Important Notices for PAU Researchers, Faculty and Students

January 3, 2019: This is the date we launched our NEW Initial Submission form which was updated to reflect the new information we need to gather from you and the new questions that IRB members need to include as part of their review to comply with the new rules.

January 21, 2019: The new rules went into effect on this date. We will start issuing approvals under the new regulations on this date. Everything approved from this date on is subject to the new requirements. For information on how this impacts existing studies, please review the document below.

If you have a study number but don't have final approval:

• Open the study from your IRB Manager dashboard

• Click "Start xForm" after you have opened the study and then select the Initial Submission form

• Copy the information from the old form into the new form. You can create a pdf of your old application by clicking the "more" button at the bottom of the page, or just open two browser tabs or windows to facilitate copying the information over.

• Answer any new questions you are asked. Some questions have also been eliminated: the information from those questions is no longer required under the new rules.

• Make sure your answers on the new form include any changes you were asked to make when the study previously underwent review.

• Describe the changes you made in response to the previous IRB review in the text box at the end of the xForm (in response to the question "Please provide any additional information that you think would be useful to the IRB.")