Informed consent is a process. A written informed consent documents this process, but cannot serve as a substitute for it. No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether or not to participate. If the subject is a minor, written parental consent or legal guardian consent is required, and the investigator must obtain the assent of the child unless the child is incapable of giving assent.
The information given to the subject, or the subject's legally authorized representative, must be in simple, easily understood language. If the subject population is not English-speaking, the informed consent must be presented in whatever language is appropriate. If the person uses an alternative form of communication (e.g. Sign Language), the informed consent process must be designed to enable effective communication in the appropriate mode. (If a potential subject is illiterate, the investigator will be required to use a competent witness to verify voluntary informed consent.)
Written documentation of the consent process (e.g., a cover letter or cover sheet) is always required unless specifically waived by the IRB. The consent document should be signed by the subject or the subject's legally authorized representative unless this requirement is waived by the IRB.
In some types of projects, it may be important for information pertaining to consent to be provided verbally. In such an instance, a written summary (script) of what the potential subject will be told must be provided to the IRB for review and approval. Investigators should explain the rationale for not obtaining written informed consent in order that the IRB may approve such an exception.
No informed consent, whether oral or written, may waive or limit in appearance or in fact, the subject's legal rights, including any release of the institution or its agents from liability or negligence.
The following information must be a part of all written informed consent documents:
Federal law mandates that copies of all informed consents be retained for a minimum of three years after completion of the research. The principal investigator is responsible for the maintenance and retention of such records. If the principal investigator is a student, the faculty sponsor is responsible for the maintenance of these records. If the investigator leaves the institution within this three year period, all records must be forwarded to the Office of Assistant Dean for Research.
One example of an acceptable informed consent document is included in the application packet which can be found in Appendix E. Additional examples are available upon request. These are only to be used as examples or guides for the formulation of individual informed consents and not as standard forms. The specific form used for each project must be tailored to the subject characteristics, specifics of the project procedures, and nature of the potential risks to subjects.
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