he name, address and/or telephone number of the principal investigator as the contact point if questions or problems should occur.
- A statement describing the method by which confidentiality of records identifying the subject will be maintained.
- A statement that participation is voluntary and that refusal to participate or a subsequent decision to discontinue participation will not result in penalty or loss of benefits to which the subject is otherwise entitled. This statement should include a description of the consequences, if any, that accompany such a decision to withdraw and should explicitly state methods of withdrawal.
- A copy of the informed consent shall be provided to the subject or the subject's legally authorized representative.
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 Institute 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 at he website for the committee. 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.