Bipolar & Depression Outcomes Research Institute

Ethics and Oversight of BDORI Studies

Bipolar & Depression Outcomes Research Institute (BDORI) is a nonprofit focused on understanding real-world outcomes for people living with bipolar and related conditions. Our current projects use an existing psychoeducation and self-assessment program (Bipolar IN Order) and do not involve experimental medications or changes to anyone’s clinical care.

Type of studies we run

Right now, our primary project is a 100-participant, 12-month outcomes pilot of the Bipolar IN Order online program. This pilot:

  • Uses an already existing educational and self-monitoring program
  • Does not alter or replace participants’ treatment, diagnosis, or care providers
  • Focuses on learning how people use the program and how their functioning and quality of life change over time
  • Is designed to refine our data collection methods and platform in preparation for a later, fully IRB-approved study with academic partners

Because this is a feasibility and data-infrastructure pilot, it is not currently overseen by a university ethics committee. Future formal trials will be submitted for review through the ethics committee of the partner institution.

Core participant protections

Across all BDORI projects, we follow standard research ethics principles:

  • Participation is voluntary, and people can stop at any time
  • Participation does not affect access to the educational program itself
  • Compensation, when offered, is clearly explained in advance
  • We encourage participants to continue working with their own clinicians and not to change medication or treatment based solely on our program

Privacy and data handling

Protecting participants’ privacy is central to how we design the platform.

  • The app can be used without providing identifying information unless participants choose to share it
  • Data used for research is de-identified wherever possible and analyzed in aggregate
  • Access to raw data is limited to authorized team members and research partners under appropriate agreements

  • Any future academic study will include an IRB-approved consent process that clearly explains data use, storage, and sharing

Future ethics committee review

Our goal is to use this pilot to:

  • Demonstrate feasibility of long-term outcomes tracking
  • Identify which measures are most informative for clinicians, participants, and payers
  • Prepare a full protocol that can be submitted to a university or hospital ethics committee (IRB or equivalent) for formal review and approval

When that stage is reached, the responsible ethics committee and institution will be clearly identified in all study materials.

Questions or concerns

If you have questions about ethics, safety, privacy, or data use in any BDORI project, please contact us through the BDORI contact page so we can review and respond directly. We welcome serious questions and concerns and are committed to handling them transparently and respectfully.