Strong data management practices are essential to maintaining research excellence. Inconsistent, incomplete, and misunderstood standards for experimental record keeping, data management and data retention in a laboratory can lead to human error and erode the rigor, reproducibility, and reliability of findings. At Harvard Medical School, the Principal Investigator (PI), as the steward of Harvard data, is responsible for establishing clear, consistent, and comprehensive data management expectations amongst laboratory personnel and trainees in compliance with University policies and sponsor requirements, including Data Management and Sharing Plans (DMSPs). Information about the responsibilities of each laboratory leader can be found in the following policies and guidance documents:
- Harvard University Research Data Ownership Policy
- Guidance on Retention and Maintenance of Research Records and Data
- The HMS Acceptable Use Policy - STAT Service Portal (service-now.com)(Requires Harvard Key sign-in), provides additional guidance on expectations related to storing and backing up research data.
- Recent relevant guidance addressing best practices for general laboratory record-keeping can be found on the NIH website in their Conduct of Research in the Intramural Research Program at NIH (2023); scientific record-keeping is addressed on pages 2-9 in the PDF.
- An additional resource that may be of use is the NIH Intramural Electronic Lab Notebook Policy | NIH Office of Intramural Research.
Harvard Medical School (HMS) acknowledges that data generated by laboratories today are larger and more complex than the past and that traditional paper-based record-keeping may be ineffective in meeting HMS’s transparency, oversight, and data sharing goals. HMS therefore strongly recommends that each laboratory consider the adoption and use of electronic laboratory notebooks (ELNs). ELNs are increasingly the standard tool used by academic and industry research professionals for scientific record keeping to facilitate management, searching, storage, and sharing of research records.
ELN Support at HMS
Harvard Medical School makes eLabNext available at no cost to any quadrangle-based laboratory that seeks an effective and IT-supported ELN tool for data management in accordance with School expectations. HMS has developed an on-boarding program to educate and train existing laboratory personnel and their new members on the functionalities of eLabNext. While HMS does not mandate the use of eLabNext by every laboratory for data management, HMS does require that the head of each laboratory establish data record-keeping and management expectations for trainees and personnel consistent with HMS and sponsor requirements--see links to the University research data policies and guidance provided in the section above.
If you are interested in using eLabNext:
- Please see https://it.hms.harvard.edu/service/electronic-lab-notebooks-eln .
- HMS has training materials for use of eLabNext posted here Coming Soon!
If you are considering using another ELN:
- Be aware that HMS and Harvard University cannot provide information technology or training support for other ELN products. Every ELN used at HMS must meet the guidelines set forth below. These guidelines outline essential features expected in any ELN used by HMS researchers and provide best practices to safeguard the security and integrity of your research records.
- If eLabNext does not meet your needs and/or you cannot find an alternative ELN that meets the expectations described below, please contact Countway Library Data Services (countwayrds@hms.harvard.libanswers.com). Countway staff can provide referrals to resources addressing other lab notebook options and data management strategies.
- General information about ELNs can also be found on the Longwood Research Data Management website.
Essential Features of every ELN at HMS
Each ELN at HMS must be:
Dependable:
- Software is well-supported and supplied by a mature, well-established, and responsive vendor with the ability to provide consistent, ongoing support for bug fixes, feature requests, and security patches.
- Software is configured to securely protect confidential information.
To help evaluate vendor dependability and data security, HMS IT can conduct vendor assessments as described in the Service-Now section of the HMS IT website.
Accountable: ELN maintains data integrity through tracking and reporting of unalterable date/timestamps and user information for all changes to ELN records.
Shareable: ELN allows for in-platform sharing of records with colleagues within the University to support collaboration.
Portable: ELN enables efficient and accurate export of all records into non-proprietary formats for reuse, distribution, or archiving. ELN vendors should be able to provide details about available export formats and instructions. Examples of non-proprietary file formats include HTML, JSON, PDF, and XML.
Additional specific best practices on ELN use should be reviewed by every laboratory head prior to and in connection with adopting an ELN for laboratory use.
Best Practices Guidelines for ELN Use
Location of stored research data
- Small data files can be uploaded and stored in ELNs. The ELN vendor or HMS IT should provide information about maximum file sizes and file numbers that can be uploaded in ELN records.
- For larger data files and datasets that cannot be uploaded into ELNs, information about file names and folder paths to storage locations should be recorded in the relevant ELN record. Simply pasting a link to a dataset or file in an ELN record is not recommended. File names and folder path links to research data stored in HMS systems change as files are moved across different storage tiers, and are therefore not persistent across the data lifecycle. Details about recommended practices to document file names and folder paths for data stored in HMS systems can be found here: coming soon!
- Every user should review and be aware of the HMS Acceptable Use Policy (“Sign in” to view the Acceptable Use Policy - STAT Service Portal (service-now.com)), which establishes expectations related to storing and backing up research data.
Permissions for data sharing
- All ELN records and related underlying data must be shared with, and available to, the Principal Investigator (PI) of the research group (and a person designated by the PI, such as the lab manager, as applicable). An individual should never set up an ELN to which they have sole access. All ELN records should be configurable for access by HMS IT, when needed, to facilitate lab transitions, to preserve intellectual property and for meeting other institutional legal and regulatory requirements.
Archiving records
- When transitions in research personnel within a lab occur (e.g. when trainees depart), ELN records should be archived appropriately in the lab. This archival process or transfer to the departing researcher’s new institution might require export to non-proprietary formats.
- Please note that access to some institutional storage systems available to researchers, such as the Microsoft 365 applications, including Office 365 email, calendar, Sharepoint, OneDrive, and Teams, is immediately disabled upon an individual’s departure. Shared content in OneDrive is available to collaborators for 30 days after an individual’s departure. For more information on how to ensure continuity of access to research data after personnel departures, please consult the following information from HU IT and work with your supervisor and department administrators to plan a smooth transition:
Sensitive Data Management (including Protected Health Information (PHI) or Personally Identifiable Information (PII))
- Investigators are responsible for ensuring that sensitive data meet the Data Security requirements of Harvard University. Protected Health Information (PHI) and Personally Identifiable Information (PII) are sensitive data that require Level 4 data security.
- Most ELN products are not set-up to securely store sensitive data and therefore should not be used for this purpose.
- HMS ELN users should consult with the HMS Associate Director for Research Data Compliance (data_ORA@hms.harvard.edu) or the HMS Information Security & IT Compliance Officer (joseph_zurba@hms.harvard.edu) to explore approved options for storing and tracking sensitive data that require Level 4 or higher security measures.
Training/Resources for ELN products
- Training and information on ELN use should be made available to all ELN users to ensure that the ELN is used properly to support lab and individual data management and sharing plans (DMSPs).
- Lab-specific guidance on ELN use should also be provided by the lab at time of individual onboarding, as appropriate.