In February 2015, the IRB Executive Committee approved a revision to the HIPAA section of the consent form template. The revisions were done to simplify the language and shorten the length of this part of the consent form. This new HIPAA section has been incorporated into the consent form template in INSPIR and on the BUMC IRB website (http://www.bumc.bu.edu/irb/files/2011/03/Main_Consent_Form_Template.rtf). The updated consent template should be used for all new consent forms. There is no requirement that you modify existing consent forms with the new HIPAA language.
There have been a number of changes to the INSPIR system since the first of the year: Some of those changes only impact the IRB Office, while others directly impact the investigators and study staff. If you received a stipulation memo in the past two months, then you may have noticed a change in the formatting and function of the stipulation page. When a stipulation is created by one of the IRB Analysts which requires a revision to the Application, the Analyst will also create a link to the specific section of the Application that needs to be revised. This means that when you are asked in a stipulation to revise a section of the Application, there will be a link that you can click on which will bring you to the correct section. When a member of the study staff clicks on the link, three important things happen: 1) a revised version of the Application is automatically created; 2) you are brought directly to that section of the Application which needs to be revised; and 3) the new version of the Application is automatically attached to your response.
After you have opened the stipulations form, under the first stipulation you will see a row that says “Links to Components;” and at the end of that row you will see an icon that says, “Add Revision,” which is a link to a section of the Application. This link will create and attach the revised version of the Application. Once the revised Application has been created, you will see that the “Add Revision” icon has gone away, but you can still click on the link under the “Edit/View” column for each stipulation to bring you directly to that section of the Application.
When making the revisions to the Application, remember to save your changes by clicking on the “Save and Continue to the Next Section” button. Once you have saved the changes, you can click on the “Back” button, and it will return you to the stipulations. If you have additional stipulations that require a change to the Application, you will then click on the link under the “Edit/View” column, and it will bring you directly to that section. If you also need to revise any study documents (consent forms, questionnaires, recruitment materials, etc.), you can still access those documents from the “Review Response Submission Form” by clicking on the gray button in the “Previous Submission” section of the form. That will bring you to the “Initial Review Submission Packet” where you can create revisions to the appropriate document’s section.
The rest of the process for responding to stipulations remains unchanged. As always, we recommend that study staff review the instructions that can be found on the IRB website: http://www.bumc.bu.edu/irb/files/2011/03/Review-Response-Submission-Form-Initial-Review1.pdf.