Research involving Data and Biospecimens Track

2019 AER Conference

A12 - Operationalizing Data Sharing Policies—Challenges and Solutions

Speaker(s)

• 

  Shannon Sewards, MA, CIP
  

  Director, Harvard University Area IRB, Harvard University
  
• 

  Carrie D. Wolinetz, PhD
  

  Acting Chief of Staff; Associate Director, Science Policy, National Institutes of Health
  

The NIH Genomic Data Sharing Policy became effective in January 2015, and the policy applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Many journals will not accept manuscripts unless it can be shown the data is being shared within some national database. Compliance with the policy requires engagement of both the organization receiving federal funds and the IRB to complete the required institutional certification and provide assurances that the requirements of the policy have been met. This process is not without challenge and involves complex considerations (e.g., assessment of the adequacy of consent to permit sharing; potential limitations on data sharing that should be indicated by the organization; certifications when multiple institutions are contributing). During this session, speakers and attendees will:

Learning Objectives:

• Review the NIH’s Genomic Data Sharing Policy
• Discuss the ethical and regulatory implications of data sharing
• Identify potential challenges for organizations and IRBs in complying with the policy
• Share examples to discuss operational solutions and review processes to facilitate compliance