Institutional Review Board

Informed Consent


One significant outcome of the Nuremberg medical trials was the establishment in 1947 of the Nuremberg Code, which set forth ten principles for conducting research involving human subjects. The first of those principles states, "the voluntary consent of the human subject is absolutely essential." Thus, no investigator may involve a human being as a subject in research, as defined in this policy and procedure manual, unless the investigator has obtained the subject's informed consent. The process of informed consent is constituted by two essential elements: (1) the subject has the information he or she requires to make an effective decision, and (2) the subject's participation is not coerced, i.e. his or her consent is voluntary. Once informed consent is obtained, documentation to that effect shall follow the procedures outlined in this manual in the "Documentation" section below.

Additionally, the researcher should be aware that litigation against the College is always a possibility. From this perspective, even an ethical informed consent is not sufficient. Rather, we need an ethical informed consent which is legally valid and the legal validity of which can be demonstrated should such a need arise.

General Requirements

The process of obtaining informed consent shall contain the following elements:

  1. It should be obtained from the subject or the subject's legally authorized representative
  2. It should be in language understandable to the subject or his or her legal representative
  3. It should be obtained under circumstances that provide the subject with the opportunity to consider whether or not to participate, and that minimizes the possibility of coercion or undue influence.

Additional Elements

When required by the IRB, one or more of the following elements shall be provided to each subject:

Exceptions from Requirements for Informed Consent

DHHS Exceptions

The IRB may approve a consent procedure which does not include, or which alters, some or all or the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents:

FDA Exceptions

Obtaining informed consent may be waived if both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

If immediate use of the test article is required to save the life of the subject and time is not sufficient to obtain independent determination by another physician, a determination by the investigator shall be made.

This determination by the investigator is to be reviewed and evaluated by a physician who is not participating in the investigation within five (5) days after the use of article.

The documentation required above must be submitted to the IRB within five (5) working days after the use of the test article.

Documentation