Human Subjects Research

Use of IRB-Approved, Date-Stamped Informed Consent Documents

Beginning in June, 2000, the NIU Institutional Review Board instituted a policy requiring that informed consent documents given to subjects participating in non-exempt research bear the approval stamp of the NIU IRB. The stamped document is the only consent form that may be photocopied for distribution to study participants. The original date stamped consent form is returned to the investigator along with the project approval letter. A copy of the stamped form is kept on file in the ORC.

Continuing review of non-exempt projects is required at least annually until all identifiers that could link the subjects to the collected data have been removed. If the project will continue beyond the date stamped on the form, a fresh, unstamped copy of the consent form should be provided when continuation of IRB approval is sought (this should accompany the "Application for Continuation of Approval of Research Involving the Use of Human Subjects" form). Upon completion of the continuing review process the consent form bearing the updated stamp will be sent to the investigator with the project approval letter. Again, the research participants are to be given photocopies of this date-stamped consent form.

If modifications to the form are needed the investigator should contact the Office of Research Compliance for assistance. Any revision or amendment to a study protocol or to an informed consent document must be approved by the IRB before the requested changes can be implemented unless subject safety is an immediate concern. The investigator should provide three versions of the informed consent document:

the version that had original IRB approval,

the version incorporating the proposed revisions with the revisions highlighted,

the version incorporating the proposed revisions without highlighting.

The "clean" version will then be date stamped and returned to the investigator along with the letter from the IRB chair approving the requested revisions.

Other important information relevant to the informed consent process:

It is important to note that research investigators involved with human subjects are responsible for ensuring that the project has current IRB approval at all times, and for retaining the signed consent forms obtained from subjects in a secure place for a minimum of three years after the study is concluded. If consent to participate is being given by proxy (guardian, etc.), it is the investigators responsibility to document the authority of that person to consent for the subject. The NIU IRB also recommends that the informed consent include an acknowledgment by the subject, or the subject's representative, that he or she has received a copy of the consent form.

Click here to view a checklist of the required elements of informed consent.