WCG IRB Policy on Consent Forms

The IRB will require consent forms approved with new protocols starting March 1, 2024, to start with a concise summary/key information section at the beginning of the consent form, along with requiring any other applicable additional elements of consent under the common rule. If a consent form is submitted without these elements, the Board will add this language to the consent form.

This will not apply to consent forms reviewed under protocols that were approved prior to March 1, 2024. Thus, if you are submitting a new investigator or a change in research for a protocol approved prior to this date, these additional consent form elements will not be added unless the research was already required to be reviewed under the current common rule (i.e. was federally funded, or had other state or institutional requirements to apply the common rule).

WCG IRB makes changes to consent forms to ensure the content complies with our SOPs (which includes a review to ensure compliance with the regulations), is factually correct and conforms to the requirements of institutions and sponsors. In the “redline” version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.