Some studies do not require the investigator to obtain the formal written consent of subjects using an IRB-approved consent form. The circumstances in which documentation of consent can be waived are described in UAMS IRB Policy 15.3 (see section II.B).
Please note, however, that even when a waiver of documentation of consent is requested/granted, some kind of consent process will usually still occur. You may discuss the study with potential subjects and/or use an information sheet that you give to participants. Therefore, when you complete your new submission form in CLARA, be careful to note that you are requesting a waiver of documentation of consent, and not a waiver of the entire consent process.
Specifically, the CLARA query reading “Indicate the consent process(es) to be used in the study (Check all that apply)” should be answered “Informed Consent,” not “Requesting Waiver of Consent Process.” We’ve seen a lot of people click the “Requesting Waiver of Consent Process” box when that doesn’t accurately describe their intent. They will still do a consent process, but do not propose to collect a signed consent form from the subject.
The next question will ask “Are you requesting Waiver of Documentation for the Consent/Assent Process?” – click this one “yes”. You will be led to some follow-up questions to help document that the study meets the criteria for a waiver of documentation of consent. Please also remember to include copies of any information sheets or scripts that will be used when presenting the study to potential subjects.