Data Use Policies
Read about the All of Us Research Program policies governing your access and use of All of Us data and the Research Hub below. Learn about access to the data by visiting the Data Access page.
ETHICAL CONDUCT OF RESEARCH POLICY
Key points from the Ethical Conduct of Research Policy. Data users should follow the full policy, available for download at the bottom of this page.
The All of Us Research Program requires all authorized users of the All of Us data to conduct research that follows and conforms to the ethical principles upheld by the program. This means that as a user you must:
- Know and follow all laws and regulations regarding research involving human data and data privacy that are applicable in the area where you are conducting research, including all applicable federal, state, and local laws.
- Know and follow the Common Rule principles as defined by The Belmont Report:
- Respect for persons. Participants must be treated as individuals with the ability to consider and make choices about their participation consistent with their own interests and goals. Vulnerable populations are entitled to additional protections from human subject research. This includes children, prisoners, and women who are pregnant.
- Beneficence. Researchers working with human participants must ensure participants’ wellbeing. Research should not intentionally harm participants, should maximize the possible benefits, and should minimize any potential harm.
- Justice. This principle requires that the benefits and harms resulting from research be distributed fairly amongst people by using ethical inclusion and exclusion criteria. Researchers must ensure that people benefit from their research according to need and not affordability.
- Understand that non-human subject research can still cause psychological, social, and economic harm even if the risk for physical harm is low.
- Understand the effects your research results can have on communities and society.
Conducting ethically sound research thus affirms commitment to the core values of the All of Us Research Program by respecting the dignity and choices of participants as partners and actively considering the vulnerabilities and disadvantages of varied individuals and communities.
POLICY ON STIGMATIZING RESEARCH
Key points from the policy on Stigmatizing Research. Data users should follow the full policy, available for download at the bottom of this page.
The All of Us Research Program defines stigmatizing research as any research proposal, project, or question that has the potential to instigate or promote marginalization of, discrimination against, or loss of status by a person or group of people. Stigma may be inherent in the research design (e.g., the formation of a research question based on prejudicial biases) or a byproduct of the research findings (e.g., the interpretation of findings in a way that promotes negative stereotypes) and may be intentional or unintentional.
While complete elimination of stigmatizing research based on the use of All of Us data resources is likely impossible, the program takes steps in earnest to prevent resource use with the potential to stigmatize. Conduct of stigmatizing research using the All of Us data resources is prohibited, and the program reserves the right to penalize violators of this policy as appropriate.
PUBLICATION AND PRESENTATION POLICY
Key points from the Publication and Presentation policy. Data users should follow the full policy, available for download at the bottom of this page.
Researcher Workbench users are obligated to inform the program of any upcoming publications or presentations resulting from the use of All of Us Research Program data (including peer-reviewed manuscripts or conference abstracts) at least two weeks before the date of publication or presentation. You can do this by contacting User Support in your Researcher Workbench account. Your manuscript will not go through any program review. The information will only be used to allow the program to prepare for any media coverage or communication regarding the upcoming publication. Any embargoes will be honored.
Additionally, you must submit an electronic version of a final, peer-reviewed manuscript to PubMed Central immediately upon acceptance for publication, to be made publicly available immediately without any embargo period.
Researcher Workbench users must honor the contribution of those who take part in All of Us to the research project’s work. This includes in all oral and written presentations, disclosures, and publications resulting from any analyses of the data. The following is an example of an acknowledgement statement:
“The All of Us Research Program is supported by the National Institutes of Health, Office of the Director: Regional Medical Centers: 1 OT2 OD026549; 1 OT2 OD026554; 1 OT2 OD026557; 1 OT2 OD026556; 1 OT2 OD026550; 1 OT2 OD 026552; 1 OT2 OD026553; 1 OT2 OD026548; 1 OT2 OD026551; 1 OT2 OD026555; IAA #: AOD 16037; Federally Qualified Health Centers: HHSN 263201600085U; Data and Research Center: 5 U2C OD023196; Biobank: 1 U24 OD023121; The Participant Center: U24 OD023176; Participant Technology Systems Center: 1 U24 OD023163; Communications and Engagement: 3 OT2 OD023205; 3 OT2 OD023206; and Community Partners: 1 OT2 OD025277; 3 OT2 OD025315; 1 OT2 OD025337; 1 OT2 OD025276. In addition, the All of Us Research Program would not be possible without the partnership of its participants.”
DATA USER APPEALS POLICY
Key points from the All of Us Research Program Data User Appeals policy. Data users should follow the full policy, available for download at the bottom of this page.
The All of Us Research Program Data User Code of Conduct requires data users to establish a project workspace for each unique research project. Each project workspace, in turn, must bear a meaningful and accurate description of the research purpose that is created at the time of workspace initiation. These workspaces and descriptions are subject to review upon public or user request or during periodic audits of the Research Hub. The All of Us Resource Access Board (RAB) is charged with conducting any reviews necessary to determine compliance with the Data User Code of Conduct. The Resource Access Board shall do so, according to the policies and guidelines set forth by the All of Us Research Program. The RAB will determine whether the workspace project is compliant with the Data User Code of Conduct and recommend corrective or enforcement action. In some instances, data users may disagree with RAB determinations. In these situations, data users may appeal the determination according to the policy below.
DATA AND STATISTICS DISSEMINATION POLICY
Key points from the All of Us Research Program Data and Statistics Dissemination Policy. Data users should follow the full policy, available for download at the bottom of this page.
Under the All of Us Data and Statistics Dissemination Policy:
- No participant count of 1 to 20 can be published or distributed directly (a count of 0 is permitted); and
- No data or statistics can be reported that allow a participant count of 1 to 20 to be derived from other reported cells or information, including in text, tables, or figures. This includes the use of percentages or other mathematical formulas that in combination would allow an individual to deduce a participant count of less than 20.
This policy permits data users who wish to report data or aggregate statistics that correspond to fewer than 20 participants to obscure these values using scientifically accepted strategies, including collapsing data across cells, coarsening data, or cell suppression. More information about acceptable strategies and how to employ them are available in the Researcher Workbench.
DATA USER CODE OF CONDUCT
Key points from the All of Us Research Program Data User Code of Conduct. The full agreement is available for download at the bottom of this page.
The Data User Code of Conduct describes how All of Us Research Program data can and cannot be used for research projects. For researchers, this includes but is not limited to agreeing to the following terms. As an “Authorized Data User” of the All of Us Research Program data, you will:
- respect the privacy of research participants at all times.
- You will NOT use or disclose any information that directly identifies one or more participants.
- Use the All of Us data only for the purpose of biomedical or health research.
- Provide a meaningful and accurate description of your research purpose every time you create an All of Us Research Program workspace.
- Take full responsibility for any external data, files, or software that you import into the All of Us Researcher Workbench and the consequences thereof.
- DO NOT share your login information with anyone, including other authorized data users of the All of Us Research Program.
- DO NOT attempt to contact All of Us Research Program participants.
- DO NOT take screenshots or attempt in any way to copy, download, or otherwise remove any participant-level data from the All of Us Researcher Workbench.
- You will NOT publish or otherwise distribute any participant-level data from the All of Us Research Program database.
- You will NOT publish or otherwise distribute any data or aggregate statistics corresponding to fewer than 20 participants unless expressly permitted under the terms of the All of Us Data and Statistics Dissemination Policy.
- DO NOT redistribute or publish registered or controlled tier data
- DO NOT attempt to link registered or controlled tier All of Us Research Program data at the participant level with data from other sources.
- DO NOT use All of Us Research Program data or any part of Research Hub for marketing purposes.
- DO NOT represent that the All of Us Research Program endorses or approves of any research unless such endorsement is expressly provided in writing by the All of Us Research Program.
DATA ACCESS FRAMEWORK
Key points from the Data Access Framework. The full document is available for download at the bottom of this page.
The Data Access Framework explains how the All of Us data is structured, the steps Research Hub users must take to access the data, and how the program oversees the data’s use.
The framework is inclusive; this means data can be accessed not only by researchers affiliated with institutions, but also by citizen and community scientists and individuals conducting research outside of academic medical centers.
There are three tiers of data access: public (no login required); registered (login required); and controlled (additional approval required).
Authorization for access to the registered and controlled data tiers will be user based, rather than project based. Authorized users will receive a “data passport.” The data passport is required for gaining access to the registered and controlled data tiers and for creating workspaces to carry out research projects.
Each user is required to submit a description of their project. These descriptions will be made public and searchable for auditing purposes and to facilitate public engagement. This helps to further the program’s commitment to partnership and transparency with participants (Precision Medicine Initiative: Privacy and Trust Principles) and compliance with the 21st Century Cures Act (Pub.L. 114-255). See below for the full text of the Data Access Framework.