The Office of Research Integrity (ORI) provides centralized support, education, and policy development to facilitate and promote the responsible and ethical acquisition, use, sharing and maintenance of research data at Brown. ORI partners with the research community to assist with the implementation of strategic initiatives involving the use of research data, helping to build new models of data sharing and related processes to enable Brown to achieve its research collaboration and growth objectives.
For questions concerning research data use, retention, and management, please contact us at [email protected].
During the COVID – 19 public health emergency the NIMH Data Archive is following the Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 guidance provided by the National Institutes of Health. If you are unable to meet any NDA milestones (Data Submission Agreement, Data Expected or Data Submission) due to COVID – 19 please follow the NIH Guidance.
NIH Policy for Data Management and Sharing
On October 29, 2020, NIH issued its final NIH Policy for Data Management and Sharing. This Policy sets forth a number of standards for good data management practices and data sharing expectations applicable to research funded by NIH. Most notably:
Researchers applying for NIH funding must create and submit to the NIH a Data Management and Sharing Plan (a “Plan”) outlining how scientific data and any accompanying metadata used in research will be managed and shared, considering any potential restrictions or limitations. A Plan should include a brief summary of:
- The type of data managed, preserved, and shared;
- Related tools, software, and/or code used;
- Standards applied to the data;
- Methods of data preservation, access, and associated timelines;
- Approach for access, distribution, and reuse considerations; and
- Oversight of data management and sharing.
- Researchers should consider how to maximize appropriate sharing of data, while acknowledging existing legal, ethical, or technical factors that may call for justified limitations or exceptions.
- In particular, NIH highlights the importance of informed consent and emphasizes that researchers should clearly communicate with prospective subjects how their scientific data are expected to be used and shared.
Statement on Final NIH Policy for Data Management and Sharing
Elements of an NIH Data Management and Sharing Plan
Allowable Costs for Data Management and Sharing
Selecting a Repository for Data Resulting from NIH-Supported Research
NIH Institutes, Centers, and Offices Data Sharing Policies
NIH Data Sharing Policies
Notice of Data Sharing Policy for NIMH
Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research
NHGRI Implementation of the NIH Genomic Data Sharing Policy
Notice of Data Sharing Policy for Autism Data
Data Risk Classification Levels
Brown has classified its data into risk-based categories for the purpose of determining who is allowed to access the information and what security precautions must be taken to protect it against unauthorized access. It is the data and service owner’s responsibility to ensure appropriate security measures are taken depending on the risk classification. To learn more, watch this video.
Data Use Agreements
Do you need to access data from another institution or share your research data outside of Brown? A Data Use Agreement (DUA) is a formal, written contractual agreement into which two or more parties enter and establishes specific ways in which data may be used and how it must be protected. To learn more, visit our DUA Page and watch our DUA online training.
Research Data Management Onboarding Checklists
Are you starting a new lab or a new research project? Check out our research data management onboarding checklists online training to learn how to best manage your research data. This presentation is intended to supplement the research data onboarding checklists document.
Research Data Management Offboarding Checklists
Are you closing out a project or leaving Brown? Check out our research data management offboarding checklists online training to learn how to best manage your research data. This presentation is intended to supplement the research data offboarding checklists document.
Research Data and Research Materials Management, Sharing, and Retention (RDM) Policy
When you leave Brown, can you take your lab notebooks with you? Who owns the data you’ve collected? Can you delete your data files after your manuscript has been published? Research data are the data/information another researcher would need to reproduce or evaluate your results. This includes items such as lab notebooks, photographs, digital images, data files, software, statistical records, etc. To answer these research data questions and more, review the RDM Policy, RDM FAQs, and this online training video.
Have you ever wondered when is the right time or how to close a study? Do you need guidance on how to fill out the Human Research Protection Program's study closure form? Are you questioning the data management and retention schedule involved with closing a study? This video will answer all these questions and more.
The National Institute of Mental Health Data Archive (NDA) Webinars and Tutorials
The National Institute of Mental Health Data Archive (NDA) makes available human subjects data collected from hundreds of research projects across many scientific domains. NDA provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. For researchers new to NDA data sharing, we highly recommend watching the NDA New Grantee Orientation for an overview of the entire data submission and sharing process. For access to all NDA webinars and tutorials, click here.
Uploading a Data Set to the Brown Digital Repository (BDR)
Are you interested in using the BDR to store or share your research data? Watch this training for a step-by-step guide. In order to comply with journal expectations and requirements, we recommend reviewing the De-Identification Certification Form and BDR Data Sharing Statement Resource discussed in the presentation.
This resource provides a step-by-step guide on how to utilize the BDR (page 1), a guide to what data should and should not be made available (page 2), suggested journal data sharing statements (page 3), and example data sharing statements in journals using the BDR (page 4).
Protected health information (PHI) may be classified as de-identified by (1) certifying that none of the 18 HIPAA-defined identifiers are present, or (2) certifying through statistical analysis that the likelihood of an individual being identified using the data is very small. The purpose of this form is to confirm that data has been properly de-identified using either of these methods. This form should be used before depositing de-identified data into the BDR.
Researchers who are funded by several NIH Institutes are now required to deposit de-identified human subjects data into federal repositories. If an award has this requirement, participants must consent before their research data can be shared.
The NIH Data Repository Informed Consent Addendum is intended to supplement the informed consent process and explain the requirement to participants.
The purpose of these checklists is to serve as a guide for Brown researchers starting a new laboratory (checklist 1) or starting a new research project (checklist 2) with regard to research data by orienting them to existing policies, guidance, and tools available at Brown.
The purpose of these checklists is to serve as a guide for Brown researchers closing out a project (checklist 1) or leaving Brown (checklist 2) with regard to research data by orienting them to existing policies, guidance, and tools available at Brown.