ORP provides administrative support to the Institutional Review Board (IRB). If you have any questions or concerns as you navigate your way through the IRB process, please do not hesitate to contact us. We are available by phone (x24778) or email (irb@bc.edu) during normal business hours. We look forward to working with you to help facilitate a positive experience with the IRB.
Institutional Review Board (IRB)
The mission of the IRB is to protect the rights and welfare of human subjects who volunteer to participate in research at Boston College. Federal regulations and University Policy require prospective review and approval of all human subject research conducted by faculty, staff, or students. As with Boston College's Jesuit tradition of excellence, service and beneficence, the goal of the IRB is to ensure the safe and ethical treatment of research participants.
Protocols are processed in the order that they are received. We encourage PI's to submit their protocols early in order to avoid any delays.
NIH has issued new guidancefor sponsored projects involving human participant research. The agency has changed its requirement for what types of grant changes involving human subjects need NIH prior approval from thh NIH grant office.
A sample site permission letter has been added to the sample forms section of our website.
New Procedures
The Continuing Review application form now contains a new section requiring PI's to list all current members of their research team along with the dates of their human subjects training certificate.
Reminders
It is essential that PI's read the conditions outlined in their IRB approval letter. According to the terms of the letter, all changes, however minor, must be approved by the IRB through the use of an amendment form prior to implementing any changes. This includes adjusting the language in the consent form(s) and increasing the number of participants. Noncompliance is a serious matter especially concerning federally funded protocols.
Following the instructions on the application forms and letters requesting changes is a key step in avoiding delays in the approval of protocols. For example, when sending revisions to a protocol, PI's should include only the materials that have been revised, not the entire protocol. Protocols are returned to PI's if they have not complied with ORP's instructions. PI's who are unsure of the instructions are encouraged to call ORP.
Some PI's have been experiencing technical issues when using Internet Explorer (IE) to view and download IRB applications. If you are having trouble with IE, please use another browser such as Firefox.
Section VIII question A on the Initial IRB Application includes a list of all required elements of consent. PI's are instructed to mark only the elements that have been included in their consent forms. If an element is checked off and the statement is not included in the consent form, the protocol will be returned to the PI.
The IRB Training Policy has been revised to include an exception to the policy for those PI's who are strictly dealing with de-identified data sets and are not conducting research using federal funding. PI's who meet that criteria are exempt from the training policy.Please continue to check our website for the most recent IRB forms and applications. We cannot accept old forms since they may not contain information that is now required.
