Research involving Data and Biospecimens Track

2019 AER Conference

D12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient

Speaker(s)

• 

  Gretchen L. J Anding, MA
  

  Assistant Director, Health Sciences IRBs Office, University of Wisconsin-Madison
  
• 

  Elizabeth A. Buchanan, PhD
  

  Endowed Chair in Ethics, University of Wisconsin-Stout
  

The criteria for IRB approval have always included a requirement that IRBs consider, when appropriate, that there are sufficient protections in place to maintain the confidentiality of data. The revised Common Rule, specifically the new requirements for limited IRB review, place emphasis on this review criterion. Minimal guidance exists to assist IRBs in determining whether proposed safeguards for research data are sufficient. This session will review the challenges IRBs face in reviewing protocols to determine if the plans for maintaining confidentiality are sufficient, and it will highlight solutions for how data management and security review may be incorporated into the IRB review process. This session is appropriate for biomedical and SBE research audiences. During this session, speakers and attendees will:

Learning Objectives:

• Review the requirements IRBs should consider in creating plans to maintain confidentiality as part of the IRB review process
• Highlight the ways in which the revised Common Rule may impact the IRB's review of confidentiality plans
• Discuss practical solutions for incorporating the review of data security and management plans in the IRB review process
• Provide case examples to help evaluate when data needs to be protected, how to know that, and what IRBs can do, particularly when there isn’t a robust IT security department, or one that is not engaged