or their derivatives must be reviewed by Stanford's Stem Cell Research Oversight Committee.

The PI must certify that the necessary review has taken place before protocols will be approved. In the case of NIH-funded research, the agency requires the PI's statement to this effect before they will release their funds to the University.

Partly as a result of situations where it appeared that human subjects were not adequately protected, there is now increased national attention in this area, particularly in the conduct of clinical trials.

Resources: Human Subject Protections
[ OHRP web site ]

Stanford University has an Institutional Animal Care and Use Committee (IACUC) charged with reviewing all research protocols involving lab animals. No research involving the use of vertebrate animals can proceed without the approval of this panel.

In addition to concern for the humane care and use of the animals, research with laboratory animals can also raise environmental health and safety issues.

Lab Animals:
Resource Page

[ Dean of Research
site ]

The Comparative Medicine Department and Veterinary Services Center in the School of Medicine staffs the Occupational Health Program for all researchers working with lab animals.

Any questions on either the use of human subjects or laboratory animals in research should be directed to the Research Compliance Office.


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