June 15, 2011 July 20, 2011 August 17, 2011 September 21, 2011
October 19, 2011
November 16, 2011 December 21, 2011
Office for Research Protections (ORP)
The Office for Research Protections (ORP) provides administrative support to the 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.
Have a wonderful Summer! ORP staff will be here throughout the summer to process your protocols and answer your questions. 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 participants who volunteer to take part 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.
Latest News
ORP developed a new telephone consent script which will be posted on our website shortly. Please use this guide.for studies that are no more than minimal risk where oral consent is applicable with a partial waiver of the subject's signature.
The Director of ORP performed an assessment to determine whether BC is in compliance with the federal regulations and/or guidance concerning the readability and comprehension level of informed consent documents. A random sample of 13 consent documents indicates that over half of the consent forms were written above the comprehension levels of the participants. It is the PI's responsibility to check the consent documents for comprehension level.
There are three ways to effectively test comprehension levels:
1. The Flesh-Kincaid scale is available in Microsoft Word. 2. http:www.addedbytes.com/code/readability-score/ 3. http:www.online-utility.org/english/readibility _test_and_improve.jsp
ORP keeps the IRB informed of protocol approvals on a monthly and annual basis. It is interesting to note that in FY 2009 there were 397 approved protocols while in FY 2010 the number was significantly higher with 726 approved protocols.
IRB Faculty Advisor brochures have been distributed across campus. Please let us know if you would like us to deliver more brochures to you or your department.
New Procedures
The IRB no longer needs to review protocols for investigators purely in the data analysis stage. If the investigator no longer has any interaction with humans or their personally identifying information, he/she should complete the new data analysis form which will allow OPR to close the protocol.
.
The new Data Analysis form is a simple one page form which asks the PI to fill in his/her name, the title of the study, check three boxes and provide a signature. By filling out this form, PI's are helping ORP identify active and closed protocols.The form is located with all of our application forms and can be faxed to us at 617-552-0498.
Reminders
The Policy for the Protection of Human Research Participants and the Standard Operating Procedures for Researchers are now available on our website. We invite you to read these important documents which contain substantial information regarding the process of IRB protocol submissions and approval.
If an investigator is in the data analysis stage and will have interaction with human participants or access to identifiers, the investigator must complete the Continuing Application form to seek IRB approval for continuing review of their project.
Please use the correct contact information for ORP on your consent forms. The name of our office is the Office for Research Protections. Participants can contact us via telephone at (617)-552-4778 or email at irb@bc.edu.
ORP will be offering an education series for new investigators titled Demystifying the IRB beginning in the Fall. Please contact Carolyn O'Connor, Assistant Director, ORP for more information.
The IRB's position on the issue of compensation for participants is that they prefer that compensation be done on a prorated basis at minimum when possible and should be in recognition of time and effort.
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.
Undergraduate student research may be subject to IRB review if the project meets the definitions of research and human subjects and the results of the project will be published or presented at meetings.
As is always the case, it is best to talk over any questions with the ORP staff. We welcome your questions and will be more than happy to talk over any uncertainty that may exist in an undergraduate's project and whether it needs to be reviewed by the IRB.
