NIH continues to expect that the initial investigators may benefit from first and continuing use but not from prolonged exclusive use. of California, San Diego) Social Sciences and Various (Univ. Many research efforts supported by NIH do not include human subjects. Investigators who incorporate data sharing in the initial design of the study may more readily and economically establish adequate procedures for protecting the identities of participants and share a useful dataset with appropriate documentation. November 6, 2020 by Lewis-Burke Associates, LLC As part of its ongoing work to standardize and promote the sharing of data generated from biomedical research, the National Institutes of Health (NIH) published its final NIH Policy for Data Management and Sharing (DMS) on October 29, 2020. STRIDES Initiative; NIH Data Repositories; Common Data Elements (CDE) Data Sharing Policies; Research Funding; About. NIH expects researchers to: be clear in the DMP about where they plan to share (“to be determined” is no longer acceptable), notify them if plans change, and actually follow the plan. - 59 KB). To research applications submitted beginning October 1, 2003. Do you need a template to draft a data management plan? Clinical Quality Management Plan. Investigators who are working for or who are themselves covered entities under the Health Insurance Portability and Accountability Act (HIPAA) must consider issues related to the Privacy Rule, a Federal regulation under HIPAA that governs the protection of individually identifiable health information. Restricted Data - datasets that cannot be distributed to the general public, because of, for example, participant confidentiality concerns, third-party licensing or use agreements, or national security considerations. The final policy does not create uniform requirements to share all scientific data. Thus, applicants can request funds for data sharing and archiving in their grant application. Study Registration and Data Submission to an NIH-Designated Controlled-Access Data Repository and related links NEWS: New NIH Policy on Data Management and Sharing (effective January 25, 2023). Software is not regarded as "data" but it is recognized that access to software and other tools may be necessary to to access and interpret the data (i.e. Follow the link below and select "Get started!". For most studies, final research data will be a computerized dataset. For example, while the statement, "NIH does not expect researchers to share all scientific data generated in a study" will likely reduce the administrative burden for researchers, a classification of "required", "optional", "not NSF Faculty Early Career Development (CAREER) Program, NSF Career Proposal Support Letters Guidelines, Limited Submissions: Frequently Asked Questions, NIH Data Sharing Policy and Implementation Guidance), Notice of Intent to Publish a Funding Opportunity Announcement for Improving Health Disparities in Alcohol Health Services (R01 Clinical Trial Optional), Notice of Extension of the Expiration Date for PAR-18-530 "Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional)", Notice of Special Interest (NOSI): Availability of Administrative Supplements to Adapt/Repackage Visualization Methods for Enhancing Cancer Moonshot Data, Pre-Application Webinar for NOT-CA-21-008, Notice of Special Interest (NOSI): Availability of Administrative Supplements to Adapt/Repackage Visualization Methods for Enhancing Cancer Moonshot Data, Presolicitation Notice: Request for Proposals (RFP) 75N91021R00007 "Preclinical Pharmacokinetic and Pharmacology Evaluations of Agents Being Developed for Cancer Patients". Researchers who seek access to individual level data are typically required to enter into a data-sharing agreement. Any restrictions on data sharing due to cofunding arrangements should be discussed in the data-sharing plan section of an application and will be considered by program staff. The $500,000 threshold corresponds to the threshold set in the October 16, 2001 NIH Guide, where applicants requesting $500,000 or more in direct costs for any year must seek agreement by NIH Institute or Center (IC) staff to accept assignment of their application at least 6 weeks prior to the anticipated submission date. Alternatively, researchers may want to add their data to a data archive or a data enclave. Public Data Management Plans from the DMPTool; NIH Examples of Data Sharing Plans; ICPSR Sample Plan; DMPTool Harvard currently uses the DMPTool, a software tool in development. unacceptable "Data Management and Sharing Plan". Final Research Data - Recorded factual material commonly accepted in the scientific community as necessary to document and support research findings. Background and Significance Section (PHS 398 Research Plan Section B). Grantees should note that, under the NIH Grants Policy Statement, they are required to keep the data for 3 years following closeout of a grant or contract agreement. It applies to research that involves human subjects and laboratory research that does not involve human subjects. for their particular dataset. The policy applies to all NIH grantees and establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH … Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. Contact Us Get Email Updates. Others may simply share the data by transferring them to a data archive facility to distribute more widely to interested users, to maintain associated documentation, and to meet reporting requirements. As NIH notes,it also permits the "creation of new data sets when  data from multiple resources are combined. Sharing though data enclaves would grant access only to researchers who agree to preserve the privacy of subjects and provide means to protect the confidentiality of the data. It is particularly important for unique data that cannot be readily replicated. Not everyone wants to use the DMPTool, and we understand. What is a Data Management Plan? Who Jon R. Lorsch, Ph.D., director of the National Institute of General Medical Sciences, is available to comment on this strategic plan. https://ssl.isr.umich.edu/hrs/. NIH Data Management and Sharing Activities Related to Public Access and Open Science nih-gds template. For example, a redacted dataset could be made available for general use, but stricter controls through a data enclave would be applied if access to more sensitive data were required. Datasets that cannot be distributed to the general public, for example, because of participant confidentiality concerns, third-party licensing or use agreements that prohibit redistribution, or national security considerations, can be accessed through a data enclave. Even with the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects given the physical characteristics of subjects, the type of clinical data (including imaging) that we will be collecting, and the relatively restricted area from which we are recruiting subjects. Smaller NIH […] A data management plan, or DMP (sometimes also called a data sharing plan), is a formal document that outlines what you will do with your data during and after a research project. Data Enclave - A controlled, secure environment in which eligible researchers can perform analyses using restricted data resources. The precise content of documentation will vary by scientific area, study design, the type of data collected, and characteristics of the dataset. Related Extramural SOP: Data Sharing for Grants: Final Research Data This is an actual plan from a PI with [brackets] in place of identifying information. The tool includes references to VT Resources. Some investigators have more experience than others in estimating costs associated with preparing the dataset and associated documentation, and providing support to data users. NIH Data Book. When no additional NIH and/or NIH ICO data sharing expectations apply, researchers should propose their own approaches to data management and sharing in a Plan. This application requests support to collect public-use data from a survey of more than 22,000 Americans over the age of 50 every 2 years. For example, many early phase clinical trials use small samples, which make it difficult to protect the privacy of the participants. Investigators from foreign institutions and U.S. investigators collecting data in other countries should familiarize themselves with the policies governing data sharing in the countries in which they plan to work and to address any specific limitations in the data-sharing plan in their application. In the case of noncompliance (depending on its severity and duration) NIH can take various actions to protect the Federal Government's interests. Contact the Research Data Curation Program with questions about our services or to provide feedback on our new website. An example of a researcher who may be a covered entity is a physician who electronically bills for health care services and conducts clinical trials. A set of decision tools on "Am I a covered entity?" The current NIH Data Sharing policy, in effect since 2003, remains in effect until January 25, 2023. Letters of Support), and would not count towards the application page limit. Data Management Follow Best Practices Write an Effective Data Management Plan Sample NSF Data Management Plans NIH Policy on Rigor and Reproducibility Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators may also wish to develop a "mixed mode" for data sharing that allows for more than one version of the dataset and provides different levels of access depending on the version. DMP Tool – Open access data management plan tool designed to help researchers meet funding agencies’ DMP requirements. Here is a list of data management plan examples for grants covering biological/medical and social sciences: Data Management Plan Examples (NCSU) General - (Univ. NIH considers “digital” data to be data that has been recorded in any electronic format that can be accessed using a computer. As you may know, NIH publicly announced its intent to encourage broad data sharing in 2015, with the release of the NIH Plan for Increasing Access to Scientific Publications and Digital Scientific Data From NIH Funded Scientific Research, and further stakeholder input was sought via the 2017 NIH Request for Information: Strategies for NIH Data Management, Sharing, and Citation (NOT … The Report Catalog is a menu driven interface geared for the NIH familiar user to provide customized reporting. NIH Guidance for Investigators in Developing Genomic Data Sharing Plans (7/2015) NIH Genomic Data Sharing. Unedited comments will be compiled and may be posted, along with the submitter's name and affiliation, on the NIH Office of … Beginning in 2023 all NIH researchers will be required to submit data management and sharing plans. The NIH data-sharing policy applies to applicants seeking $500,000 or more in direct costs in any year of the proposed research. (Some fields refer to data documentation by other terms, such as metadata or codebooks). It is especially important to share unique data that cannot be readily replicated. Data sharing benefits the scientific community and the public. One possible approach is to withhold some part of the data. Furthermore, some study designs afford greater privacy protection to subjects than others. Data sharing promotes many goals of the NIH research endeavor. NIH has issued a new Final NIH Policy for Data Management and Sharing, which will require NIH funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. Accessible, well-organized, secure, and efficiently operated data resources are critical to … Such an agreement usually indicates the criteria for data access, whether or not there are any conditions for research use, and can incorporate privacy and confidentiality standards to ensure data security at the recipient site and prohibit manipulation of data for the purposes of identifying subjects. Data management is essential, from before your sponsored research project begins and throughout the research process, to ensure that the data is current, usable, protectable, and accessible. Recognizing that the value of data often depends on their timeliness, data sharing should occur in a timely fashion. In support of this effort, NIH released its first Strategic Plan for Data Science in June 2018 that provides a roadmap for modernizing the NIH-funded biomedical data science ecosystem. The proposed research will include data from approximately 500 subjects being screened for three bacterial sexually transmitted diseases (STDs) at an inner city STD clinic. of Michigan) Subject Guide Thomas Harrod. Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible. This rare craniofacial disorder is associated with distinguishing facial features, as well as mental retardation. NIH has issued a new Final NIH Policy for Data Management and Sharing, which will require NIH funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. To applicants seeking $500,000 or more in direct costs in any year of the proposed project period through grants, cooperative agreements, or contracts. They may prohibit the recipient from transferring the data to other users or require that the data be used for research purposes only, among other provisions, and they may stipulate penalties for violations. In general, a data-sharing plan should address the following: This policy replaces the 2003 NIH Data Sharing Policy. For the most part, NIH makes awards to institutions and not individuals (with very few exceptions, such as F32 awards). Success Rates. Regardless of the mechanism used to share data, each dataset will require documentation. This does not mean summary statistics or tables; rather, it means the data on which summary statistics and tables are based. Investigators will need to determine which method of data sharing is best Provides basic summary statistics on extramural grants and contract awards. Although Small Business Innovation Research (SBIR) applicants are also to address data sharing in their applications, under the Small Business Act, SBIR grantees may withhold their data for 20 years after the end of the award. The precise content and level of detail to be included in a data-sharing plan depends on several factors, such as whether or not the investigator is planning to share data, the size and complexity of the dataset, and the like. That policy directs applicants to contact in writing or by telephone IC program staff during the development process of the application but no later than 6 weeks before the anticipated submission date. Many examples of data sharing agreements for specific datasets are available on the Internet, including the following: AHRQ National Inpatient Sample at http://www.ahcpr.gov/data/hcup/datause.htm, Russian Longitudinal Monitoring Survey at http://www.cpc.unc.edu/dataarch/iprimary/rlms.html, Center for Medicare and Medicaid Services Data at http://hrsonline.isr.umich.edu/rda/userdocs/cmsdua.pdf For the most part, it is not appropriate for the initial investigator to place limits on the research questions or methods other investigators might pursue with the data. Most journals now expect that DNA and amino acid sequences that appear in articles will be submitted to a sequence database before publication. About data management plans (DMPs) A data management plan (DMP) is a written document that describes the data you expect to acquire or generate during the course of a research project, how you will manage, describe, analyze, and store those data, and what mechanisms you will use at the end of your project to share and preserve your data. Deductive disclosure of individual subjects becomes more likely when there are unusual characteristics of the joint occurrence of several unusual variables. A Data Management Plan, or DMP (sometimes also called a data sharing plan), is a formal document that outlines what you will do with your data during and after a research project. A data enclave provides a controlled, secure environment in which eligible researchers can perform analyses using restricted data resources. Data Management Plans. NIH recognizes that the sharing of data from clinical trials and under other situations may require making the data anonymous or sharing under more controlled means, as through a restricted access data enclave. It also makes clear that data sharing is a fundamental part of the research process. If support is being sought to develop a large database that will serve as an important resource for the scientific community, the applicant may wish to make a statement about this in the significance section of the application. Data Management Plan Templates. Even if NIH support is sought to transform or link datasets (as opposed to producing a new set of data), the investigator should still include a data-sharing plan in the application. For projects generating large-scale genomic data, the data management and sharing plan should also address compliance with the NIH Genomic Data Sharing (GDS) Policy. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. of Tech.) This management function will guide the development and implementation of NIH’s data science activities and provide leadership within the broader biomedical research data ecosystem. The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all SBIR data developed from work performed under an SBIR funding agreement for a period of 20 years after the closeout of either a phase I or phase II grant unless NIH obtains permission from the awardee to disclose these data. Technical Issues: It is the responsibility of the investigators, their Institutional Review Board (IRB), and their institution to protect the rights of subjects and the confidentiality of the data. Data Archive - A place where machine-readable data are acquired, manipulated, documented, and finally distributed to the scientific community for further analysis. Research Data Management (Health Sciences) National Institutes of Health - DMP Requirement Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible. NIH Data Management Plans. Thus, the grantee institution may have additional policies and procedures regarding the custody, distribution, and required retention period for data produced under research awards. Thus, if an application describes a data-sharing plan, NIH expects that plan to be enacted. they may need to be covered in your plan). In addition to removing direct identifiers, e.g., name, address, telephone numbers, and Social Security Numbers, researchers should consider removing indirect identifiers and other information that could lead to "deductive disclosure" of participants' identities. It is expected that the data sharing discussion will be provided primarily in the form of a brief paragraph immediately following the Research Plan Section of the PHS 398 application form (i.e., immediately after I. Stripping a dataset of items that could identify individual participants is referred to by several different terms, such as "data redaction," "de-identification of data," and anonymizing data. Data and Safety Monitoring Plans (DSMP) As previously noted, all grants involving human subjects require a Data and Safety Monitoring Plan. Final research data are recorded factual material commonly accepted in the scientific community as necessary to document, support, and validate research findings. Protocol: