IRB Informed Consent Provisions

(1) Informed consent is required for all human participants.

(2) Informed consent forms must be sufficiently detailed to enable a prospective participant to make well-reasoned judgments about the nature of the research and the potential risks and benefits of participation (sample informed consent forms are available on the St. Joseph’s IRB website). To this end, all informed consent forms must include the following elements:

a) a statement indicating the purposes of the research, its expected duration and the procedures to which the participant will be exposed;

b) contact information pertaining to the principal investigator and faculty supervisor;

c) a description of reasonably foreseeable risks or discomforts to the participant;

d) a description of any expected benefits to the participant or to others;

e) a statement indicating the degree of confidentiality afforded the participant’s data;

f) a statement noting participation is voluntary and that the participant may refuse or withdraw from participation, for any reason or no reason, at any time without penalty;

g) for research involving more than minimal risk, an explanation of the medical and/or psychological services that will be provided, or are available; and

h) an indication that the research has been approved by the St. Joseph’s IRB, as well as contact information pertaining to the IRB Chair — should the participant have ethical questions or wish to submit a claim to the IRB Executive Committee for a perceived violation of their rights and/or a research-related injury.

(3) When informed consent is in written format (in-person research), participants (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, their 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 St. Joseph’s IRB 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 participants.

(4) When informed consent is obtained online, participants who indicate consent (e.g., via choices, radio buttons, or text responses) and click to continue will be considered to have given their consent to participate. However, online researchers must observe the following conventions:

(a) The informed consent form must be isolated from the rest of the survey so that none of the survey is revealed to the participant until after they provide consent.

(b) The participant must be given a choice to participate (gives consent) or not participate (does not give consent) and, if they do not give consent, the survey must be designed to terminate immediately. The participant must not be allowed to continue if they do not provide consent.

(c) None of the items in the survey can be “forced-choice,” as the participant has the right to refuse to respond to any item.

(d) A working link to the completed survey must be included in the IRB application so that above points may be reviewed before approval can be given.

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 participants 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]).