Informed Consent Provisions

A) A written and signed informed consent is normally required for all human subjects unless all the following conditions are met -

(1) the research poses no more than minimal risk for physical or psychological harm,

(2) all intended subjects are 18 years of age or older with no known cognitive, emotional, or situational constraints which would impede their ability to make autonomous informed decisions,

(3) the research does not involve audiotaping, videotaping, or photographing of subjects, and

(4) the written informed consent would be the only identifier linking specific subjects to their data.

B) If conditions (1) through (4) are met, the subjects’ participation in the research protocol can be deemed as implied consent. If the research does not meet all of these conditions, however, a waiver from informed consent provisions must be justified by the principal investigator and can be obtained only with the full review and approval of the IRB Executive Committee.

C) When written informed consent is obtained, subjects, or their legal representatives when appropriate, must sign and date two copies of the consent form, retaining one copy for themselves and returning one copy to the investigator. As with any identifying data that is collected, the principal investigator must store the collected consent forms in a secure location for a period of at least three years after the conclusion of the research. For research in which the principal investigator is a student, his/her faculty supervisor must retain and store the collected forms under the same conditions. At any time during the three-year storage period, in response to a request from the IRB chair, the investigator or faculty supervisor must produce the collected forms for examination by the Executive Committee. At the conclusion of the storage period, all consent forms must be destroyed in a manner that protects the identities of the research subjects.

D) Written consent forms must be sufficiently detailed to enable a prospective subject to make reasoned judgments about the nature of the research and the potential risks and benefits of his/her participation (see the Sample Informed Consents for use by Non-Student Investigators or for use by Student Investigators). To this end, written consent forms normally should include the following elements -

(1) a statement indicating the purposes of the research, its expected duration, and the procedures to which subject will be exposed

(2) contact information pertaining to the principal investigator and faculty supervisor

(3) a description of reasonably foreseeable risks or discomforts to the subject

(4) a description of any expected benefits to the subject or to others

(5) a statement indicating the degree of confidentiality afforded the subject’s data

(6) a statement noting participation is voluntary; and that the subject may refuse or withdraw from participation at any time without penalty

(7) for research involving more than minimal risk, an explanation of the medical and/or psychological services that will be provided

(8) an indication the research has been approved by the IRB, as well as contact information pertaining to the relevant IRB representative should the subject have ethical questions or wish to submit a claim to the Executive Committee for a perceived violation of his/her rights and/or a research-related injury.

While the previously cited elements are sufficient for most written consent forms, the IRB reserves the right to require additional elements when it deems they are needed to protect the rights of prospective subjects in a specific research protocol.

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