Frequently Asked Questions

The Breast Users Committee is the supervising body for use of the breast cancer curated clinical data and/or specimens from the HCC.

The Users Committee is composed of at least one member from each participating organization which includes Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and Massachusetts General Hospital, representing the disciplines of pathology, surgery, and medical oncology, radiation oncology, and biostatistics. Members will be appointed by their respective organizations with no pre-specified term limits. The current membership & structure of the Users Committee is presented below:

HCC Breast Users Committee Members (as of January 1, 2018) 

Co-chairs

• Nancy Lin, MD; DFCI
• Deborah Dillon, MD; BWH
• Laura Collins, MD; BIDMC

Users Committee Members

• Jennifer Bellon, MD; DFCI
• Myles Brown, MD; DFCI
• Leif Ellisen, MD PhD; MGH
• Judy Garber, MD, MPH; DFCI
• Mehra Golshan, MD; BWH
• Michael Hassett, MD, MPH; DFCI
• Steven Isakoff, MD, PhD; MGH
• Tari King, MD; BWH
• Ian Krop, MD, PhD; DFCI
• Beth Mittendorf, MD, PhD; BWH
• Beverly Moy, MD; MGH
• Ann Partridge, MD, MPH
• Stuart Schnitt, MD; BIDMC
• Barbara Smith, MD; MGH
• Nadine Tung, MD; BIDMC
• Eric Winer, MD; DFCI
• Julia Wong, MD, DFCI
• Jean Zhao, PhD, DFCI 

Proposals Involving Use of Oncomap/Oncopanel Data

A smaller subset of the HCC Breast Users Committee will review all proposals involving use of Oncomap and/or Oncopanel data in breast cancer patients.

This committee is structured as follows:

Co-chairs

• Nancy Lin, MD
• Deborah Dillon, MD 

Members

• Eric Winer, MD
• Ian Krop, MD, PhD
• Tari King, MD 

Ad-hoc Members

• Jennifer Bellon, MD (as needed for proposals involving local therapy questions)
• Judy Garber, MD, MPH (as needed for germline genetics expertise)

Proposals Involving Qualitative and Survey Studies

A smaller subset of HCC Breast Users Committee will review all proposals involving the use of qualitative and survey study in breast cancer patients. The committee will review for the validity and feasibility of such studies within our department and clinic and ensure that there is coordination and no redundancy from the perspective of our patients.

This committee is structured as follows:

Chair

• Rachel Freedman, MD, MPH 

Members

• Tari King, MD 
• Ian Krop, MD, PhD 
• Ann Partridge, MD, MPH 
• Nancy Lin, MD 
• Elizabeth Frank 

Ad-hoc Members

• Jennifer Bellon, MD (as needed for proposals involving local therapy questions) 
• Judy Garber, MD, MPH (as needed for germline genetics expertise)
• Michael Hassett, MD, MPH 
• Eric Winer, MD

Please see the general, submission, approval, biospecimen, renewal, grant and publication policies on the Policies Page. 

Biospecimen and Clinical Data Policies

Investigators within HCC must submit a RedCap form directly to the Breast Users Committee for access to curated clinical data and/or specimens collected within HCC Breast. 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 HCC must have an investigator (collaborator) that is a faculty member at 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.

Qualitative and survey related studies will be reviewed using the same process for submission, review, and approval; however, a different committee reviews these studies. 

Submission Policy

Investigators within HCC must submit a RedCap form directly to the Breast Users Committee for access to curated clinical data and/or specimens collected within HCC Breast. 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 HCC must have an investigator (collaborator) that is a faculty member at 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.

Qualitative and survey related studies will be reviewed using the same process for submission, review, and approval; however, a different committee reviews these studies. 

Approval Policy

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, 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 as we await IRB approval and any other MTA and/or DUA.

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 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.

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 project manager of User Committee will send the investigator and study contact a link to a RedCap form to submit the annual renewal form each year until the project is completed.  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 submit a RedCap form to close the study.

Grant Policy

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.

Feasibility requests

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.

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 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 HCC IRB.  Please refer to the OHRS website for details of submission and application templates for IRB review of low risk protocols.

Click here for more information regarding biological materials data.

PUBLICATION POLICY:

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 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 HCC Protocol #05-246 should acknowledge:

• Harvard Cancer Consortium 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.

• We provide an overview and descriptions of data sources within the breast department, primarily from clinical trials and clinical databases on the Sources of Breast Data and Specimens page.

  If you wish to use these data resources in your research, please refer to the Project Proposals page to submit an application to the Users Committee or OncDRS as appropriate.

There may be fees associated with requests for clinical data, tissue/blood specimens and pathology services. Details will be sent upon approval of proposals.  For outside tissue block requests, there are additional fees (including requests for BWH).

Investigators within HCC must submit a RedCap form directly to HCC Breast Users Committee for access to curated clinical data and/or specimens collected within HCC Breast. Depending on whether the request for clinical data and/or specimen is for deidentified or identified patient-level information, the submission of your research project will have different requirements related to the User Committee proposal and the type of IRB applications.

For questions related to these requirements, please contact Melissa Hughes (Melissa_hughes@dfci.harvard.edu).

Go to the Breast SPORE Projects page to see the SPORE projects and details about each.

A smaller subset of HCC Breast Users Committee will review all proposals involving the use of qualitative and survey study in breast cancer patients. The committee will review for the validity and feasibility of such studies within our department and clinic and ensure that there is coordination and no redundancy from the perspective of our patients.

Qualitative and survey review application

This committee is structured as follows:

Chair

• Rachel Freedman, MD, MPH

Members

• Tari King, MD
• Ian Krop, MD, PhD
• Ann Partridge, MD, MPH
• Nancy Lin, MD
• Elizabeth Frank

Ad-hoc Members

• Jennifer Bellon, MD (as needed for proposals involving local therapy questions)
• Judy Garber, MD, MPH (as needed for germline genetics expertise)
• William Barry, PhD
• Michael Hassett, MD, MPH
• Eric Winer, MD