It is now about two months since NIH’s new Data Management and Sharing (DMS) Policy took effect and several months since we originally presented about it. NIH continues to share guidance and clarification, as this is a new process for everyone.
What we include below are updates we have come across since January and thought our followers would appreciate.
eRA System Validation
The eRA Systems (ASSIST, Commons) perform certain validation checks to ensure that there is a DMS Plan attachment, a budget line item, and a justification when the DMS Policy applies. The system knows which FOAs need DMS plans and which don’t. As we know, the DMS policy applies to applications that will generate scientific data. For example, it applies to R (Research) applications but not T (training) or F (Fellowships) applications.
Additionally, the system checks for whether there is a line item called “Data Management and Sharing Costs“ in “F. Other Direct Costs” of the budget form. It also checks that there is an attachment under Additional Narrative Justification. What it can’t check for is whether you have included the proper content in the attachment.
A more detailed discussion regarding DMS plan budgeting follows below.
Budgeting
All costs for DMS activities, including personnel costs, must be included in the single line item mentioned above. This includes the salary and fringe benefits corresponding to the time it takes personnel to undertake data activities (e.g., formatting, curating, developing supporting documentation). Don’t include effort for DMS activities in “A. Senior/Key Person” or “B. Other Personnel”. However, if the Principal Investigator or other Key or Other Personnel will be doing both non-DMS and DMS activities, the costs for non-DMS activities should be reported in Sections A or B, as appropriate, and costs for DMS activities would be included in Section F.
If no DMS costs are included, the “Data Management and Sharing Costs” line item in Section F of the budget must still be included, but with a dollar value of $0. The Additional Budget Justification needs to be included with a statement that no costs related to DMS activities are expected.
If submitting a grant application with a modular budget, there will not be a line item for the DMS costs. The only additional item that is included in this scenario is the Additional Narrative Justification with either the DMS costs explained or a statement that there are no costs for DMS activities.
Applicants should also check with their respective organization for any institution-specific policies. For example, some organizations may prefer that researchers use the NIH repositories as a first option.
DMS Costs for Subawards
DMS costs for each subaward must be listed as a single line item on the R&R Budget for the subaward. If a subaward will not have DMS costs, then the line item is not required. A DMS costs line item must still be listed on the project/parent R&R Budget Form for the parent DMS costs, including $0 if no costs are anticipated for the parent.
DMS Costs for other applications
For complex grant applications that have an overall budget and multiple project/core budgets, DMS costs must be included within the applicable component(s). For multi-project applications, the DMS plan must only be included in the overall component.
DMS Plans on SBIR/STTR applications
Under SBIR and STTR policies, SBIR and STTR awardees may withhold applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals. This justification can be included in the DMS Plan.
DMS Plans and Human Subjects Research
Award recipients must comply with any applicable laws, regulations, statutes, guidance, or institutional policies related to research with human participants and protecting participants’ privacy.
The DMS Policy acknowledges this and encourages award recipients to:
- Address DMS plans during informed consent to ensure potential participants understand how their data will be managed and shared;
- Outline steps they will take for protecting the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification and other protective measures);
- Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing the data; and
- Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing via controlled access may be specified by certain funding opportunity announcements (FOAs).
Sample DMS Plans
NIH has a growing list of sample DMS plans.
