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:

• Statement that procedure may involve unforeseeable risks to the subject
• Description of circumstances under which the subject's participation may be terminated by the investigator without the subject's consent
• Additional costs to the subject resulting from participation in the research
• Consequences of the subject's decision to withdraw from the research and procedures for termination of participation by the subject
• Statement that significant new findings developed during research which may relate to subject's willingness to continue will be provided to the subject
• Approximate number of subjects involved in the study.

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:

• The research involves no more than minimal risks
• The rights and welfare of subjects will not be adversely affected
• The research could not practicably be carried out without the waiver or alteration
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation
• The research is to be conducted for the purpose of demonstrating or evaluating federal, state, or local service programs which are not research programs, etc.

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:

• Subject is in a life-threatening situation necessitating use of test article;
• Consent cannot be obtained because of an inability to communicate with or obtain consent from the subject
• Time is not sufficient to obtain consent from subject's legal representative
• No alternative generally approved method is available.

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

• Informed consent will be documented by using a written consent form approved by the IRB. The form will be signed by the subject or the subject's authorized representative. A copy will be given to the person signing the form.
• Two types of consent forms are permissible:
  • a written consent document that includes all of the following basic elements:
    1. a statement that the study involves research
    2. an explanation of the purpose of the research and the expected duration of the subject's participation
    3. a description of the procedures to be followed and the identification of any procedures which are experimental
    4. the disclosure of alternative procedures
    5. a description of risks and possible discomforts to the subject
    6. a description of foreseeable benefits to the subject and others
    7. a description of the extent to which confidentiality will be maintained
    8. an explanation as to whether compensation or medical treatments are available if injury occurs (for research involving more than minimal risk)
    9. an explanation of whom to contact if questions arise or injury occurs
    10. a statement that participation is voluntary, that refusal to participate involves no penalty, and that the subject may discontinue participation and have any data already collected destroyed at any time, and
    11. no language through which the subject is made to waive any of his/her legal rights or which releases the investigator, the sponsor, or the institution from liability for negligence.
  • a short form which states that the elements of informed consent have been obtained from the subject. When using the short form the following conditions must be met:
    1. the written summary of what is to be said receives prior approval of the IRB
    2. a witness must be present at the oral presentation
    3. the short form is signed by the subject or his or her representative
    4. the witness signs both the short form and the written summary is given to the person signing the form, and
    5. a copy of both the short form and the written summary is given to the person signing the form.

  Exceptions to Documenting Informed Consent

  The IRB may waive the requirement to obtain a signed consent form for some or all subjects if:

  • the only record linking the subject and the research would be the consent document and the principal risk would be harm resulting from breach of confidentiality or
  • the research presents no more than minimal risk and involves no procedures for which written consent is normally required.

  In cases where documentation is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

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