Tips for Creating a Consent Document
Getting Started The consent form or study information sheet is a document used to guide your consenting process. The consent form should include several sections, which are called “elements.” To help investigators create a consent document that includes all of the necessary elements, and is more readable, the IRB has created consent/assent form templates. We […]
BU IACUC Submission Process
All research involving animals on the BU Charles River Campus, BU Medical Campus, and at the Boston Medical Center is subject to the requirements of the BU IACUC, regardless of funding source or other regulatory requirements. All animal care and use protocols: Must be approved by the IACUC before animals are procured. Must be approved […]
Protocol Review Outcomes
Work may commence immediately upon full approval of a protocol. Approval is valid for the study as described in the protocol form for a period of three years from the approval date. PI’s must also complete an annual renewal each year. The Boston Public Health Commission requires notification upon IBC approval of any new BSL-3 project at […]
Three Year IBC Renewal
After three years, the application must be resubmitted and reviewed by the committee. Three-Year Resubmission Instructions General IBC Three-Year Resubmission Instructions: For all expiring IBC Protocols, complete a Three-Year Resubmission in RIMS (see instructions below) and click “confirm the submission” to send it to the IBC Office for review. Make sure the PI and all […]
Annual Renewals
An email notice of Annual Renewal will be sent to the PIs at the first and second years after initial approval of a protocol. This Annual Renewal should be completed in RIMS. Detailed instructions on completing the Annual Renewal in RIMS are found below. To complete the renewal, PIs should list all proposed modification from the […]
Amendments
Amendments must be submitted to the IBC for approval of changes within an approved project. All changes should be described in detail, and these must be reviewed and approved by the IBC according to the table below. IBC approval is required before any changes in the work can commence. For all IBC Protocols, complete the […]
New IBC Application
All IBC applications are completed online in the Research Information Management System (RIMS). Principal Investigators (PIs) must complete a RIMS PI Account Registration in order to access the IBC application. The PI can designate others to assist in completing the application, however, only the PI can submit the application. IBC requires that all PIs be members of the […]
Application Review and Approval
IBC approval of recombinant or synthetic nucleic acid molesules and biohazardous research protocols is effective for three years. PIs must complete an IBC Annual Renewal each year to continue work for up to three years after the initial approval. After three years, the application must be resubmitted and reviewed by the committee. What Needs IBC […]
Assent Form Template
For use when the study plan is to enroll children age 12 years and older. Consent of the parent is documented on the separate Consent Form.
Request for Modification Response Form
Use to document the principal investigator’s response to IRB requests for additional information made during the review of an IRB submission.