Intramural Electronic Lab Notebook Policy

As of June 30, 2024, NIH IRP Investigators are required to use only electronic resources to document new and ongoing research, consistent with the NARA/OMB Federal wide Transition to Electronic Records mandate. To facilitate the transition, NIH has developed the information presented here, which taken together comprises the NIH IRP Electronic Lab Notebook (ELN) Policy. Additionally, NIH is providing centrally supported commercial electronic laboratory notebooks for use NIH wide. Use of NIH-provided ELNs offers numerous benefits to the researcher such as in-platform collaboration, accelerated data sharing, and extensive capabilities for assuring data integrity. Further, use of centrally supported ELNs reduces operating costs and simplifies compliance with applicable regulations and Investigator responsibilities. For these reasons, selection of ELN resources pre-approved by NIH is encouraged whenever possible. 

1. Implementation of the NARA/OMB Federal-Wide Transition to Electronic Records
2. Definitions
3. Applicability
4. Investigator Responsibilities for ELN Management
5. Platforms Currently Available for Use NIH-Wide
6. NIH IT System Requirements for ELNs

• Additional Resources
• Relevant Policies and Determinations

I. Implementation of the NARA/OMB Federal-Wide Transition to Electronic Records Mandate

NARA/OMB M-19-21 / M-23-07 mandates that all Federal Records must be transitioned to electronic format by June 30, 2024. Because they are Federal records owned by the NIH, the mandate applies to lab notebooks, and includes all phases of the document lifecycle. No requests for extensions or exceptions are under consideration. In practice, this means that no new paper laboratory notebooks will be created after June 30, 2024. Specifically:

• New research initiated after June 30, 2024 must be documented using approved electronic lab notebooks (ELNs).
• Ongoing research must be transitioned to approved ELNs by June 30, 2024.
• Final documentation of research expected to conclude shortly after June 30, 2024 but no later than December 31, 2024 may be completed using lab notebooks already in use, as long as no new paper notebooks are created.
• Legacy paper notebooks needed for scientific reference should continue to be managed in accordance with applicable records management requirements but do not need to be digitized.
• Digital images of paper-only data sources such temporary paper notes and printouts from benchtop instruments needed for documentation must be captured and added to the ELN using compliant approaches. See Investigator Responsibilities, Section A.

II. Definitions

At NIH, an electronic laboratory notebook (ELN) is a system used to create, store, retrieve and share electronic research records in a manner that replaces all the functions of a paper notebook and complies with NIH records management and security requirements.

As with paper lab notebooks, ELNs serve as the complete research record, documenting why specific experiments were initiated, how they were performed, what data and observations were produced, where the data are stored, and how the data were analyzed and interpreted, in sufficient detail so the research can be reproduced by others. This means that a scientifically literate person with no prior knowledge of the project should be able to use the documentation provided in the ELN to navigate the rationale, methods, experimental samples, results, analysis, and basis for the major conclusions entirely from the ELN. Use of a specialized digital systems other than ELN software approved for NIH-wide use can serve in this role if used in a manner that meets the reproducibility standard for documenting the complete research record and is deemed to meet NIH IT System Requirements for ELNs by the IC or NIH CIO.

III. Applicability

A. Lab Notebook Owners

All data generated from IRP-funded research is owned by the NIH. The responsibility to manage and safeguard the data produced from NIH-funded research is delegated to IRP Scientists who manage independent or targeted research budgets or who have been assigned data management responsibilities by their ICs; these individuals serve as "Lab Notebook Owners" and are bound by the draft guidance contained in this document. They include:

• NIH Principal Investigators (PIs) who receive resources to conduct independent research. This includes these DDIR/OIR-approved Intramural Professional Designations: Senior Investigator, Investigator, Senior Clinician, Senior Scientist, Assistant Clinical Investigator, and Independent Research Scholar.
• Non-PI IRP Lead Investigators who file annual reports and receive or manage funding targeted to the operation and management of technology-based research facilities and/or research support teams.
• Other group leads who have been assigned data management responsibilities by the IC SD and who are formally responsible for the conduct of the research activity but are not formally responsible for managing the associated budget.

B. Lab Notebook Users

All trainees and scientific staff regardless of employment mechanism who work as part of a research team led by an NIH PI, non-PI Lead Investigator, or other group lead designated by the IC serve as "Lab Notebook Users" and are bound by the draft guidance contained in this document.

IV. Investigator Responsibilities for ELN Management

1. Addition of Paper-Only Records to an ELN
2. Index Record
3. Access Control
4. Records Retention

A. Addition of Paper-Only Records to an ELN

Investigators must use compliant approaches to capture and add images of data sources that are available only as a paper documents. Examples include temporary paper notes generated while working without internet connectivity and printouts from benchtop instruments that do not produce digital files.

Requirements

• Paper records which cannot be produced as digital files must be captured in acceptable electronic file formats with specific metadata no later than 72 hours after production using GFE or compliant applications running on personally owned equipment (POE) to an NIH-approved ELN platform.
• The electronic copy must be a true and accurate representation of the paper original, with sufficient resolution and contrast to be human readable.
• Acceptable formats include Tagged Image File Format (TIFF) v. 4,5&6, Jpeg 2000 (Jpeg2), Portable Network Graphics 1.2 (PNG), Portable Document Format/Archival (PDF/A) PDF/A-1.
• Specific metadata as mandated in NARA Bulletin 2015-04 (filename, title, description, creator, creation date) must accompany the uploaded file.

Examples of Compliant Approaches

• Scanning paper documents on GFE document scanners to produce pdf files and posting them to an approved ELN as an attachment. This is ideal if the data consist of multiple pages.
• Sending photos from POE or GFE cell phones directly to an ELN by accessing the ELN's camera app or approved 3^rd party camera app via the phone's browser. Images must be stored in a compliant JPEG format and not retained on the device. This capability is currently available in LabArchives for both Apple and Android operating systems and works well for single pages of temporary notes and printouts from benchtop instruments.

B. Index Record

As with paper lab notebooks, each Investigator is required to maintain a complete list of the ELNs used to document the research for which they are responsible, as part of their overall index record of retrievable data sources. For ELNs, the index record requirement is met by assuring that the ELN system in use by the Investigator, based on OIR’s 2024 Investigator ELN Planning Survey, is properly recorded in the ELN Management Dashboard (EMD).

C. Access Control

• ELN content must always be under the control of and available to the responsible Investigator per the Conduct of Research in the Intramural Program at NIH.
• For commercial ELN software, this means that the Investigator should be designated within the electronic system as the ELN "Owner."
• For document based ELNs, this means the ELN should be stored in a location such as a SharePoint or Teams site for which the Investigator is the designated "Owner."
• ELNs should never be stored on a team member's OneDrive and should only be stored on the Investigator's OneDrive in cases when the Investigator is the sole user of the ELN.
• ELN content must be made available to IC leadership upon request. Note that in some cases, such as allegations of research misconduct, IC leadership may choose to obtain access to the ELN directly, without notice to the Investigator, in accordance with NIH's enterprise licensing agreements. It is anticipated that such cases will be exceedingly rare.
• ELN content can be made available to departing staff at the discretion of IC scientific leadership in consultation with the Investigator. Departing staff must comply with Manual Chapter 1743 - Managing Federal Records, complete NIH-Form 3000, and obtain approval prior to taking a copy of ELN content.

D. Records Retention

The same records retention considerations apply to ELNs as to paper lab notebooks. Briefly:

• ELNs documenting projects deemed to be of historical significance should be transferred to the National Archives for permanent retention after conclusion of the research.
• ELNs supporting patents must be retained for 30 years after the patent is filed.
• ELNs documenting all other intramural research must be retained for 7 years after completion of the project and until no longer needed for scientific reference.
• ELNs documenting intramural research that is regulated by the FDA or IRB are subject to additional retention requirements.

V. Platforms Currently Available for Use NIH-Wide

The purpose of this section is to compare key user-facing features, security controls, and records management capabilities for the current set of commercial platforms available for ELN use NIH-wide. The platforms listed below have been procured by NIH and meet IT System Requirements for ELNs when used as recommended. The platforms offer different combinations of user-facing features and specialized records management capabilities aimed at supporting the wide range of needs across NIH. Users with highly specialized needs are advised to check with their IC leadership about IC Provided Resources that may be available for use within their ICs..

1. LabArchives
2. Signals
3. Management of MS Documents for General Purpose ELNs
4. Determination on the Use of OneNote and MS Document ELNs
5. IC-Provided Resources

Platforms Comparison Chart

Table 1: Comparison of Platform Features for NIH-wide ELN Use

A. LabArchives

• Discipline-agnostic ELN appropriate for documenting research across multiple domains.
• All NIH Investigators or their designees can directly request LabArchives accounts for their group members starting in January 2024 by using this link: ELN Support and Onboarding [NIH Only].
• LabArchives is on track to achieve FedRAMP certification with NCI sponsorship by the end of FY24. LabArchives will operate under an NCI provisional ATO until FedRAMP certification is completed.
• All Lab Archives ELNs are stored in the LabArchives cloud because it is provided to NIH as "Software as a Service (SaaS)".
• Provides CFR Part 11 compliant electronic signatures, audit trails, time stamps, page locking, and other features needed to support research expected to generate intellectual property (IP).
• Molecular biology capabilities are provided by an integration with SnapGene.
• Statistical analysis capabilities are provided by an integration with GraphPad Prism.
• Compatibility with Microsoft (MS) documents is provided by the MS Office 365 (O365) plug-in.
• Enhanced chemistry capabilities are available to NIH users via Revvity ChemDraw.
• Additional major strengths include a composite dashboard view, activity feed, and advanced search capabilities across all ELNs for which a user is authorized; in-platform collaboration with authorized internal and external users; external data sharing capabilities via persistent Digital Object Identifiers (DOIs); in-platform widget-based creation of databases (Fall 2024); in-platform access to PubMed and full journal articles covered by NIH licenses; outstanding documentation, user training, and support.

B. Signals

• Chemistry-specific ELN with extensive support for molecular biology.
• NIH Investigators initially requested Signals accounts for their group members by responding to the Investigator ELN planning survey in February 2024. New groups can be added by contacting their IC ELN coordinator [NIH Only] or by submitting an ELN Support and Onboarding request [NIH Only].
• Signals is on track to achieve FedRAMP certification with NCATS sponsorship in 2025. Signals will operate under an NCATS provisional ATO until FedRAMP certification is completed.
• All Signals ELNs are stored in the Revvity cloud because Signals is provided to NIH as SaaS.
• Provides CFR Part 11 compliant electronic signatures, audit trails, time stamps, page locking, and other features needed to support research expected to generate intellectual property (IP).
• GxP compliant-ready; suitable for use in user-validated GLP and GMP environments.
• Native in-platform molecular biology capabilities are augmented by an integration with SnapGene.
• Statistical analysis capabilities are provided by an integration with Spotfire.
• Compatibility with MS documents is provided by the MS O365 plug-in.
• Major strengths and other considerations: Signals accounts include full in-platform chemistry intelligence and customized group-specific set-up and onboarding tailored to the group's workflows. However, the set-up and training process is considerably more extensive than for LabArchives and is most appropriate for groups requiring in-platform chemistry intelligence.

C. Management of MS Documents for General Purpose ELNs

Based on the NIH Determination on the Use of OneNote and MS Document ELNs MS documents, but NOT OneNote, are approved for limited use as general purpose ELNs in cases where no intellectual property is expected to be produced if the ELN is managed as described in Section II and if the IC has accepted the inherent risks and IC-level oversight responsibilities discussed in Section I.

1. IC-Level Risks and Responsibilities Associated With Use of MS Documents as ELNs
   1. Risks
   2. IC-Level Responsibilities for Oversight of MS Document ELNs
2. Investigator-Level Responsibilities Associated With Use of MS Documents as ELNs
   1. Investigator ELN Index Record
   2. Documentation of Research Anticipated to Produce Intellectual Property
   3. Use of Approved MS Document Types for General Purpose ELNs
   4. Proper Storage of MS Document ELNs
   5. Use of the ELN-Specific Records Retention Labels (RRLs): Active and Inactive
   6. User Guide: MS Documents ELNs

1. IC-Level Risks and Responsibilities Associated With Use of MS Documents as ELNs

a. Risks

Immutable versioning and controls to prevent accidental deletion are core NIH records management requirements for ELNs and are standard capabilities provided by NIH’s enterprise wide ELNs. Because MS documents are not designed to function as true ELNs, it is not possible to completely eliminate the risk of accidental deletion of an MS document ELN or to ensure that immutable versioning occurs automatically as the platform is currently configured. Therefore, ICs wishing to approve the use of MS documents for ELNs must understand and accept the following risks and take responsibility for managing them.

1. Use of the Active ELN record retention label (RRL) prevents accidental deletion, but the Owner of the SharePoint site housing the document (i.e. the PI or non-PI group lead) has the ability to turn the RRL off. While the RRL is off, the ELN and any standard versions generated between immutable versions can be deleted by users, although any immutable versions previously generated will remain. For this reason, ICs electing to allow the use of MS document ELNs must accept responsibility for monitoring the RRL status of the IC’s MS document ELNs and accept the risk of potential data loss should the Active ELN RRL be turned off.
2. Immutable versions of MS documents in the NIH MS environment are generated only for documents tagged with a properly configured RRL and only when the document is locked. However, ELNs that are in active use for data collection are typically left in the unlocked state creating the risk that immutable versions will not be generated. Currently, the only approach available for generating immutable versions is for ELN users to manually toggle between the locked and unlocked states. For this reason, ICs electing to allow the use of MS document ELNs must accept responsibility for monitoring that immutable versions are being generated once per week for the IC’s ELNs in active use for data collection and accept the risk of potential data loss should the immutable versions not be generated.

b. IC-Level Responsibilities for Oversight of MS Document ELNs

NIH will provide an ELN Management Dashboard (EMD) [NIH Only] for use by IC leadership and designated IC staff to support IC ELN management. The EMD will provide two resources: the complete listing of each IC’s Investigator ELN Declarations and monthly reports on the status each IC’s MS document ELNs. IC staff responsible for oversight of MS document ELNs will use the EMD to:

1. Review the monthly report and take action as needed to assure that:
   • All Investigators who have declared that they will use MS document ELNs have ELNs appearing in the monthly report.
   • Immutable versions are being generated weekly for each of the IC’s MS doc ELNs.
   • No ELNs drop off of the report due to the Active ELN RRL being switched off.
   • The Active ELN RRL has not been applied to OneNote notebooks.
   • Any MS document ELNs in use for projects that develop the potential to generate IP are converted to PDF, permanently locked, signed, and, since the ELNs will be needed for reference, marked with the Active ELN RRL.
   • The RRL for MS document ELNs that are no longer needed for active data collection or scientific reference are switched from the Active ELN RRL to the Inactive ELN RRL.
   • Report and document any loss of data to the appropriate IC and NIH officials.
2. Enter and sign off on a summary of all issues identified, corrective or other actions taken, and the status any outstanding issues.

2. Investigator-Level Responsibilities Associated With Use of MS Documents as ELNs

a. Investigator ELN Index Record

As with paper lab notebooks, each Investigator is required to maintain a complete list of the ELNs used to document the research for which they are responsible, as part of their overall index record of retrievable data sources. For Investigators using commercial ELNs provided by NIH or MS document ELNs maintained in NIH’s Microsoft environment the index record requirement is met by assuring that the ELN system in use by the Investigator is properly recorded in the ELN Management Dashboard [NIH Only]. The EMD will be populated with the Investigator ELN declarations from OIR’s 2024 Investigator ELN Planning Survey.

b. Documentation of Research Anticipated to Produce Intellectual Property

MS document ELNs should not be used to document research that requires validated signatures or other capabilities commonly required to safeguard Intellectual Property (IP). In the event that a project being documented with a general-purpose MS document ELN develops the potential to produce IP:

1. The MS document ELN should be converted to pdf and digitally signed.
2. Assuming the ELN will be needed for ongoing scientific reference, the PDF version should be stored on the Investigator’s SharePoint site and marked with the Active ELN RRL.
3. A request to have the Inactive ELN RRL applied to the original MS document ELN with an indefinite retention period should be entered by submitting a MS Document ELN Service Request [NIH Only].
4. Ongoing documentation of the project should be transferred to an ELN with data management capabilities appropriate to the specific use case. (Note that convenience copies of the prior ELN pdf can be made available and fully searchable within NIH’s commercial ELNs.)

c. Use of Approved MS Document Types for General Purpose ELNs

1. MS Word, Excel, and PowerPoint are the most common MS document types used for ELNs.
2. PDFs are generally not used for ELNs needed for active data collection.
3. OneNote is NOT approved for use for any type of ELN. This is because OneNote notebooks are not a single type of MS document, but rather a collection of multiple document types; this design precludes enabling immutable versioning for the OneNote notebook and component documents.

d. Proper Storage of MS Document ELNs

1. MS document ELNs should be stored within NIH’s MS environment on a SharePoint site that is owned by the Investigator. This is required to assure that access to the ELN always remains under control of the Investigator, allows the ELN to be designated and managed as a federal record, enables immutable versions to be created, and assures that the security parameters enabled by the MS FedRAMP compliant ATO apply to the ELN.
2. Storage platforms that do not clearly designate the Investigator as the Owner of the stored documents or are outside of the NIH MS environment are not acceptable for storing ELNs. Examples of how MS document ELNs should NOT be stored:
   • ELNs should not be stored in shared drives, BOX, or other file storage platforms outside of the NIH Microsoft environment because those platforms do not support the use of RRLs and therefore cannot meet federal records management requirements
   • ELNs should not be stored on OneDrive sites assigned to individual team members other than the PI because the PI does not control access to other team members’ OneDrive sites, and could lose access to the ELN, e.g. upon the team member's departure.

e. Use of the ELN-Specific Records Retention Labels: Active and Inactive

NIH’s MS environment is configured with a records management (RM) module that allows Principal Investigators (PIs) and selected non-PI group leads to designate MS documents as both an ELN and federal record by applying either the Active ELN or Inactive ELN Records Retention Label (RRL). The RRLs are preconfigured with the appropriate settings to assure that records are retained for the correct period of time (indefinitely for active ELNs), are not accidentally deleted, and produce immutable versions when the documents are locked. Because these safeguards can be abrogated simply by turning off the ELN RRL, care must be taken by users to assure that the ELN RRL remains continuously engaged for ELNs in active use for data collection or needed for scientific reference.

NIH’s MS environment is configured with two ELN RRLs:

1. The Active ELN RRL is used to designate ELNs in two phases of the ELN lifecycle: those which are in use for active data collection, and those which are needed for scientific reference after the period of active data collection has concluded.
   1. Investigators who are approved by their IC to document their research using MS document ELNs must register their SharePoint URL where the ELNs will be stored by submitting a MS Document ELN Service Request [NIH Only] or responding to an NEIT planning survey. The Active ELN RRL can only be applied to documents stored on registered SharePoint sites.
   2. Once enabled, Investigators may designate a document as an “Active ELN” by selecting it from the RRL menu at any point, but ideally this step will be done when a new ELN is initiated. Investigators should use the Active ELN RRL sparingly:
      • Because use of this RRL enables deletion prevention and immutable versioning and marks the document as a federal record, great care should be taken by the Investigator to ensure the RRL is not applied to non-ELN documents and is not disabled once it has been applied appropriately.
      • As with paper lab notebooks and commercial ELNs, MS document ELNs should be a cohesive record covering either an entire project or a defined time period. Regardless of approach, it is anticipated that a typical trainee’s research while at NIH will be covered by a small number of MS document ELNs.
   3. Active ELNs that are in use for data collection should be toggled between the locked and unlocked state weekly to trigger the generation of immutable versions. This action can be taken by any authorized ELN user.
   4. Active ELNs that are needed only for scientific reference should be permanently locked by the Investigator when the period of active data collection concludes but continue to be designated with the Active ELN RRL.
   5. The retention period for records marked with the Active ELN RRL is set to indefinite by default. Only when the Investigator no longer has a need for the ELN for any purpose including scientific reference should a retention period “clock” be activated; this is done by changing the ELN RRL from Active to Inactive and can only be done by an NIH MS Administrator (see below).
   6. Investigators are required to review the status of all ELNs at least annually. As part of the review, the status of any Active ELNs that are no longer used for data collection AND no longer needed for scientific reference should be changed to “Inactive” by submitting a MS Document ELN Service Request [NIH Only].
2. The Inactive ELN RRL is used to designate ELNs which are no longer in use for either data collection or scientific reference. Because Inactive ELNs cannot be accessed by users, the Inactive ELN RRL should only be applied when the Owner and other stakeholders no longer need the ELN for any purpose. ELNs needed for scientific reference should NOT be designated as Inactive. The “Inactive ELN” RRL can only be set by an Administrator in response to a MS Document ELN Service Request [NIH Only] submitted by the SharePoint owner.
   1. Inactive ELNs are retained in a permanently locked state in an archival cloud repository and are not accessible to the Investigator. Inactive ELNs can be recovered only if requested by the IC, but this is expected to be a rare occurrence.
   2. Inactive ELNs are retained for the appropriate retention period based on the IRP Records Retention Schedule; most ELNs will fall under the "other intramural research projects” designation and be retained for 7 years once the Inactive RRL has been applied. Briefly:
      • ELNs supporting patents must be retained for 30 years after the patent is filed.
      • ELNs documenting preclinical studies, INDs or other processes governed by FDA follow FDA retention requirements, typically 3 years.
      • ELNs documenting IRB regulated research are subject to IRB retention requirements, typically 3 years following conclusion of the clinical trial.
      • ELNs documenting other kinds of IP should be retained for the specific period appropriate to the use case.
      • ELNs documenting projects of historical significance are the only type of ELN regarded as a permanent record. Such ELNs are retained for 5 years following conclusion of the project and then transferred to NARA.
      • ELNs supporting all other intramural research projects are retained for 7 years.
   3. After the retention period, the ELN is reviewed for disposition with the Federal Records official at the originating IC and in most cases will then be deleted.

f. User Guide: MS Documents ELNs

MS Documents ELNs User Guide [NIH Only]: Best practices emerging from the user community for the use of MS document-based ELNS.

D. Determination on the Use of OneNote and MS Document ELNs

Given the significant interest in using OneNote notebooks and MS Office documents for electronic laboratory notebooks (ELNs), CIT has performed a feasibility assessment and advised the following:

• OneNote notebooks are not suitable for general purpose ELNs or for documenting research expected to produce IP. This is because OneNote lacks immutable versioning, which is a core requirement for general ELN use, and signature validation, which are commonly required for documenting intellectual property (IP). Microsoft has advised that they do not have plans to include either capability in the future. Development of an automated workflow in which OneNote ELNs would have immutable versioning, either with or without validated signatures, would require significant time and cost, and require provision of ELN management services on an ongoing basis. CIT does not regard this as a feasible approach for providing ELNs.
• Microsoft Office documents that are properly stored on NIH SharePoint or Teams sites and marked with the Active ELN Record Retention Label have immutable versioning but lack the capability for validated signatures and therefore should only be considered for general use ELNs.

Based on CIT's assessment, OIR has determined that until further notice:

• OneNote notebooks must not be used for ELNs of any type, including general purpose ELNs or ELNs documenting projects that are anticipated to produce IP or otherwise require validated signatures.
• MS documents such as Word and Excel must not be used to create ELNs for the documentation of projects anticipated to produce IP or otherwise require validated signatures.
• MS documents are approved for use as general purpose ELNs for those ICs that have accepted responsibility for managing them in accordance with NIH requirements.
• Investigators wishing to pursue an approach for IC management of OneNote ELNs should work through their IC CIOs to prepare an exemption request and written proposal detailing the management procedures and controls that will be used by the IC to meet the NIH ELN requirements and mitigate the risks.
  • Proposals should be submitted to the NIH ELN Implementation Team (NEIT) for evaluation by a technical group that will include CIT and other appropriate domain experts.
  • Given that meeting NIH ELN requirements is expected to be cumbersome and resource intensive, ICs are urged to weight the feasibility implementing any such proposals against the perceived benefits of using OneNote rather than using the NIH-funded commercial ELNs or other compliant IC-provided ELNs that may be available before requesting a technical evaluation.

E. IC-Provided Resources

Investigators whose research requires documentation using specialized resources that have not been assessed for NIH-wide ELN use should work with their IC Chief Information Officer (CIO) to seek IC approval and discuss approaches deploying and using the software in a manner that meets applicable IT System Requirements for ELNs. Examples of domains for which electronic systems are already in widespread use and which may be adequate to document the complete research record include clinical trials research, epidemiology, computational science, and engineering.

VI. NIH IT System Requirements for ELNs

1. IT System Records Management Requirements
2. IT System Security Requirements

IT System Requirements for ELNs are based on Federal-wide standards for electronic data systems and NIH-required controls for assuring data integrity, as described in the Conduct of Research in the Intramural Program at NIH. Specifically, NIH requires that every lab notebook regardless of type must have mechanisms to control data access, protect sensitive data, and ensure that data are not altered after entry. Investigators can assume that Platforms Currently Available for Use NIH-Wide meet the IT system requirements discussed below when used in accordance with recommendations.

The most notable difference among the platforms approved for NIH-wide ELN use are the availability of advanced records management capabilities. Commercial ELN software approved for use at NIH provide validated signatures, permanent page locking, immutable versioning, time stamps, full audit trails and deletion controls at the notebook, page, and entry level. These capabilities are commonly required to safeguard intellectual property (IP) but also enhance data integrity even in cases when research is not expected to produce IP.

In contrast, NIH's Microsoft environment currently lacks validated signatures and other advanced records management capabilities. However, MS Document ELNs, but not OneNote, are expected to be approved for general purpose use (i.e., documenting research that is not expected to produce IP) after pending configuration changes to enable immutable versioning in the NIH MS environment are completed.

Investigators conducting research requiring use of specialized documentation systems other than those pre-approved for NIH-wide ELN use should work with their IC leadership and Chief Information Officer (CIO) to seek approval. Documentation approaches should meet the reproducibility standard for documenting the complete research record and software should meet IT system requirements for ELNs. Research domains where specialized documentation systems are in widespread use which may be suitable include but are not limited to clinical trials research, epidemiology, computational biology, and engineering. In most other cases, selecting commercial software approved by NIH for use as an ELN can greatly simplify assuring compliance with IT system requirements and execution of Investigator responsibilities and is encouraged whenever possible.

A. IT System Records Management Requirements

Electronic resources serving as lab notebooks should have the following capabilities:

• Permanent log of all entries, edits, and deletions, including authorized user and date/time.
  • Immutable time stamps for all entries (preferably visible without going to the log).
  • Author for all entries (preferably visible without going to the log).
• Deletion controls
  • Controls to prevent permanent deletion of entire notebooks.
  • Controls preventing permanent deletion of individual notebook entries.
• Frequent back-ups (at least daily) performed either by the ELN or NIH back-up service.
• Investigator control of user authorization (via software role-based permissions or storage platform).
• Institutional-level ownership of ELNs, including:
  • Institutional-level view of authorized users.
  • Mechanisms for rapid access to ELN contents and control of user authorization.
• Compliance with all NARA Universal Electronic Records Management (ERM) standards.
• Capabilities appropriate to the intellectual property and regulatory requirements of the research. Heightened documentation requirements apply to research involving preclinical studies, INDs, CRADAs, grants and collaborations with specialized data management requirements, or conducted in validated GLP or GMP environments. Investigators should review the capabilities of Platforms Currently Available for Use NIH-Wide to assure that the selected ELN meets requirements.

B. IT System Security Requirements

Software to be used for ELNs must receive Authority to Operate (ATO) from either the IC or NIH to assure that the software meets security requirements described in the Federal Information Security Modernization Act of 2014 (FISMA). Security must align with the value and criticality of the data being recorded. For this reason, storage of scientific data that has not yet been made publicly available is usually considered to constitute a moderate rather than low risk; this designation defines the major ATO requirements for both cloud and local server-client software deployments.

• ATOs for commercial "software as a service" (SaaS) platforms used by federal agencies must be compliant with the Federal Risk and Authorization Management Program (FedRAMP). FedRAMP standardizes cybersecurity requirements for the authorization of cloud services based on FISMA.
  • As of June 30, 2024, it is anticipated that NIH staff will have access to at least two commercial SaaS ELNs with a FedRAMP-compliant ATOs, including a multi-discipline ELN and a chemistry-specific ELN. Other commercial ELNs are expected to be added to the list as they achieve FedRAMP certification. Additionally, MS documents can be used for ELNs in cases where IP is not anticipated.
  • ICs may choose to accept the risk to use non-FedRAMP SaaS for ELNs in some cases, e.g. if the data are considered to constitute a low risk, or if the required software is “on track” for FedRamp certification, or if there is an urgent requirement for special-purpose software and no viable FedRAMP-certified alternative. Given that storage of most scientific data is considered to pose a FISMA moderate risk, exemptions are expected to be rare. (See NIH ISSO Determination on ELNs [NIH Only])
• ATOs for "server-client/browser" software deployed locally (i.e., in a traditional data center or an IC-managed cloud environment) for use as an ELN must in most cases meet FISMA moderate requirements but do not require FedRAMP certification. Although ATOs for such local deployments may be easier to obtain than ATOs for SaaS products, commercial choices for locally deployed ELNs are more limited than SaaS options. Moreover, local deployments require significant operational support costs which the authorizing IC must consider, in addition to the cost for licenses.

Additional Resources

• Request Accounts and Training: LabArchives Support and Onboarding [NIH Only]
• Management of MS Documents for General Purpose ELNs
• NIH ELN Implementation Team - IC Representatives [NIH Only]
• NIH OITE Webinar - Keeping a Lab Notebook: Basic Principles and Best Practices (October 21, 2023) [NIH Only]
• ELN Round Table Talks (March 18, 2023) [NIH Only]
• Index Record ELN Template [NIH Only]

Relevant Policies and Determinations

• Transition to Electronic Records: NARA/OMB M-19-21 and NARA/OMB M-23-07
• Conduct of Research in the Intramural Program at NIH
• NIH Manual Chapter 1743: Managing Federal Records
• NIH Manual Chapter 1743: Managing Federal Records, Appendix 5, Process for Departing Staff
• NIH Records Retention Schedule
• NIH Determination on the Use of OneNote and MS Document ELNs
• NIH ISSO Determination on Electronic Lab Notebooks (March 17, 2023) [NIH Only]