Purpose: This outlines the recommended process for investigators requesting the use of newborn blood spots and/or data from Iowa Health and Human Services (HHS).

Step 1: Contact the Division of Sponsored Programs (DSP) 

  • Contact DSP before submitting requests to Iowa HHS.
  • DSP will determine whether a Data Use Agreement (DUA), Material Transfer Agreement (MTA), contract, or other agreement is required.
  • Inform DSP if data will be shared outside the State of Iowa, as HHS has specific requirements regarding out-of-state data sharing.

Step 2: Initiate the HHS and IRB Processes Concurrently 

  • Initiate the Iowa HHS request process and the IRB application process at the same time.
  • Submit a draft IRB application and the informed consent form (ICF) to HHS as part of the HHS data request process.
  • Submit a draft HHS Data Request to HSO/IRB during IRB review.
  • If HHS asks process-related questions that cannot be answered by the study team, involve the Human Subjects Office (HSO) for assistance.
  • This process should be followed if using an external IRB of Record. 

Step 3: Informed Consent Form (ICF) Requirements

  • HHS-required consent language must be included in the ICF.
  • Iowa HHS will provide the required consent language.

Step 4: IRB-01 Approval During HHS Review

  • The IRB may approve the study while HHS review is still pending.
  • An IRB approval memo may be issued.
  • The ICF will remain watermarked until HHS approval is received.
  • After HHS approval, submit an IRB modification to remove the watermark and begin the research.

Step 5: External IRB Considerations

  • External IRB release processes will not be finalized until HHS approval is obtained.
  • Whenever possible, obtain study-level IRB approval documentation and provide it to HHS.
  • The HSO will incorporate the HHS requirements as part of the local context review materials submitted to the external IRB.

Summary Checklist

☐ Contact DSP before initiating the HHS request.

☐ Determine needed agreements (DUA, MTA, contract, etc.).

☐ Notify DSP if data will be shared outside Iowa.

☐ Initiate HHS and IRB reviews concurrently.

☐ Submit draft IRB application and informed consent form to HHS.

☐ Submit draft HHS Data Request to HSO/IRB.

☐ Consult HSO regarding HHS process questions.

☐ Include HHS-required consent language in the ICF.

☐ Obtain IRB approval memo while HHS review proceeds.

☐ Submit IRB modification after HHS approval if needed.

☐ Obtain HHS approval before finalizing external IRB release processes.