Create an Office of Co-Production at the National Institutes of Health
The National Institutes of Health (NIH) spent $49 billion in fiscal year 2023 on research and development, a significant annual investment in medical treatment discovery and development. Despite NIH’s research investments producing paradigm-shifting therapies, such as CAR-T cancer treatments, CRISPR-enabled gene therapy for sickle cell, and the mRNA vaccine for COVID-19, the agency and medical scientists more broadly are grappling with declining trust. This further compounds decades-long mistrust in medical research by marginalized populations, whom researchers struggle to recruit as participants in medical research. If things do not improve, a lack of representation may lead to lack of access to effective medical interventions, worsen health disparities, and cost hundreds of billions of dollars.
A new paradigm for research is needed to ensure meaningful public engagement and rebuild trust. Co-production —in which researchers, patients, and practitioners work together as collaborators — offers a framework for embedding collaboration and trust into the biomedical enterprise.
The National Institutes of Health should form an Office of Co-Production in the Office of the Director, Division of Program Coordination, Planning, and Strategic Initiatives.
Details
In accordance with Executive Order 13985 and ongoing public access initiatives, science funding and R&D agencies have been seeking ways to embed equity, accessibility, and public participation into their processes. The NIH has been increasingly working to advance publicly engaged and led research, illustrated by trainings and workshops around patient-engaged research, funding resources for community partnerships like RADx Underserved Populations, community-led research programs like Community Partnerships to Advance Science for Society (ComPASS), and support from the new NIH director.
To ensure that public engagement efforts are sustainable, it is critical to invest in lasting infrastructure capable of building and maintaining these ties. Indeed, in their Recommendation on Open Science, the United Nations Educational, Scientific, and Cultural Organization outlined infrastructure that must be built for scientific funding to include those beyond STEMM practitioners in research decision-making. One key approach involves explicitly supporting the co-production of research, a process by which “researchers, practitioners and the public work together, sharing power and responsibility from the start to the end of the project, including the generation of knowledge.”
Co-production provides a framework with which the NIH can advance patient involvement in research, health equity, uptake and promotion of new technologies, diverse participation in clinical trials, scientific literacy, and public health. Doing so effectively would require new models for including and empowering patient voices in the agency’s work.
Recommendations
The NIH should create an Office of Co-Production within the Office of the Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI). The Center for Co-Production would institutionalize best practices for co-producing research, train NIH and NIH-funded researchers in co-production principles, build patient-engaged research infrastructure, and fund pilot projects to build the research field.
The NIH Office of Co-Production, co-led by patient advocates (PA) and NIH personnel, should be established with the following key programs:
- A Resources and Training Program that trains patient advocates and researchers, both separately and together, so they can understand and work together as collaborators. This work would include helping researchers develop understanding about the communities affected by diseases they are investigating, relationship-building strategies, and ways to address power differentials, and helping patient advocates gain understanding about research processes, including understanding disease pathogenesis, different mechanisms of action and targets for research, and clinical research processes including regulatory requirements and ethical considerations. PAs could also be trained to qualify to serve on Data and Safety Monitoring Boards (DSMB).
- A Patient Advocate Advisors Management Program that would manage the placement of PAs into community advisory bodies, into advisory roles to NIH institutes’ major initiatives, onto ethical advisory bodies, onto DSMBs, onto peer review committees and study sections, and onto key long-range planning bodies, including those determining research prioritization.
- A Co-Production Principles and Practice Program led by a senior team of PAs and advisors that coordinates, organizes, and facilitates cross-disease understanding and solidarity and establishes basic principles for patient advocate engagement, grant requirements, and ongoing assessment of the quality of co-production and relational infrastructure. This program will focus on key principles such as:
- Sharing of power – the research is jointly owned and people work together to achieve a joint understanding
- Including all perspectives and skills – make sure the research team includes all those who can make a contribution
- Respecting and valuing the knowledge of all those working together on the research – everyone is of equal importance
- Reciprocity – everybody benefits from working together
- Building and maintaining relationships – an emphasis on relationships is key to sharing power. There needs to be joint understanding and consensus and clarity over roles and responsibilities. It is also important to value people and unlock their potential.
- A Communications, Planning, and Policy Program that works with the NIH director and institute directors to advocate for mutual goals to advance the public engagement mission of the NIH and its institutes.
- A Grantmaking Program that can pilot the expansion and scaling of NIH-sponsored Co-Production Cores and support the involvement of patient advocates in NIH-funded research across the country through equitable participation and standard compensation policies.
Creating an Office of Co-Production would achieve the following goals:
- It would address the growing gulf between the public, who ultimately fund biomedical research with their tax dollars, and researchers by directly and meaningfully engaging patient advocates in biomedical and clinical science. Co-production builds relationships and trust as it requires that relationships are valued and nurtured and that efforts are made to redress power differentials.
- By working early and often with patient populations around treatments, co-production helps medical scientists better anticipate and address risk early in the research process.
- It would institutionalize a known model for collaborative research that efficiently uses research dollars. During the HIV/AIDS crisis, rapid advances in biomedical and clinical research were made possible by patient advocate involvement in trial design, recruitment, and analysis.
- The NIH Center would create a replicable model of institutional support for co-production that can be scaled across the federal R&D agencies. The NIH should regularly report on the progress made by the Center for Co-Production to encourage replication in other agencies that can benefit from increased public participation.
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