When completing new submission forms, you’ll encounter a question that asks you to check the type of consent process(es) to be used in the research. The four response options are Assent; Parental Permission (Pediatric Consent); Informed Consent; and Requesting Waiver of Consent Process. We’ve seen some creative answers given to this question when PIs are proposing to do a consent discussion, but not collect a signed consent form, i.e. request a waiver of documentation of consent. When you plan to undertake a consent process but want to waive consent documentation, the correct response to this query in a study involving adults is “Informed Consent”; for one involving children, it is “Parental Permission (Pediatric Consent).” This indicates that you will have a consent discussion or process of some kind. The next question in the CLARA new submission form will ask if you are requesting a waiver of documentation of consent. If you check “yes” to this box, the new submission form will then lead you to the questions that support the rationale for such a waiver. It’s important to indicate up front that there will be a consent process that occurs, even if no consent form will be signed, to document the rationale for a waiver of documentation.
“Requesting waiver of consent process” is appropriate when there will be no consent process at all, such as in retrospective chart review studies.
Please don’t hesitate to get in touch with the IRB Office at 686-5667 if you have any questions about completing forms in CLARA.