NIH Office of Science Policy, Office of the Director
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. Since then, data sharing has expanded to the point where many journals will not accept manuscripts, even those not involving genomic data unless it can be shown that the data is being shared within some national data base. Compliance with these policies 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; protecting privacy and confidentiality; etc.).
Provide an overview of the various Data Sharing Policies
Consider the ethical and regulatory implications of data sharing
Discuss the various options and locations on which to share research data
Review the requirements IRBs need to consider in creating plans to maintain confidentiality as part of the IRB review process
Identify potential challenges for organizations and IRBs in complying with the policy
Share examples to discuss operational solutions and review processes to facilitate compliance