November 2022

For genomic data collected under consent forms signed pre-2015: 

You may submit genomic data to an NIH database without participant re-consent if the pre-2015 consent form does not contain “prohibitive” language that limits who can have access to the data.  An example of prohibitive language would be “your data will not be seen by anyone outside the Hopkins study team.”  An example of non-prohibitive language might be “With appropriate protections for privacy, Johns Hopkins may share your biospecimens and information with our research sponsors and partners.” 

In order for the IRB to evaluate your request, please submit the following through eIRB: 

• Genomic Data Sharing Form. This internal Hopkins form is available on our IRB website and should be uploaded under Section 9, item 3a, of the eIRB application in the space provided. 
• Pre-2015 NIH Institutional Certification Form.  To ensure that the correct form is being used, this external NIH form should be obtained from the NIH website or from your NIH project officer.  Please complete and sign the form.  Please include the following limiters in the relevant spaces provided: controlled access; Health/Medical/Biomedical; IRB approval required (IRB); Not-for-profit use (NPU).  This form should be uploaded to Section 9, item 3b. 
•  Consent form template versions.  Please upload all relevant template versions of the consent form under Section 20, item 2, of the eIRB application. 
• Data Management Plan.  Please upload the data management plan from your grant under Section 20, item 2, of the eIRB application. 

For genomic data collected under consent forms signed post-2015: 

Per the NIH Genomic Data Sharing Policy, as of 01/25/2015 (date of the policy issuance), investigators are “expected to obtain participants’ consent for their genomic and phenotypic data to be used for future research purposes and to be shared broadly. The consent should include an explanation about whether participants’ individual-level data will be shared through unrestricted- or controlled-access repositories.” The broad language, such as “With appropriate protections for privacy, Johns Hopkins may share your biospecimens and information with our research sponsors and partners,” has generally been determined to be insufficient to meet the NIH’s post-2015 requirement because it is not specific enough. The rationale for the new policy is that, post-2015, the research community is now aware of the NIH repositories and the requirements for genomic data sharing and should anticipate the sharing in the consent forms.  If the post-2015 consent language is deemed insufficient by the IRB, you may only submit data collected under those consent forms after obtaining reconsent with a revised consent form containing GWAS language.  

In order for the IRB to evaluate your request, please submit the following through eIRB: 

• Genomic Data Sharing Form. This internal Hopkins form is available on our IRB website and should be uploaded under Section 9, item 3a, of the eIRB application in the space provided. 
• Post--2015 NIH Institutional Certification Form.  To ensure that the correct form is being used, this external NIH form should be obtained from the NIH website or from your NIH project officer.  Please complete and sign the form.  Please include the following limiters in the relevant spaces provided: controlled access; Health/Medical/Biomedical; IRB approval required (IRB); Not-for-profit use (NPU).  This form should be uploaded to Section 9, item 3b. 
• Consent form template versions.  Please upload all relevant template versions of the consent form under Section 20, item 2, of the eIRB application. 
• Data Management Plan.  Please upload the data management plan from your grant under Section 20, item 2, of the eIRB application. 

For genomic data that will be prospectively collected under a new consent form: 

Include our GWAS template language in the consent form and you may submit to an NIH database.  The template language is available at the following link:  /institutional-review-board/formsgwas_consent_form.docx

In order for the IRB to evaluate your request, please submit the following through eIRB: 

• Genomic Data Sharing Form. This internal Hopkins form is available on our IRB website and should be uploaded under Section 9, item 3a, of the eIRB application in the space provided. 
• Post-2015 NIH Institutional Certification Form.  To ensure that the correct form is being used, this external NIH form should be obtained from the NIH website or from your NIH project officer.  Please complete and sign the form.  Please include the following limiters in the relevant spaces provided: controlled access; Health/Medical/Biomedical; IRB approval required (IRB); Not-for-profit use (NPU).  This form should be uploaded to Section 9, item 3b.  
• Data Management Plan.  Please upload the data management plan from your grant under Section 20, item 2, of the eIRB application. 

For genomic data where you would like to share via open access rather than controlled access: 

Open access means that any person or entity may have access to your submitted genomic data with no limiters or restrictions.  In order to allow open access to genomic data, the data must have been obtained pursuant to a consent form with language that anticipates data being shared broadly through open access. 

In order for the IRB to evaluate your request, please submit the following through eIRB: 

• Genomic Data Sharing Form. This internal Hopkins form is available on our IRB website and should be uploaded under Section 9, item 3a, of the eIRB application in the space provided. 
• Relevant NIH Institutional Certification Form(s).  To ensure that the correct form is being used, these external NIH forms should be obtained from the NIH website or from your NIH project officer.  Please complete and sign the forms.  Please indicate that you are requesting “open access.” This form should be uploaded to Section 9, item 3b.  
• Consent form template versions.  Please upload all relevant template versions of the consent form under Section 20, item 2, of the eIRB application. 
• Data Management Plan.  Please upload the data management plan from your grant under Section 20, item 2, of the eIRB application.  The Data Management Plan must require open access. 
• Documentation under Section 20, item 2, which outlines in detail the scientific justification for open access.  

For genomic data previously collected under a consent waiver: 

Johns Hopkins will not permit sharing of genomic data obtained without a consent form if the data are collected after 2015. Even if the data were collected prior to 2015, it would be a very rare circumstance where sharing of genomic data under a consent waiver would be permitted. We advise investigators to not agree to a submission to an NIH database for a study where the genomic data is collected under a consent waiver and consult the IRB proactively to discuss the permissibility of sharing data collected under a waiver of consent.  Any sharing of genomic data obtained via a waiver would require controlled access and extensive limiters as mandated by the IRB and the Institutional Official.