The Final NIH Policy for Data Management and Sharing took effect January 25, 2023.  It applies to all proposals for NIH funding that will result in the generation of scientific data, if funds are awarded.  The policy does not require all data to be shared, but does expect data sharing limitations to be explained and justified. 

The central operational piece of the policy is a Data Management & Sharing Plan (DMSP) which must be submitted at the time of application for an NIH award, and then updated during the course of the award period as needed. 

An NIH DMSP is a two-page document addressing six elements, which are meant to be customized to each proposal.  High level summaries of the six elements are as follows:

1. Data types. In this section you will write about the approximate amount of scientific data you anticipate collecting, formats and file types, and any information about how the data will be collected that helps to succinctly describe what the data will be like in your research project.
2. Related tools, software, or code. This is a section that gives you space to describe the technical requirements for reproducing the analysis that you express in your findings.  You can list versions of the software you intend to use, for example.
3. Standards. For your specific discipline, are there accepted standards for data structure and quality assurance for the type of research you are doing?  This is where you would list those.  Protocols for data organization and preservation can also go here.
4. Data preservation, access, and associated timelines. You will need to think about where your data would best be preserved before you generate it, and explain why you plan to use the repository that you have chosen.  You will also talk about when you will be able to make data accessible, and what level of aggregation/amount you anticipate sharing.
5. Access, distribution, or reuse considerations.  This section is where you can show that you have thought through the implications for preparing the contents of your data for reuse, to the extent reuse may be possible.  For human subjects data, you will want to address how informed consent, privacy, and confidentiality fit into your plan.
6. Oversight of data management and sharing. Here you are being asked to describe how the data management roles will be assigned within your team.  This will also involve some description of the process for complying with the rest of the DMSP in practice.

An NIH Data Management & Sharing Plan (DMSP) must now accompany each proposal package sent to the NIH for all funding opportunities that generate scientific data.  This is how the DMSP fits into the NIH grant process:

1. The DMSP is reviewed as part of the proposal package by an NIH program officer from the Institute, Center, or Office (ICO) administering the award. This review involves scoring the plan using a rubric that is internal to the NIH.  Reviews are completed 4-5 months after package submission.
2. The program officer returns the DMSP to the applicant and may ask for changes which can be submitted as part of Just-In-Time changes before the award decision.
3. The DMSP becomes a term and condition of the award, and compliance is reviewed by the NIH ICO as part of the annual Research Performance Progress Report (RPPR) process.
4. If changes are made during the course of the project period, the DMSP must be resubmitted to the program officer for review.
5. Failure to comply with the DMSP "may result in the NIH ICO adding special Terms and Conditions of award or terminating the award".

Please refer to the NIH standard application due dates and your NIH ICO Funding Opportunity Announcement (FOA) to find when to have your DMSP ready to submit as part of your proposal package.

When an NIH Data Management & Sharing Plan (DMSP) makes statements about how data will be stored, curated, and shared, it is necessary to think about how much it will cost to accomplish this. This can be an iterative process, because budgeting for compliance with the NIH DMS policy is influenced by factors having to do with the data type(s) and specific funder requirements. Below are resources for learning more about NIH DMSP budgeting.

Whether required as part of grant proposals/applications or created ad hoc to help manage a project, developing a data management plan (DMP) is considered best practice for conducting research. These plans identify upfront the methods, resources, and tools to be used throughout the various stages of a research project. DMPs can also function to coordinate the activities of all personnel involved in the project by clarifying roles and responsibilities.

When planning your research project, it is important to consider how data are governed at IUSM and how that affects your ability to handle (in particular, store) the data you work with for research.

To assist faculty, staff, and students with navigating this process, Indiana University (IU) has appointed Data Stewards to provide guidance. These stewards are assigned to different data subject areas and can also provide insight into the different types of data that IU recognizes and how those classifications might overlap with a particular data subject area. More information can be found on the IU Data Management website: https://datamanagement.iu.edu/.