In addition to cases where data sharing is required by policy (such as NIH Policy as detailed in Section B) there are many cases where there may be expectation for sharing (such as a requirement for publication). If data sharing may be required, the JHM IRB recommends preparing a DMS Plan and including the Plan within the protocol or as a separate supplemental document at the time of submission to the JHM IRB.

Yes, any changes or modifications made to your DMS Plan should be submitted to your funding Program Officer. After approval, the revised DMS Plan must be submitted to JHM IRB via a Change in Research. Note, changes to consent and/or re-consent may also be required, depending on the revisions made. 

No. The PI is responsible for ensuring that any commitments made in data management and sharing plans are fulfilled. Note that some funders may track data sharing of your project. 

Review any applicable consent language that would prohibit data sharing. In the absence of prohibitive data sharing language, consider the guidance contained in these FAQs to ascertain what data sharing may be permissible. Submit a Further Study Action - Change in Research conveying the requirement for data sharing and the study team’s planned data sharing for the JHM IRB’s consideration. The JHM IRB will review and determine the appropriate level of data sharing.

Review any applicable consent language that would prohibit data sharing. In the absence of prohibitive data sharing language, consider the guidance contained in these FAQs to ascertain what data sharing may be permissible. Submit a Further Study Action - Post-Termination Report conveying the requirement for data sharing and the study team’s planned data sharing for the JHM IRB’s consideration. The JHM IRB will review and determine the appropriate level of data sharing. Note that if the application never had a Termination Report (i.e., the status is “Expired” or “Progress Report Past Due” with an expiration notice sent) you will need to first submit a Termination Report for review and acknowledgement; then a Post-Termination Report may be submitted for the proposed data sharing.

In accordance with NIH’s Data Management and Sharing Policy which took effect on January 25, 2023, applications for federal funding submitted on or after this date must include a DMS Plan. This includes federally funded grants, contracts, intramural research projects and other funding agreements. This applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. Note: scientific data includes any data needed to validate and replicate research findings.

For federally-funded projects subject to the NIH policy, investigators are expected to plan and budget for managing and sharing data, submit a DMS Plan when applying for funding and comply with the approved plan. Both the DMS Plan and Consent Form, containing consistent language, must be submitted to the JHM IRB. The proposed DMS Plan must be consistent within the eIRB application sections (e.g., protocol, Risk Tiers Calculator, etc.) that describe data sharing.

If the IRB requires changes to a DMS Plan approved as a condition of funding, the requirements and a revised plan must be a) submitted to the IRB and, once approved b) submitted to the Program Officer as a required change. If the Program Officer does not accept the revised plan, please contact the IRB at jhmeirb@jhmi.edu for assistance to discuss next steps. Note that modifications may also be reviewed by, or suggested by, other ancillary review entities that have a role in how we share data and could affect the changes you make to your DMS Plan (i.e., JHM AI & Data Trust and/or CCDA review of de-identification protocol). Similarly, if changes to your DMS Plan are required by your Program Officer and the JHM IRB has already approved it, the revised DMS Plan must be submitted to the JHM IRB via a Change in Research (CIR). 

For studies subject to NIH’s requirements, data sharing must occur no later than the time of publication or the end of the performance period, whichever comes first. 

No, the DMS Policy does not apply to research and other activities that do not generate scientific data. Examples include training, infrastructure development, conference grants, and non-research activities. For details see: NIH Research Covered Under the Data Management & Sharing policy linked here.

Yes. The NIH Policy requires that the plan specify whether external access to scientific data derived from humans will be controlled and if so, how. Data sharing and management plans must also describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data including any informed consent or privacy/confidentiality limiters. Examples of limiters may be limiters imposed by the research consent, HIPAA requirements or any agreements with third parties about future use of the data. Additional JHURA Human-Derived Data FAQs are linked here.

Additional help about NIH DMS Plans can be found here: https://sharing.nih.gov/, JHU Welch Medical Library NIH DMS Plan Guidance, and JHURA NIH budget Guidance.

No. The Data Management and Sharing Plan (DMS Plan) is different from the Data Safety Monitoring Plan (DSMP) covered in eIRB Section 32. Please see our DSMP guidance linked here: 103.6c Organization Policy on Data and Safety Monitoring of Proposed Research | Johns Hopkins Medicine

The DMS Plan may encompass both planned scientific data sharing and planned genomic data sharing. Applicable projects funded by the NIH are subject to two separate policies (see: https://sharing.nih.gov/genomic-data-sharing-policy). Institutional Certification is required for genomic data sharing subject to the genomic data sharing policy. For more information on complying with the Genomic Data Sharing Policy, please see: NIH Human Genomic Data Sharing Policy FAQs

Please review the Genomic Data Risk Tiers to determine what ‘Tier’ the data is, which will help guide how it may be shared. Include this information in your eIRB application and the JHM IRB will review and determine the appropriate level of data sharing.

The JHM IRB pays close attention to access, distribution, or reuse of data considerations, a required component of NIH’s DMS Plan. The JHM IRB will check to see if there are any potential limiters of what data can be shared based on what participants consented to and any contractual agreements pertaining to future sharing of data. The JHM IRB will also consider the risk to participants, the sensitivity of the data as well as cultural considerations and expectations. See additional guidance linked here: JHU IRB Expectations for Sharing of Individual Level Research Data. If sharing JHM patient data, please see: Data Sharing Tiers for Broad Sharing of Clinically Derived Data .The IRB may consult additional offices such as the Clinical Trial Contracting Team or Office of Research Administration related to limitations imposed by contracts or other agreements.

The types of requirements for accessing the research data are what differentiates Controlled Access from Open Access. There are many different types of controls that can be implemented for “Controlled Access”. Examples include, but are not limited to, a research review committee that determines what projects may access the data; requiring specific credentials to access the data; or the data only being accessible in secure research environments. Open Access data is available to the public. For more information on controlled versus open access, please see Data Sharing Tiers for Broad Sharing of Clinically Derived Data.

The IRB will consider the risk level to the individual participants/communities/groups; other applicable laws, approvals or agreements that govern the data (e.g., funding, MTAs, DUAs); the rationale for Open Access data sharing; and the consent obtained for the type of data and level of data to be shared. Data may only be shared via Open Access if participants explicitly agree to share their data in this way. The JHM IRB has provided language that must be included within the consent form if Open Access data sharing is planned: JHM IRB Consent Form Template Language: Open Access Data Sharing

In cases where there is not an appropriate repository or where the consent did not allow for deposit in a repository, an alternative method may be proposed to share data by request. Generally, it is required that an individual or entity other than the lead investigator manage these requests to promote fair access to the data. Plans where the PI manages data access are generally not acceptable to funding agencies that require DMS plans or journals that require a data access plan. Generally, when sharing data by request, a Data Use Agreement (DUA) must be established with each recipient. For help initiating a DUA, contact the Office of Research Administration (ORA): Route an Agreement for Review

Generally, studies that propose to share data via Open or Controlled Access repositories will not meet the criteria for Exempt review. Studies that have been determined Exempt that would like to share data in an Open or Controlled Access repository should submit a Change in Research to propose the planned data sharing for the JHM IRB to assess the proposed sharing and applicable consent requirements (i.e., obtain regulatory consent or grant a Waiver of Consent).   

Yes, please consider the potential in-country laws and regulations where specific requirements are in place for data sharing (for example, GDPR) and consent, explaining these within your DMS plan and throughout your application. For help regarding international data sharing, contact Associate General Counsel and Deputy Chief Compliance Officer for International Activities, Carrie Kroll McMullan: ckmcmullan@jhu.edu

The IRB’s current consent language linked here: JHM IRB Combined Informed Consent/HIPAA Authorization Template covers data sharing and contemplates sharing for future use and with many different types of external collaborators. The template discusses sharing of data through data repositories as well. 

If you are planning to share data from a Johns Hopkins Medicine (JHM) IRB-approved protocol that had multiple consent versions, older consents may not contain adequate data sharing language and will need to be revisited and updated to enable data sharing. Language from Section 4 of the current JHM consent template (“What happens to data and biospecimens that are collected in the study?”) may be added to your older consent forms to cover data sharing to enable the broadest sharing. If reconsent of existing or past participants is practicable using the revised consent with language enabling data sharing, the JHM IRB’s expectation is that reconsent of participants occur prior to sharing their data. If reconsent is not practicable, the JHM IRB will make determinations to waive reconsent on a case-by-case basis. Please note that if your older consent form does not cover sharing with commercial third parties, you will only be permitted to share data with not-for-profit companies. Additionally, the JHM IRB’s template language is geared towards sharing via controlled access which is the standard for sharing of most human-derived research data. 

If study teams wish to share data openly (e.g., Open Access), specific language must be added to the consent to account for this. See the IRB’s template language on Open Access data sharing as a guide for developing any language to describe open access data sharing.

Given the length and complexity of the language used to obtain individuals’ consent for this sharing, if an oral consent or waiver of documentation of consent process is proposed, study teams should provide participants an information sheet or copy of the electronic consent which details the language for participants’ reference. Use of an electronic consent process in these cases is preferred so the study team also has record of participants’ consent to this sharing, however documentation in the research record of the oral (verbal) consent process is acceptable. 

There are additional considerations and limitations for sharing data that was collected under a Waiver of Consent. Data that was collected under a Waiver of Consent may not be shared via Open Access. Data that was collected under a Waiver of Consent may only be eligible for sharing if it is de-identified and the sharing of data may not pose greater than minimal risk (as determined by the IRB). See additional guidance linked here: JHU IRB Expectations for Sharing of Individual Level Research Data.

If your research is NIH funded, you can upload a copy of the DMS Plan, as included with your grant application in eIRB Section 9, Item 4.

Information about data sharing should also be described within the protocol, Section 4 of the Consent Form(s), the Risk Tiers Calculator (RTC), and in Section 36, Item 2 of eIRB. 

The DMS Plan can be submitted if funding is pending. Please note, the finalized plan or confirmation that changes to the plan were not required upon award should be submitted to the IRB in a future Change in Research with documentation uploaded into eIRB Section 20, Item 2 (e.g., email from the Program Officer).

Yes, you can upload your sponsor required plan in eIRB Section 20, Item 2. 

When JHM is the Single IRB, we will review the data management and sharing plan for all participating sites (pSites). The lead/coordinating center should check with pSites to determine if they have any limitations or local policies that might impact the data management and sharing plan, as the plan should be implementable at all pSites.

If there are different policies and procedures at a pSite that might impact their ability to share data, that information should be provided as part of the pSite’s local context review and any specific policies impacting the site’s plan for data management and sharing should be called out in the site’s completed local context questionnaire. It is important that protocols and associated data management and sharing plans proactively account for site variances to avoid delays in site onboarding if the plans for sharing do not align with site requirements. 

When JHM is relying on an External IRB, as part of our local context review, we will review the data management and sharing plan approved by the External IRB to ensure our institutional policies and guidance are adhered to, and that the approved plan does not differ from our expectations.  

• JHU IRB Guidance on Data Sharing: this guidance was developed by the 3 Johns Hopkins IRBs (Homewood, School of Public Health, and Johns Hopkins Medicine) to guide considerations for data sharing, including what the consent requirements would be and what other factors the IRB should evaluate when determining if a proposed sharing plan is appropriate
• Data Sharing Tiers: this guidance was developed by the JHM AI & Data Trust and adopted from the JHURA guidance to elaborate on the different types of sharing and the factors that guide where JHM data can be shared. This guidance has been adopted by the JHM IRB to govern not only JHM clinical data, but all data generated by JHM research studies. 

Sample plans and additional information regarding developing your management and sharing plan can be found here: 

• Start here: Johns Hopkins Libraries: Data Management Plan (DMP) Tool,
  • Email Data Services to schedule a consult: dataservices@jhu.edu
• NIH: Writing a Data Management and Sharing Plan

• Example JHM research study DMS Plan:
  • Example - Data sharing plan

It is the responsibility of investigators to ensure their data is appropriately de-identified. If the study team does not have de-identification expertise, they may want to consider hiring a third party. In certain cases, a de-identification service may be required to do so. JHU Data service can provide guidance on deidentification plans and techniques but does not physically de-identify data. In certain cases, if sharing is considered high risk, verification of de-identification by an appropriate expert may be required. JHM Data Trust requires CCDA to review and provide verification of de-identification plans when approving data sharing of JHM clinical data with external collaborators or data repositories.

• Core for Clinical Research Data Acquisition (CCDA) for studies including JHM patient data: https://ictr.johnshopkins.edu/service/informatics/ccda/
• JH Library Services: Data Services: Home - Data Management and Sharing - Guides at Johns Hopkins University (jhu.edu)

If data includes information about individuals that may have a high risk of re-identification (e.g., rare diseases, unique family histories, highly sensitive data), additional review may be required of these datasets to ensure the data are de-identified prior to sharing. The IRB may require verification by an appropriate expert in deidentification that the data have been appropriately de-identified if there is high risk associated with the sharing.

• JHU Data Sharing guidance: General JHU IRB Expectations for Sharing of Individual Level Research Data 
• JH Libraries Data Services: JH Libraries Data Services - NIH Data Management and Sharing Plan Support  
• If you still have questions or need assistance to find a repository to share your data, please contact JHU Data Services via dataservices@jhu.edu, https://guides.library.jhu.edu/dataservices
• For questions related to external sharing of JHM clinical data, please contact datatrust@jhmi.edu

• Data Repository Guidance
• Sheridan Libraries Data Management and Sharing
• JHURA Data Management & Sharing: New: Data Management and Sharing | JHURA

• NIH List of Generalist Repositories
• NIH-Selecting a Data Repository: Selecting a Data Repository | Data Sharing (nih.gov)
• NIH-supported Data Repositories 

• Welch Medical Library – Examples of Controlled-Access Repositories
• dbGaP
• Vivli – Center for Global Clinical Research Data

• GEO: open access
• Johns Hopkins Research Data Repository (JHRDR): Steps to Deposit Data
  

• Re3data.org to search a data repository appropriate to host your data: https://www.re3data.org/

• Inter-university Consortium for Political and Social Research (ICPSR) offers options for open- and controlled-access

• The Qualitative Data Repository: offers options for open- and controlled-access

• FAIRsharing.org - Repositories
• MIT Repository Finder: https://data-repository-finder.ll.mit.edu/
• NNLM repository finder: www.nnlm.gov/finder