IRB Requirements for Use of Discarded Materials

Pre-Requisites

1. In all cases, a review from the Institutional Review Board (IRB) is required. Please contact us for more information about your IRB requirements.
   • Partners investigators should select the "Crimson" option in the Partners institutional review board (IRB) form for requesting discarded materials.
   • Non-Partners, Harvard Medical School-affiliated investigators wishing to access anonymized materials in Crimson Open Banks must provide a copy of their institutional IRB protocol or a waiver letter from their local IRB, indicating that their use of anonymized materials does not constitute human subjects research.
2. In all cases, a Date Use Agreement (DUA) is required. Please contact us to receive the appropriate DUA template

IRB Documentation

The following capabilities, if used, must be detailed in the IRB protocol:

Obtaining Samples from Crimson Banks

If you are intending to obtain samples from an existing anonymous bank within the Crimson application:

Samples will be obtained from the anonymous BWH Specimen Bank or MGH Clinical Research Core maintained by the Partners HealthCare Biobank. The investigator and study staff will select appropriate samples from the available inventory. Samples are released with age and gender only to the IRB protocol of the receiving investigator. Materials will be used for <indicate use of the samples>

Sample Review Functions

• If you plan to use the Sample Review functions in the Crimson application to assist in finding discarded samples meeting particular criteria, you will need to add the following language to your protocol:

Samples will be collected through the Crimson application used by the BWH Specimen Bank and MGH Clinical Lab Research Core, as sponsored by the Partners HealthCare Biobank. Study requests for samples are first registered with the Biobank team. A study can be activated after verification that its IRB protocol is active, and subsequent discussion with study staff regarding materials to be collected. Upon activation of the study, rule sets can be created to locate pertinent discarded samples meeting defined criteria. Queries are run against a 30-day rolling window of data on all accessions coming into the clinical laboratories. Searchable fields include the patient age, sex, ordering location, patient status (e.g. inpatient, outpatient), tests ordered, test results and lab or visit ICD.9 codes.

The investigator and study staff will be given privileges in the Crimson software application to view a daily list of all accessions found by their queries. This "picklist" includes data found on a laboratory accession, namely the accession#, patient MRN, name, and DOB. Investigators may then perform necessary medical record checks (e.g. medications, radiology reports) to determine which samples should be collected. Within the Crimson application, study staff will check off samples not meeting additional criteria, leaving a list of samples for collection by Biobank staff. When samples are collected, Biobank staff physically remove the lab accession label and enter the sample in the Crimson application. A new CrimsonSampleID and CrimsonPatientID are created and associated with the sample. This action physically de-identifies all samples collected by the Specimen Bank.

While links to patient data are retained, samples may not be released to study staff until (1) the patient has been consented to allow links to remain, or (2) all links to identifying information within Crimson have been broken (anonymized). Thus, investigators either receive a consented or anonymized patient sample from the Biobank.

In addition, you must include what data will be reviewed (pharmacy, radiology reports, etc.), from what source (charts, EMR, etc.) and that all links to identifiers will be removed after completion of the analysis.

• If you need to include specific annotations from the data review with samples to be collected, you must provide the Crimson team a list of canned comments that will be used. Crimson staff will associate canned comments with samples to be collected. Free-text entries are not allowed, as they could potentially be used to re-identify samples.

Time-Limited Links on Samples

A time-limited link sample has a link to the MRN that is limited to a given time period, generally less than 30 days. The time-limited link may be used or requested for the following circumstances:

• If there is a window period where diagnostically a sample placed into clinical escrow may be retrieved for additional clinical testing. During this period, the link remains so the sample could be retrieved for clinical purposes.
• Additional chart review or other de-identified data collection will be performed to ultimately create a de-identified dataset. After these activities the link will be broken.
• Approach the patient for consent. Should the patient be consented during the window of the time-limited link, the sample will convert to a consented state. If not, it may be discarded or converted to a de-identified state, pending what's stipulated in the investigator's IRB protocol.

Already Collected Lists

To prevent duplicate collection of samples from the same individuals, the Biobank may maintain an "Already Collected List" of medical record numbers (MRN) on samples that have been accessioned. Study staff will not have access to this list. It is only for use in the Biobank. Added MRNs are routinely sorted numerically to prevent linking of MRNs with collected samples. The list may persist as long as the IRB protocol is active; thereafter, it will be deleted. The following language should be incorporated in the IRB protocol to allow creation and use of an Already Collected List.

An "Already Collected List" will be maintained in Crimson. This list is used to prevent duplicate collection of samples from the same patient. Prior to accessioning a new sample, the MRN is checked against this list to make certain materials have not been previously collected. After accession of a discarded sample, Crimson staff will list MRNs from samples collected for each query. The Already Collected List is routinely sorted to be in numeric order such that no one MRN can be associated with a sample. The list thus represents an aggregate of MRNs with no link to any collected sample. Study staff will not have access to MRNs on the list.

The List may persist as long as the investigator's IRB protocol is valid. Upon expiration of the IRB protocol, the list will be permanently deleted.

Do-Not-Collect List

A "Do-Not-Collect" list may be provided by study staff to the Biobank for the purpose of avoiding collection of samples on individuals for whom the study already has materials (commonly consented patients in the study). Prior to collecting samples, this list will be checked to make certain the MRN is not found. Use of a "Do-Not-Collect List" must be documented in your IRB protocol.

Collection of Samples on Consented Patients

If you are collecting discarded materials from consented patients, check off the "Crimson" box on the IRB form regarding means of sample collection.

After obtaining consent, study staff will register patients in the Crimson software application for sample collection under the investigator's study. Each night, samples recently accessioned in the BWH and MGH Clinical Labs will be searched for materials matching the list of patients consented by the study. In particular, we will be collecting <enter sample type(s) to be collected - serum, purple tops, etc. >. <Enter number of samples to be collected per patient - one tube only, all samples, etc. >