In a rapidly evolving landscape of biomedical and behavioral research, the National Institutes of Health (NIH) is inviting public input on the utilization of Real-World Data (RWD), including Electronic Health Records (EHR), to enhance research methodologies and improve patient outcomes. As the NIH explores the potential of RWD, it is keenly aware of the need to balance scientific advancement with ethical considerations and participant privacy.
The Rise of Real-World Data
Traditionally, research studies have relied on controlled environments. However, the paradigm is shifting, with researchers increasingly integrating real-world data into their studies. Real-world data, as defined by the U.S. Food and Drug Administration, encompasses a broad spectrum of information related to patient health and healthcare delivery, ranging from electronic health records to data from disease registries and digital health technologies. While RWD holds immense promise for advancing biomedical and behavioral research, it comes with its own set of challenges. NIH acknowledges the diversity of sources and mechanisms through which RWD is collected, posing both opportunities and obstacles for researchers. One of the critical aspects the NIH aims to address is the privacy and autonomy of participants, ensuring that as research evolves, ethical considerations remain at the forefront. Respondents can address listed topics and other relevant subjects for NIH’s consideration.
Scientific Value and Quality Considerations
The NIH is seeking comprehensive input on the scientific value and quality considerations surrounding the collection, use, and sharing of RWD in biomedical and behavioral research. Stakeholders are encouraged to provide insights into biomedical and behavioral research questions that could be explored using RWD, shedding light on novel and unexpected findings. Additionally, barriers such as bias, underrepresentation, and technical issues in data harmonization are open for discussion.
RWD in the Scientific Paradigm
The RFI emphasizes the role of RWD in shaping the scientific paradigm. Input is sought on collaborative approaches, ensuring reproducibility, and validating RWD data used in research. The NIH is particularly interested in understanding how researchers assess the validation and verification of RWD and how open science practices, aligned with FAIR principles, can be maximized.
Administrative and Logistical Considerations
The logistical aspects of acquiring, using, and sharing RWD for biomedical research are crucial focal points. The RFI solicits opinions on various approaches to obtaining RWD, such as algorithms or secure enclaves, and explores considerations related to licensing, costs, and third-party involvement. The role of emerging deidentification technologies and data storage/sharing considerations is also open for discussion.
Recognizing the ethical implications of RWD usage, the NIH is eager to receive input on strategies for protecting participant privacy and autonomy. Stakeholders are encouraged to share their perspectives on potential reidentification risks, the technical feasibility of reidentifying linked data, and the ethical dimensions of treating data as a “commodity” in the context of buying and selling personal health data.
How to Contribute
This unique opportunity for public input is open through December 14, 2023. Responses can be submitted electronically, and anonymity is preserved for those who choose to contribute without revealing their identity. The NIH emphasizes that this RFI is for informational and planning purposes, not a solicitation for applications, ensuring that the insights gathered will inform the NIH’s approach to RWD responsibly. Visit the official NIH notice for the complete RFI and comment submission form.