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office for research protections


Changes to the Common Rule 45CFR46

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.

Research Data

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.

Level I

Level II

Level III

-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:
(1) Departmental servers
(2) Google drive

Data Storage Options:
(1) Departmental servers
(2) Data Archive
(3) RedCap
(4) Linux Cluster

Data Storage Options
PI’s should contact Research Services before submitting an IRB application.

 

Departmental Servers
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
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
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
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
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 2017

January 18, 2017
February 15, 2017
March 15, 2017
April 19, 2017
May 17, 2017
June 21, 2017
July 19, 2017
August 16, 2017
September 20, 2017
October 18, 2017
November 15, 2017
December 20th, 2017