Calls for open science have increased in the past decades, with open access publishing becoming more popular, public repositories for code, data, protocols, and software growing rapidly, and the introduction of novel practices such as open peer review and large-scale open-source online education. These calls have been fueled, in part, by increasing concern over what is deemed the reproducibility crisis, where more than 70% of investigators are unable to reproduce previously published findings. Other motivations include increased transparency to eliminate fraud and maximizing research dollars by providing broad access to critical datasets. Additionally, data management requirements have increased at institutions and funding agencies. Poor data management can increase errors, demand unnecessary time to locate, and can be costly to individual investigators as well as their institutions and the funding agencies that fund their work.
The new National Institutes of Health (NIH) Data Management and Sharing policy will go into effect on January 25, 2023. For all grant submissions after January 25th, 2023, investigators will have to submit a Data Management and Sharing plan that outlines how data, and accompanying metadata, generated as part of the proposal will be shared and managed. Investigators who are awarded funding will be expected to comply with the approved Data Management and Sharing (DMS) plan. Previously DMS plans were only required for large grants receiving over $500,000 in direct costs or that generated large-scale genomic data, and these tended to be no more than a paragraph in length. The new format will require far more information, including the following five categories:
- Data Type-Investigators will need to describe the type and the estimated amount of data that will be shared as well as the manner in which it was collected, aggregated, and processed. This will also include which data will be shared and which will not be. Per the NIH guidelines, they do not expect that all data generated during the course of the project are shared, whether due to legal, ethical, technical, or other sufficient reasons. The plan must include a list of metadata and documentation (e.g.,protocols, instrumentation information) that will accompany shared data.
- Related Tools, Software and/or Code- The plan must describe any specialized tools (e.g.,instrumentation, software, code) that are necessary to access or analyze the shared data and where those tools can be acquired, if applicable.
- Standards-The plan should describe the standards used for both data and metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
- Data Preservation, Access, and Associated Timelines-The DMS must include a timeline for data preservation and access as well as where those data will be made available (i.e., the name of the repository(ies) where scientific data and metadata will be archived). The plan should also include any identifiers or other indexing tools utilized to make the scientific data findable.
- Access, Distribution, or Reuse Considerations- If there are considerations about access or reuse of the data that other investigators would need to be aware of, such as informed consent and any limits on human data access, privacy and confidentiality protections or other restrictions (e.g., federal, state, tribal, or local laws or policies), or any considerations that limit access in some way.
For many research groups, this may be a big adjustment and seem overwhelming. LabArchives can help you meet the NIH data management needs and help you make this transition as seamless as possible.
LabArchives Electronic Lab Notebook (ELN) is already designed to maintain data security and provide secure data sharing options that can meet institution and funder requirements. For instance, LabArchives ELN for research is compliant with 21 CFR part 11, HIPAA, NIST 800-171 requirements. LabArchives ELN provides all the electronic witnessing and signature functions necessary for many regulatory agencies. Once signed – whether single or dual signatures – a notebook page is permanently frozen. Only the ELN owner can permanently delete content. Here are a few of the specific ways LabArchives ELN can meet the new NIH requirements:
Data Management Plan
- Create and store a DMP securely in the notebook
- Upload external files with links
Persistent Digital Identifiers
- Generate a DOI for shared data
- Utilize ORCID ID for researchers
- Add DMP IDs to notebooks via our API
Data Sharing Options
- Share directly from LabArchives
- Approve public shares to control IP
- Create DOIs in the sharing process
- Integration with FigShare and other data repositories
Molly Cooper is LabArchives Business Information Security Officer. Molly’s professional experience includes leading governance, risk, and compliance teams, and implementing information security compliance programs such as PCI-DSS, HIPAA, NIST CSF, and NERC-CIP. Also serving as an associate professor of information security and intelligence, her areas of research include phishing, social engineering prevention, security controls, gamification of cybersecurity concepts, space cybersecurity, and artificial intelligence. As a researcher, Molly has led or assisted with many published works including grants funded by the National Science Foundation.
Molly’s certifications include Certified Information Systems Auditor (CISA) and Payment Card Industry Professional (PCIP). She holds a Ph.D. in information assurance, as well as undergraduate and graduate degrees in information security and intelligence. Molly’s background also includes a significant amount of experience in the performing arts, music production, voice-over, and media production. She has placed music in over 200 movies and television shows. She has also formed several culture-building committees and initiatives focusing on women and underrepresented groups in IT.