Can I obtain a letter of support for my grant application?
The LABS Core can provide you with a letter of support for your grant application. The letter will confirm that LABS either can provide the sample(s) you intend to use in your proposed analyses or the service(s). The letter will state that the LABS Core is committed to supporting your study, following receipt of funding and committee approvals, as applicable (e.g., SRC approval for COVID-19 samples). Please contact us with your request for a letter of support at least two weeks before you require it.
What happens after my COVID-19 Biorepository sample request is approved?
The Admin Core will communicate the approval of your sample request via email, accompanied by an approval letter. A document with guidance/instructions for Biorepository investigators will accompany your approval and will describe next steps. A number of documents and pieces of information are required for study activation, described further below.
What happens after my BARC sample request is approved?
The team will be in touch after approval to talk through the needs of the study and next steps.
What is required to activate my study and receive samples?
Depending on the study and the source of samples you’re requesting from, different elements will be required to activate your study and release samples. The Biorepository may require some combination of the following:
- BMC/BU IRB approval letter or non-human subjects research (NHSR) determination letter
- BMC/BU IBC approval letter
- Executed MTA/DUA(s)
- Documentation of Clinical Data Warehouse (CDW) approval
- Attestation for accessing protected health information (PHI)
- Account/address information for invoicing
These elements are discussed in more detail below. When your study is approved, you will be sent an invitation generated from REDCap to complete an online Study Activation Form where you will provide this information.
Do I need to obtain IRB approval for my study?
You are required to undergo IRB review of your proposed study, even if it is to obtain a non-human subjects research (NHSR) determination. The LABS team will require your IRB approval letter or NHSR letter before releasing samples or performing services.
Do I need to obtain IBC approval for my study?
If you are requesting samples from the LABS Core, the laboratory where samples will be held and analyzed must have the necessary IBC approvals. If you are holding and analyzing samples at a BU or BMC lab, you will be required to provide the IBC approval letter before samples will be released. Please review the CDC’s current guidance on biosafety levels (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html) to ensure your lab meets the necessary standards
Do I need a material transfer or data use agreement (MTA/DUA) for my study?
If samples and/or data are being transferred to any collaborator or third party outside of BMC (including BU), an MTA and/or DUA is required. For BMC PIs, you can complete the agreement request form here. The completed form should be emailed to DUA.MTARequest@bmc.org. Include any associated committee review request forms, approval letters, and any data/material transfer agreement provided by external collaborator (if applicable). For BU PIs, complete the agreement request form here. Submit the form via the “Submit” button in the application, or email the completed form to firstname.lastname@example.org.
Can external investigators and institutions (including industry partners) apply to use Biorepository samples?
LABS Core prioritizes sample and service requests submitted by BU/BMC investigators. However, if you are an external party and wish to inquire about samples or services, please contact our team.
When will I be billed for the samples I requested?
The LABS team will generate an invoice for the samples after they have been released to your custody or services after they have been rendered. If samples were shipped, you will be invoiced for any relevant shipping charges. If you are paying from a BMC account, the payment will be automatically journaled from your account. An invoice will still be sent to you for reference purposes. If you are paying for samples or services from a BU or other external account, directions for remitting payment will be included on the invoice.
This page is under development. If you have a question that is not listed here, please contact our team.