HCSRA HINT: Statement of Work (SOW) with Data Exchange

May 28, 2021
 

When a PI is writing a Statement of Work (SOW) that involves data exchange, it's helpful if the PI includes the following clarifying information in the SOW:

  1. State all of the direction(s) of data between organization (one way or two ways? How will you provide access to your data by other researchers? How will others discover your data?)
    1. e.g., Purdue University will send de-identified data to Harvard Chan consortium PI and Harvard Chan consortium PI will ____ (do what with the data?)
  2. List the type of data(What is the source of your data? In what formats are your data? Will your data be fixed or will it change over time? How much data will your project produce?)
    1. De-Identified Data: De-identified data stripped of all person's "direct identifiers", (e.g., stripped of HIPAA's 16 categories of direct identifiers)
    2. Limited Data Set: stripped of all person's "direct identifiers" but can include geographic data, dates, and other unique identifier, characteristic or code other than those specified in the list of 16 identifiers that are expressly disallowed.
    3. Fully Identifiable: information with any personal identifiers, as well as information about an individual, or his or her relatives, household members, or employer that alone or in combination could identify the individual, including full-on HIPAA covered under Protected Health Information.
  3. If the data exchange is with a 3rd party, (be specific about the role of the 3rd party and under which organization the 3rd party directly falls. Then, follow bullet points 1), 2) and 4))
    1. e.g., BWH, sub under Purdue University, will provide a limited data set to Harvard Chan and Harvard Chan will___(do what with the data?)
  4. Include DUA and MTA info in SOW
    1. Data Use Agreement (DUA)
      1. Add to SOW: “If necessary, a data-use agreement (DUA) will be executed between the parties.”
    2. Material Exchange Agreement (MTA)
      1. Identify the materials and state all of the direction of the materials exchange -> from which organization to which organization?
      2. Add to SOW: “If necessary, a material transfer agreement (MTA) will be executed between the parties.”