DF/HCC Breast Data and Specimen Use Policies
All research projects and publications using DF/HCC curated clinical data and/or specimens from breast cancer patients treated at any of the participating institutions must be reviewed by the DF/HCC Breast Users Committee and is subject to a required annual renewal process. Generally exempt from this scope are requests for aggregate data – for example, identification of the number of eligible patients with curated clinical data and/or specimens based on specific clinically defined subset to determine feasibility. In addition, studies that are pre-specified in prospective therapeutic clinical trials are exempt from this scope. For example, use of archival tissue specimens for the purpose of assessing a pre-specified biomarker to determine eligibility into an IRB-approved clinical trial does not require additional Users Committee approval to proceed. In contrast, secondary use of clinical data and/or biospecimens from clinical trials not explicitly specified in the original IRB-approved protocol is subject to Users Committee review.
The process of submission, review, approval/renewal and publication of a research project are described below.
BIOSPECIMEN AND CLINICAL DATA POLICIES:
Biospecimens are banked in the DFCI/BWH tissue bank (Bank Director: Dr. Deborah Dillon). All requests for biospecimens housed within the DF/BWH tissue bank must be approved by the DF/HCC Breast Users Committee prior to release, as do requests for curated clinical data.
Researchers can request de-identified tissue or blood samples and linked clinical data from the bank without obtaining additional IRB approval for the specific research question. Users must sign a data use agreement stating that the bank will not provide, and the user will not attempt to learn, the identity of the patients. Please note that there may be additional time and/or funding required depending on the scope of the tissue and/or clinical data request, and not all requests will be deemed feasible. If an identified data set (e.g. a data set that contains patient names, medical record numbers, etc) or a limited data set (e.g. a data set that contains dates of treatment) is requested, then DF/HCC IRB approval specific to the project must be obtained by the requesting researcher before release of clinical data or specimens. Consultation with the Co-Chairs of the Breast Data/Tissue Users Committee is available to researchers prior to submission of a proposal to the Users Committee, prior to IRB submission, and during the IRB approval process. The Users Committee will require documentation of IRB approval (if needed) prior to release of tissue or clinical data. If the samples need to be sent out of DFCI/BWH to another institution, the DFCI investigator is required to contact the Belfer Office for Dana-Farber Innovations (BODFI) for assistance with a Material Transfer Agreement (MTA). A MTA needs to be in place prior to transfer of patient samples from DFCI/BWH to the external collaborators or entities. In addition, transfer of curated clinical data from DFCI/BWH to an external collaborator must have a signed data transfer agreement. Administrative staff will maintain a flowsheet to follow the progress of each request and maintain contact with the investigators during the review process.
Investigators within DF/HCC must submit a proposal form directly to the Breast Users Committee via email to the project manager for access to curated clinical data and/or specimens collected within DF/HCC Breast. Depending on whether the request for clinical data and/or specimens is for deidentified or identified patient-level information, the submission of your research project will have different requirements that are outlined on the Project Proposals page.
Investigators must come from an institution in which significant contribution is being made in terms of specimen and/or clinical data collection in order to submit a research proposal. Investigators that are external to DF/HCC must have an investigator (collaborator) that is a faculty member at DF/HCC to submit on his/her behalf via email directly to the project manager. The project manager for the Users Committee will ensure distribution of the research proposal to the members of the Users Committee for review and comment via email. Members will reply with a decision whether to 1) approve, 2) reject; or 3) request revision and resubmission.
The project manager will convey the decision and/or any questions from the Users Committee to the investigator within 2 weeks after the proposal is distributed to members for review.
Separate proposal form can be completed for qualitative and survey related studies. The process for submission, review, and approval is the same; however, a different committee reviews these studies.
When making final approval of a research proposal, all efforts will be made to come to consensus. If needed, simple majority voting will be used and quorum will be at least half of all active Users Committee participants and 2 of the 3 co-chairs. Each of the co-chairs has veto power if a proposal has a major flaw and can re-route the proposal to the full Users Committee for additional consideration. Once approved by the committee and the DF/HCC IRB if required, the project manager will forward the investigator a letter stating the users’ committee final approval. The project manager then will work with the appropriate staff to identify and generate datasets and collection of specimens based on the cohort specifications. All approved research proposals are cataloged in the Breast Users Committee existing projects log for reference.
All proposals that require the use of curated clinical data (for example, collected as part of 93-085 CRIS or RedCAP database, 09-204 metastatic database, or proposed secondary analysis previously unplanned as part of a therapeutic clinical trial) must also be approved by the relevant study PI, who will be a study collaborator.
All proposals for secondary use of clinical data and/or samples collected under an existing DF/HCC IRB-approved therapeutic clinical trial must also be approved by the relevant study PI.
If the samples need to be sent out of DFCI/BWH to another institution, the DFCI investigator is required to contact the Belfer Office for Dana-Farber Innovations (BODFI) for assistance with a Material Transfer Agreement (MTA). A MTA needs to be in place prior to transfer of patient samples from DFCI/BWH to the external collaborators or entities. In addition, transfer of curated clinical data from DFCI/BWH to an external collaborator must have a signed data transfer agreement.
Once the Users Committee’s approval and other relevant approvals are made, the project manager then will work with the appropriate staff to identify and generate datasets and collection of specimens based on the cohort specifications.
All approved research proposals are cataloged in the Breast Users Committee existing projects log for reference.
Annual Renewal Policy:
There is a required annual review of previously approved projects.
The goals of an annual review are as follows:
- To receive a progress report on the projects that have been previously approved
- To understand how the specimens and/or data has been used in each project
- To determine whether any publications have been generated from each project
- To assess whether projects have been completed or are still on-going, and ongoing, what the timeline is for completion.
The annual renewal form should be submitted to the project manager each year until the project is completed. The project manager will forward the annual renewal form to the project team when the renewal is due. The renewal form should be completed within a month of receipt or the project (e.g. access and use of specimens and/or data) will be put on hold. An updated approval letter will be distributed upon re-review and approval by the Users Committee.
Once the project has completed its research, the investigator will be required to complete the project closure form.
Investigators may need information to support grant proposals such as estimated number of patients/samples for a cohort or group of patients for a study or trial, letters of support from the Users Committee, and documentation of IRB approval for the grant. Policies related to these topics are provided below.
If an investigator is preparing a grant proposal, aggregate data and/or de-identified data to determine feasibility can be provided for the application, if available. We encourage investigators to reach out in advance to the co-chairs of the Users Committee to determine whether the desired biospecimens/clinical data are available and the timeline for turnaround of a feasibility request. More details on this process can be found here.
Letters of support
Upon receipt of a brief synopsis, listing of specific aims, and if relevant enumeration of types and amount of tissue/blood/clinical data required for the proposed study, the Users Committee is able to provide a generic letter of support to investigators in good standing within DF/HCC, which outlines the relevant clinical data and biospecimens that could be available and indicates the process by which a concept is vetted by the Users Committee. A sample approval letter can be found here. The turnaround time for this letter is two weeks. Investigators who wish to attach a letter for a grant application with a more firm commitment (e.g. Users Committee ‘pre-approval’) must submit a full Users Committee application at least four weeks before the grant deadline.
Documentation of IRB Approval
Recently, studies and/or proposals supported with NCI or DOD grant funding have required documentation of IRB approval and review of the grant proposal/application by the IRB. For studies using clinical data and/or specimens collected under any of the data sources outlined above, the aims of the study outlined in the grant proposal will need to be approved by the Users Committee and/or OHRS (depending on the nature of the study and need for identified data or not).
In terms of OHRS review, you may contact OHRS as to their requirements for reviewing the grant proposal to meet the NIH or DOD policies. In some circumstances, IRB approval of the data and tissue collection ‘umbrella protocol’ and documentation of approval through the Users Committee mechanism will fulfill NCI/DOD requirements. However, increasingly, granting agencies are requiring documentation of IRB review of the specific research proposal in the grant, even it is using de-identified samples and de-identified clinical data obtained from an IRB-approved ‘umbrella protocol’. Please also note that amendments to the existing cohort study protocols will not be submitted for each proposed individual grant proposal. Instead, investigators will need to submit a low-risk protocol application summarizing the proposed work to the DF/HCC IRB. Please refer to the OHRS website for details of submission and application templates for IRB review of low risk protocols and protocols related to research related to biological materials and data.
Prior to abstract or manuscript submission, investigators should notify the Breast Users Committee for guidance regarding authorship and funding acknowledgements.
In general, an investigator from each institution represented in the analysis of clinical data and/or specimens should be included in the authorship. In addition, for publications that include curated clinical data (i.e. from a cohort database), the PI/leaders of the relevant database should be included as an author(s). For publications including biospecimens, the bank director should generally be included as an author. For secondary use of an existing clinical trial’s clinical data or biospecimens, the trial PI should be included as an author. Failure to adhere to the publication policy may result in loss of privileges to access clinical data or biospecimens for research.
All manuscripts which include the use of bio-specimens or clinical data abstracted from Protocols 93-085, 09-204 and/or 05-246 should reach out to the Users Committee to discuss acknowledgements, as funding sources have varied over time. In particular, it is important that all manuscripts express acknowledgement of the contribution to the DF/HCC Breast SPORE: Specialized Program of Research Excellence (SPORE), An NCI funded program, Grant 1P50CA168504.
Research that has used tissue and/or blood samples collected under DF/HCC Protocol #05-246 should acknowledge:
- Dana-Farber/Harvard Cancer Center SPORE grant #P50CA168504. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health/NCI.
- ACT-NOW Fund at Dana-Farber Cancer Institute
Depending on the samples and annotated clinical data required, the research may also need to acknowledge:
- Breast Cancer Research Foundation
- National Comprehensive Cancer Network Oncology Research Program (in collaboration with Pfizer Independent Grants for Learning & Change)
- Fashion Footwear Association of New York
- Friends of Dana-Farber Cancer Institute
Please check with the Users Committee chairs, Nancy U. Lin, MD, Deborah Dillon, MD, and Laura Collins, MD, prior to manuscript submission to confirm the correct acknowledgements are included.