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. How do I submit a research proposal? 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. Please refer to the section, “Do I need to submit through OncDRS, the Users committee, or both” for additional details. Request Type for clinical OncDRS Request Users IRB data and/or specimens form Committee (paper application) Aggregate data (e.g. No, can either directly No No number of eligible access OncDRS patients with clinical aggregate query tool data/specimens) or complete Clinical Research Data Request form. De-identified data for Yes No No feasibility analysis Must agree not to publish or identify patients without Users Committee approval De-identified clinical Yes, an option for DFCI Yes. (Note, if OncDRS is No data based investigators, used, an additional and replaces users paper application is not committee paper required) application Identified Retrospective Yes, an option for DFCI Yes. (Note, if OncDRS is Yes. Either complete OncDRS data, discrete data based investigators, used, an additional application which will then elements and replaces users paper application is not automatically route to IRB after committee paper required) users committee approval is application granted (only available for investigators). Or, submit users committee application by email and a separate IRB protocol. Identified data (which No Yes Yes. Studies that intend to collect may or may not require data from identified patients (for retrospective data), with example, a prospective cohort plan for continued study) require an IRB protocol and prospective data approval and cannot be submitted collection for additional solely through OncDRS. Complete data elements users committee application and complete “New Project Application: Research use of retrospective medical records or previously collected specimens.”
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. How do I submit a research proposal? 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. Please refer to the section, “Do I need to submit through OncDRS, the Users committee, or both” for additional details. 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 investigators). Or, submit users committee application by email and a separate IRB protocol. 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.”
FAQ_3-15-2017.docx