Project Proposals

Investigators within DF/HCC must submit a proposal form directly to DF/HCC Breast Users Committee via email to the project manager or via OncDRS for access to curated clinical data and/or specimens collected within DF/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 that are outlined in the 'How To' section on this page. 

Investigators outside of DFCI must submit the proposal form via email since they cannot directly access OncDRS. For DFCI investigators, please refer to the How-to section below to determine how to submit your proposal.

Any questions regarding the proposal submission and review process may be directed to the project manager, Lauren Knelson (laurenp_knelson@dfci.harvard.edu).

Depending on the request type for clinical data and/or tissue, the submission of your research proposal to Users Committee (and IRB if applicable) will have different requirements.

Based on the table below, if your proposal needs to be submitted to OncDRS, please refer to the OncDRS tab.
 

Request Type for clinical data and/or specimens

OncDRS Request form

Users Committee (paper application)

IRB

Aggregate data (e.g. number of eligible patients with clinical data/specimens)

No, can either directly access OncDRS aggregate query tool or complete Clinical Research Data Request form.

No

No

De-identified data for feasibility analysis

Yes

No

Must agree not to publish or identify patients without Users Committee approval

No

De-identified clinical data

Yes, an option for DFCI based investigators, and replaces users committee paper application

Yes. (Note, if OncDRS is used, an additional paper application is not required)

No

Identified Retrospective data, discrete data elements

Yes, an option for DFCI based investigators, and replaces users committee paper application

Yes. (Note, if OncDRS is used, an additional paper application is not required)

Yes. Either complete OncDRS application which will then automatically route to IRB after users committee approval is granted (only available for DFCI-based investigators)Or, submit users committee application by email and a separate IRB protocol. http://www.dfhcc.harvard.edu/research/clinical-research-support/office-for-human-research-studies/

Identified data (which may or may not require retrospective data), with plan for continued prospective data collection for additional data elements

No

Yes

Yes. Studies that intend to collect data from identified patients (for example, a prospective cohort study) require an IRB protocol and approval and cannot be submitted solely through OncDRS.  Complete users committee application and complete “New Project Application: Research use of retrospective medical records or previously collected specimens.

Any study requiring patient contact and/or prospective collection of new biospecimens, whether or not minimal risk

No 

Yes

Yes

De-identified biospecimens

No

Yes

No

Identified biospecimens

No

Yes

Yes. Studies that required identified biospecimens require an IRB approved protocol to specify the types of PHI and clinical data which will be collected and the individuals who will have access to PHI. In some cases, this can occur under an existing cohort or banking study, depending upon the research question and composition of the collaborating investigators.

Secondary use of

de-identified

Prospective/Clinical Trial data or specimens

No

Yes

Depends.  The consent form of the clinical trial will need to be reviewed to determine whether the proposed research falls within the boundaries of the consent language.  If yes, then no additional IRB protocol is required.  If no, then complete “New Project Application: Research use of retrospective medical records or previously collected specimens.”

Secondary use of

identified

Prospective/Clinical Trial data or specimens

No

Yes

Yes. Complete users committee application and complete “New Project Application: Research use of retrospective medical records or previously collected specimens.” An alternative is to complete the Users Committee application and amend the IRB protocol.

 

 
     


Aggregate or de-identified data/specimens for feasibility study:
If you are interested in obtaining aggregate patient data/specimens or de-identified data/specimens for feasibility study, you do not need Users Committee approval since data will be either provided in aggregate as a patient count or de-identified and will never be published. For data available in OncDRS – you can use the Aggregate Query Tool with OncDRS. For data that is not available in OncDRS (CRIS, caTissue, data from breast oncology cohort studies (e.g. 09-204, 05-246) or you need assistance with OncDRS, complete the Clinical Data Request Form. Once you wish to move ahead with the formal study that needs identified data, you will need to submit a full research proposal to the users’ committee.

De-identified clinical data and/or specimens: If you are interested in obtaining de-identified clinical data and/or specimens, you will need to submit a research proposal to the Users Committee for approval. However, you are not required to obtain additional IRB approval for the specific research question. The proposal may be submitted via OncDRS, but if the request is solely for tissue samples, we would encourage investigators to submit the proposal form via email since this form allows for more specific requests on type, quantities and preparation of tissue samples needed for the study. 

Identified clinical data and/or specimens dataRetrospective study: If you are interested in obtaining identified retrospective data (e.g. chart review with patient names, MRN) or a limited data set (e.g. data set that contains dates of treatment), you will need IRB approval specific to the project along with Users Committee review and approval. You can submit the proposal form via OncDRS which will automatically route the proposal to IRB after Users Committee approval is granted (note: this is only available to DFCI-based investigators). Otherwise, you can submit the proposal form via email to the project manager and then submit a separate IRB protocol‘New Project Application: Research Use of Retrospective Medical Records or Previously Collected Specimens.’

Prospective study: For studies where you intend to collect prospectively data from identified patients (e.g. prospective cohort study) or wish to have patient contact, you are required to submit Users Committee proposal and obtain IRB approval via a separate submission process. You cannot submit solely through OncDRS. You will need to complete‘New Project Application: Prospective Collection of Human Material and/or Clinical Data for Research Purposes’. 

Secondary use of de-identified or identified prospective/clinical trial data or specimens: These studies need to be submitted for review by the Users Committee. If de-identified data and/or specimens are requested, the consent form of the clinical trial will need to be reviewed to determine whether the proposed research falls within the boundaries of the clinical trial. If it is covered by the trial, then no additional IRB protocol is required, but Users Committee approval is still required. If it is not covered by the trial, then the investigator must work with the PI and the DF/HCC IRB to determine what options may be available to them.

If it is identified data and/or specimens, both Users Committee and IRB approval is needed.

Other types of requests (Operational, Quality Improvement, and Clinical Trial):

  • Operational and quality improvement data: If the goal is to examine operational, clinical or data quality improvement, with no intent to publish - you can just request a report using the following links:
        -For research operational tasks such as data quality on CRIS, research statistics or consenting reports - use this link: http://dfcionline.org/departments/informationsystems/clinres/coris/
        -For clinical operations tasks such as clinical operations management or clinical quality improvement use this link: http://dfcionline.org/managerstoolkit/dart/
  • Note on clinical trials: The Users Committee mechanism is not intended to be used for the implementation of clinical trials and it will not routinely review clinical trials. If you are interested in starting a clinical trial, please refer to the OHRS website: http://www.dfhcc.harvard.edu/research/clinical-research-support/

Annual Renewal Policy: As of March 2016, we have initiated 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. An updated approval letter will be distributed upon re-review and approval by the Users Committee.

Click the button below to download a catalog of the current projects that have been approved by the DF/HCC Breast Users Committee. This document serves as a guide for researchers who might be interested in a research project that is already being addressed by an approved proposal. The catalog will be updated quarterly. Completed projects are removed from this main grid; if you have questions about the approved projects, please contact project manager Lauren Knelson, laurenp_knelson@dfci.harvard.edu