News & Announcements
office for research protections
Changes to the Common Rule 45CFR46
Review important changes to the Common Rule which goes into effect on July 19th, 2018.
After two years in the making, the U.S. Department of Health and Human Services, along with other federal agencies, issued new rules governing the protection of human subjects who participate in research. The changes to the federal regulations, 45CFR46, referred to as the Common Rule, will go into effect in January 2018. There have been no significant changes to the Common Rule in many years. These new rules are intended to strengthen human subjects protections and include updates to exempt categories of research, the use of single IRBs for multi-site research and the elimination of continuing review in some instances. The IRB asks for your patience while it works with ORP and the Administration to interpret the new regulations and make any revisions deemed appropriate to applicable IRB policies and procedures. Please stay tuned for updates.
The BC IRB has previously required PI's to store their data in MyFiles as an added level of protection for human subjects data. BC retired MyFiles at the end of 2015. ORP has since developed a classification system for storing human subjects data. This new 3-level classification system is designed to apply to the three types of human subjects data that we typically see at Boston College. The idea is that as the risk posed by the research project increases, so do the requirements for maintaining human subjects data.
If you have questions about the IRB requirements for storing and protecting your human subjects data, it is best to contact ORP. ORP works with Research Services regarding data resources. PI's are encouraged to contact Research Services or their TC's for more specific information on how to access and work with these tools.
|-Information that is de-identified
-Information that is considered public information
-Information that is non-sensitive, benign (disclosure will not cause harm to human subjects)
|-Information that has identifiers
-Information that is confidential
-Information that is sensitive
-Information that is protected by state or federal laws
-PHI (Protected Health Information)
-Information that requires a data security agreement
|-Information that is highly sensitive and the disclosure of the information would cause harm to human subjects
-Protocols that require full board review would typically meet Level III classification
Data Storage Options:
Data Storage Options:
Data Storage Options
Consult your TC to set this up for you. Departmental servers allow you to restrict permissions. PI’s have the option of requesting an S drive which is set up by the Systems Group.
Google drive is an acceptable tool to store data if it meets Level I criteria. Google drive with cloud lock is available to BC faculty and staff.
RedCap was originally developed by researchers, for researchers and it was meant to be a data repository. It can be used for data entry, creating surveys, and storing data. PIs can upload data from an Excel spreadsheet.
Data Archive is similar to dropbox and is considered a good way to share data. It is stored on the BC campus and requires the PI to be on the VPN.
Linux Cluster can be used for secure, bigger pieces of restricted data that falls under license agreements. It can also be used for smaller data sets. If sits behind a firewall at BC. PI's are encouraged to contact Research Services or their TC's for more specific information on how to access and work with these tools.
IRB Meeting Dates 2018
January 17, 2018
February 21, 2018
March 21, 2018
April 18, 2018
May 16, 2018