New Questions in Cede Application:

To ensure compliance with requirements for depositing genetic data in NIH’s dbGAP, new questions have been added to the cede application. The questions ask whether genetic testing will be conducted and if so, whether genetic data will be deposited into dbGAP. While NIH funded studies must submit genetic data to dbGAP, such data can be deposited regardless of funding source. To determine whether data will be deposited in dbGAP, you may need to consult with the study sponsor, coordinating center, and/or PI.

Tips for Cede Applications to Other External IRBs (University, Health Care System):

• Before submitting a cede application, confirm whether the UW is engaged in human subjects research. If your role in a study is limited to activities such as data analysis, consulting on study design, or manuscript preparation, a cede application may not be required for your role in that study. Please see HRP 311 Engagement Determination for guidance.
• Single IRB review is not required for exempt studies and the UW will not cede IRB review for exempt projects.
• Do not submit a cede application until you have confirmation that the lead study team has begun the process of adding the UW to the study.
• If subjects will be enrolled at the UW, be sure to use the consent template approved by the reviewing IRB and refer to HRP 502 Institutional Consent Language when drafting the UW version of the consent document.