Writing an NIH Data Management & Sharing Plan

DMS Plan Section Instructions

Briefly describe the scientific data to be managed and shared:

• Summarize the types (for example, 256-channel EEG data and fMRI images) and amount (for example, from 50 research participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing.
• Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all data generated in a study, but does expect the scientific data needed to validate and replicate the findings to be shared where possible. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions.
• A brief listing of the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data

Expectations for data subject to the Genomic Data Sharing (GDS) Policy:

• GDS Plans will not be accepted once the DMS Policy takes effect (January 25, 2023).  A DMS Plan will be required instead.
• Data types expected to be shared under the GDS Policy should be described in this element. Note that the GDS Policy expects certain types of data to be shared that may not be covered by the DMS Policy’s definition of “scientific data”. For more information on the data types to be shared under the GDS Policy, consult Data Submission and Release Expectations.

Example 1

There are two sources of clinical data: 1) data gathered via structured interview with participants; and 2) data extracted from the electronic medical record, including demographic characteristics, anthropomorphic characteristics, and results of radiologic tests.

Participants may have genetic testing or other molecular assays performed on a research basis, which utilize the biospecimens that are collected as part of the study. The clinical data are entered into IU REDCap (https://kb.iu.edu/d/bdhl). Family data are recorded as pedigrees, scanned electronically, and stored in the Microsoft Secure Storage (https://kb.iu.edu/d/bgfb) space created for the project. The results of radiological studies are recorded on an electronic spreadsheet, which is also stored in Microsoft Secure Storage (https://kb.iu.edu/d/bgfb).

Example 2

This project involves four data streams:

1. Participants will provide self-reported data that will be entered into the REDCap database.
2. Participants will be asked interview questions and interviewer will enter data into the REDCap   database.
3. Field data will be recorded on paper (stored in study binders) and entered into an IU system approved for use with critical data including PHI.
4. Information will be collected from the Electronic Medical Record (EMR) and entered into an IU system approved for use with critical data including PHI.

Specimens are collected specifically for research purposes and include: recording of a history and physical examination, photographs and recording of skin lesions and clinical data, surface cultures, skin biopsies and blood. Data include subject demographics, contact information, HIV serology and pregnancy tests. The history, physical exam, laboratory and daily visit data are recorded on a paper chart, where the linkage to a study number and subject identifiers can be made. All laboratory specimens are coded with the subject number and have no other identifiers. Data concerning each subject (age, gender, ethnicity, trial, date of infection, date of biopsy, days infected, outcome of each infected site, hypertrophic scar formation, specimens that are stored) are stored in an IU system approved for use with critical data including PHI. The database does not contain patient identifiers. For the blood drawing protocol, specimens are coded with a participant number without other identifiers; data concerning each subject (age, gender, ethnicity, date of donation, amount donated) are recorded in REDCap.

IU Libraries provide support for researchers seeking NIH-funding. We are actively monitoring updates and guidance available from the NIH, as well as the IU Research Data Management Plan Working Group. We will continue to update the information here to reflect those changes. Our support includes:

• data management planning
• selecting the appropriate repository(ies) for sharing data
• planning for documentation that will enable data sharing, and
• some aspects of preparing data for deposit
• support decision-making related to data management and sharing that occurs during project start-up and active conduct of research

We will also connect you with other experts across IU who can help you submit the best DMS Plan possible. We are not able to write DMS Plans on behalf of research teams of which we are not members.

To request a consultation, contact the data librarian for your campus or school:

• Heather Coates, IUPUI - hcoates@iu.edu 
• Levi Dolan, Indiana University School of Medicine - dolanl@iu.edu
• Ethan Fridmanski, Indiana University Bloomington - ejfridma@iu.edu