IRB 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 participant to make well-reasoned judgments about the nature of the research, any potential risks, and the benefits of participation (see below for a template you could use to make sure you have everything you need on the informed consent). Written consent forms must 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.

Informed Consent & Assent Templates

The informed consent template below is designed to make it easier for researchers to include all that is needed on the form. Yellow highlights mark the areas that should be modified with explanations as to what information should go where. Note: Researchers do not need to use the St. Joseph's University informed consent template, but all informed consent forms must contain the appropriate information. Any questions should be directed to the IRB chair: Dr. Michael W. Magee, Ph.D. ([email protected]).