1. "Submission of a [Plan]
Outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations."
2. "Compliance with the awardee’s plan as approved by the NIH ICO."
It seems simple, but the requirement is much more than a basic checklist. There are many gray areas--some that the NIH are still determining.
1. "Submission of a [Plan]
Outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations."
We need some definitions before we can fully understand the policy definition of a Plan:
NOT-OD-21-013.Section II. Definitions
The Plan basically describes what researchers will do with data during the project as well as after the project is completed.
Scientific data is defined in the policy as:
“The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens."
Metadata is recorded in the policy as:
“Data that provide additional information intended to make scientific data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables)."
This includes both:
technical metadata, such as instrumentation settings.
human-made metadata, such as README files.
If metadata related to the scientific data is produced,
it needs to be included in a Plan.
The Plan must address the concerns and explain why such data cannot be shared.
The first requirement of the DMS Policy is that a Plan addressing the management and sharing of all scientific data and metadata must be submitted.
2. "Compliance with the awardee’s plan as approved by the NIH ICO."
It is simply that the Plan must be followed.