Key Dates

Related Announcements

NOT-OD-24-063 - Request for Information (RFI): Proposed Use of Common Data Elements (CDEs) for NIH-Funded Clinical Research and Trials.

NOT-LM-21-008 - Notice to Extend the Response Date for NOT-LM-21-005

Issued by

National Library of Medicine (NLM)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Request for Information (RFI) is to solicit public comment on the use of Common Data Elements (CDEs) in NIH-funded research, particularly in the context of research on COVID-19.

Background:

Common Data Elements (CDEs) are standardized, precisely defined questions paired with a set of specific allowable responses, used systematically across different sites, studies, or clinical trials to ensure consistent data collection. CDEs may consist of a single data element, such as height, gender, or date of birth, or a collection of connected questions, such as a survey instrument used as a depression index or a quality of life scale. For over a decade the National Institutes of Health (NIH) has encouraged the use and development of CDEs in patient registries, clinical studies, and other human subjects research. Use of common data elements fosters rigor and responsibility in research, and re-use of properly consented data for future research projects. Resources like the NIH CDE Repository (hosted by the National Library of Medicine, NLM), PhenX, and the NIH Disaster Research Response (DR2) resource help promote awareness and facilitate use of CDEs.

Collecting data with CDEs facilitates data sharing and interoperability, enabling integration and meta-analysis of data across multiple studies. CDEs can also help improve data quality and enhance research reproducibility, enable data harmonization across studies, and increase the fairness of data the extent to which they are findable, accessible, interoperable, and reusable. CDEs can facilitate the reuse of common variables and measures to provide consistency across multiple data sets and encourage the connections between research and clinical encounters. CDEs can make the data meaningful by structuring and defining commonly used, community shaped, recommended measures and assessment instruments. NIH currently requires four CDEs to standardize collection of participant demographics. These include: 1) sex/gender (male, female, and unknown or not reported); 2) race and ethnicity using a standard specified by the US Office of Management and Budget; and 3) age at enrollment.

In the context of COVID-19 research, use of CDEs to describe study participants can help ensure that data are collected consistently across multiple sites and studies. Selecting and carefully defining a set of CDEs for key COVID-19 research projects will increase data quality and enable researchers to pool data collected from different studies, providing more observations and therefore greater statistical power in the context of studies that require a large participant pool. In addition, judicious use of CDEs will foster comprehensive and concise description of participants involved in COVID-19 research projects and support public accountability. Given the urgent need to develop new vaccines and therapeutics, design tools for rapid diagnosis, and understand the health impacts of COVID-19, CDEs are an important tool for collecting data in systematic and consistent ways to facilitate their use and reuse. By defining shared language and variables, CDEs help enhance communication and promote the exchange of knowledge.

Information Requested

NIH is requesting public comment on the use of CDEs, particularly in the context of COVID-19 research, including opportunities for advancing research with CDEs, challenges to adopting CDEs, and guidance or tools that could facilitate use of CDEs. These comments will be used to inform NIH’s continuing development of guidance of CDE use for COVID-related research and assist in the planning for adequate funding of CDE efforts through research awards and contracts.

Response to this RFI is voluntary. Respondents are free to address any or all topics listed below, as well as other relevant topics, for NIH’s consideration.

1. Current use of Common Data Elements in research projects. NIH seeks broad input on how researchers are currently using CDEs, regardless of whether research is related to COVID-19.
   1. Explain how you identify, select, deploy, and encourage use of CDEs in your research
   2. Describe the benefits to you of using CDEs in your research.
   3. Identify existing incentives or resources that have facilitated your use of CDEs.
   4. Describe COVID-19 research activities you have engaged in and how you have used CDEs to collect data.
2. Challenges to adopting CDEs. NIH seeks broad input on barriers to adopting CDEs in the context of both research activities generally and COVID-19 research specifically.
   1. Describe the major barriers you have encountered in using CDEs.
   2. Provide specific examples of challenges you have encountered in identifying and/or using CDEs in your research.
   3. Describe why you have or have not chosen to use CDEs in your research.
3. CDE guidance, tools, infrastructure, and incentives. NIH seeks broad input on what guidance, tools, and incentives would facilitate wider uptake of CDEs.
   1. Suggest specific guidance or information that would enhance your understanding and use of CDEs.
   2. Describe how the NIH CDE Repository could be enhanced to facilitate discovery and use of relevant CDEs.
   3. Describe resources that would enable use of CDEs, such toolkits for including CDEs in studies or tools that support researchers mapping existing data to CDEs.
   4. Describe incentives that would encourage and increase use of CDEs.
   5. Provide specific examples of questions you have about how to identify, select, deploy and use CDEs.

How to Submit a Response

To respond to this RFI, please submit your response via this webform. To ensure consideration, responses must be submitted by May 28, 2021. Names need not be associated with responses; responses are voluntary and may be submitted anonymously.

This RFI is for planning purposes only and should not be construed as a solicitation or an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The NIH does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the Government’s use of such information.

NLM will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be shared publicly or appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Office of Strategic Initiatives
National Library of Medicine
Email: NLMStrategicPlanning@nih.gov

M. Carolina Mendoza-Puccini, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: (301) 827-4007
E-mail: carolina.mendoza-puccini@nih.gov