IRB Documentation for Use of Discarded Materials

Pre-requisites
  1. Partners investigators should check off the "Crimson" option in the Partners IRB form for requesting discarded materials.
  2. Non-Partners, HMS-affiliated investigators wishing to access anonymized materials in the core's 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.
  3. Investigators and study staff must sign the core's tissue transfer letter, which will be prepared by core staff.
  4. Studies requesting microbial isolates must have a valid COMS protocol covering the species to be received.
IRB Documentation:
The following capabilities, if used, need to be detailed in the IRB protocol:

Obtaining Samples from Open Banks

If you are intending to obtain samples from an existing anonymous bank maintained by the core

Samples will be obtained from the anonymous <Indicate which Crimson Bank> maintained by the BWH Specimen Bank. 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>

If you are receiving microbial isolates:

Microbial isolates will be obtained from the Isolate Bank maintained by the Crimson Core. The investigator and study staff will select appropriate isolates from available inventory. Samples are released with the microbial species (if available), antibiogram and source, if available, 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 Crimson Core in the BWH Clinical Laboratories. Study requests for samples are first registered with the core. 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 (inpatient, outpatient, e.g.), tests ordered, test results and lab or visit ICD.9 codes.

The investigator and study staff will be given privileges in Crimson 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 (medications, radiology reports, e.g.) to determine which samples should be collected. Within the application, study staff will check off samples not meeting additional criteria, leaving a list of samples for collection by the Specimen Bank. When samples are collected, the Specimen Bank staff physically remove the lab accession label and enter the sample in the application. A new SampleID and PatientID are created and associated with the sample. This action physically de-identifies all samples collected by the core.

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 core.

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 Specimen Bank a list of canned comments that will be used. Specimen Bank 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

Time-limited links allow identified information to remain associated with a discarded sample for a limited window of time, generally <<30days. Limited links may be in place to allow final resulting of test results desired in the anonymized dataset associated with samples, chart review to create canned comments to annotate collected samples, or for clinical purposes if materials need to be held in escrow should the Clinical Laboratories or Pathology department need to retrieve materials set aside for eventual research use, to complete additional diagnostic testing.

During the window period of the limited link, samples will not be released to study staff. The Crimson Core acts as the honest broker and will hold all samples until such time as links to identified information are broken.

<Study> requests use of time-limited links to proected health information for the purposes of <state reason(s)>. A period of <# days> days is requested. During the period of the link, Crimson will retain a link between the patient MRN and LIMS-generated sample and subjectIDs. Study staff do not have access to samples while links are in place; materials remain in posession of the Crimson Core. After links to protected health information have been removed in the LIMS, samples may be released to study staff.

Already Collected Lists

To prevent duplicate collection of samples from the same individuals, the Crimson Core may maintain an "Already Collected List" of MRNs on samples that have been accessioned. Study staff will not have access to this list. It is only for use in the core. 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 the Crimson Core. 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, core 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 Crimson Core 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" needs to 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 wil register patients in the Crimson Application for sample collection under the investigator's study. Each night, samples recently accessioned in the BWH 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. >