I’m reviewing a protocol that references All of Us Data.  What do I need to know?

• Data accessed through the NIH All of Us Research portal is covered by a single IRB that is directed by the All of Us project under NIH.  GS projects that do not accept biospecimens or individual level data that is downloaded outside of the All of Us portal do not require additional review.  The following links provide additional information.
  • All of Us – introduction

1. GS access website – https://www.georgiasouthern.edu/research/researchintegrity/all-of-us-data-access/
2. All of Us IRB Determination and letter access 
3. Informed consent to participate in All of Us  https://allofus.nih.gov/sites/default/files/f1_primary_consent_form-eng-sample.pdf
4. Informed Consent Analysis https://www.tandfonline.com/doi/full/10.1080/23294515.2020.1847214 – IC analysis

• Citation –  Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver & John Wilbanks (2021) Assessment of the All of Us research program’s informed consent process, AJOB Empirical Bioethics, 12:2, 72-83, DOI: 10.1080/23294515.2020.1847214

5. Restricted Tier and Controlled Tier Data – Single IRB

Last updated: 2/20/2023