| IRB Meetings (full board review only) |
June 20,2012
July 18, 2012
August 15, 2012
September 19, 2012
October 17, 2012
November 21, 2012
December 19, 2012
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Office for Research Protections (ORP)
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. However, please note that we close at 3pm on Fridays in the Summer. 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.
The IRB continues to review protocols during the Summer months. However, due to vacations and other commitments, protocol approvals may take slightly longer than usual. We encourage PI's to submit their protocols early in order to avoid any delays.
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Latest News
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- Section 45 CFR 46.109(e) requires the IRB to conduct continuing review of research and..."have authority to observe the consent process and the research." Beginning on June 1, 2012, ORP will initiate the annual process of monitoring a random sampling of IRB approved protocols per year.
- ORP has seen a record number of protocol actions in Fiscal Year 2012. We cannot stress enough the importance of sending in IRB applications as early as possible. The present workload and staffing shortage have combined to make it impossible to accept requests for a quick turn-around for protocol approvals.
- All of the IRB application forms have been revised. Please ensure that the most recent version of the form is being used by visiting our applications page on our website. Please note that the most current initial application now includes a readability section where PI's must verify the comprehension level of the consent form.
- 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.
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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.
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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.
- PI's should use their protocol number each time they communicate with ORP. This will facilitate a faster response time.
- 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.
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