November 2023

In order to accommodate programs with a repository of biospecimens that will be frequently shared with outside entities for similar projects, an “Umbrella” protocol may be submitted to the Johns Hopkins Medicine IRB (JHM IRB). Plans to submit an Umbrella protocol should be discussed with the OHSR and Biospecimen Program Administrator in advance of submission to ensure the planned activity aligns with an umbrella protocol model. In the submission, an Umbrella protocol must include: 1) a rationale for the biorepository or a single study with plans to share frequently, 2) a description of the types of biospecimens and source(s) that are covered by the protocol and may be subject to sharing, and 3) an overall plan of governance for transfer requests from the repository. Generally, Umbrella protocols must be submitted to the JHM IRB as a new application in the electronic IRB system. The Umbrella protocol application must be approved by the BTC at a convened meeting.  

Please keep in mind that in general, BTC does not permit certain types of transfers, such as those where the project is non-collaborative and those where the donor samples come from unconsented patients. 

Key Requirements for New Umbrella Protocols:

•  Umbrella protocols should be submitted to the JHM IRB using the eFormR (for repositories) or eFormS (for single studies with plans to share frequently) protocol templates. The template is located on the following link: Johns Hopkins Medicine Institutional Review Board Forms.
  • The protocol should include a description of source of samples in the repository and how they were collected, (e.g., with informed consent under IRB approved applications).
  • Data Trust requirements related to registries must be addressed in the protocol. Please see: https://hpo.johnshopkins.edu/enterprise/policies/1099/39500/policy_39500.pdf.
• The PI must provide a statement certifying that an appropriate institutional agreement will be executed prior to each transfer. This can be delineated in Section 6c of the eFormR, and Section 3q of eFormS.
• If your repository includes samples collected under more than three consent versions/variations, please include an Excel table documenting the following information (for each patient and their associated sample(s)): Patient/Sample ID, IRB protocol, consent version, each consent form version’s language detailing what will happen future to data and/or biospecimens.
• If any of the consent forms included optional future biospecimen sharing language, please include a column identifying that the patient stated yes or no to whether samples could be used in the future. For those consent forms where the sharing was not optional, indicate that it is not applicable (N/A).

eIRB Application:

• Section 1 (General Information), Item 6 must explicitly include the purpose of the research to develop an Umbrella protocol as a biorepository for future biospecimen transfers. The eFormR must be uploaded in Section 6 (Protocol Information), Item 2.0. 

• In Section 23 (Human Biological Samples), Item 4, the box next to “Other” must be selected. This will trigger BTC review of the Umbrella protocol. The following Items related to the biorepository should be included in Section 23 (Human Biological Samples), Item 4:

1. Copies of the unsigned consent form (research/clinical) used for collection of the biospecimens with highlighted language allowing for transfer of the samples to external entities;
2. Confirmation of a submitted Data Use Agreement for data leaving Hopkins. This confirmation is also supplied by providing the COEUS PD number (Please note: if you have not yet begun the MTA process, you may submit this as a CIR after the Umbrella protocol is approved.)
3. Template for listing all transfer requests under the Umbrella protocol, (that shall be updated with each subsequent transfer request)
4. Scope of work (SOW) template to be used for each subsequent transfer request. 

Submitting New Transfer Requests for Umbrella Protocols:

Once the Umbrella protocol has been approved by the JHM IRB and BTC, each transfer request should be submitted in a Change in Research (CIR) to include the following:

• an updated list of transfers should be uploaded to Section 23.4 (Protocol Information). This should be updated using the “Update” button in eIRB in order to update the existing document. A new document should not be uploaded using the “Add” button.
• a completed SOW specific to the transfer request, uploaded in Section 23 (Human Biological Samples), Item 4.
• approval documents from the recipient site, if applicable, uploaded in Section 23(Human Biological Samples), Item 4.
• the name of the Research Administration contact specialist(s) to assist with the institutional transfer agreement.

The CIR may be reviewed by expedited process and may include more than one transfer request. However, the CIR may be referred to a convened meeting in certain situations, such as those with a conflict of interest or a device.