Starting May 15th, 2020, the University will be implementing a partial rollout of the updated Research Data Security Policy Guidance!
 

What is meant by partial?

• As part of their review, IRB’s will begin assigning non-Sensitive/Sensitive determinations, as opposed to a specific Data Security Level (DSL). The content of the IRB’s review will not change, just the specificity of their determinations.

  • Something to note is that only those studies where a new assessment of data is taking place will be routed through this revised process. That means that if you are submitting an initial study or are revising your already approved study to include new types of data that may increase the level of sensitivity this new process will be used.
     

• All projects deemed “Sensitive” by the IRB, and all research data that, based on HUIT guidance, appears to be DSL 3, 4 or 5, will be required to be submitted in the Safety Application for information & school security officers (ISO’s) review. The Safety Application may be found here - http://researchsafety.harvard.edu

  • Interested in what is considered sensitive? Check out the newly revised Data Security Levels – Research Data Examples here - https://security.harvard.edu/data-security-levels-research-data-examples

  • Not sure what tools might support a specific HUIT security level? Check out the HUIT Collaboration Tools Matrix which provides a listing of what Harvard tools are available according to data security levels here - https://security.harvard.edu/collaboration-tools-matrix

• Once the Safety Application is in place for those studies that are determined Sensitive by the IRB, ISO’s will work with researchers to determine the applicable DSL.

• Similarly, all data that is subject to a Data Use Agreement (DUA) will be required to be submitted in the Safety Application for ISO review (in addition to submitting a request in the Agreements-DUA Application).
   

Need more information? Here are some resources at your disposal:

• Research Data Management @ Harvard website - https://researchdatamanagement.harvard.edu/
• Safety System Guidance - https://ras.fss.harvard.edu/data-safety
• ESTR-IRB System Guidance - https://estrsupport.fss.harvard.edu/
• Agreements – DUA Guidance - https://ras.fss.harvard.edu/agreements